Finlepsin retard testimony. What is the difference between Finlepsyn and Finlepsin Retard? Indications for the use of Finlepsin Retard

Finlepsin Retard is a drug for the treatment of epilepsy dibenzazepine series. It has antidepressive, neuroleptic, vasopressin-like action. In persons with the damage to the peripheral nerves, characterized by the attacks of pain in the innervation zone of any nerve, manifests an anesthetic effect. Pharmacological effect It is due to the inactivation of potential-sensitive sodium channels, as a result of which the membranes are stabilized excessively excited neurons, the generation of multiple successive neurons discharges and pulses in synapses is suppressed. It prevents the exit to the intercellular space of glutamate - amino acids with the function of the neurotransmitter, moves the threshold of the convulsive preparedness of the brain, thereby showing anti-epileptic effect. Promotes more active Transmembrane transport of potassium-ions. In persons suffering from epilepsy (first of all it concerns patients of children's and adolescence) anxiety decreases under the influence of the drug, the severity of depressive manifestations will decrease, irritability decreases, aggression is reduced. The impact on cognitive activity and psychomotor characteristics is determined by the adopted dose of the drug. Anticonvulsant action begins to manifest itself in the range from 3-4 hours to several days (in some situations - up to 30 days). With a hangover syndrome, the threshold readiness of the brain reduced under the influence of alcohol, suppresses abstinence (eliminates increased excitability, involuntary finger trembling, normalizes the gait).

The neuroleptic effect is manifested in 7-10 days. Such a long start of action of the drug in this direction can be associated with the suppression of the exchange of dopamine and norepinephrine. Finlepsin retard - a long-term dosage form, providing a stable level of the active substance in plasma with a multiplicity of reception 1-2 times a day. For oral reception The drug is slowly, but in full absorbing in the gastrointestinal tract (the presence of food contents does not have a pronounced effect on the speed and completeness of suction). The peak concentration of the active component in the blood is marked 32 hours after the reception. The half-life average is about 70 hours. Elimination from the body is mainly carried out by the kidneys and to a lesser degree - intestine. Optimal reception time - along with meals or immediately after it. It is allowed before taking a pre-dissolve tablet or part of it in water: the duration of the drug does not suffer from this. Multiplicity of reception - 1-2 times a day. The drug course starts with a small daily dose with a consistent increase of it until a pronounced therapeutic response.

Pharmacology

Antiepileptic agent, derivative of tricyclic iminolben. It is believed that anticonvulsant action is associated with a decrease in neurons' ability to maintain a high frequency of development of repeated potentials by inactivating sodium channels. In addition, it seems that the inhibition of the release of neurotransmitters is important by blocking the presynaptic sodium channels and the development of action potentials, which in turn reduces the synaptic transmission.

It has a moderate antimanic, antipsychotic effect, as well as an analgesic effect with neurogenic pains. The mechanisms of action may involve GABA receptors that can be associated with calcium channels; Also, apparently, it matters the effect of carbamazepine on the system of neuropold modulators.

The antidiuretic action of carbamazepine can be associated with the hypothalamic influence on the Osselo-designer, which is mediated through the secretion of ADG, and is also due to the direct action on the renal tubules.

Pharmacokinetics

After taking inside, carbamazepine is almost completely absorbed from the gastrointestinal tract. Bonding with plasma proteins is 75%. It is the inducer of hepatic enzymes and stimulates its own metabolism.

T 1/2 is 12-29 hours. 70% is excreted with urine (in the form of inactive metabolites) and 30% - with feces.

Form release

Tablets of prolonged action from white to white with a yellowish colors, rounded, flat, with beveled edges, with cruciform fault lines on both sides and 4 scubs on the side surface.

	1 tab.
carbamazepine	200 mg

Auxiliary substances: ethyl acrylate copolymer, methyl methacrylate and trimethylammonioethyl methacrylate (1: 2: 0.1) (Eudragit RS30D), triacetyline, talc, copolymer of methacrylic acid and ethyl acrylate (1: 1) (Eudragit L30D-55), microcrystalline cellulose, cross-formon, silicon colloidal dioxide , magnesium stearate.

10 pieces. - Blister (5) - Cardboard packs.
10 pieces. - Packaging cell contour (5) - packs cardboard.
10 pieces. - Packaging cell contour (3) - packs cardboard.
10 pieces. - Packaging cell contour (4) - packs cardboard.

Dosage

Install individually. When taking inside for adults and adolescents, 15 years and older, the initial dose is 100-400 mg. If necessary, and taking into account the clinical effect, the dose increases by no more than 200 mg / day with intervals of 1 week. Reception frequency - 1-4 times / day. Supporting dose is usually 600-1200 mg / day in several techniques. The duration of treatment depends on the testimony, the effectiveness of treatment, the patient's reaction to therapy.

In children under the age of 6 years, 10-20 mg / kg / day are used in 2-3 divided doses; If necessary, and taking into account portability, the dose increases by no more than 100 mg / day with an interval of 1 week; Supporting dose is usually 250-350 mg / day and does not exceed 400 mg / day. Children aged 6-12 years old - 100 mg 2 times / day on the first day, then the dose increases by 100 mg / day with an interval of 1 week. until the optimal effect is obtained; Supporting dose is usually 400-800 mg / day.

Maximum doses: when taking inside adults and adolescents 15 years and older - 1.2 g / day, children - 1 g / day.

Interaction

With the simultaneous use of CYP3A4 inhibitors, it is possible to increase the concentration of carbamazepine in the blood plasma.

With the simultaneous use of inductors of the CYP3A4 isoenzyme system, the system may accelerate the metabolism of carbamazepine, a decrease in its blood plasma concentration, a decrease in the therapeutic effect.

With the simultaneous use of carbamazepine stimulates anticoagulant metabolism, folic acid.

With simultaneous use with valproic acid, it is possible to reduce the concentration of carbamazepine and a significant decrease in the concentration of the valproic acid in the blood plasma. At the same time, the concentration of metabolite carbamazepine - carbamazepine-epoxide increases (probably due to the inhibition of its transformation into carbamazepine-10,11-trans-diol), which also has anticonvulsant activity, so the effects of this interaction can be leveled, but more often, side reactions occur - a fuzziness of vision, Dizziness, vomiting, weakness, nystagm. With the simultaneous use of valproic acid and carbamazepine, it is possible to develop a hepatotoxic effect (apparently due to the formation of a secondary metabolite of valproic acid, which has a hepatotoxic effect).

With simultaneous use, the valpromide reduces the metabolism in the liver of carbamazepine and its carbamazepine-epoxide metabolite due to the enzyme enzyme hydrolase. The specified metabolit has anticonvulsant activity, but with a significant increase in blood plasma concentration can have a toxic effect.

With simultaneous use with verapamil, diltiazem, isoniazide, dextropropoxyphen, viloxasin, fluoxetine, fluouxamine, cimetidine, acetasolamide, danasol, desipramine, nicotinomide (in adults, only in high doses), erythromycin, toleandomycin, josamicin, clarithromycin; with Azoles (including with itraconazole, ketoconazole, fluconazole), terpheneenadine, Loratadine It is possible to increase the concentration of carbamazepine in the blood plasma with the risk of side effects (dizziness, drowsiness, ataxia, diplopia).

With simultaneous use with hexamidine, anticonvulsant action of carbamazepine weakens; with hydrochlorothiazide, furosemide - it is possible to reduce the content of sodium in the blood; With hormonal contraceptives - it is possible to weaken the action of contraceptives and the development of acyclic bleeding.

With simultaneous use with hormones of the thyroid gland it is possible to increase the elimination of thyroid hormones; with cloneazepam - it is possible to increase cliens of cloneazepam and a decrease in carbamazepine clearance; With lithium preparations, a mutual increase in neurotoxic action is possible.

With simultaneous use with the prison, it is possible to reduce the concentration of carbamazepine in the blood plasma. There are reports that the prison may increase the concentration in the plasma of the pharmacologically active metabolite - carbamazepine-10,11-epoxy.

With simultaneous use with ritonavir, the side effect of carbamazepine is possible; with sertraline - it is possible to reduce the concentration of sertraline; with theophylline, rifampicin, cisplatin, doxorubicin - it is possible to reduce the concentration of carbamazepine in the blood plasma; With Tetracycline - it is possible to weaken the effects of carbamazepine.

With simultaneous use with Felbamat, it is possible to reduce the concentration of carbamazepine in the blood plasma, but an increase in the concentration of active carbamazepine-epoxide metabolite, and it is possible to reduce the concentration in the plasma of Felbamate.

With simultaneous use with phenytino, the phenobarbital decreases the concentration of carbamazepine in the blood plasma. It is possible a mutual weakening of anticonvulsant, and in rare cases - its strengthening.

Side effects

From the CNS and the peripheral nervous system: often - dizziness, ataxia, drowsiness; Possible headache, diplopia, accommodation violations; rarely - involuntary movements, nystagm; In some cases, oculotor disorders, dysarthria, peripheral neurites, paresthesia, muscle weakness, symptoms of paresis, hallucinations, depression, feeling of fatigue, aggressive behavior, assessment, violations of consciousness, intensification of psychosis, violations of taste sensations, conjunctivitis, noise in ears, hyperactus.

From side digestive system: nausea, raising GGT, increasing the activity of the SFF, vomiting, dry mouth; rarely - increasing the activity of transaminases, jaundice, cholestatic hepatitis, diarrhea or constipation; In some cases, a decrease in appetite, abdominal pain, glossite, stomatitis.

From the side of the cardiovascular system: rarely - myocardial conductivity disorders; In some cases, bradycardia, arrhythmias, AV blockade with syncope, collapse, heart failure, manifestation of coronary insufficiency, thrombophlebitis, thromboembolia.

From the system of blood formation: leukopenia, eosinophilia, thrombocytopenia; rarely - leukocytosis; In some cases, agranulocytosis, aplastic anemia, erythrocyte aplasia, megaloblastic anemia, reticulocytosis, hemolytic anemia, granulomatous hepatitis.

From the metabolism: hyponatremia, fluid delay, swelling, increase in body weight, decrease in plasma osmolality; In some cases, an acute intermittent porphyry, a deficiency of folic acid; Calcium exchange disorders, increasing cholesterol and triglycerides.

From the endocrine system: gynecomastia or galathery; Rarely - the function of the thyroid gland.

From the urinary system: rarely - impaired kidney function, interstitial jade and renal failure.

From the respiratory system: in some cases, the disposage, pneumonites or pneumonia.

Allergic reactions: skin rash, itching; Rarely - lymphadenopathy, fever, hepatosplegegaly, arthralgia.

Indications

Epilepsy: large, focal, mixed (including large and focal) epileptic seizures. Painful syndrome predominantly neurogenic genesis, incl. essential neuralgia trigeny nerve, neuralgia of a trigeminal nerve when scarm sclerosis, Essential Glosso Fargeal Neuralgia. Prevention of attacks in alcoholic abstinence syndrome. Affective and schizoaffective psychosis (as a means of prevention). Diabetic neuropathy with pain syndrome. Nonacharic diabetes of central genesis, polyuria and polydipsia neurogormonal nature.

If necessary, use during pregnancy (especially in the first trimester) and during the lactation period should be carefully weighed the expected benefit of the treatment for the mother and risk for the fetus or child. At the same time, carbamazepine is recommended to be used only in the form of monotherapy in minimal effective doses.

Women of childbearing age in the period of treatment with carbamazepine, it is recommended to use non-correctional contraceptives.

Application with violations of liver function

Caution is used with pronounced liver function disorders.

Application with violations of the kidney function

Caution is used with pronounced kidney function.

Application in children

Carefully apply in children.

Application in elderly patients

Caution is used in older patients.

special instructions

Carbamazepine is not used for atypical or generalized small epileptic seizures, myoclonic or atonic epileptic seizures. Should not be used to remove conventional pain; As a prophylactic agent during the long periods of remission of the neuralgia of a trigeminal nerve.

Caution is used in concomitant diseases of the cardiovascular system, pronounced disorders of the liver and / or kidney function, sugar diabetes, increase intraocular pressure, when indicating a history of hematological reactions to the use of other drugs, hyponatremia, urine delay, increased sensitivity Tricyclotic antidepressants, when instructions in history, to interrupt the course of treatment with carbamazepine, as well as children and older patients.

Treatment should be carried out under the control of the doctor. With long-term treatment, it is necessary to control the blood pattern, the functional state of the liver and kidney, the concentration of electrolytes in the blood plasma, conduct an ophthalmic survey. It is recommended to periodically determine the level of carbamazepine in the blood plasma for controlling the effectiveness and safety of treatment.

Not less than 2 weeks before the start of carbamazepine therapy, it is necessary to stop the treatment of MAO inhibitors.

During the treatment period, not to use alcohol.

Impact on the ability to driving vehicles and control mechanisms

During treatment, it is necessary to refrain from practicing potentially hazardous activities that require increased attention, the speed of psychomotor reactions.

Finlepsin Retard preparation contributes to the normalization of the state in epileptic attacks, eliminates the pain, negative symptoms in disabilities of the nervous system. It has an impact on a number of biochemical processes in the body, so use this medicine It follows under the control of a specialist. Benefits include low price.

Carbamazepine. Name by latin - Carbamazepine.

ATX

N03AF01 carbamazepine

Forms of release and composition

You can purchase the drug only in the form of tablets. The difference of Finlepsina Retard is the presence of a shell characterized by special properties. It provides prolonged effect of the drug. This means that the active substance is released slowly. The drug is one-component. Carbamazepine acts as the main substance. Its amount consisting of 1 tablets: 200 and 400 mg. Other components:

• copolymer of ethyl acrylate, trimethylammonioethyl methacrylate, methyl methacrylate;
• triacenetin;
• copolymer of methacrylic acid and ethyl acrylate;
• talc;
• crospovidon;
• cellulose microcrystalline;
• magnesium stearate;
• silicon colloidal dioxide.

You can purchase a drug in packages containing 3, 4 or 5 blisters (in each 10 tablets).

How valid

Main properties:

• anti-epileptic;
• anesthetic;
• antidiuretic;
• antipsychotic.

The pharmacological effect of this tool is based on blocking sodium channels. The desired effect can be obtained only if they are potential-dependent. As a result, the elimination of the increased excitability of neurons is noted, which is due to the stabilization of their membranes. Also, under the influence of the drug, the intensity of the synaptic conductivity process of pulses is reduced.

The basis of anti-epileptic therapy is an increase in the lower limit of convulsive readiness.

There is a decrease in the intensity of the generation of glutamate - amino acids, which contributes to an increase in the excitation of neurotransmitters. Thanks to these properties, the likelihood of epileptic attack is reduced. The main component is involved in the processes of transportation of potassium ions, calcium.

The drug shows activity and reduces the intensity of negative symptoms in the occurrence of attacks of different character. During the treatment of patients with diagnosed epilepsy, there is an improvement in such pathological conditions such as anxiety, depression, aggressiveness, irritability.

Antipsychotic effect is due to the oppression of norepinephrine exchange processes, dopamine. With alcohol poisoning, the intensity of the development of seizures is reduced. This is due to the increase in the lower limit of convulsive readiness. If the neuralgia of a trigeminal nerve is developing, thanks to Finlepsin Retard decreases severity pain attacks. In addition, timely treatment with this drug helps prevent pain occurrence with such a diagnosis.

Pharmacokinetics

The duration of the release of the active substance is 12 hours. At the end of this period, an increase in the level of efficiency is noted to the maximum. The drug is absorbed by the walls of the gastroof organs completely.

The active substance is associated with plasma proteins with different intensity: up to 60% in children, 70-80% in adult patients.

The process of metabolism of carbamazepine occurs in the liver, the result is released 1 active and 1 inactive component. This process is implemented with the participation of the CYP3A4 isoenzyme.

Most of the carbamazepine in the transformed form is excreted when urinating, a small share - with a fee during defecation. Of this amount, only 2% of the active substance is removed unchanged. In children, carbamazepine metabolism is faster. For this reason, it is used in elevated dosages.

