Reviews for the relief. Relium: Instructions for the use of religion diazepam

05.06.2020

tablets covered with shell 5 mg

Registration number:

P № 015047 / 02-2003

Tradename

Relium (Relium)

International non-proprietary title

Diazepam (Diazepam)

Dosage form, dose

tablets covered with shell, 5 mg

Structure:

active substance:
diazepam 5 mg

excipients:
potato starch, gelatin, twin 80, talc, magnesium stearate quinoline yellow e 104, lactose

the composition of the shell:
phthalate acetylcellulose, polyethylene glycol 6000

Description

Tablets covered with film shell, round, on both sides of convex, without expelled edges and cracks, yellow color. On the bell of yellow.

Pharmacological group:

Group affiliation according to the classification of PBX: N 03 AE, N 05 BA.
Anxolytic agent from a group of benzodiazepines

Pharmacological properties

Pharmacodynamics

Diazepam refers to the group of benzodiazepine derivatives.

The drug acts on many structures of the central nervous system. The mechanism of action of the drug is closely associated with the brake endogenic neuromediator of gamma-amine oil acid (GABA) and the gamke-A receptor, through which the neurotransmitter implements its effects in the central nervous system.

Like all other benzodiazepines, diazepam enhances the braking effect of GAMK-Ergic neurons in the central nervous system.

The clinical action of diazepam is manifested by a pronounced anxiolytic and anticonvulsant action; Single and central minelaxing effect is somewhat weaker.

Pharmacokinetics

Suction

After oral application Diazepams are well and quickly absorbed from the digestive tract, bioavailability is 98%.

After oral administration of one dose of 20 mg, the maximum concentration of the blood serum (with MAX) is achieved in 50-90 minutes and is approximately 500 ng / ml.

Distribution

Diazepam approximately in 94-99% binds to blood proteins. The drug passes through the hematostephalic and placental barrier, penetrates the mother's milk. Exhibits a large affinity for adipose tissue, in which deposited and from there is gradually released into blood.

The amount of distribution is 1.1-1.5 l / kg.

Metabolism

Diazepam is intensively metabolized in the liver to active N-dismeteraldiazepama metabolites (Nordazepama) and N-methylocazepama. Both metabolites are transformed into pharmacologically active oxazepam, which binds to glucuronic acid.

Half-life (T 1/2) is 24-48 hours; can lengthen in newborns, patients in senior age (Active metabolites extend the semi-elimination period; the period of semi-elimination of the N-dismeteraloxazepama can reach 100 hours, depending on the age and activity of the liver).

Selection

The drug is displayed mainly with urine in the form of metabolites; Up to 25% of the drug can be excreted by kidneys unchanged. Repeated doses of the drug can lead to cumulating the drug and its metabolites.

Indications for use

neurosis, borderline states with stress phenomena, anxiety, anxiety, fear
in the syndrome of alcohol abstinence, in order to reduce the symptoms of excitation
in complex therapy for diseases associated with an increased tone of skeletal muscles (after injuries, spastic states after cerebral strokes)
violations of sleep
in the complex therapy of epilepsy (in combination with other anticonvulsants)
motor excitement of various etiology
when preparing for operating interventions and diagnostic procedures

The drug should be applied strictly to the appointment of a doctor to avoid complications.

Method of application and dose

Dosage and duration of treatment should be selected individually for each patient in order to obtain maximum treatment effects.

The following doses are usually applied:

Adults

Fear states: 2-10 mg 2-4 times a day.

Alcoholic abstine syndrome: 10 mg 3-4 times a day during the first day, then (if necessary) 5 mg 3-4 times a day.

Diseases accompanied by increased tone of skeletal muscles: 2-10 mg 3-4 times a day.

Sleep disorders: 5-15 mg in a single dose before bedtime.

Epilepsy (in combination with other drugs): 2-10 mg 2-4 times a day.

Preparation for operational interventions and diagnostic procedures: 5-20 mg in a single dose or in separated doses before operating intervention.

Maximum daily dose: up to 60 mg / day (in complex therapy epilepsy, often in spastic states)

0.1-0.8 mg per 1 kg of body weight of the child per day.

From 1 to 3 years: 1-1.5 mg - 2-3 times a day. Daily dose 2.5 - 5.0 mg.

3 - 7 years: 1.5-2.5 mg - 2-3 times a day. Daily dose 5-7mg.

The drug does not apply in children up to 1 year old.