For what appoints

The main direction of application is epilepsy. In addition, the drug shows effective with such pathological conditions and symptoms:

• saves of different character: partial, convulsive;
• mixed form of epilepsy;
• neuralgia various character: trigeminal nerve, idiopathic glossy neuralgia;
• pain syndrome caused by peripheral neuritis, which may be a consequence of diabetes;
• convulsive states that occur during smooth muscles, multiple sclerosis;
• violation of speech, limited movements (neurological pathology);
• bouts of pain in dysfunction of the vegetative nervous system;
• alcohol poisoning;
• psychotic disorders.

Contraindications

The drug has not so many restrictions on use, among them notes:

• violation of the blood formation system, which is accompanied by such pathological states as leukopenia, anemia;
• AV blockade;
• the genetic disease of the porphyria is accompanied by a pigment exchange violation;
• individual negative reaction or hypersensitivity.

A number of pathological conditions are noted, under which carbamazepine control in plasma is obligatory:

• bone beams;
• neoplasms in the prostate;
• increased intraocular pressure;
• heart function failure;
• hyponatremia;
• alcoholism.

How to take Finlepsin retard

The drug shows an effectiveness equally when used before and after meals. The tablet cannot be chewed, but you can dissolve in any liquid. The scheme differs depending on the type of pathological state. It is often prescribed no more than 1200 mg of substance per day. Dose is divided into 2 receptions, but you can use the drug once. The maximum permissible daily amount is 1600 mg. Instructions for use with different pathologies:

• epilepsy: The initial amount of drug varies in the range of 0.2-0.4 g per day, then it increases to 0.8-1.2 g;
• neuralgia of a trigeminal nerve: Begin the course of therapy from 0.2-0.4 g per day, gradually the dose increases to 0.4-0.8 g;
• alcoholic poisoning: 0.2 g in the morning, 0.4 g in the evening, as a last resort, the dose increases to 1.2 g per day and divided it into 2 receptions;
• therapy of psychotic disorders, convulsive states With multiple sclerosis: 0.2-0.4 g 2 times a day.

Pain in diabetic neuropathy

Standard scheme: 0.2 g of substance in the morning and doubled dose (0.4 g) in the evening. In exceptional cases, they are prescribed 0.6 g 2 times a day.

After how much acts

Performance peak is marked 4-12 hours after the start of treatment.

Cancel

It is forbidden to drastically stop the course of therapy, since this can provoke the development of an attack. It is recommended to reduce the dose gradually - for 6 months. If the sharp need to cancel Finlepsina Retard, therapy is carried out by appropriate drugs. This reduces the likelihood of negative effects.

Side Actions Finlepsina Retard

The disadvantage of the drug is the high risk of developing individual reactions of a different nature in response to therapy. This is due to the fact that the active substance in its composition participates in the biochemical processes of the body. Notes the risk of dizziness, drowsiness, sharp weakening of muscles, headaches. Rarely occur involuntary movements, nystagm, hallucinations, depression and other impaired psyche.

Gastrointestinal

The appearance of dryness in the oral cavity is noted, appetite disappears. Nausea arises, and after it is a lot of call, changing the chair, pain in the abdomen. Such pathological conditions are developing: stomatitis, colitis, gingivitis, pancreatitis, etc.

Blood formation organs

Anemia, leukopenia, thrombocytopenia, agranulocytosis, porphyry of different character.

From the urinary system

Insufficiency of the kidney function, nephritis, various pathological conditions, provoked by a violation of urine disheavage (delay in liquid leads, incontinence).

From the cardiovascular system

Changes to intracardiac conductivity, hypotension, pathological conditions caused by an increase in blood viscosity and the increase in the intensity of platelet aggregation, complications for coronary disease, heart rate disorders.

From the endocrine system and metabolism

Obesity, swelling, which is associated with a fluid delay in tissues, an impact on blood test results, a change in bone metabolism, which leads to diseases of the musculoskeletal system.

Allergies

Hives. Erythrodermia may develop.

Impact on the ability to manage mechanisms

The drug has a negative impact on the work of many organs and systems, it provokes hazardous symptoms: a violation of consciousness, hallucination, dizziness, etc. For this reason, caution should be taken when controlling vehicles. Better for a while refuse driving.

special instructions

Start the course of therapy with small doses. Gradually, the daily number of the main component increases. It is important to control the level of carbamazepine content in the blood.

It should be borne in mind that therapy of antiepileptic means provokes the appearance of suicidal intentions, therefore it is necessary to observe the patient until the course of treatment is completed.

Before starting therapy, the condition of the liver, kidneys is evaluated. It is necessary to pass the blood test, urine, to carry out the electroencephalogram.

Application in old age

It is allowed to use medicine to patients over 65 years. However, the recommended dose is 0.2 g per day once.

Application during pregnancy and during lactation

The drug can penetrate the placenta, in breast milk, and the concentration of carbamazepine is 40-60% of the total amount, which is contained in the blood. During pregnancy, there is a risk of developing pathologies from the fetus against the background of the reception of the fund under consideration. However, it is still allowed to use the drug, but it should be done only by strict indications if positive effects The treatment is superior to treatment.

Appointment of Finlepsina Retard Children

Application in violation of the kidney function

The drug is allowed for use in pathologies of this body, but it is necessary to observe the patient's condition.

Application in violation of the liver function

Allowed to assign a tool in this case. If the liver disorders are strengthened, you need to interrupt the course.

What to do under the overdose of Finlepsina Retard

There are a number of negative manifestations that arise with a regular and substantial increase in the permissible amount of carbamazepine:

• coma;
• violation of the nervous system: overexcitation, drowsiness, involuntary movements, impairment;
• hypotension;
• heart rate violation;
• oppression of the function of the respiratory system;
• vomiting and nausea;
• changing results laboratory studies.

Conduct treatment aimed at eliminating consequences. In this case, they are observed for the work of the heart, control the body temperature. Correction of violation of the water and electrolyte balance is performed. The level of the content of the active substance in the blood is determined. Stomach washing. Take an absorbent. Instead activated coal Any means of this group can be assigned: Smekt, enterosgel, etc.

Interaction with other drugs

Before starting treatment, the risk of complications is taken into account, which may be due to the use of other medicines.

Carefully

Increasing the level of maintenance of the main component in the blood plasma provoke the following drugs: verapamil, feelodipine, nicotinamide, windscreen, diltiazem, fluvoxamine, cimetidine, danazole, acetasolamide, desipramine, and a number of macrolide groups, azols. For this reason, the dosage correction is performed, which will allow to normalize the concentration of carbamazepine.

There is an increase in the effectiveness of folic acid, the prazicvantel. In addition, the elimination of thyroid hormones is enhanced.

It is noted to increase the efficiency of Finlepsina Retard with collaboration with Depaakin.

The appointment of Finlepsina Retard together with other drug-inhibitors CYP3A4 provokes the development of negative consequences. And, on the contrary, CYP3A4 inductors contribute to the acceleration of metabolic processes and the excavation of the active substance, which leads to a decrease in the effectiveness of the drug.

Compatible with alcohol

It is forbidden to use alcohol-containing drinks with Finlepsin therapy. Substances are valid based on opposite principles, while there is a decrease in the effectiveness of the drug. In addition, alcohol increases the burden on the liver.

Structure

Activity: carbamazepine;

1 tablet contains 200 mg carbamazepine;

Auxiliary substances: ammonium copolymer methacrylate (type B) dispersion, triacetin, talc, methacrylate copolymer dispersion, crossidone, silicon colloidal dioxide, magnesium stearate, microcrystalline cellulose.

Dosage form

Tablets prolonged action.

Maintenance physiochemical properties: White or yellowish color Round flat tablets in the form of a leaf of clover, with beveled edges, with a cross-shaped fault line on both sides and 4 notches on the sides, with a smooth surface and solid edges and the same appearance.

Pharmacological group

Antiepileptic agents.

Pharmacological properties

Pharmacological.

Anticonvulsant, derivative tricyclic iminolben. Exhibits anti-epileptic, neurotropic and psychotropic activity. The therapeutic effect is primarily due to the braking of synaptic excitation transmission and thereby reducing the spread of convulsions. In high concentrations of carbamazepine causes a decrease in post-suitantic potentiation. Reduces pain in neuralgia of a trigeminal nerve. This effect is due to the braking of the synaptic transmission of irritation in the spinal core of the trigeminal nerve.

For nonachar diabetes The drug has antidiuretic effects, probably due to the hypothalamic influence on the Osselo-designer.

Pharmacokinetics.

After receiving inside, carbamazepine is absorbed slowly and almost completely. The recruitment period is 8.5 hours and has a large range (approximately 1.72-12 hours). After a single reception, the maximum concentration of carbamazepine in the blood plasma in adults is achieved after 4-16 hours (very rarely - after 35 hours), in children - in about 4-6 hours. The concentration of carbamazepine in the blood plasma is not in linear dependence on the dose and when applying higher doses, the concentration curve in the blood plasma has the form of a plateau.

When applying a prolonged action tablets is achieved more than low concentration Carbamazepine in blood plasma than when applying ordinary tablets.

Equilibrium concentration is achieved in 2-8 days. There is no close correlation between the dose of carbamazepine and the concentration of stable equilibrium in the blood plasma.

Regarding the therapeutic and toxic concentrations of carbamazepine in the blood plasma indicates that attacks may disappear at the level of blood plasma 4-12 μg / ml. The concentrations of the drug in blood plasma exceeding 20 μg / ml deteriorate the picture of the disease.

At the concentration of the active substance in the blood plasma, 5-18 μg / ml eliminates pain in the neuralgia of a trigeminal nerve.

70-80% of carbamazepine binds to blood plasma proteins. The proportion of carbamazepine unrelated with proteins at its concentration is 50 μg / ml remains constant.

48-53% of the pharmacologically active carbamazepine-10,11-epoxide metabolite binds to blood plasma proteins. Concentration of carbamazepine B. spinal fluid It is 33% of the blood plasma concentration.

Carbamazepine penetrates through a placental barrier, in breast milk.

After one-time reception, carbamazepine is derived from blood plasma with a half-wing period of 36 hours. With long-term treatment, the half-life decreases by 50% due to the induction of microsomal liver enzymes.

W. healthy people The total plasma clearance is approximately 19.8 ml / h / kg, in patients with monotherapy - approximately 54.6 ml / h / kg, in patients with combined treatment - approximately 113.3 ml / h / kg. After one-time reception of carbamazepine, 72% of the dose in the form of metabolites is derived from the body by the kidneys. Other 28% are removed from the feces, partly - unchanged. Only 2-3% of the substance derived from the urine is carbamazepine unchanged.

Indications

• epilepsy:
• complex or simple partial convulsive seizures (with loss or without loss of consciousness) with secondary generalization or without it;
• generalized tonic-clonic convulsive seizures;
• mixed shapes of convulsive seizures.

Finlepsin ® 200 retard can be used as monotherapy and as part of combined therapy.

• Sharp manic states; Supporting therapy for bipolar affective disorders in order to prevent exacerbations or to alleviate clinical manifestations of exacerbation.
• Alcohol abstine syndrome.
• Idiopathic neuralgia of triple nerve and trigeminal nerve neuralgia with multiple sclerosis (typical and atypical).
• Idiopathic neuralgia of the language inheritant nerve.

Contraindications

Finlepsin ® 200 retard should not be appointed:

• with installed hypersensitivity to carbamazepine or to those in chemical relations of drugs (tricyclic antidepressants), or to other components of the drug;
• with an atrioventricular blockade;
• patients with bone marrow in history
• patients with hepatic porphyria (for example, acute intermittent porphyria, mixed porphyria, late porphyria of the skin) in history
• in combination with Inhibitors of MAO (MAO)
• in combination with voriconazole, since treatment may be ineffective.

Interaction with other medicines and other types of interactions

Cytochrome P450 Z4 (CYP3A4) is the main enzyme that catalyzes the formation of the active metabolite of carbamazepine-10,11-epoxy. The simultaneous use of CYP3A4 inhibitors can cause an increase in the concentration of carbamazepine in the blood plasma, which in turn can lead to the development of adverse reactions. The simultaneous use of CYP3A4 inductors can enhance carbamazepine metabolism, which leads to a potential reduction in the concentration of carbamazepine in serum and therapeutic effect. Similarly, the cessation of the reception of the CYP3A4 inductor can reduce the speed of carbamazepine metabolism, which leads to an increase in the level of carbamazepine in the blood plasma.

Carbamazepine is a powerful inducer of CYP3A4 and other enzyme phase I and phase II in the liver, therefore, it may reduce the concentration of other drug plasma preparations, mainly metabolized by induction of their metabolism.

Human microsomal epoxide hydrolase is an enzyme responsible for the formation of 10,11-transdolphid carbamazepine. The simultaneous purpose of the inhibitors of human microsomal epoxide hydrolase can lead to an increase in concentrations.

carbamazepine-10,11-epoxide in blood plasma.

Preparations that can raise carbamazepine and / or carbamazepine-10,11-epoxy in blood plasma.

Since the increase in the level of carbamazenine in the blood plasma can lead to the appearance of unwanted reactions (such as dizziness, drowsiness, ataxia, diplopia), the dosage of the drug must be corrected and / or control its levels in the blood plasma while using the drugs below.

Analgesics, anti-inflammatory drugs: dextropropoxyfen, ibuprofen.

Androgens: Danazole.

Antibiotics: macrolide antibiotics (for example erythromycin, toleandomycin, josamicin, clarithromycin, ciprofloxacin).

Antidepressants: Desipramine, fluoxetine, fluvoxamine, nefazodon, paroxetine, windsazin, trazodon.

Anti-Epileptic agents: Stipentol, Wigabria.

Antifungal agents: Azolov (for example, antrakesole, ketoconazole, fluconazole, voriconazole). Patients receiving voriconazole or itraconazole treatment can be recommended alternative anti-epileptic agents.

Antihistamines: Terfenadine, Loratadine.

Antipsychotic drugs: Olanzalin, Locupin, Quetiapine.

Anti-tuberculosis drugs: isoniazid.

Antiviral drugs: protease inhibitors for HIV treatment (for example ritonavir).

Carboangeerase inhibitors: acetazolamide.

Cardiovascular preparations: Verapamil, Diltiazem.

Preparations for the treatment of diseases of the gastrointestinal tract: Cimetidine, omeprazole.

Miorlaxants: Oxybutinin, Dentrenolen.

Antiagregative preparations: Tiklopidine.

Other ingredients: Nicotinamide (in adults, only in high doses), grapefruit juice.

Preparations that can increase the level of active carbamazepine-10,11-epoxide-epoxy metabolite in blood plasma.

Insofar as elevated level The active metabolite of carbamazepine-10,11-epoxide in the blood plasma can cause the development of adverse reactions (for example dizziness, drowsiness, ataxia, diplopy), the dosage of carbamazepine must be adjusted accordingly and / or control the level of the drug in blood plasma, if Finlepsin ® 200 retard is at the same time With such drugs, Locupin, Quetiapine, Prison, Progbid, Valproic Acid, Valpromide.

Preparations that can reduce the level of carbamazepine in the blood plasma.

The dose correction of Finlepsin ® 200 retard may be needed while simultaneously use with the drugs below.

Anti-Epileptic drugs: phenobarbital, phenytoin, prison, Felbamat, Metsuximid.

Antitumor drugs: doxorubicin, cisplatin.

Anti-tuberculosis drugs: rifampicin.

Broutine or anti-asthma preparations: Theophylline, aminoophyllin.

Dermatological preparations: Isotretinoin.

Others: Hypericum Perforatum preparations.

MEFLOKHIN may exhibit antagonistic properties on the anti-epileptic effect of carbamazepine. According to the dose of carbamazepine, it must be corrected.

Isotretinoin, as reported, changes bioavailability and / or clearance of carbamazepine and carbamazepine-10,11-epoxy; It is necessary to control the concentration of carbamazepine in the blood plasma.

The effect of carbamazepine at the level of the blood plasma at the same time appointed drugs

Carbamazepine can reduce the level of some drugs in blood plasma and reduce or level their effects. There is a need to correct the dose of the following drugs in accordance with clinical requirements.

Analgesics, anti-inflammatory drugs: buprenorphine, methadone, paracetamol (long-term use of paracetamol carbamazepine can be associated with the development of hepatotoxicity), tramadol, fenazone.

Antibiotics: doxycycline.

Anticoagulants oral anticoagulants (for example, Warfarin, Fenprocaon, Dicumurol, Acentokumarol).

Antidepressants: bupropion, cytalopram, Mianserin, Nefazodon, Sertalin, TRACDON, tricyclic antidepressants (for example imipramine, amitriptyline, northriptyline, clomipramine).

Antoonly: aperst.

Anti-Epileptic drugs: hlobazam, clonazepam, ethosucimide, felbamate, prison, lamotrin, oxcarbazepine, thiagabine, topiramate, hollow acid. Under the influence of carbamazepine, plasma concentrations of phenytoin can grow or decrease. In exceptional cases, this may affect the state of confusion of consciousness and even to whom.

Antifungal drugs: voriconazole, itraconazole, ketonazole. Patients receiving voriconazole or itraconazole treatment can be recommended alternative anti-epileptic agents.

Anthelmintic drugs: Prasikvantel, Albendazole.

Antitumor drugs: Imatinib, cyclophosphamide, Lapatinib, Temsyrolymus.

Neuroleptic preparations: Clozapine, Haloperidol and Bromperidol, Olanzapine, Risperidone, Quetiapine, Ziprazidon, Aripiprazole, Paliperidone.

Antiviral drugs: protease inhibitors for HIV treatment (for example Ritonavir, Indinavir, Saquinavir).

Anxiolitics: Midazolam, Alprazolam.

Broutine or anti-asthma drugs: Theophylline.

Contraceptive preparations: hormonal contraceptives. In patients receiving hormonal contraceptives, the efficiency of contraception may decrease and the interventus bleeding suddenly begin. Therefore, it should be given to the possibility of applying alternative methods of contraception.

Cardiovascular preparations: calcium channel blockers (dihydropyridine group), such as Felodipine, Digoxin, Isragian, County, Propranolol, Simvastatin, Atorvastatin, Lovastatin, Cerivastatin, Ivabradin.

Corticosteroids: prednisone, dexamethasone.

Means used for the treatment of erectile dysfunction: Tadalafil.

Immununopressants: Cyclosporin, Everolimus, Tharolimus, Sirolimus.

Thyroid drugs: Levothyroxin.

Other preparations containing estrogens and / or progesterone (alternative contraceptive methods should be considered); Bucrenorphine, Gestrinon, Tibolon, Toronifen, Mianserin, Sertraline.

Combinations of drugs that require separate consideration.

The simultaneous use of carbamazepine and levetyracetam can lead to an increase in carbamazepine toxicity.

The simultaneous use of carbamazepine and isoniazide can lead to an increase in the hepatotoxicity of isoniazide.

The simultaneous use of carbamazepine and lithium or metoclopramid preparations, as well as carbamazepine and neuroleptics (hanoperidol, thiuridazine) can lead to an increase in side-neurological effects (in the case of the last combination, even with the therapeutic levels in the blood plasma).

The combined application of Finlepsin ® 200 retard with most diuretics (hydrochlorothiazide, furosemide) can cause symptomatic hyponatrémia.

Carbamazepine can antagonize the effects of nonpolarizing muscle relaxants (for example, punching). There may be a need to increase doses of these drugs, and patients need careful monitoring for the possibility of quickly than expected, the completion of the neuromuscular blockade.

Carbamazepine, like other psychotropic drugs, can reduce alcohol tolerance, so patients are advised to refrain from alcohol use.

contraindicated interaction

Since carbamazepine is structurally similar to tricyclic antidepressants, Finlepsin ® 200 Retard is not recommended to be used simultaneously with Mao inhibitors (IMAO). Between the beginning of carbamazepine reception and the completion of the IMAO reception, at least two weeks or more, if it allows the clinical state of the patient.

Impact on serological studies.

Carbamazepine can give a false-positive result of the top-analysis (highly efficient liquid chromatography) to determine the concentration of perphinezine.

Carbamazepine and carbamazepine-10,11-epoxide can give a false-positive result of immunobiological analysis according to the method of polarized fluorescence to determine the concentration of tricyclic antidepressants.

Features of application

Carbamazepine should be prescribed only under control, only after estimating the ratio of benefit / risk, subject to careful monitoring of patients with cardiac, hepatic or renal disorders, side hematological reactions to other drugs, or patients with interrupted courses of carbamazepine therapy.

Carbamazepine shows light anticholinergic activity, so patients with elevated intraocular pressure should be prevented and advised about possible risk factors.

It should be remembered about the possible activation of hidden psychosis, and in the patients of elderly - about the possible activation of the confidence of consciousness and the development of anxiety arousal.

The drug is usually ineffective in absissues (small epileptic seizures) and myoclonic seizures. Individual cases indicate that the strengthening of attacks may occur in patients with atypical absans.

Hematological effects. The development of agranulocytosis and aplastic anemia is associated with the use of the drug, however, due to the extremely low frequency of the development of these states, it is difficult to estimate significant risk when taking carbamazepine.

Patients need to inform about early signs Toxicity and symptoms of possible hematological disorders, as well as symptoms of dermatological and hepatic reactions. The patient should be prevented that in the event of the appearance of such reactions as heat, angina, skin rashes, ulcers in the oral cavity, bruises that easily occur, point hemorrhages or hemorrhagic purple should immediately consult a doctor.

If the number of leukocytes or platelets is significantly reduced during therapy, the patient's condition is subject to close monitoring, a permanent overall analysis of the patient's blood should also be carried out. Carbamazepine treatment must be discontinued if the patient develops leukopenia, which is a serious, progressive or accompanied by clinical manifestations, such as fever or sore throat. Application of carbamazepine should be discontinued when signs of oppression of the bone marrow function.

Periodically, or often there is a temporary or resistant reduction in the number of platelets or leukocytes due to carbamazepine reception. However, for most of these cases, their situation is confirmed and they do not testify to the development of aplastic anemia or agranulocytosis. Prior to the start of therapy and periodically, blood test should be carried out, including the determination of the number of platelets (as well as, perhaps the number of reticulocytes and hemoglobin levels).

Serious dermatological reactions. Serious dermatological reactions, including toxic epidermal necrolis (TEN) or Lailel syndrome, Stevens-Johnson syndrome (CDD), when applying carbamazepine, arise very rarely. Patients with serious dermatological reactions may require hospitalization, since these states may threaten their lives and have a fatal character. Most cases of the development of the SSD / TEN are noted during the first few months of carbamazepine treatment. With the development of features and symptoms indicating serious dermatological reactions (for example, Laella / Tenn syndrome), the reception of carbamazepine should be discontinued immediately and assign alternative therapy.

Pharmacoenomy.

There is more and more evidence of the influence of various alleles HLA the tendency of the patient to the emergence of adverse reactions associated with the immune system.

Communication with (HLA) -B * 1502

Retrospective studies in the Chinese patients of the Ethnic group of Khan have demonstrated a pronounced correlation between SVD / TEN skin reactions associated with carbamazepine, and the presence of human leukocyte antigen in these patients (HLA), allele (HLA) -B * 1502. A large frequency of SDS development reports (Rarely, than very rarely) is characteristic of some Asia countries (for example, Taiwan, Malaysia and the Philippines), where allele (HLA) prevails among the population. The number of carriers of this allele among the population of Asia is more than 15% in the Philippines, in Thailand, Hong Kong and Malaysia, about 10% in Taiwan, almost 4% - in Northern China, from about 2% to 4% - in South Asia (including India) and less than 1% - in Japan and Korea. The spread of the allele (HLA) -B * 1502 is insignificant among European, African peoples, among the indigenous population of America and the Latin American population.

In patients, treated as genetically belong to risk groups, before starting treatment, carbamazepine should be tested for the presence of an allele (HLA) -B * 1502. If the analysis of the patient for the presence of an allele (HLA) -B * 1502 gives a positive result, the treatment of carbamazepine to start Do not, except those cases when there are no other options for therapeutic treatment. Patients who have passed the examination and obtained a negative result of software (HLA) -B * 1502, have a low risk of RCED development, although very rarely such reactions can still meet.

Currently, due to lack of data, it is exactly unknown, for all persons of southeastern Asian origin there are risks.

Allel (HLA) -B * 1502 may be a risk factor for the development of SSD / TEN in patients, which receive other antiepileptic agents that can be associated with the occurrence of CED / TEN. Thus, the use of other drugs, which can be associated with the occurrence of CVD / TEN, in patients having an allele (HLA) -B * 1502, if other, alternative therapy can be used. It is usually not recommended to carry out genetic screening of patients, among the nationalities of which the low allele coefficient (HLA) -B * 1502. It is usually not recommended to screensing in individuals who are already obtained by carbamazepine, since the risk of SDS / TEN is significantly limited to the first few months regardless of the presence in the first few months. The henges of the patient Allel (HLA) -B * 1502.

In patients, the European-like race between the genome (HLA) -B * 1502 and the occurrence of CDS is absent.

Communication with (HLA) -A * 3101

The leukocytar antigen of the person may be a risk factor for the development of skin adverse reactions, such as the SSL, TEN, drug rash with eosinophilia and system symptoms (DRESS), acute generalized examatosis Pustulose (AGEP), maculopapulous rash. If the analysis reveals the presence of HLA-A * 3101 allele, then the use of carbamazepine should be abstained.

Restrictions of genetic screening

The results of genetic screening should not replace the appropriate clinical observation and treatment of patients. Other possible factors are played by role in the occurrence of these heavy skin adhesive reactions, such as the dosage of antiepileptic agents, compliance with the treatment regime, concomitant therapy. The influence of other diseases and the level of monitoring of skin disorders was not studied.

Other dermatological reactions. It is possible to develop transient and such that do not threaten health, light dermatological reactions, such as isolated macular or maculopapulous exammatime. Usually they pass in a few days or weeks both with constant dosage and after a decrease in the dose of the drug. Since the early signs of more serious dermatological reactions can be very difficult to distinguish from light rapid reactions, the patient must be supervised to immediately stop the use of the drug if the reaction will deteriorate with it.

The presence of a patient allele (HLA) -B * 1502 is not a risk factor for the occurrence of less serious unwanted reactions from the skin on carbamazepine, such as hypersensitivity syndrome to anticonvulsants or minor rash (maculopapulous rashes). However, it was found that the presence (HLA) -B * 1502 may indicate the risk of the emergence of the aforementioned reactions.

Hypersensitivity. Carbamazepine can provoke the development of hypersensitivity reactions, including drug rash with eosinophilia and systemic symptoms (DRESS), multiple reactions of slow-type hypersensitivity with fever, rash, vasculitis, lymphadenopathy, pseudolimphoma, arthralgia, leukopenia, eosinophilia, hepatosplegegia, changed liver function and disappearance syndrome bile ducts (including the destruction and disappearance of Intrahnevny ducts).

Also possible effect on other organs (lungs, kidneys, pancreas, myocardium, colon).

The presence of a patient HLA-A * 3101 is associated with the occurrence of less serious unwanted reactions to carbamazepine from the skin, such as hypersensitivity syndrome to anticonvulsants or minor rashes (maculopapulous rashes).

Patients with hypersensitivity reactions on carbamazepine should be informed that approximately 25-30% of such patients may also have hypersensitivity reactions to oxcarbazepine.

When applying carbamazepine and phenytoin, it is possible to develop cross-hypersensitivity.

In general, with the appearance of signs and symptoms indicating hypersensitivity, the use of carbamazepine should be terminated immediately.

Saves. Carbamazepine should be used with caution to patients with mixed attacks, which include absans (typical or nonypical). Under such circumstances, the drug can provoke attacks. In the case of provoking the attacks, the use of carbamazepine should be stopped immediately.

Increasing the frequency of attacks may occur during the transition from oral forms of the drug to supositories.

Liver function. During the treatment with the drug, it is necessary to evaluate the liver function at the initial level and periodic estimates of this function during therapy, especially in patients with liver diseases in history and in elderly patients. With exacerbation of violations of the liver function or patients with the active phase of the liver disease, it is necessary to immediately stop taking the drug.

Some indicators of laboratory tests with which they estimate the functional state of the liver in patients receiving carbamazepine can go beyond the limits of the norm, in particular gamma-glovedransferase (GGT). This is probably due to the induction of hepatic enzymes. Induction of enzymes can also lead to a moderate increase in level alkaline phosphatase. Such an increase in the functional activity of hepatic metabolism is not an indication for cancellation of carbamazepine.

Heavy liver reactions due to the use of carbamazepine are very rare. In the event of signs and symptoms of hepatic dysfunction or active liver disease, it is necessary to urgently examine the patient, and the treatment of carbamazepine is suspended until the survey results are obtained.

Hyponatremia. There are cases of the development of hyponatremia when applying carbamazepine. In patients with an existing impaired kidney function, which is associated with a reduced sodium level, or in patients with concomitant drug treatment, which reduce sodium levels (such as diuretics, drugs that are associated with inadequate adg secretion), the level should be measured before treatment. Sodium in the blood. Next should be measured every 2 weeks, then with an interval in one month during the first three months of treatment or according to clinical need. This applies primarily by elderly patients. It follows in this case to limit the amount of water consumption.

Hypothyroidism. Carbamazepine can reduce the concentration of thyroid hormones, due to the increase in dose of replacement therapy with hormones of thyroid

glands in patients with hypothyroidism.

Anticholinergic effects. Carbamazepine exhibits moderate anticholinergic activity. Thus, patients with elevated intraocular pressure should be under close observation during therapy.

Mental effects. It should be remembered for the likelihood of activating latent psychosis and in the patients of older age - confusion or excitement confusion.

Suicidal thoughts and behavior. Several certificates of suicidal thoughts and behavior in patients receiving antiepileptic drugs were registered. The meta-analysis of the data obtained during placebo-controlled studies of anti-ebileptic drugs also showed a slight increase in the risk of suicidal thoughts and behavior. The mechanism for the occurrence of such risk is unknown, and the available data does not exclude the risk of suicidal thoughts and behavior for carbamazepine.

Therefore, patients need to be checked for suicidal thoughts and behavior and, if necessary, assign appropriate treatment. Patients (and persons who care for patients) should be recommended to consult a doctor in case of signs of suicidal thoughts and behavior.

Endocrine effects. Through the induction of liver enzymes, carbamazepine can cause a decrease in the therapeutic effect of estrogen preparations and / or progesterone. This can lead to a decrease in the effectiveness of contraception, recurrence of symptoms or breakthrough bleeding or bleeding. Patients who take carbamazepine and for which hormonal contraception is necessary should obtain a drug containing at least 50 μg of estrogen, or for such patients should be given to the use of alternative non-coronal contraceptive methods.

Monitoring the level of the drug in blood plasma. Despite the fact that the correlation between the dosage and level of carbamazepine in the blood plasma, as well as between the level of carbamazepine in the blood plasma and clinical efficacy and tolerance is unreliable, monitoring the level of the drug in the blood plasma may be appropriate in the following cases: with a sudden increase in the frequency of attacks, checking Patient compliance, during pregnancy, in the treatment of children and adolescents; If absurribution is suspected, during suspected toxicity and when applying more than one drug.

Reduced dose and discharge syndrome. The sudden abolition of the drug can provoke the attacks, so carbamazepine should be canceled gradually within 6 months. If it is necessary to immediately cancel the drug to patients with epilepsy, the transition to a new antiepileptic drug must be carried out against the background of therapy with appropriate drugs.

Application during pregnancy or breastfeeding.

Treatment of carbamazepine of pregnant women, patients with epilepsy, should be carried out with extreme caution.