Sick senior age (over 65 years old)

Diazepam must be used with caution in elderly patients. A dose reduction is recommended. Usually 2 - 2.5 mg 1 - 2 times a day. If necessary, the dose can be gradually increased (subject to good tolerability of the drug).

Patients with impaired liver and kidney function.

The duration of therapy is usually 4 weeks (including the time of gradual reduction in the dose of the drug). Do not take the drug over 4 weeks without re-evaluating the need to continue therapy.

It is impossible to abruptly cancel the drug, it is always necessary to gradually controlled by a doctor, a reduction in the dose. A sharp cancellation of diazepam can lead to sleep and mood disorders, and even mental disorders. Especially dangerous sharp cancellation during long-term therapy or when using large doses of the drug. Symptoms of cancellation are then more pronounced.

SIDE EFFECT

The most commonly occurring undesirable action during therapy with the drug is: drowsiness, fatigue, fatigue, disorders of coordination of movements.

Less likely meet: dizziness and headache, disorders from the digestive tract (nausea, constipation), violation of vision, illegal speech, liquefaction arterial pressure Blood, Depression, Disoormentation States, Reducing Libido, Skin allergic reactions, urination disorders, neutropenia, jaggility skin Pokrov (During long-term therapy, periodic monitoring of the blood pattern and functional samples of the liver), paradoxical reactions (states of psychomotor excitation, insomnia, fear) are shown.

In case of paradoxical reactions, it is necessary to immediately interrupt the treatment.

The systematic use of the drug more than 2-3 weeks can lead to the development of drug dependence, as well as the abstineent syndrome in the case of a sharp cancellation.

Warnings

The long-term use of diazepam leads to a gradual weakening of the effect of the drug as a result of the development of the phenomenon of tolerance.

The long-term intake of the drug contributes to the development of psychophysical drug dependence and abstinence syndrome in the case of a sharp cancellation of diazepam. Abstine syndrome is characterized by psychomotor excitation, fear, vegetative disorders and insomnia.

During the treatment with diazepam and within 3 days after its completion, it is impossible to use any alcoholic beverages.

Contraindications

increased sensitivity to benzodiazepines,
respiratory disorders of central origin and severe conditions of respiratory failure, regardless of the cause,
miastiya
clotted glaucoma form
violations of consciousness.

Do not apply in children up to 1 year old.

Application in pregnancy and breastfeeding

The use of drugs during pregnancy is allowed only if its use of the mother has absolute readings, and the use of a more secure, alternative means is impossible or contraindicated. In the treatment of diazepam, it is impossible to breastfeed.

Interaction with other drugs

Pharmaceutical

Pharmaceutical types of incompatibility are not defined

Pharmacodynamic

The inhibitory effect of diazepam on the central nervous system is reinforced by all drugs with a similar action: sleeping pills (eg barbiturates), drugs reduced blood pressure central action, neuroleptics, antidepressants, anticonvulsant drugs, narcotic analgesics.

A similar action is manifested ethanol. Alcohol use during diazepam treatment, except for the summing inhibitory effect on the CNS, can provoke paradoxical reactions: psychomotor excitation, aggressive behavior.

The drug enhances the effect of funds that reduce the tone of skeletal muscles.

Pharmacokinetic

Oral contraceptive means can slow down the metabolism of diazepam and strengthen its action.

Smoking can lead to the weakening of the action of diazepam.

OVERDOSE

As a result of the overdose of diazepam, the following symptoms may appear: drowsiness, the state of disintegration, indispensable speech, and in severe cases loss of consciousness and coma.

For acute poisoning It is necessary to cause vomiting, rinse the stomach.

Treatment in the overdose of diazepam is primarily symptomatic and is monitored by the main life functions (respiration, pulse, blood pressure).

Specific antidote is fluumazenyl (benzodiazepine receptor antagonist).

SPECIAL INSTRUCTIONS

Impact on the ability to control vehicles and maintain moving mechanical devices

During treatment with the drug and within 3 days after its completion, it is impossible to control vehicles, maintain moving mechanical devices and perform work that requires special attention and rapid reaction.

Form release

Sheath-covered tablets 5mg

Packaging

20 tablets in the blister.
One blister along with the instructions for use is placed in a cardboard pack.

STORAGE CONDITIONS

Store at temperatures up to 25 ° C. Protect from light and moisture.
List of potent and poisonous substances No. I on PKN
Store in places inaccessible to children.