In animals, the oral use of carbamazepine caused the development of defects.

In children whose mothers suffer from epilepsy, there is a tendency to violations of intrauterine development, including congenital malformations. The likelihood that carbamazepine, like most anti-epileptic agents, increases the frequency of violations, but convincing evidence within controlled studies of carbamazepine monotherapy, are absent. At the same time, a violation of intrauterine development and congenital malformations, including a spinal gap and other congenital abnormalities, such as maxillofacial defects, cardiovascular defects, hypospadias and developmental defects, hypospadias and developmental defects are reported various systems organism.

It should be borne by such data.

• The use of carbamazepine pregnant women, patients with epilepsy, requires special attention.
• If a woman who gets carbamazepine, pregnant, plans pregnancy or during pregnancy the need to use carbamazepine, should be carefully weighed with potential benefits of the use of the drug compared to a possible risk (especially in the first trimester of pregnancy).
• Women of reproductive age in case of carbamazepine capabilities should be prescribed as monotherapy.
• It is recommended to assign minimum effective doses and monitor the level of carbamazepine in the blood plasma.
• Patients need to be informed about the possibility of increasing the risk of developing congenital defects and should provide them with the possibility of prenatal screening.
• During pregnancy, it should not be interrupted by effective anti-epileptic therapy, since the aggravation of the disease threaten the health of both mother and the child.

Observations and prevention. It is known that during pregnancy, folic acid deficiency is possible. Anti-epileptic drugs can increase the level of folic acid deficiency, therefore the additional purpose of folic acid is recommended before and during pregnancy.

Newborn. In order to prevent blood clotting disorders in newborns, it is recommended to assign vitamin to 1 mothers over the past weeks of pregnancy and newborn children.

A few cases of the court and / or the oppression of breathing in newborns, several cases of vomiting, diarrhea and / or poor appetite in newborns are associated with accepting carbamazepine.

Breastfeeding. Carbamazepine penetrates into breast milk (25-60% of blood plasma concentrations). The advantages of breastfeeding with a distant probability of developing side effects near the baby should be carefully weighed. Mothers that get carbamazepine can be breastfeed only if the child is observed on the development of possible adverse reactions (for example, excessive drowsiness, allergic skin reactions).

Fertility.

It was very rarely reported on cases of disruption of fertility in men and / or a deviation from the norm of spermatogenesis.

The ability to influence the reaction rate when managing motor vehicles or other mechanisms.

The ability of a patient receiving carbamazepine to a quick reaction (especially at the beginning of therapy or during the reconnaissance period and / or when using a combination with other drugs acting on the central nervous system) may be violated due to the occurrence of adverse reactions on the part of the central nervous system (dizziness, drowsiness, fatigue). Therefore, when driven by a car or other mechanisms and work requiring the position of the body without support, the patient should be careful.

This effect is enhanced in combination with alcohol.

Method of application and dose

Finlepsin ® 200 retard is administered orally, usually a daily dose of the drug should be distributed on 2 receptions. You can take the drug while eating, after eating or between meals between meals, drinking a small amount of fluid.

Before starting treatment, patients who belong to the Chinese ethnic group of Khan, or patients of Thai origin, are necessary, if possible, undergo a survey for HLA-B * 1502, since this allele can provoke the development of severe carbamazepine-associated syndrome of Stevens-Johnson.

epilepsy

Treatment to start with the use of a low daily dose, which in the future slowly increase (adjust, given the needs of each particular patient) until the optimal effect is achieved.

In cases where it is possible, Finlepsin ® 200 retard should be assigned in the form of monotherapy, but in the case of use with other drugs, it is recommended that the mode of the same gradual increase in the dose of the drug is recommended. If Finlepsin ® 200 retard add to the already existing antiepileptic therapy, the dose should be raised gradually, with the dose of drugs applied not to change or if necessary.

To select the optimal dose of the drug, it may be useful to determine the level of active substance in the blood plasma. The therapeutic concentration in the blood plasma should be 4-12 μg / ml.

In some patients, when applying the retard tablets, the dose of the drug may arise.

adults

The recommended initial dose is 100-200 mg 1-2 times a day, then gradually increase the dose until the optimal effect is achieved; Usually, the daily dose is 800-1200 mg, distributed to 2 receptions. Some patients may require the dose of Finlepsin ® 200 retard, which reaches 1600 mg or even 2000 mg / day.

Elderly patients

Considering medicinal interactions and various pharmacokinetics of anti-epileptic drugs, elderly patients dose Finlepsin ® 200 retard should be selected with caution.

Children from 5 years

Typically, treatment should be carried out with a dose of 10-20 mg / kg body weight per day (in several receptions).

Children aged 5 to 10 years - 400-600 mg / day.

Children aged 10 to 15 years - 600-1000 mg / day.

Acute manic states and supporting treatment of affective (bipolar) disorders.

The dose range is from 400 to 1600 mg / day, 2 reception. Usually therapy is carried out at a dose of 400-600 mg / day in 2 receptions.

In the treatment of sharp manic states, the Dose Finlepsin ® 200 retard should be raised quite quickly to 800 mg / day. In the case of supporting therapy of bipolar disorders in order to ensure optimal tolerance, a gradual increase in small doses is recommended.

Alcohol abstineent syndrome.

The average dose is 600 mg per day, in 2 receptions. In severe cases, during the first few days, the dose can be enhanced (for example, up to 1200 mg per day, divided into 2 receptions). With severe manifestations of alcohol abstinence, the treatment began to begin with a combination of Finlepsin ® 200 retard with sedative-sleeping preparations (for example, with cleotiazole, chloridiazepoxide), observing the above indications on dosages. After the acute phase of treatment, Finlepsin ® 200, the retard can be continued in the form of monotherapy.

Idiopathic neuralgia of triple nerve and trigeminal nerve neuralgia with multiple sclerosis (typical and atypical). Idiopathic neuralgia of the language inheritant nerve.

The initial dose of Finlepsin ® 200 retard is 200-400 mg per day (100 mg 2 times a day for older patients). It should be slowly raised to disappear pain sensations (Usually up to a dose of 400-800 mg, divided into 1-2 receptions). In some cases, a daily dose of 1600 mg may be required. After the cessation of pain, the dose should be gradually reduced to the minimum supporting.

From the side of the respiratory system: inhibition of breathing, pulmonary swelling.

Cardiovascular system: Tachycardia, arterial hypotension, arterial hypertension, conduction disorders with expansion qRS complex; Stopping a heart accompanied by loss of consciousness.

From the gastrointestinal tract: vomiting, the latency of the passage from the stomach, the decline in the motorcycle of the colon.

On the part of the musculoskeletal system: rhabomiolesis associated with the toxic influence of carbamazepine.

From the urinary system: urine delay, oliguria or anouria fluid retention; Hypershydration due to the effect of carbamazepine, similar to the action of ADG.

Changes in laboratory indicators: hyponatremia, metabolic acidosis, hyperglycemia, increase the muscular faction of the KFK.

Treatment. Specific antidote is absent. First, treatment should be based on the clinical state of the patient; The hospitalization is shown. To determine the concentration of carbamazepine in the blood plasma to confirm the poisoning by this means and evaluating the degree of overdose.

Evacuation of the contents of the stomach, washing the stomach, the intake of activated carbon. Late evacuation of gastric content can lead to delayed suction and reappearing symptoms of intoxication during recovery. Apply symptomatic supporting treatment in the intensive care unit, monitoring of heart functions, closer correction of electrolyte disorders.

Special recommendations. In the development of arterial hypotension, the introduction of dopamine or dobutamine is shown; With the development of violations of the rhythm of the heart, treatment is made individually; With the development of convulsion - the introduction of benzodiazepines (for example, diazepama) or other anticonvulsants, such as phenobarbital (with caution due to the increased risk of inhibition of breathing) or paraglidehyde; In the development of hyponatremia (aqueous intoxication) - restriction of fluid administration, slow cautious infusion 0.9% sodium chloride solution. These measures can be useful to prevent brain edema.

It is necessary to envisage the possibility of re-enhancing the symptoms of overdose for the 2nd and 3rd day after it began, which is due to the slow suction of the drug.

Adverse reactions

Side effects that were observed, more often occurred with a combined treatment than with monotherapy. Depending on the dose of I, in the beginning of treatment, certain side effects may occur. In general, they disappear independently for 8-14 days or after a temporary reduction in the dose.

From the side of the circulatory and lymphatic system: leukocytosis, eosinophilia, leukopenia, thrombocytopenia, folic acid deficiency, agranulocytosis, aplastic anemia, barbecue, erythrocyte aplasia, anemia, megaloblastic anemia, acute interspersed porphyria, varigatin porphyria, late skin porphyria, reticulocytosis, hemolytic anemia is possible , bone marrow deficiency.

From side immune system: Drug rash with eosinophilia and systemic symptoms (Dress), multi-hard-type hypersensitivity with fever, skin rashes, vasculitis, lymphadenopathy; Symptoms resembling lymphoma; Arthralgia, leukopenia, eosinophilia, hepatosplegileegaly and anomalous results of hepatic samples arising in various combinations, the syndrome of the disappearance of bile ducts (destruction and disappearance of intrahepatic bile ducts) aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactic reaction, angioedema swelling, hypogammaglobulinemia. Other organs can be involved (for example, liver, lungs, kidneys, pancreas, myocardium, a fat intestine).

From the endocrine system: swelling, fluid delay, increasing body weight, hyponatremia and decreased plasma osmolarity due to the effect of carbamazepine, is similar to the action of ADG (ADG), which sometimes leads to hyperifying, which is accompanied by lethargia, vomiting, headache, consciousness and confusion and consciousness Neurological disorders, increasing the level of prolactin with or without clinical symptoms, such as Galactere and Gynecomastia Anomalous Test Results of the Thyroid Function: Reduced L-thyroxine level (FT4, T4, T3) and an increase in TSH, which usually passes without clinical manifestations, disorders of bone indicators Metabolism (Reducing the level of calcium in blood plasma and 25-hydroxycalcaliferol in the blood plasma, which entails osteomation / osteoporosis, increasing cholesterol levels, including HDL, cholesterol and triglycerides. Carbamazepine can reduce the level of folic acid in serum. Also reported under the influence of carbamazepine Levels in Tamino B 12 in Ove The orotk of blood and the increase in homocysteine.

From the metabolic party and diet): Folate deficiency, reducing appetite, stroke porphyria, incostulant porphyria.

From the psyche: hallucinations (visual or auditory), depression, loss of appetite, anxiety, aggressive behavior, assessment, nervous excitement, confusion, activation of latent psychosis, mood changes, such as depressive or manic mood fluctuations, phobias, lack of motivation, casual Movements such as Asterixis.

From the nervous system: total weakness, dizziness, ataxia, drowsiness, sedative effect, fatigue, headache, abnormal reflex movements (for example tremor, large-sized tremor, dystonia, tick), nystagm, orofacial dyskinesia, difficult thinking, speech disorders (for example dysarthilation or inexpressible speech), choreoathethetosis, peripheral neuropathy, paresthesia, muscle weakness and parires , violation of taste, malignant neuroleptic syndrome, memory deterioration, ataxic and cerebellar disorders, are sometimes accompanied by a head.

From the side of the organ of vision: conjunctivitis, violation of accommodation (diplopia, vagueness of the image), an increase in intraocular pressure, crust of lens, retinotoxy, oculotor disorder.

From the side of hearing organs and the vestibular apparatus: the disorders of hearing, the noise in the ears, the ringing in the ears, hyperactus, hypoacusa, violation of the perception of the height of the sound.

From the side of the cardiovascular system: disorders of intracardiac conductivity, bradycardia, arrhythmia, deterioration of the flow of coronary heart disease, stagnant heart failure, circulatory collapse, blockade with syncope, arterial hypertension or hypotension, vasculitis, thrombophlebitis, thromboembolism (for example, lung vessel embolism).

From the respiratory system: increased lung sensitivity, which is characterized by increasing temperature, shortness of breath, bulconite or pneumonia. In the event of such reactions of hypersensitivity, the reception must be discontinued.

From the digestive tract: decline in appetite, dry mouth, nausea, vomiting, diarrhea, constipation, abdominal pain, stomatitis, gingivitis, glossitis, pancreatitis, colitis.

Hepatobiliary system: changes in the indicators of the functional liver test (increase in the level of gamma-glutamiltransferase, increase the level of alkaline phosphatase, increasing the level of transaminase), jaundice, various forms Hepatitis (cholestatic, hepatocellular, granulomatous, mixed), acute hepatitis, threatening life, liver failure.

From the side of the skin and subcutaneous fiber: allergic dermatitis, urticaria, itching, exfoliative dermatitis, erythrodermia, necrosis of surface areas with bubble syndrome (Layella syndrome), photosensibilization, skin hyperemia with polymorphic rashes in the form of spots I formation of nodes, with hemorrhages ( Exudative multiform erythema, multiform nodular erythema, Johnson's syndrome), Patechian hemorrhage into the skin and red lupus (red disseminated lupus, alopecia), hyperhydrosis, skin pigmentation, acne, girsutism, vasculitis, purpura, increased sweating, acute generalized examtosectous bustlese (AGEP), Lichhenoid keratosis, inhibit.

On the part of the musculoskeletal system: arthralgia, Malgy, muscle cramps, muscle pain, fractures, reducing the mineral density of bone tissue.

From the kidneys and urinary tract: Proteinuria, hematuria, oliguria, dizuriy, pollakiuria, urine delay, tubulinistial nephritis, renal failure, increase blood urea / azotemia), rapid urination.

From the reproductive system and the mammary glands: disorders of spermatogenesis (with a decrease in the amount and / or mobility of spermatozoa), erectile dysfunction, impotence, reduced sexual entry.

Infection and invasion: reactivation of the Herpes Herpes VI type.

Deviation of laboratory research results: hypogammaglobulinemia.

Shelf life

Storage conditions

Store at a temperature not higher than 30 ° C in an inaccessible place for children.

Packaging

10 tablets in a blister. 5 or 10 or 20 blisters in the box.

At a temperature not higher than 30 ° C.
Keep out of the reach of children.

Shelf life from the date of manufacture

Product description

Tablets of prolonged action

pharmachologic effect

Finlepsin Retard - anticonvulsant, derived tricyclic iminolben. Exhibits anti-epileptic, neurotropic and psychotropic activity. The therapeutic effect is primarily due to the braking of synaptic excitation transmission and, as a result, reducing the spread of convulsive seizures. In higher concentrations of carbamazepine causes a decrease in post-approach potentiation. Finlepsin retard reduces the severity of pain in neuralgia of a trigeminal nerve. This effect is due to the braking of the synaptic transmission of irritation in the spinal core of the trigeminal nerve. With incommary diabetes, Finlepsin retard has an antidiuretic effect, due to the hypothalamic influence on the Osoricceptors.

Pharmacokinetics

After oral administration, carbamazepine is absorbed slowly and almost completely.

The half-life period is 8.5 hours and has a large range (about 1.72-12 h). After a single reception of Cmax carbamazepine in the blood plasma in adults is achieved after 4-16 hours (very rarely after 35 hours), in children approximately 4-6 hours. The concentration of carbamazepine in the blood plasma is not in linear dependence on the dose, and Application in higher doses curve concentration in blood plasma has a form of plateau.

When applying a prolonged action tablets, a lower concentration of carbamazepine in the blood plasma is achieved than when using conventional tablets.

Equilibrium concentration is achieved in 2-8 days. There is no close correlation between the dose of carbamazepine and the stable concentration in the equilibrium state in the blood plasma.

Regarding the therapeutic and toxic concentrations of carbamazepine in the blood plasma indicates that the attacks may disappear at its level in the blood plasma 4-12 μg / ml. The concentration of the drug in the blood plasma, exceeding 20 μg / ml, worsens the picture of the disease.

Finlepsin Retard at the concentration of the active substance in the blood plasma 5-18 μg / ml eliminates the pain in neuralgia of a trigeminal nerve.

70-80% of carbamazepine binds to blood plasma proteins. A portion of the unrelated with proteins of carbamazepine at its concentration of 50 μg / ml remains constant. 48-53% of the pharmacologically active metabolite carbamazepine-10, 11-epoxide binds to blood plasma proteins. The concentration of carbamazepine in the CMF is 33% of the concentration in the blood plasma.

Carbamazepine penetrates through a placental barrier, excreted into breast milk.

After receiving a single dose of carbamazepine is derived from the blood plasma from T1/2 36 hours. With long-term treatment, T1/2 decreases by 50% due to the induction of microsomal liver enzymes.

In healthy persons, the overall clien from blood plasma is about 19.8 ml / h / kg of body weight, in patients with monotherapy - about 54.6 ml / h / kg, in patients with combined treatment - about 113.3 ml / h / h / h kg.

After one-time reception of carbamazepine, 72% of the dose in the form of metabolites is highlighted from the body by the kidneys. The remaining 28% are outlined together with the feces, partially - unchanged. Only 2-3% of the substance derived from the urine is carbamazepine unchanged.

Indications for use

epilepsy: complex or simple partial convulsive seizures (with loss or without loss of consciousness) with secondary generalization or without it; generalized tonic-clonic convulsive seizures; Mixed shapes of convulsive seizures.

Finlepsin retard can be used both as monotherapy and as part of combination therapy.

Sharp manic states; Supporting therapy for bipolar affective disorders in order to prevent exacerbations or to reduce the severity of clinical manifestations of exacerbation.

Alcohol abstine syndrome.

Idiopathic neuralgia of triple nerve and trigeminal nerve neuralgia with multiple sclerosis (typical and atypical).

Idiopathic neuralgia of the language inheritant nerve.

Application during pregnancy and during lactation

With caution

special instructions

carbamazepine should be prescribed only under medical supervision, only after estimating the ratio of benefits / risk and, subject to careful monitoring of patients with heart, hectoral or renal disorders, side hematological reactions to other drugs in history, or patients with interrupted courses of carbamazepine therapy.

Carbamazepine shows light anticholinergic activity, so patients with elevated intraocular pressure should be prevented and advised about possible risk factors.

It should be remembered about the possible activation of hidden psychosis, and relative to the elderly patients - about the possible activation of the confidence and development of anxiety.

The drug is usually ineffective in absissues (small epileptic seizures) and myoclonic seizures. Individual cases indicate that the strengthening of attacks may occur in patients with atypical absans.

Hematological effects. With the use of the drug bind the development of agranulocytosis and aplastic anemia; However, due to the extremely low frequency of cases of development of these states, it is difficult to estimate significant risk when taking carbamazepine.

Patients should be informed about the early signs of toxicity and symptoms of possible hematological disorders, as well as the symptoms of dermatological and hepatic reactions. The patient should be prevented that in the event of such reactions such as fever, angina, skin rashes, ulcers in the oral cavity, bruises, which are easily arising, point hemorrhage or hemorrhagic purple, should be applied to the doctor immediately.

If the number of leukocytes or platelets is significantly reduced during therapy, the patient's condition is subject to careful monitoring, and a permanent overall analysis of the patient's blood should also be carried out. Carbamazepine treatment must be discontinued if the patient develops leukopenia, which is a serious, progressive or accompanied by clinical manifestations, such as fever or sore throat. Application of carbamazepine should be discontinued when signs of oppression of the bone marrow function.

Periodically, or often there is a temporary or stable reduction in the number of platelets or leukocytes due to carbamazepine reception. However, for most of these cases, their situation is confirmed and they do not testify to the development of aplastic anemia or agranulocytosis. Before the start of therapy and periodically, a blood test should be carried out during it, including the determination of the number of platelets (as well as, possibly quantities of reticulocytes and hemoglobin levels).

Serious dermatological reactions. Serious dermatological reactions, including toxic epidermal necrolis (TEN) or Lailel syndrome, Stevens - Johnson syndrome (CED), when applying carbamazepine, occurs very rarely. Patients with serious dermatological reactions may require hospitalization, since these states can threaten their lives and have a fatal outcome. Most cases of the development of CDS / TEN are celebrated during the first few months of carbamazepine treatment. In the development of signs and symptoms, indicating serious dermatological reactions (Layella / TEN syndrome), the reception of carbamazepine should be immediately terminated and assign alternative therapy.

Pharmacoenomy. There is more and more evidence of the effect of various HLA alleles on the patient's tendency to the emergence of adverse reactions associated with the immune system.

Communication with (HLA) -B * 1502. Retrospective studies in patients - Chinese Ethnic Group of Ethnic Group demonstrated a pronounced correlation between SVD / TEN skin reactions associated with carbamazepine, and the presence of human leukocyte antigen (HLA), allele (HLA) -B * 1502. A large frequency of the RCD development messages (rather rarely, than very rarely) is characteristic of some Asia countries (for example, Taiwan, Malaysia and the Philippines), where the allele (HLA) prevails among the population. The number of media of this allele among the population of Asia is\u003e 15% in the Philippines, in Thailand, Hong Kong and Malaysia, ≈10% - on about. Taiwan, almost 4% - in North China, ≈2-4% - in South Asia (including India) and
In patients who are considered as genetically related risk groups, testing for allele (HLA) -B * 1502 should be carried out before starting treatment with carbamazepine. If the analysis for the presence of an allelet (HLA) -B * 1502 gives a positive result, then the treatment of carbamazepine should not be started, except in cases where other options for therapeutic treatment are missing. Patients who have passed the survey and obtained a negative result of software (HLA) -B * 1502, have a low risk of the development of CDS, although very rarely such reactions can still develop.

Currently, due to the lack of data, it is exactly unknown, for all persons of southeastern Asian origin there are risks.

Allel (HLA) -B * 1502 may be a risk factor for the development of SSD / TEN in patients, which receive other antiepileptic agents that can be associated with the occurrence of CED / TEN. Thus, the use of other drugs can be avoided, which can be associated with the occurrence of CVD / TEN, in patients with the allele (HLA) -B * 1502, if other, alternative therapy can be applied. It is usually not recommended to carry out genetic screening of patients, for the nationalities of which is characterized by a low allele coefficient (HLA) -B * 1502. It is usually not recommended to perform screening in individuals already receiving carbamazepine, since the risk of SDS / TEN is significantly limited to the first few months, regardless of the presence of an allele (HLA patient genes) -B * 1502.

In patients, the European-like race between the genome (HLA) -B * 1502 and the occurrence of CDS is absent.

Communication with (HLA) -A * 3101. The leukocytar antigen of the person can be a risk factor for the development of skin adhesive reactions, such as SSD, TEN, drug rash with eosinophilia and systemic symptoms (DRESS), acute generalized examatosis Pustuez (AGEP), maculopapulous rash. If the analysis reveals the presence of an allele HLA-A * 3101, then from the use of carbamazepine should be abstained.

Restriction of genetic screening. The results of genetic screening should not replace the appropriate clinical observation and treatment of patients. Other possible factors are played by role in the occurrence of these heavy skin adhesive reactions, such as the dosage of antiepileptic agents, compliance with the treatment regime, concomitant therapy. The influence of other diseases and the level of monitoring of skin disorders was not studied.

Other dermatological reactions. It is possible to develop transit and not threatening healthy pulmonary reactions, such as an isolated macular or maculophaulous examination. Usually they pass in a few days or weeks both with constant dosage and after a decrease in the dose of the drug. Since the early signs of more serious dermatological reactions can be very difficult to distinguish from the pulmonary reactions of the rapid flow, the patient must be supervised to immediately terminate the use of the drug if the reaction will deteriorate with it.

The presence of a patient allele (HLA) -B * 1502 is not a risk factor for the occurrence of less serious unwanted reactions to carbamazepine from the skin, such as hypersensitivity syndrome to anticonvulsant or minor rash (maculopapulous rash). However, it has been established that the presence (HLA) -B * 1502 may indicate the risk of the emergence of the aforementioned reactions.

Hypersensitivity. Carbamazepine can provoke the development of hypersensitivity reactions, including drug rash with eosinophilia and systemic symptoms (DRESS), multiple reactions of slow-type hypersensitivity with fever, rash, vasculitis, lymphadenopathy, pseudolimphoma, arthralgia, leukopenia, eosinophilia, hepatosplegegaly, changing liver function and disappearance syndrome bile ducts (including the destruction and disappearance of intrahepatic bile ducts).

Also possible effect on other organs (lungs, kidneys, pancreas, myocardium, colon).

The presence of an allele HLA-A * 3101 in the patient is associated with the occurrence of less serious unwanted reactions to carbamazepine from the skin, such as hypersensitivity syndrome to anticonvulsant or minor rash (maculopapulous rash).

Patients with hypersensitivity reactions on carbamazepine should be informed that about 25-30% of such patients may also have a reaction of hypersensitivity to oxcarbazepine.

When applying carbamazepine and phenytoin, it is possible to develop cross-hypersensitivity.

In general, when signs and symptoms indicating hypersensitivity, the use of carbamazepine should be terminated immediately.

Attacks. Carbamazepine should be used with caution in patients with mixed attacks, which include abscans (typical or nonypical). Under such circumstances, the drug can provoke attacks. In the case of provoking the attacks, the use of carbamazepine should be stopped immediately.

Increasing the frequency of attacks can be observed in the transition from oral forms of the drug on suppositories.

Liver function. During the period of therapy, the drug it is necessary to evaluate the liver function at the initial level and the periodic estimate of this function during therapy, especially in patients with liver diseases in history and in elderly people. With the exacerbation of violations of the liver function or in patients with the active phase of the liver disease, it is necessary to immediately stop taking the drug.

Some indicators of laboratory tests by which they estimate the functional state of the liver, in patients receiving carbamazepine can go beyond the limits of the norm, in particular gamma-glovedransferase. This is probably due to the induction of hepatic enzymes. Induction of enzymes can also lead to a moderate increase in the level of the SFF. Such an increase in the functional activity of hepatic metabolism is not an indication for cancellation of carbamazepine.

Heavy liver reactions when applying carbamazepine are very rare. In the event of signs and symptoms of hepatic dysfunction or active liver disease, it is necessary to urgently examine the patient, and the treatment of carbamazepine is suspended until the survey results are obtained.

Hyponatremia. There are cases of the development of hyponatremia when applying carbamazepine. In patients with an existing impaired renal function, which is associated with a reduced sodium level, or in patients with concomitant drug treatment, which reduce sodium levels (such as diuretics, drugs that are associated with inadequate secretion of antidiuretic hormone), should be determined before treatment. Sodium level in blood. Next should be measured every 2 weeks, then with an interval of 1 month during the first 3 months of treatment or according to clinical need. This applies primarily by elderly patients. It follows in this case to limit the amount of water consumed.

Hypothyroidism. Carbamazepine can reduce the concentration of thyroid hormones, therefore it is necessary to increase the dose of replacement therapy hormones of the thyroid gland for patients with hypothyroidism.

Anticholinergic effects. Carbamazepine exhibits moderate anticholinergic activity. Thus, patients with elevated intraocular pressure should be under observation during therapy.

Psychotic effects. It should be remembered for the likelihood of activating latent psychosis and in the patients of older age - confusion or excitement confusion.

Suicidal thoughts and behavior. Several reports of suicidal thoughts and behavior in patients receiving anti-epileptic drugs were registered. The metaanalysis of the data obtained during placebo-controlled studies of antiepileptic drugs also indicates a slight increase in the risk of suicidal thoughts and behavior. The mechanism for the occurrence of such risk is unknown, and the available data does not exclude the risk of suicidal thoughts and behavior for carbamazepine.

Therefore, patients must be examined for suicidal thoughts and behavior and, if required, assign appropriate treatment. Patients (and persons who care for patients) should be recommended to consult a doctor in case of signs of suicidal thoughts and behavior.

Endocrine effects. Due to the induction of liver enzymes, carbamazepine can cause a decrease in the therapeutic effect of estrogen preparations and / or progesterone. This can lead to a decrease in the efficiency of contraception, recurrence of symptoms or breakthrough bleeding or bleeding. Patients taking carbamazepine and for which hormonal contraception is necessary, should receive a drug containing at least 50 μg of estrogen, or for such patients should consider using alternative non-correlative methods of contraception.

Monitoring the level of the drug in blood plasma. Despite the fact that the correlation between the dose and the level of carbamazepine in the blood plasma, as well as between the level of carbamazepine in the blood plasma and clinical efficacy and tolerance of unreliable, monitoring the level of the blood plasma can be appropriate in the following cases: with a sudden increase in the frequency of attacks, compliance checks. patient, during pregnancy, in the treatment of children and adolescents; With suspected disturbance of absorption, in suspected toxicity and the use of more than one drug.

Reduced dose and discharge syndrome. The sudden cancellation of the drug can provoke the attacks, so carbamazepine should be canceled gradually for 6 months. If it is necessary to immediately cancel the drug in patients with epilepsy, the transition to a new anti-epileptic drug should be carried out against the background of therapy with appropriate drugs.

Use during pregnancy and lactation. Pregnant carbamazepine treatment with epilepsy should be carried out with extreme caution.

In animals, the oral use of carbamazepine caused the development of defects.

In children, whose mothers celebrate epilepsy, detect a tendency to violations of intrauterine development, including congenital malformations. There was a chance that carbamazepine, like most anti-epileptic agents, increases the frequency of these violations, but there are no convincing evidence within controlled studies of carbamazepine monotherapy. At the same time, violations of intrauterine development and congenital developmental defects associated with the use of carbamazepine, including the cleft of the spine and other congenital anomalies, such as maxillofacial defects, cardiovascular anomalies, hypospades and anomalies of the development of various organism systems.

It should be kept in mind the following data:

the use of carbamazepine in pregnant women with epilepsy requires special attention;
if a woman who takes carbamazepine became pregnant, plans pregnancy or during pregnancy the need to use carbamazepine, should be carefully weighed the potential benefit of the use of the drug compared to a possible risk (especially in I trimester of pregnancy);
women of reproductive age, if possible, carbamazepine should be prescribed as monotherapy;
it is recommended to assign minimum effective doses and monitor the level of carbamazepine in the blood plasma;
patients should be informed about the possibility of increasing the risk of developing congenital defects and should provide them with the possibility of prenatal screening;
during pregnancy, it should not be interrupted by effective anti-epileptic therapy, since the aggravation of the disease threatens health as a mother and a child.
Observation and prevention. It is known that during pregnancy the deficiency of folic acid is possible. Anti-epileptic drugs may increase the level of folic acid deficiency, therefore, it is recommended to further apply folic acid before and during pregnancy.

Newborn. In order to prevent blood clotting violations in newborns, it is recommended to prescribe vitamin K1 mothers over the past weeks of pregnancy and newborn. There are several cases of convulsion and / or inhibition of respiratory function in newborns, several cases of vomiting, diarrhea and / or poor appetite in newborns, which are associated with the use of carbamazepine.

Lactation. Carbamazepine penetrates into breast milk (25-60% of blood plasma concentrations). The advantages of breastfeeding with a distant probability of developing side effects in a child should be carefully weighed. Mothers that get carbamazepine can be breastfeed only if the child is observed regarding the development of possible adverse reactions (for example, excessive drowsiness, allergic skin reactions).

Fertility. It was very rarely reported on cases of disruption of fertility in men and / or a deviation from the norm of spermatogenesis.

Children. Carbamazepine in this dosage form are not prescribed children under the age of 5 years.

The ability to influence the reaction rate when driven by vehicles or working with other mechanisms. The ability of a patient taking carbamazepine to a rapid reaction (especially at the beginning of therapy or during the reconnaissance period and / or when applying a combination with other drugs operating on the CNS) may be violated due to the occurrence of adverse reactions from the CNS (dizziness, drowsiness, fatigue) . Therefore, when driven by vehicles or other mechanisms and work requiring the position of the body without support, caution should be taken to the patient.