SHELF LIFE

3 years
Before applying the drug, it is necessary to check the shelf life indicated on the package.
The drug cannot be used later specified on the duty packaging.

Conditions of vacation from pharmacies:

according to the doctor's prescription.

MANUFACTURER

Tarhominsky Pharmaceutical Plant "Polafa" Joint-Stock Company

ul. A. Fleming 2.

The relium is a tranquilizer that has a sedative, anxiolytic, central minelaxing and anti-epileptic effect.

Release form and composition

The drug has two dosage forms:

Solution 5 mg / ml (in 2 ml ampoules, 50 ampoules in a carton);
Tablets in a film shell of 5 mg (20 pieces in a blister, 1 blister in a cardboard box).

The existing substance of the relief is diazepam.

Indications for use

The use of the Relief is shown at:

Neurotic disorders and borderline states that are accompanied by fears, anxiety, voltages, anxiety;
Abstinence syndrome due to chronic alcoholism;
Sleep disorders and motor excitation of various genesis in psychiatry and neurology;
Spastic conditions caused by the damage to the spinal or brain;
The lesions of the musculoskeletal system, which are accompanied by a stress of skeletal muscles (including in arthritis, mosites, bursts);
Epileptic status;
Tetanus;
Gods, including premature (the drug is applied to relieve generic activity);
Premature placental detachment.

The relium can be used as a component of the combined anesthesia and for premedication before anesthesia.

Contraindications

The religion is contraindicated at:

Severe chronic hypercapnia;
Respiratory disorders of central origin;
Glaucoma;
Violations of consciousness;
Dizziness;
Severe miastic;
Equilibrium disorders;
Presence in history of instructions for medicinal or alcohol dependence (an exception is the acute abstinence);
Depressive states with suicide tendency;
Hypersensitivity to the components of the drug and other benzodiazepines.

As for the use of the Relief in Pediatrics, the drug is not recommended to appoint newborns. This is due to the fact that the enzyme system participating in the metabolism of diazepam in children at this age is not yet fully formed.

The relium does not apply in the first trimester of pregnancy. The exceptions are cases of extreme necessity. However, it should be remembered that diazepams can significantly change the frequency of heart abbreviations in the fetus.

In cases where a nursing woman according to the testimony is recommended to regularly take the relief, breast-feeding should be stopped.

It is necessary to abide care, assigning the religion to patients with:

Respiratory or heart failure and organic brain lesions (in these cases, only the tableted form of the drug should be prescribed;
Miastenia;
Clotted glaucoma or predisposition to it.

Method of application and dosage

The religion in tablets are taken inside, the solution is injected intramuscularly or intravenously. The treatment regimen is selected individually: a single dose, the duration of application and the frequency of receptions depend on the characteristics of the clinical situation and the testimony.

Daisy dose of diazepam may vary from 0.5 to 60 mg.

Tablets are taken briefly in a daily dose of 5-20 mg in several techniques.

In the syndrome of alcoholic abstinence, treatment starts with a dose of 30 mg / day. Make it on 3 receptions. According to the testimony, the daily dosage can be increased to 60 mg.

With insomnia, the religation is taken over half an hour to sleep for 1 or 2 tablets.

In case of muscle spasticity, the daily dose for an adult is 5-10 mg, in some cases the doctor can increase it to 60 mg.

Daily dose of diazepam for children:

2-3 years - 2-5 mg for 2-3 receptions;
4-7 years - 4-6 mg for 2-3 receptions;
8-17 years - 5-8 mg for 2 receptions.

The injection solution is introduced into a vein or deep into large muscles. The therapeutic dose for an adult can be from 2 to 20 mg.

When conducting premedication, the relium is introduced slowly in / c at a dose of 10 mg. The highest dosage (20 mg) can only be appointed provided that the patient does not get narcotic analgesics simultaneously with diazepam. Also allowed intramuscular injection of the solution in a dosage of 5-10 mg. Injection is made half an hour before the appointed procedure / operation.

With acute cases of anxiety and anxiety, the religion is introduced in / m or in / c at a dose of 2-5 mg. If there is a need for this, the injection is repeated after 3-4 hours.

With heavy neurotic statesaccompanied by obsessive fears (phobias), the solution is introduced in / m or V / V at a dose of 5-10 mg. Repeated injection is possible after 3-4 hours.