This effect is enhanced in combination with alcohol.

With caution (precautions)

Considering the drug interactions and various pharmacokinetics of antiepileptic drugs, the elderly patients dose Finlepsin retard should be selected with caution. Caidarbamazepine should be used with caution in patients with mixed attacks, which include absans (typical or nonypical). Under such circumstances, the drug can provoke attacks. In the case of provoking the attacks, the use of carbamazepine should be stopped immediately.

Contraindications

Finlepsin retard should not be appointed:

with the installed hypersensitivity to carbamazepine or similar in the chemical plan drugs (tricyclic antidepressants), or other components of the drug;
with AV blockade;
patients with the oppression of the bone marrow function in history;
patients with hepatic porphyria (for example, acute intermittent porphyria, mixed porphyria, late porphyria of the skin) in history;
in combination with Mao inhibitors;
in combination with voriconazole, since treatment may be ineffective.

Method of application and dose

Inside, during or after eating, drinking sufficient liquid. For ease of use, the tablet (as well as half or a quarter) can be pre-dissolved in water or juice, because The property of the prolonged release of the active substance after dissolving the tablet in the liquid is preserved. The range of doses used is 400-1200 mg / day, which are distributed on 1-2 receptions per day.

The maximum daily dose should not exceed 1600 mg.

Epilepsy

In cases where it is possible, Finlepsin® retard should be assigned in the form of monotherapy. Treatment is beginning with the use of a small daily dose, which is subsequently slow to achieve an optimal effect. The addition of Finlepsin® drug to the already conductive antiepileptic therapy should be carried out gradually, while the doses of the drugs used are not changed or, if necessary, corrected. If the patient forgot to take the next dose of the drug in a timely manner, should take a missed dose at once, as soon as this omission has become noticed, and it is impossible to take a double dose of the drug.

Adults. The initial dose is 200-400 mg / day, then the dose is gradually raised until the optimal effect is achieved. Supporting dose - 800-1200 mg / day, which are distributed on 1-2 reception per day.

Children. The initial dose for children from 6 to 15 years - 200 mg / day, then the dose is gradually increased by 100 mg / day until the optimal effect is achieved. Supporting doses for children 6-10 years old - 400-600 mg / day (in 2 receptions); For children 11-15 years old - 600-1000 mg / day (in 2 receptions). The pressure depends on the testimony and individual reaction of the patient for treatment. The decision to transfer the patient to Finlepsin® retard, the duration of its use and cancellation of treatment is made by a doctor individually. The possibility of reducing the dose of the drug or cessation of treatment is considered after a 2-3-year period of the complete absence of seizures.

Treatment is stopped, gradually reducing the dose of the drug for 1-2 years, under the control of EEG. In children, with a decrease in the daily dose of the drug, an increase in body weight with age should be taken into account.

Neuralgia Triple Nerva, Idiopathic Gloss-Faringeal Neuralgia

The initial dose is 200-400 mg / day, which are distributed to 2 receptions. The initial dose is raised up to the complete disappearance of pain, an average of up to 400-800 mg / day. After that, a certain part of patients, treatment can continue to continue the lower supporting dose of 400 mg.

Elderly patients and patients sensitive to Karabamazepine, Finlepsin® Retard is prescribed in the initial dose of 200 mg 1 time per day.

Pain in diabetic neuropathy

The average daily dose is 200 mg in the morning and 400 mg in the evening. In exceptional cases, Finlepsin® Retard can be prescribed at a dose of 600 mg 2 times a day.

Treatment of alcohol abstinence in hospital

The average daily dose is 600 mg (200 mg in the morning and 400 mg in the evening). In severe cases, in the first days, the dose can be raised to 1200 mg / day, which are distributed to 2 receptions.

If necessary, Finlepsin® retard can be combined with other substances used to treat alcohol abstinence, except for sedatives.

During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma.

In connection with possible development side effects On the part of the central and vegetative nervous system for patients, careful observation is established in the hospital.

Epileptiform cramps with multiple sclerosis

The average daily dose is 200-400 mg 2 times a day.

Treatment and prevention of psychosis

The initial and maintenance dose is usually the same - 200-400 mg / day. If necessary, the dose can be raised to 400 mg 2 times a day.

Overdose

symptoms. Symptoms and complaints arising in overdose usually reflect the defeat of the CNS, cardiovascular and respiratory systems.

From the CNS: the oppression of the functions of the CNS; disorientation, excitation, reduced level of consciousness, drowsiness, excitation, hallucination, coma; Bulk vision, vision, dysarthria, nystagm, ataxia, dyskinesia, hyperreflexia (first), hyphotexia (later); Clear, psychomotor disorders, myoclone, hypothermia, mydriasis.

From the side of the respiratory system: inhibition of breathing, pulmonary swelling.

Cardiovascular system: Tachycardia, arterial hypotension, hypertension, conduction disorder with the expansion of the QRS complex; Stopping a heart accompanied by loss of consciousness.

From the head of the gastrointestinal tract: vomiting, the latency of the passage from the stomach, the decline in the motorcycle of the colon.

On the part of the musculoskeletal system: rhabdomiolysis associated with the toxic effect of carbamazepine.

From the urinary system: urinary delay, Oliguria or Anururia; fluid delay; Hypershydration, due to the effect of carbamazepine, similar to the action of antidiuretic hormone.

Changes in laboratory indicators: hyponatremia, metabolic acidosis, hyperglycemia, increase the muscular faction of the KFK.

Treatment. Specific antidote is absent. Initially, treatment should be based on the clinical state of the patient; The hospitalization is shown. The concentration of carbamazepine in the blood plasma is determined to confirm the poisoning by this tool and evaluation degree of overdose.

The content of the contents of the stomach, washing the stomach, the receipt of activated carbon is evacuated. Late evacuation of gastric content can lead to delayed suction and re-occurrence of symptoms of intoxication during recovery. Symptomatic supporting treatment in the intensive care unit, monitoring of heart functions, careful correction of electrolyte disorders is used.

Special recommendations. In the development of arterial hypotension, it is shown in / in the introduction of dopamine or dobutamine; When developing violations of the heart rhythm, treatment is selected individually; With the development of convulsion - the introduction of benzodiazepines (for example, diazepama) or other anticonvulsants, such as phenobarbital (with caution due to the increased risk of inhibition of respiratory function) or paraglidehyde; In the development of hyponatremia (aqueous intoxication) - restriction of fluid administration, slow cautious infusion of 0.9% p-ra sodium chloride. These measures can be useful to prevent brain edema.

It is necessary to provide for the possibility of repeated increase in the severity of the symptoms of overdose for the 2nd and 3rd day after its start, due to the slow suction of the drug.

Side effect

celebrated side effects More often occurred with a combined treatment than with monotherapy. Depending on the dose and, mainly at the beginning of treatment, certain side effects may occur. In general, they disappear independently after 8-14 days or after a temporary decline in the dose.

Blood and lymphatic system: leukocytosis, eosinophilia, leukopenia, thrombocytopenia, folic acid deficiency, agranulocytosis, aplastic anemia, barbecue, erythrocyte aplasia, anemia, megaloblastic anemia, acute interspersed porphyria, Variant Porphyria, late skin porphyria, reticulocytosis, hemolytic anemia is possible , bone marrow deficiency.

From the immune system: drugs with eosinophilia and system symptoms (DRESS), multi-trumped hypersensitivity of a slow-type with fever, skin rashes, vasculitis, lymphadenopathy; Symptoms resembling lymphoma; arthralgia, leukopenia, eosinophilia, hepatoslenomegaly and abnormal results of hepatic samples, arising in various combinations, the syndrome of the disappearance of bile ducts (destruction and disappearance of intrahepatic bile ducts); Aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactic reaction, angioedema edema, hypogammaglobulinemia. Other organs can be involved (for example, liver, lungs, kidneys, pancreas, myocardium, a fat intestine).

From the endocrine system: swelling, fluid delay, increasing body weight, hyponatremia and decrease in blood plasma osmolarity through a carbamazepine effect, similar to the action of antidiiuretic hormone, which sometimes leads to hyperifying, which is accompanied by lethargia, vomiting, headache, confusion and neurological disorders, raising the level of prolactin with or without clinical symptoms, such as Galactere and Gynecomastia; Anomalous test results of the thyroid function: Reducing the level of L-thyroxine (FT4, T4, T3) and an increase in TSH, which usually passes without clinical manifestations, disorders of bone metabolism (reduction in calcium levels in blood plasma and 25-hydroxycaliferol in blood plasma, which Osteomalysis / osteoporosis entails, increasing the level of hs, including HS HPPP and TG. Carbamazepine can reduce the level of folic acid in the blood plasma. It also reported to decrease under the influence of carbamazepine level vitamin B12 in the blood plasma and raising homocysteine \u200b\u200blevels.

From the metabolism and nutritional impairment: Folate deficiency, decline in appetite, stroke porphyria, chronic porphyria.

From the psyche side: hallucinations (visual or auditory), depression, lack of appetite, anxiety, aggressive behavior, assessment, nervous arousal, confusion, activation of latent psychosis, mood changes, such as depressive or manic mood fluctuations, phobias, lack of motivation, involuntary Movements such as Asterixis.

From the nervous system: general weakness, dizziness, ataxia, drowsiness, sedative effect, fatigue, headache, abnormal reflex movements (for example, tremor, large-sized tremor, dystonia, tick), nystagm, orofacial dyskinesia, slow thinking, speech disorders (for example, dysarthria or a vast speech), choreoaththyetheosis, peripheral neuropathy, paresthesia, muscle weakness and paresis, violation of taste, malignant neuroleptic syndrome, impairment of memory, ataxic and cerebellar disorders, which are sometimes accompanied by headache.

From the body of the vision: conjunctivitis, violation of accommodation (diplopia, vision of vision), an increase in intraocular pressure, clouding of lens, retinotoxicity, oculotor disorders.

From the side of the hearing body and the vestibular apparatus: hearing impairment, ears, tinnitus, hyperacts, hypoacusa, violation of the height perception of sound.

From the side of the cardiovascular system: disorders of intracardiac conductivity, bradycardia, arrhythmia, deterioration of coronary heart disease, stagnant heart failure, circulatory collapse, AV blockade with syncope, ag or hypotension, vasculitis, thrombophlebitis, thromboembolism (for example, lung vessel embolism).

From the respiratory system: increased sensitivity by lungs, which is characterized by an increase in body temperature, shortness of breath, bulconite or pneumonia. In the event of such reactions of increased sensitivity, the reception must be discontinued.

From the digestive system: reduction of appetite, dry mouth, nausea, vomiting, diarrhea, constipation, abdominal pain, stomatitis, gingivitis, glossitis, pancreatitis, colitis.

Hepatobiliary violations: changes in the functional test of the liver (raising the level of gamma-glutamiltransferase, increasing the level of SFF, transaminase), jaundice, various forms of hepatitis (cholestatic, hepatocellular, granulomatous, mixed), threatening life acute hepatitis, liver failure.

From the side of the skin and subcutaneous fluid: allergic dermatitis, urticaria, itching, exfoliative dermatitis, erythrodermia, necrosis of surface areas with bubbles (Layella syndrome), photosensibilization, redness of the skin with polymorphic rash in the form of spots and the formation of nodes, with hemorrhages ( Exudative Multiform Erythema, Multiform Nodded Erythema, Stevens Syndrome - Johnson), Petechial Hemorrhage in Skin and Red Magnifice (Red Disseminated Lupus, Alopecia), Diaphraosis, Skin Pigmentation Changes, Acne, Hisutism, Vasculitis, Purple, High Speeding, Acute General Exandtematous Pustuez (AGEP), Lichhenoid keratosis, inhibit.

On the part of the musculoskeletal system: arthralgia, Malgy, muscle cramps, muscle pain, fractures, reducing the mineral density of bone tissue.

From the side of the kidneys and urinary tract: proteinuria, hematuria, oliguria, dizuriy, pollakiuria, urine delay, tubulinistial nephritis, renal failure, increase blood urea levels / azotemia, urination rapidly.

On the part of the reproductive system and the mammary glands: a spermatogenesis (with a decrease in the amount and / or mobility of sperm), erectile dysfunction, impotence, reduced sexual entry.

Infection and invasion: reactivation of the Herpes Herpes VI type.

Deviation of laboratory research results: hypogammaglobulinemia.

Structure

Carbamazepine 200 mg
Other ingredients: copolymer methacrylate, triacetamine, talc, microcrystalline cellulose, silicon high-dispersed dioxide, magnesium stearate, crosspovidon.

Interaction with other drugs

cytochrome P450 Z4 (CYR Z4) is the main enzyme that catalyzes the formation of the active metabolite of carbamazepine-10, 11-epoxy. The simultaneous use of Cyrian inhibitors can cause an increase in the concentration of carbamazepine in the blood plasma, which, in turn, can lead to the development of adverse reactions. The simultaneous use of Cyr-C4 inductors can enhance carbamazepine metabolism, which leads to a potential decrease in carbamazepine concentration in blood plasma and its therapeutic effect. Similarly, the cessation of the reception of the Inductor SR C4 may reduce the speed of carbamazepine metabolism, which leads to an increase in the level of carbamazepine in the blood plasma. Carbamazepine is a powerful Inductor CYR C4, so it can reduce the concentration of other drug plasma preparations, mainly metabolized by induction of their metabolism.

The microsomal human hydrolase epoxy is an enzyme responsible for the formation of 10,11-transdiol derigative carbamazepine. The simultaneous purpose of human microsomal-hydrolase inhibitors can lead to an increase in the concentrations of carbamazepine-10,11-epoxy in the blood plasma.

Preparations that can raise carbamazepine and / or carbamazepine-10,11-epoxy in blood plasma. Since the increase in the level of carbamazenine in the blood plasma can lead to the appearance of adverse reactions (such as dizziness, drowsiness, ataxia, diplopia), the dose of the drug must be adjusted accordingly and / or control its level in blood plasma while simultaneously use with the preparations:

analgesics, anti-inflammatory drugs: dextropropoxifen, ibuprofen;
androgens: Danazole;
antibiotics: macrolide antibiotics (for example erythromycin, trolandomycin, josamamicin, clarithromycin, ciprofloxacin);
antidepressants: desipramine, fluoxetine, fluvoxamine, nefazodon, paroxetine, windsazin, trazodon;
anti-Epileptic Tools: Stipentol, Wigabolin;
antifungal agents: Azol (for example, etraconazole, ketoconazole, fluconazole, voriconazole). Patients who receive treatment by voriconazole or itraconazole can be recommended alternative anti-epileptic agents;
antihistamines: Terfenadine, Loratadine;
antipsychotic drugs: Olanzalin, Locupin, Quetiapine;
anti-tuberculosis drugs: isoniazide;
antiviral drugs: protease inhibitors for HIV treatment (for example ritonavir);
carbonithih inhibitors: acetazolamide;
cardiovascular preparations: Verapamil, Diltiaze;
drugs for the treatment of diseases of the gastrointestinal tract: cimetidine, omeprazole;
miorlaxants: Oxybutinin, Dentrenolen;
antiagregative preparations: Tiklopidine;
other substances: nicotinamide (in adults, only in high doses), grapefruit juice.
Preparations that can increase the level of active carbamazepine-10,11-epoxide-epoxy metabolite in blood plasma. Since the increased level of active carbamazepine-10,11-epoxide metabolite in blood plasma can lead to the development of adverse reactions (for example dizziness, drowsiness, ataxia, diplopia), dose of carbamazepine must be adjusted accordingly and / or control the level of the drug in the blood plasma, if Finlepsin Retard Take simultaneously with such drugs: locked, quetiapine, prison, propagad, valproic acid, vipromide.

Preparations that can reduce the level of carbamazepine in the blood plasma. The dose correction may be required by Finlepsin Retard, while simultaneously use with the drugs below.

Anti-Epileptic drugs: phenobarbital, phenytoin, prison, Felbamat, Metsuximid.

Antitumor drugs: doxorubicin, cisplatin.