With alcoholic abstine syndrome, a single V / M or V / in the introduction of 10 mg of diazepam is shown. If necessary, after 3-4 hours, it is re-injected in a dosage of 5-10 mg.

In muscle spasms, athettosa and tetanus, the solution is introduced in / m or in / in a dose of 5-10 mg. When a tetanus may need to use higher doses.

Patients with epileptic status, as well as patients who have recurrent convulsive seizures, the solution is introduced into the muscle or in Vienna. The initial dose is 5-10 mg, if necessary after 10-15 minutes and after 2-4 hours they make repeated injections in the same dose. The maximum allowable dosage is 30 mg.

When conducting electropulse therapy, the religion is introduced into a vein in 5-10 minutes before the procedure starts at a dose of 5-10 mg.

Children with tetanus show slow intravenous or intramuscular injections. The dose depends on the age of the patient:

From the 5th week of life - 1-2 mg;
Over 5 years old - 5-10 mg.

Repeated injection is possible after 3-4 hours.

With epileptic status and recurrent convulsive seizures, children are introduced into / in for 2-5 minutes. The dose also establishes depending on age:

From the 5th week of life and up to 5 years - 0.2-0.5 mg, the highest dosage - 5 mg;
Over 5 years old - 1 mg, maximum dose of 10 mg.

If necessary, the drug is introduced repeated after 2-4 hours.

Immediately before injection, the religion is bred by 5% glucose or saline solution:

For in / in administration, the contents of 1 ampoules are diluted to a volume of 10 ml. The rate of injection in this method of use should not exceed 4 mg (4 ml) per minute;
For drip / in infusion - the contents of 10 ampoules are divorced in 500 ml of injection mortar. The rate of administration is 40 ml / h (8 mg of diazepama).

Side effects

From side nervous system: drowsiness, muscle weakness, dizziness; rarely - depression, confusion of consciousness, violations, dysarthria, diplopia, headache, ataxia, tremor; In isolated cases - paradoxical reactions (excitation, sleep disorders, increased anxiety, hallucination). After the introduction to Vienna, the IKOT is sometimes marked. Long-term use can lead to a violation of memory and drug dependence;
From side digestive system: rarely - dry mouth, constipation, nausea, savory amplification; In isolated cases - jaundice, improving the activity of serum transaminases and alkaline phosphatase in the blood plasma;
From side endocrine system: rarely - a change in libido;
From the urinary system: rarely - urinary incontinence;
From side of cardio-vascular system: perhaps a slight decrease in blood pressure;
From the side of the respiratory system: in isolated cases, breathing may be disturbed;
Allergic reactions: rarely - rash on the skin.

special instructions

The treatment of the religion is stopped gradually. Sudden cancellation after long use May be accompanied by excitation, concern, convulsions, tremor.

In the case of development in a patient, paradoxical reactions (for example, hallucinations, acute excitation or anxiety), the religion should be canceled.

After intramuscular injection In the blood plasma can increase the activity of creatine phosphocainase. This should be remembered when differential diagnosis Myocardial infarction.

During the entire period of treatment, it is forbidden to use alcoholic beverages.

Diazepams can reduce the rate of mental and / or motor reactions, which the patients whose activities are associated with a risk for health and life should be warned.

When applying a relief in combination with drugs that depress the CNS (sleeping pills and sedatives, drugs for anesthesia, neuroleptics, opioid analgesics, etc.), the inhibitory effect on the CNS and the respiratory center increases, a pronounced decrease in blood pressure occurs.

In patients who for a long time were obtained antihypertensive means of central action, β-adrenergic receptor blockers, cardiac glycosides and anticoagulants, mechanisms and degrees of drug interaction can be unpredictable. In this regard, caution should be taken, assigning religion to people who have long received listed drugs (especially at the initial stages of treatment).

The drug aggravates the effect of tricyclic antidepressants on the CNS, increases their plasma concentration and enhances the severity of the cholinergic effect. The enhancement of Miorolaxanta, diazepam increases the risk of apnea.

In addition, while using the relief simultaneously:

Increases bupivacain concentration in blood plasma;
Enhances the action and suppresses the metabolism of phenytoin;
May give the anti-plasonic effect of Levodopa.

Preparations affecting the effectiveness of the application of diazepam:

Fluvoxamine - increases plasma concentration and enhances side effects;
Omeprazole, cimetidine and disulfiram - increase the intensity and duration of the influence of the tranquilizer;
Oral contraceptives - can enhance the effect, increasing the chance of developing breakthrough bleeding;
Isoniazide and paracetamol - reduce the excretion;
Rifampicin, phenytoin, carbamazepine, phenobarbital, preparations that cause the induction of hepatic enzymes (including anti-epileptic) - accelerate elimination;
Caffeine - reduces sedative and, possibly, anxioly effects;
Theophylline (low doses) - perverts sedative effect.

Application of a relief in combination with:

Clozapine - can cause a sharp reduction in blood pressure, loss of consciousness, inhibition of breathing;
Diclofenaco - increases the likelihood of dizziness;
Metoperolol - worsens mental and motor reactions, reduces visual sharpness;
Lithium carbonate - in isolated cases may cause the development of a comatose state;
Risperidone - increases the risk of malignant neuroleptic syndrome;
Ethanol - enhances the oppressive effect on the CNS, primarily on the respiratory center, and increases the risk of developing pathological syndrome.

Analogs

Apaurin, Valium Rosh, Daespaben, Diazepam, Dizepam Nicomed, Diazpex, Ratiopharm Diazepam, Sibazon, Relanium.

Terms and conditions of storage

Store the drug follows in a darkened place at temperatures up to 25 ºС.

The shelf life of the Relief is 3 years.

Dosage form: & nbspintravenous solution intramuscular administration Structure:

The composition of the drug for 1 ml of solution:

active substance : Diazepam5 mg

excipients: propylene glycol455 mg

ethanol (ethyl alcohol) 96% 100 mg

benzyl alcohol15,5 mg

sodium benzoate49 mg

benzoic acid1 mg

water for injection 1 ml

One ampoule contains 10 mg of diazepam in 2 mg of solution.

Description:

Transparent or slightly opalescent, from colorless to greenish yellow color solution.

Pharmacotherapeutic Group:Anxolytic remedy (tranquilizer). List of III List of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation. ATH: & NBSP

N.05.B.A.01 Diazepam

Pharmacodynamics:

Diazepam belongs to the group of benzodiazepine derivatives.

Diazepam has an oppressive effect on the central nervous system (CNS), implemented mainly in Talamus, the hypothalamus and the limbic system. Enhances the inhibitory effect of gamma-amine-oil acid (gamc),

which is one of the main mediators of pre- and postsynaptic inhibition of the transfer of nerve impulses in the central nervous system. It has anxiolytic, sedative, sleeping pills, central minelaxing and anticonvulsant action. The mechanism of action of the drug is determined by the stimulation of the benzodiazepine receptors of the supramolecular gamke-benzodiazepine-chlorionophore of the prescription complex, leading to the activation of the GABA receptor, which causes a decrease in the excitability of subcortical structures of the brain, the braking of polysinactic spinal reflexes.

Pharmacokinetics:

Suction

With intramuscular administration, the absorption of diazepam can be slow and non-permanent (depends on the place of administration); When introduced into the deltoid muscle - the absorption is fast and complete. Bioavailability - 90%. The maximum concentration in the blood plasma is reached after 0.5-1.5 hours with intramuscular administration (hereinafter recommended) and in the range of 0.25 hours at intravenous administration (hereinafter in / c). The equilibrium concentration is achieved with constant introduction after 1-2 week.

Distribution

Diazepam passes through the hematostephalic and placental barriers. Penetrates the maternal milk. Approximately 98% binds to blood proteins. The degree of binding to proteins in newborns and in patients with liver failure is reduced. Especially high concentrations achieves in the cerebral cortex, cerebellum, middle brain and spinal cord. The drug shows a large affinity for adipose tissue, in which deposited and from there is gradually released into blood. Repeated administration The drug can lead to cumulating the drug and its metabolites (can be stored in the blood for several days or even weeks).

Metabolism

Diazepam is subjected to metabolism in the liver with the formation of active metabolites:N. -Temethyldiazepama (Nordazepama) andN. -Methyloxazepama. Both metabolites are converted into pharmacologically active, which binds to glucuronic acid.

Election

The half-life is 24-48 hours and can be led by patients in old age, children and patients with liver failure. Active metabolites extend the half-life. The drug is derived mainly with the urine in the form of metabolites (about 70%), part is excreted unchanged (can reach 25%) and less than 10% is derived by the carte masses.

Indications:

Treatment of neurotic and neurosis-like disorders with alarm manifestation. Psychomotor excitation relief associated with anxiety.