Anti-tuberculosis drugs: rifampicin.

Broutine or anti-asthma preparations: Theophylline, aminoophyllin.

Dermatological preparations: Isotretinoin.

Others: Hypericum Perforatum preparations.

Mephlochin can show antagonistic properties relative to the anti-epileptic effect of carbamazepine. Accordingly, it is necessary to adjust the dose of carbamazepine.

Isotretinoin, as reported, changes the bioavailability and / or clearance of carbamazepine and carbamazepine-10,11-epoxy; It is necessary to control the concentration of carbamazepine in the blood plasma.

The effect of carbamazepine at the level of the blood plasma at the same time prescribed drugs. Carbamazepine can reduce the level of some drug plasma and reduce severity or level their effects. The need for a dose correction of the following drugs, respectively, clinical requirements is possible.

Analgesics, anti-inflammatory drugs: buprenorphine, methadone, paracetamol (long-term use of paracetamol carbamazepine can be associated with the development of hepatotoxicity), tramadol, fenazone.

Antibiotics: doxycycline.

Anticoagulants: oral anticoagulants (for example, Warfarin, Fenprocaon, Dicumurol, Acentokumarol).

Antidepressants: bupropion, cytital, meanserin, nefazodon, sertalin, trazodon, tricyclic antidepressants (for example imipramine, amitriptyline, northriptyline, clomipramine).

Antiwheat preparations: Aperstitis.

Anti-Epileptic preparations: hlobazam, clonazepam, etosuccimide, felbamate, prison, laxigin, oxcarbazepine, thiagabin, topiramate, valproic acid. Under the influence of carbamazepine can increase or decrease by plasma concentrations of phenytoin. In exceptional cases, this may cause the state of confusion of consciousness and even to whom.

Antifungal drugs: voriconazole, itraconazole, ketonazole. Patients who receive treatment with voriconazole or itraconazole can be recommended alternative anti-epileptic agents.

Anthelmintic drugs: Prasikvantel, Albendazole.

Antitumor drugs: Imatinib, cyclophosphamide, Lapatinib, Temsyrolymus.

Neuroleptic preparations: Clozapine, Haloperidol and Bromperidol, Olanzapine, Risperidone, Quetiapine, Ziprazidon, Aripiprazole, Paliperidone.

Antiviral drugs: protease inhibitors for HIV treatment (for example Ritonavir, Indinavir, Saquinavir).

Anxiolitics: Midazolam, Alprazolam.

Broutine or anti-asthma drugs: Theophylline.

Contraceptive preparations: hormonal contraceptives. In patients using hormonal contraceptives, the efficiency of contraception may decrease and the intermenstrual bleeding suddenly begin. Therefore, it should be given to the possibility of applying alternative methods of contraception.

Cardiovascular preparations: calcium channel blockers (dihydropyridine group), such as Felodipine, Digoxin, Isragian, County, Propranolol, Simvastatin, Atorvastatin, Lovastatin, Cerivastatin, Ivabradin.

GKS: prednisone, dexamethasone.

Means used for the treatment of erectile dysfunction: Tadalafil.

Immununopressants: Cyclosporin, Everolimus, Tharolimus, Sirolimus.

Thyroid drugs: Levothyroxin.

Others: Preparations containing estrogens and / or progesterons (alternative contraception methods), buprenorphine, gestrinone, tibolone, corewarefen, Mianserin, sertraline.

Combinations of drugs that require separate consideration. The simultaneous use of carbamazepine and levetyracetam can lead to amplification of carbamazepine toxicity.

The simultaneous use of carbamazepine and isoniazide can lead to an increase in the hepatotoxicity of isoniazide.

The simultaneous use of carbamazepine and lithium or metoclopramid preparations, as well as carbamazepine and neuroleptics (hanoperidol, thiuridazine) can lead to an increase in the severity of side neurological effects (in the case of the last combination, even with the therapeutic levels in the blood plasma).

The combined application of Finlepsin retard with most diuretics (hydrochlorothiazide, furosemide) can cause symptomatic hyponatremia.

Carbamazepine can antagonize the effects of nonpolarizing muscle relaxants (for example, pants). It may be necessary to increase doses of these drugs, and patients require careful monitoring due to the more quickly than expected, the completion of the neuromuscular blockade.

Carbamazepine, like other psychotropic drugs, can reduce alcohol tolerance, so patients are advised to refrain from alcohol use.

Contraindicated interactions. Since carbamazepine is structurally similar to tricyclic antidepressants, Finlepsin Retard is not recommended to be used simultaneously with MAO inhibitors. Between the beginning of carbamazepine reception and the completion of the reception of the MAO inhibitors, at least 2 weeks or more, if it allows the patient's clinical state.

Impact on serological studies. Carbamazepine can give false positive result HPLC analysis (highly efficient liquid chromatography) to determine the concentration of perphinezine.

Carbamazepine and carbamazepine-10,11-epoxide can give a false positive result of immunobiological analysis according to a polarized fluorescence procedure to determine the concentration of tricyclic antidepressants.

Tablets of prolonged action - 1 Tab:

• active substance: carbamazepine - 200/400 mg;
• auxiliary substances: EUDRAGIT® RS30D (ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate copolymer (1: 2: 0.1) - 11/22 mg; triacetin - 2.2 / 4.4 mg; Talc - 15.6 / 31.2 mg; Eudragit® L30D-55 (methacrylic acid and ethyl acrylate copolymer) - 35/70 mg; MKC - 21.8 / 43.6 mg; Crosspovidone - 12.4 / 24.8 mg; silicon colloidal dioxide - 1.33 / 2, 66 mg; magnesium stearate - 0.67 / 1.34 mg.

Tablets of prolonged action, 200 mg, 400 mg. 10 tables. In a PVC blister / PVDC / aluminum foil. 3, 4 or 5 bl. Place in a cardboard pack.

Description of the dosage form

Tablets, 200, 400 mg: from white to yellowish color, rounded, flat, in the form of a clover sheet with beveled edges, with cruciform lines of faults on both sides and 4 scubons on the side surface, with a smooth surface, intact edges and a homogeneous appearance.

pharmachologic effect

Analgesic, antipsychotic, anti-epileptic, anticonvulsant.

Pharmacokinetics

Absorption is slow, but complete (food intake does not significantly affect the speed and degree of suction). After one-time reception, the Cmax tablet is achieved after 32 hours. The average value of the Cmax of the unchanged active substance after one-time intake of 400 mg of carbamazepine is about 2.5 μg / ml. The CSS of the drug in plasma is achieved after 1-2 weeks, the achievement rate depends on the individual characteristics of metabolism (autoinduccination of enzyme liver systems, heteroinduccia by other LS used), as well as on the patient's condition, dose of the drug and the duration of treatment. Significant individual differences of CSS values \u200b\u200bin the therapeutic range are observed: Most patients fluctuate from 4 to 12 μg / ml (17-50 μmol / l). The concentrations of carbamazepine-10,11-epoxy (pharmacologically active metabolite) make up about 30% of the concentration of carbamazepine.

Communication with plasma proteins in children - 55-59%, in adults - 70-80%.

Apparent VD - 0.8-1.9 l / kg. In the spinal fluid and saliva, concentrations are created proportional to the amount of an active substance unrelated with proteins (20-30%). Penetrates through a placental barrier. The concentration in breast milk is 25-60% of this plasma.

Metabolized in the liver, mainly by epoxy path with the formation of basic metabolites: active carbamazepine-10,11-epoxide and an inactive conjugate with glucuronic acid. The main isoenzyme that ensures the biotransformation of carbamazepine in carbamazepine-10,11-epoxy is cytochrome P450 (CYP3A4). As a result of these metabolic reactions, metabolite 9-hydroxy-methyl-10-carbamoylacridan, which has a weak pharmacological activity, is also formed.

Carbamazepine can induce its own metabolism. T1 / 2 After the intake of one-time dose is 60-100 hours (on average, about 70 hours), with a continuous reception T1 / 2 decreases due to autoinduction of enzyme liver systems. After a single reception of carbamazepine, 72% of the adopted dose is derived from the urine and 28% - with the feces; In this case, about 2% of the adopted dose is derived from the urine in the form of unchanged carbamazepine, about 1% - in the form of a 10.11-epoxy metabolite.

Data indicating that carbamazepine pharmacokinetics changes in elderly patients, no.

Pharmacodynamics

Anti-Epileptic (Dibenzazizepine derivative), which also has antidepressive, antipsychotic and antidiuretic effect, has an analgesizing effect in patients with neuralgia. The mechanism of action is associated with blockade of potential-dependent sodium channels, which leads to the stabilization of the membranes of over-excited neurons, inhibiting the emergence of serial discharges of neurons and a decrease in synaptic pulses. Prevents the re-education of Na +-independent potentials of action in depolarized neurons. Reduces the release of glutamate exciting neurotiator amino acid, increases the reduced convulsive threshold of the CNS and thus reduces the risk of developing an epileptic attack. Increases the conductivity K +, modulates the potential-dependent CA2 + - channels, which can also contribute to the anticonvulsant effect of the drug. Effective in focal (partial) epileptic attacks (simple and complex), accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic exposures, as well as when combining these types of attacks (usually ineffective with small attacks - Petit Mal, absans and myoclonic attacks) .

Patients with epilepsy (especially children and adolescents) have a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggressiveness. Influence at cognitive function and psychomotor indicators depends on the dose. The beginning of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduccia metabolism).

With the essential and secondary neuralgia of the trigeminal nerve carbamazepine, in most cases, prevents pain attacks. The weakening of pain with neuralgia of a trigeminal nerve is observed in 8-72 hours.

In the syndrome of alcoholic abstinence increases the threshold of convulsive readiness, which is usually reduced in this state, and reduces the severity of clinical manifestations of syndrome (increased excitability, tremor, gait disruption).

Antipsychotic (antimanical) action is developing in 7-10 days, it may be due to the oppression of dopamine metabolism and norepinephrine. The prolonged dosage form ensures the maintenance of a more stable concentration of carbamazepine in the blood when receiving 1-2 times per day.

Indications for the use of Finlepsin Retard

• epilepsy (primary-generalized seizures (with the exception of absans), partial forms of epilepsy (simple and complex seizures), secondary generalized seizures);
• neuralgia of a trigeminal nerve;
• idiopathic glossofaring neuralgia;
• pain in the lesions of peripheral nerves in diabetes, pain in diabetic neuropathy;
• epileptiform cramps with multiple sclerosis;
• cramps of facial muscles with neuralgia of a trigeminal nerve;
• tonic convulsions, paroxy violations of speech and movements (paroxysmal dysarthria and ataxia);
• paroxysmal paresthesias and pain attacks;
• alcohol abstine syndrome (anxiety, convulsions, hyperoportability, sleep disorders);
• psychotic disorders (affective and schizoaffective disorders, psychosis, violations of the limbic system).

Contraindications to apply Finlepsin Retard

• increased sensitivity to carbamazepine and other components of the drug, as well as tricyclic antidepressants;
• disorders of bone marrowing (anemia, leukopenia);
• acute interspersed porphyria (including a history);
• atrioventricular blockade;
• the simultaneous purpose of the drugs of lithium and Mao inhibitors.

With caution: decompensated chronic heart failure; hyponatremia of dilution (Hypersecretion syndrome of ADG, hypocituitarism, hypothyroidism, lack of adrenal cortex); Lack of liver and kidney function; elderly age; active alcoholism (the depression of the central nervous system increases, carbamazepine metabolism increases); oppression of bone marrowing against the background of drug intake (a history); prostate hyperplasia; Increased ing Combination with sedative and sleeping agents.

Finlepsin Retard Application during pregnancy and children

Women reproductive age Finlepsin® retard as possible in the form of monotherapy, in a minimally effective dose, because frequency congenital anomalies Newborns from mothers who took combined anti-epileptic treatment, higher than during monotherapy.

At the occurrence of pregnancy, it is necessary to compare the expected benefit of therapy and possible complications, especially in the first trimester of pregnancy.

It is known that children of mothers suffering from epilepsy are predisposed to violations of intrauterine development, including malformations. Finlepsin® Retard is able to raise the risk of these violations. There are isolated reports of cases of congenital diseases and malformations, including the incoming of the arms of the vertebrae (Spina Bifida). Anti-epileptic agents enhance folic acid deficiency, often observed during pregnancy, which can contribute to an increase in the frequency of congenital defects in children, so before the onset of the planned pregnancy and during pregnancy is recommended to receive folic acid. In order to prevent hemorrhagic complications in newborns, women in the last weeks of pregnancy, as well as newborn, it is recommended to appoint Vitamin K.

Carbamazepine penetrates breast milk, so you should compare the benefit and possible unwanted consequences of breastfeeding in conditions of continuing therapy. When continuing to breastfeeding against the background of the drug, it is necessary to monitor the child due to the possibility of developing adverse reactions (for example, pronounced drowsiness, allergic skin reactions).

Finlepsin retard side effects

When estimating the frequency of occurrence of various adverse reactions, the following gradations are used: very often - 10% or more; often - 1-10%; Sometimes - 0.1-1%; rarely - 0.01-0.1%; Very rare - less than 0.01%.

The development of adverse reactions from the CNS may be a consequence of the relative overdose of the drug or significant oscillations of the concentration of carbamazepine in the blood plasma.

From the CNS: often - dizziness, ataxia, drowsiness, general weakness, headache, accommodation paresis; Sometimes - anomalous involuntary movements (for example, tremor, "fluttering" tremor - Asterixis, dystonia, teaks); Nistagm; rarely - hallucinations (visual or auditory), depression, decline in appetite, anxiety, aggressive behavior, psycho-motor arousal, disorientation, activation of psychosis, oropacial dyskinesia, eye violations, violations of speech (for example, dysarthilation or inexpressible speech), choreathyoid disorders, peripheral Neuritis, paresthesia, muscle weakness and stemmes. The role of the drug in the development of malignant neuroleptic syndrome, especially in combination with neuroleptics, remains unexplained.

Allergic reactions: often - urticaria; Sometimes - erythrodermia, multi-core reactions of slow-type hypersensitivity with fever, skin rashes, vasculitis (including erythema, as a manifestation of skin vasculitis), lymphadenopathy, features resembling lymphoma, arthralgia, leukopenia, eosinophilia, hepatostegaly and changed liver function indicators ( These manifestations are found in various combinations). Other organs can also be involved (for example, light, kidney, pancreas, myocardium, a thick intestine, aseptic meningitis with myoclone and peripheral eosinophilia, anaphylactoid reaction, angioedema edema, allergic pneumonite or eosinophilic pneumonia. In the occurrence of the above allergic reactions, the use of the drug must be discontinued; Rarely - a lupus-like syndrome, itching of the skin, multiform exudative erythema (including Stevens-Johnson), toxic epidermal necroliz (Layella syndrome), photosensitivity.

From the oral formation organs: often leukopenia, thrombocytopenia, eosinophilia; Rarely - leukocytosis, lymphadenopathy, folic acid deficiency, agranulocytosis, aplastic anemia, true erythrocyte aplasia, megaloblastic anemia, acute interspersed porphyria, reticulocytosis, hemolytic anemia, splenomegaly.

From the digestive system: often - nausea, vomiting, dry mouth, increase activity of GGT (due to the induction of this enzyme in the liver), which usually does not have clinical significance, increasing the activity of the SCF; Sometimes - increase the activity of hepatic transaminases, diarrhea or constipation, abdominal pain; Rarely - glossitis, gingivitis, stomatitis, pancreatitis, hepatitis cholestatic, parenchymal (hepatocellular) type, jaundice, granulomatous hepatitis, liver failure.

From the side of the SCC: rarely - disorders of intracardiac conductivity; Reducing or increased blood pressure, bradycardia, arrhythmias, AV blockade with faints, collapse, aggravation or development of HSN, exacerbation of IBS (including the appearance or increase in angina attacks), thrombophlebitis, thromboembolic syndrome.