The relief of epileptic seizures and convulsive states Various etiology. Used under states accompanied by an increase in muscle tone (tetanus, with acute brain circulation disorders, etc.).

The relief of the abstinence syndrome and delirium during alcoholism.

It is also used for premedication and atalagesia in combination with analgesics and other neurotropic drugs in various diagnostic procedures, in surgical practice.

In the clinic of internal diseases: in complex therapy hypertensive disease (accompanied by anxiety, increased excitability), hypertensive crisis, spasms of vessels, macterus and menstrual disorders.

Contraindications:

Individual intolerance of benzodiazepine derivatives, respiratory disorders of central origin and pronounced respiratory failure, regardless of the cause, violation of consciousness, glaucoma, miastic, pregnancy (especially I trimester) and breastfeeding, depressive states with suicide, shock, coma, head injuries, acute alcoholic intoxication with a weakening of vital functions, acute intoxication by drugs that affect the central nervous system (narcotic, sleeping pills and psychotropic means), Absanx or Lennox-Gasto syndrome (with intravenous administration, contributes to the occurrence of tonic epileptic status), childhood up to 5 weeks.

Carefully:

Epilepsy or epileptic seizures in history (the beginning of treatment with diazepam or its sharp cancellation can accelerate the development of seizures or epileptic status), liver and / or renal failure, cerebral and spinal ataxia, hyperkinesis, phenomena in history, organic brain disease, psychosis (possible Paradoxical reactions), hypoproteinemia, night apnea (installed or alleged), elderly age.

If you have one of the listed states and / or diseases before taking the drug, you will definitely consult your doctor.

Pregnancy and lactation:

During pregnancy, only in exceptional cases and only on "life" testimony. The drug has a toxic effect on the fruit and increases the risk of development. congenital defects When applied in the first trimester of pregnancy. Reception therapeutic doses In a later date of pregnancy, the oppression of the central nervous system of the newborn may cause. Permanent use during pregnancy can lead to physical dependence - the symptoms of cancellation in the newborn can be possible.

In the treatment of diazepam, it is impossible to breastfeed.

Method of use and dose:

Dosing mode and duration of the course of treatment, depending on the state and the patient's reaction - strictly by appointment of the doctor.

Adults

The relief of psychomotor excitation associated with the alarm is prescribed 5-10 mg intramuscularly (in / m) or intravenously (in / c), if necessary, the dose is repeated after 3-4 hours.

When the tetanus is prescribed in / m, in / in the jet or drip 10-20 mg every 2-8 hours.

In the epileptic status, they are prescribed in / m or V / B of 10-20 mg, if necessary, the dose is repeated after 3-4 hours.

To remove the spam skeletal muscles - 10 mg per / m per 1-2 hours before the operation.

For acute syndrome Alcohol abstinence: at the beginning of 10 mg intramuscularly or intravenously, then 5-10 mg in 3-4 hours.

For premedication: 0.1-0.2 mg / kg body weight

In the complex therapy of hypertension (accompanied by anxiety, increased excitability), hypertensive crisis, vessel spasms,

climetheus and menstrual disorders: doses, the multiplicity of administration and the course of treatment are selected individually, on average, one-time dose is 5-10 mg.

Children

Newborn is prescribed after the 5th week of life (over 30 days) in / in slowly at 0d-0.3 mg / kg body weight to a maximum dose of 5 mg, if necessary, injection is repeated after 2-4 hours (depending on clinical symptoms) .

Children from 5 years and older - in / in slowly 1 mg every 2-5 minutes to a maximum dose of 10 mg; If necessary, treatment can be repeated in 2-4 hours.

Sick senior age (over 65 years old)

Elderly, weakened or depleted patients are recommended a dose not exceeding half of the dose of appointed adult patients, because They are more sensitive to drugs acting on the central nervous system.

Patients with impaired liver and kidney function

With caution to prescribe a drug to patients with impaired liver and kidney function. Recommended a dose of the drug. The dose is selected individually depending on the degree of liver and renal (creatinine clearance) of insufficiency.

Method of administration

- Intramuscular injections

The contents of the ampoule should be introduced slowly, deep into large muscle groups.

- Intravenous injections

The contents of the ampoule should be administered slowly at a rate of 0.5-1 ml (2.5-5 mg) per minute, into large elbow veins.