From the endocrine system and metabolism: often - swelling, fluid delay, increasing body weight, hyponatremia (decrease in plasma osmolarity due to the effect similar to the action of ADG, which in rare cases leads to hyponatremia of breeding, accompanied by lethargia, vomiting, headache, disorientation and neurological disorders); rarely - an increase in prolactin concentration (may be accompanied by galattere and gynecomastia); Reducing the concentration of L-thyroxine and an increase in the concentration of TSH (usually not accompanied by clinical manifestations), disorders of calcium-phosphoric metabolism in bone tissue (decrease in Ca2 + concentration and 25-one-cholecalciferol in blood plasma): osteomalacia, hypercholesterolemia (including hslpvp), hyperitriglyceridemia and An increase in lymph nodes, girsutism.

From the genital system: rarely - interstitial nephritis, renal failure, impairment of kidney function (for example, albuminuria, hematuria, oliguria, urea / azotemia increase), urination rapid, urine delay, reducing potency.

On the part of the musculoskeletal system: rarely - arthralgia, myalgia or convulsions.

From the side of the senses: rarely - violations of taste sensations, an increase in VGD; clouding lens, conjunctivitis; hearing impairment, incl. Noise in ears, hyperacts, hypoacusa, changes in the perception of sound height.

Others: skin pigmentation disorders, purpura, acne, sweating, alopecia.

Medicinal interaction

The simultaneous purpose of carbamazepine with CYP3A4 inhibitors can lead to an increase in its concentration in the blood plasma and the development of adverse reactions.

The joint use of CYP3A4 inductors can lead to the acceleration of carbamazepine metabolism, a decrease in its concentration in blood plasma and a decrease in the therapeutic effect; On the contrary, their cancellation can reduce the rate of biotransformation of carbamazepine and lead to an increase in its concentration.

The concentration of carbamazepine in the plasma verapamil, diltiazene, felodipine, dextropropoxyfen, vilodpine, fluoxetine, fluoksamine, cymetidine, acetasolamide, danazole, desipramine, nicotinamide (in adults, only in high doses); macrolides (erythromycin, josamamicin, clarithromycin, toleandomycin); Azol (Iratenazole, ketoconazole, fluconazole), terphelanadine, Loratadine, Isoniazide, propoxyphen, grapefruit juice, inhibitors of viral protease used in HIV therapy (for example, ritonavir) - a dosing mode correction or monitoring of the plasma carbamazepine concentration is required.

Felbamate reduces the concentration of carbamazepine in the plasma and increases the concentration of carbamazepine-10,11-epoxy, and it is possible to simultaneously decrease the concentration in serum in Feelbamate.

The concentration of carbamazepine is reduced by phenobarbital, phenytoin, prison, metorsximide, phenutsamide, theophylline, rifampicin, cisplatin, doxorubicin, possibly clonazepam, valpromide, rope acid, oxarbazepine and vegetable preparations containing hypertecery (Hypericum Perforatum).

There is the possibility of displacement with valproic acid and a carbamazepine prison due to plasma proteins and an increase in the concentration of pharmacologically active metabolite (carbamazepine-10,11-epoxy). With a combined application of Finlepsin with valproic acid in exceptional cases, coma and confusion of consciousness may occur.

Isotretinoin changes bioavailability and / or clearance of carbamazepine and carbamazepine-10,11-epoxy (monitoring of the concentration of carbamazepine in plasma is necessary). Carbamazepine can reduce the concentration in plasma (reduce or even to completely level effects) and require the correction of doses of the following drugs: hlobazama, clonazepama, digoxin, ethosuximide, prison, valprooic acid, alprazolam, GKS (prednisone, dexamethasone), cyclosporine, tetracycline (doxycycline), Haloperidol, methadone, oral preparations containing estrogens and / or progesterone (selection of alternative methods of contraception), theophylline, oral anticoagulants (warfarin, phenprochamone, dickyurola), lamidridge, topiramata, tricyclic antidepressants (imipramine, amitrilthylin, nodriptyline, clomipramine), clozapine , Felbamate, TiagaBabine, Okskarbazepine, protease inhibitors used for HIV therapy (Indinavir, Ritonavir, Savinovira), BKK (Dihydropyridon group, for example, Felodipine), Itraconazole, Levothyroxin, Midazolam, Olanzapine, Praziquantera, Risperidone, Tramadol, Tsiprazidone. It is possible to increase or reduce the level of phenytoin in the blood plasma against the background of carbamazepine and increase the level of measurement.

With the simultaneous use of carbamazepine and lithium preparations, the neurotoxic effects of both active substances may increase.

Tetracyclines can weaken the therapeutic effect of carbamazepine. When co-use with paracetamol, the risk of its toxic effect on the liver increases and the therapeutic efficacy (acceleration of paracetamol metabolism) is reduced. The simultaneous purpose of carbamazepine with phenothiazine, pimisid, thioxanthenes, moldunion, haloperidol, maproletin, clozapine and tricyclic antidepressants leads to an increase in the oppressive effect on the CNS and the weakening of the anticonvulsant effect of carbamazepine.

Mao inhibitors increase the risk of developing crisis crises, hypertensive crimes, cramping, deadly outcome (before appointing carbamazepine Inhibitors of the MAO must be canceled at least 2 weeks or, if the clinical situation allows, even for a longer period).

Simultaneous appointment with diuretics (hydrochlorothiazide, furosemide) can lead to hyponatremia accompanied by clinical manifestations. Weakens the effects of non-polarizing muscle relaxants (pankronia). In the case of applying such a combination, it may be necessary to increase the dose of minelaxants, and careful monitoring of the patient's condition is necessary due to the possibility of a faster cessation of the actions of the muscle relaxants.

Carbamazepine reduces ethanol tolerability.

Myelotoxic drugs enhance the manifestations of hematotoxicity of the drug.

Accelerates metabolism indirect anticoagulantov, hormonal contraceptive drugs, folic acid; Prazicvantel, can enhance the elimination of thyroid hormones.

Accelerates the metabolism of drugs for anesthesia (enfluran, halotan, fluorotan) and increases the risk of hepatotoxic effects; Enhances the formation of nephrotoxic metabolites of methoxyfluran. Enhances the hepatotoxic effect of isoniazide.

Dosage Finlepsin Retard

Inside, during or after eating, drinking sufficient liquid. For ease of use, the tablet (as well as half or a quarter) can be pre-dissolved in water or juice, because The property of the prolonged release of the active substance after dissolving the tablet in the liquid is preserved. The range of doses used is 400-1200 mg / day, which are distributed on 1-2 receptions per day.

The maximum daily dose should not exceed 1600 mg.

Epilepsy

In cases where it is possible, Finlepsin® retard should be assigned in the form of monotherapy. Treatment is beginning with the use of a small daily dose, which is subsequently slow to achieve an optimal effect. The addition of Finlepsin® drug to the already conductive antiepileptic therapy should be carried out gradually, while the doses of the drugs used are not changed or, if necessary, corrected. If the patient forgot to take the next dose of the drug in a timely manner, should take a missed dose at once, as soon as this omission has become noticed, and it is impossible to take a double dose of the drug.

Adults. The initial dose is 200-400 mg / day, then the dose is gradually raised until the optimal effect is achieved. Supporting dose - 800-1200 mg / day, which are distributed on 1-2 reception per day.

Children. The initial dose for children from 6 to 15 years - 200 mg / day, then the dose is gradually increased by 100 mg / day until the optimal effect is achieved. Supporting doses for children 6-10 years old - 400-600 mg / day (in 2 receptions); For children 11-15 years old - 600-1000 mg / day (in 2 receptions).

The duration of use depends on the testimony and individual reaction of the patient for treatment. The decision to transfer the patient to Finlepsin® retard, the duration of its use and cancellation of treatment is made by a doctor individually. The possibility of reducing the dose of the drug or cessation of treatment is considered after a 2-3-year period of the complete absence of seizures.

Treatment is stopped, gradually reducing the dose of the drug for 1-2 years, under the control of EEG. In children, with a decrease in the daily dose of the drug, an increase in body weight with age should be taken into account.

Neuralgia Triple Nerva, Idiopathic Gloss-Faringeal Neuralgia

The initial dose is 200-400 mg / day, which are distributed to 2 receptions. The initial dose is raised up to the complete disappearance of pain, an average of up to 400-800 mg / day. After that, a certain part of patients, treatment can continue to continue the lower supporting dose of 400 mg.

Elderly patients and patients sensitive to Karabamazepine, Finlepsin® Retard is prescribed in the initial dose of 200 mg 1 time per day.

Pain in diabetic neuropathy

The average daily dose is 200 mg in the morning and 400 mg in the evening. In exceptional cases, Finlepsin® Retard can be prescribed at a dose of 600 mg 2 times a day.

Treatment of alcohol abstinence in hospital

The average daily dose is 600 mg (200 mg in the morning and 400 mg in the evening). In severe cases, in the first days, the dose can be raised to 1200 mg / day, which are distributed to 2 receptions.

If necessary, Finlepsin® retard can be combined with other substances used to treat alcohol abstinence, except for sedatives.

During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma.

In connection with the possible development of side effects on the part of the central and vegetative nervous system, careful observation in the hospital is established for patients.

Epileptiform cramps with multiple sclerosis

The average daily dose is 200-400 mg 2 times a day.

Treatment and prevention of psychosis

The initial and maintenance dose is usually the same - 200-400 mg / day. If necessary, the dose can be raised to 400 mg 2 times a day.

Overdose

Symptoms usually reflect violations by the central nervous system, CSS and respiratory system.

CNS and sense organs - the oppression of the functions of the CNS, disorientation, drowsiness, excitement, hallucinations, coma; Curiousness of vision, vision, dysarthria, nystagm, ataxia, dyskinesia, hyperreflexia (at the beginning), hypoxicia (later), convulsions, psychomotor disorders, myoclonus, hypothermia, mydriasis).

CSS - tachycardia, decreased blood pressure, sometimes increased blood pressure, disorders of intraventricular conductivity with the expansion of the QRS complex; fainting, stop heart.

The respiratory system is the oppression of breathing, the swelling of the lungs.

The digestive system is nausea and vomiting, retention of food evacuation from the stomach, reduced motorcycle gut.

Urinary system - urine delay, oliguria or anouria; fluid delay; hyponatremia.

Laboratory indicators - leukocytosis or leukopenia, hyponatremia, metabolic acidosis is possible, hyperglycemia and glucosuria, an increase in the muscle fraction of the KFK.

Treatment: Specific antidote is absent. It is necessary symptomatic supporting treatment in the intensive care unit, monitoring of heart function, body temperature, corneal reflexes, kidney and bladder function, correction of electrolyte disorders. It is necessary to determine the concentration of carbamazepine in a plasma to confirm the poisoning by this tool and evaluation of the degree of overdose, washing the stomach, the purpose of activated carbon. Late evacuation of gastric content can lead to delayed suction on the 2nd and 3rd days and the re-appearance of the symptoms of intoxication during the recovery period. Forced diuresis, hemodialysis and peritoneal dialysis are ineffective; However, dialysis is shown in a combination of severe poisoning and renal failure. Children may have a need for hemotransfusion.

Precautions

The monotherapy of epilepsy is beginning with the appointment of a low initial dose, gradually increasing it to achieve the desired therapeutic effect.

When selecting the optimal dose, it is advisable to determine the concentration of carbamazepine in the blood plasma, especially when combined therapy. In some cases, the optimal dose can be significantly deviated from the recommended initial and maintenance dose, for example, in connection with the induction of liver microsomal enzymes or due to interactions for combined therapy.

Finlepsin should not be combined with sedative hypnotic means.

If necessary, it can be combined with other substances used for the treatment of alcohol abstinence. During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma. In connection with the development of side effects on the part of the central and vegetative nervous system, careful observation in the hospital is established for patients. When the patient is transferred to carbamazepine, it is necessary to gradually reduce the dose of the previously prescribed antiepileptic tool up to its complete cancellation. Sudden cessation of carbamazepine reception can provoke epileptic attacks. If it is necessary to abruptly interrupt treatment, you should translate the patient to another anti-epileptic agent under the cover of the drug shown in such cases (for example, diazepama, in / in or rectally, or phenyotine, in / c).

Several cases of vomiting, diarrhea and / or low nutrition, seizures and / or oppression of breathing in newborns, whose mothers took carbamazepine simultaneously with other anticonvulsants (possibly, these reactions are manifestations of newborns of cancellation syndrome). Before the appointment of carbamazepine and during treatment, it is necessary to study the liver function, especially in patients, in the history of which there are information about liver diseases, as well as in elderly patients. In the case of increased liver disorders or when active liver disease appears, the drug should be canceled immediately.

Before starting treatment, it is necessary to conduct a study of blood pattern (including platelet counting, reticulocytes), iron levels in blood serum, general urine analysis, blood urea level, EEG, determination of the electrolyte concentration in serum (and periodically during treatment, because It is possible to develop hyponatremia). Subsequently, these indicators should be monitored during the first month of treatment weekly, and then monthly.

In most cases, the transient or resistant decrease in the number of platelets and / or leukocytes is not precursors of the beginning of aplastic anemia or agranulocytosis. Nevertheless, before starting treatment, and periodically in the process of treatment, clinical blood tests should be carried out, including the counting of platelet numbers and, possibly, reticulocytes, as well as determine the level of iron in the serum.

The immanent asymptomatic leukopenia does not require cancellation, however, treatment should be discontinued when the progressive leukopenia or leukopenia appears, accompanied by clinical symptoms infectious disease.

Carbamazepine should be immediately canceled when the reactions of hypersensitivity or symptoms appear presumably testifying to the development of Stevens-Johnson's syndrome or Lylela syndrome. Weakly pronounced skin reactions (isolated maculse or maculopapulous examtime) usually pass within a few days or weeks even with the continuation of treatment or after a decrease in the dose of the drug (the patient should be under the closer observation of the doctor at this time).

It is necessary to take into account the possibility of activation of latent flowing psychosis, and in elderly patients - the possibility of developing disorientation or psychomotor excitation.

In some cases, treatment with antiepileptic drugs was accompanied by suicidal attempts / suicidal intentions. It was also confirmed when conducting a meta-analysis of randomized clinical trials using antiepileptic agents. Since the mechanism for the occurrence of suicidal attempts using anti-epileptic drugs is unknown, it is impossible to exclude their occurrence and in the treatment of Finlepsin® patients. Patients (and service personnel) need to be prevented about the need to follow the appearance of suicidal thoughts / suicidal behavior and in the event of symptoms immediately apply for medical care.

There are disorders of male fertility and / or spermatogenesis disorders, but the relationship of these violations with carbamazepine intake is not yet established.

The appearance of intermented bleeding with the simultaneous use of oral contraceptives is possible. Carbamazepine can adversely affect the reliability of oral contraceptive drugs, so alternative prevention methods should be applied to women reproductive age during the treatment period.

Carbamazepine should be applied only under medical supervision. You must bring to the attention of patients information about early signs of toxicity, as well as symptoms from skin Pokrov and liver. The patient informs about the need to immediately consult a doctor in case of such unwanted reactions, such as fever, throat pain, rash, ulceration of the oral mucosa, the unfortunate occurrence of bruises, hemorrhages in the form of petechs or purpura.

Before starting treatment, it is recommended to conduct an ophthalmic examination, including the research of the eye dNA and the measurement of the WGD. In the case of prescribing the drug, patients with increasing WFA requires constant monitoring of this indicator.

Patients with severe cardiovascular diseases, lesions of the liver and kidney, as well as elderly people prescribe lower doses of the drug. Although the relationship between the dose of carbamazepine, its concentration and clinical efficacy or tolerance is very insignificant, nevertheless, regular determination of the level of carbamazepine may be useful in the following situations: with a sharp increase in the frequency of attacks; In order to check whether the patient takes the drug properly; during pregnancy; in the treatment of children or adolescents; if suspected disorders of the drug absorption; If the development of toxic reactions is suspected if the patient takes several LS.