- Intravenous drip infusion

The contents of the ampule (10 mg / 2 ml) are diluted at least 50 ml of 0.9% sodium chloride solution or 5% dextrose solution. More than 40 mg should not be diluted (8 ml of solution - 4 ampoules) in 500 ml of 0.9% solution of sodium chloride or 5% decompose solution. The prepared solution of the drug relief must be slow.

Too rapid intravenous administration of the drug may result in the oppression of the respiratory function and reduce blood pressure.

The solution must be prepared immediately before administration and use for 6 hours.

The drug relium should not be mixed with other drugs in one syringe or an infusion bottle.

For the preparation of solutions, it is necessary to use glass bottles.

Sometimes, during dilution of the drug, it may be cloudy disappearing in a few minutes. If cloues will not disappear, the drug does not enter.

With the exception of emergency cases, with intravenous administration of the drug, one person must always be present; Always always need to be available. resuscitation set. It is recommended that patients are under the supervision of a doctor at least for another hour after the administration of the drug. Houses with the patient should always be a responsible adult person.

Side effects:

- from the nervous system: at the beginning of treatment (especially in the elderly patients) - increased fatigue, violation of the concentration of attention, lethargy, dulling emotions, slowing down mental and motor reactions, antegradine amnesia (develops more often than when receiving other benzodiazepines); drowsiness, deceleration of the reaction, headache and dizziness, confusion states of consciousness and disorientation, ataxia; rarely - euphoria, the depression of mood, stupor, dystonic extrapyramidal reactions (uncontrolled body movements, including eyes), hypothexy, dysarthria; Paradoxical reactions (aggressive outbreaks, psychomotor excitation, fear, suicidal inclination, muscular spasmod, confusion, hallucinations, acute excitement, irritability, anxiety, insomnia). During treatment with diazepam, an undiagnosed depression has previously been manifested.

- from the side of the blood formation organs: leukopenia, neutropenia, agranulocytosis (chills, hyperthermia, sore throat, unusual fatigue or weakness), anemia, thrombocytopenia;

- from the digestive system: dry mouth or hypersalization, heartburn, idiot, gastralgy, vomiting, anorexia; disorders of the liver function, increasing the activity of "liver" transaminase and alkaline phosphatase, jaundice;

- from the cardiovascular system: heartbeat, tachycardia, reduction in blood pressure;

- from side gOOD SYSTEM: impaired kidney function, dysmenorrhea, libido disorders;

- allergic reactions: anaphylactic reactions, allergic skin reactions (rash, itching, urticaria) are very rarely noted;

- impact on the fetus: teratogenicity (especially I trimester), the oppression of the central nervous system, respiratory disorder and the suppression of sucking reflex in newborns, whose mother used the drug;

- local reactions: during intramuscular administrations, pain often appears, and sometimes erythema at the place of administration. Sometimes a phlebit may develop at the injection site;

- others: addiction, drug addiction; rarely - the oppression of the respiratory center, a violation of the function of external respiration, violation of vision (diplopy, fuzzy vision), bulimia, loss of body weight;

- with a sharp decline in the dose or termination of reception - the "cancellation" syndrome (irritability, headache, anxiety, excitement, excitement, feeling of fear, nervousness, sleep disturbance, dysphoria, spasm smooth muscles internal organs and skeletal muscles, depersonalization, strengthening of sweating, depression, nausea, vomiting, tremor, perception disorders, incl. Hyperacusia, paresthesia, photophobia, tachycardia, convulsions, hallucinations, rarely - acute psychosis).

- When applied in obstetrics - in docking and premature children - muscle hypotension, hypothermia, dysnae;

- with quick intravenous administration, the oppression of blood circulation and breathing was observed. The horizontal position of the patient for the entire time of injection or intravenous infusion and compliance with the recommended range of diazepam administration almost completely prevents the development of complications of this type.

If any of the side effects indicated in the instructions are exacerbated, or you Noticed any others side effects not specified in the instructions , tell Ob. This doctor.

Overdose:

Symptoms: drowsiness, disor fixed state, violate, violation coordination of movements, paradoxical excitement, reducing reflexes, violation impairment (nystagm), tremor, bradycardia, reduction in blood pressure; In severe cases - loss of consciousness, oppression of respiratory and cardiac activity, coma. Dangerous for life may be poisoning caused by the simultaneous use of diazepam with other means acting in oppressing to the central nervous system or diazepam with alcohol.

Treatment: symptomatic (maintaining breathing and blood pressure), Forced diuresis. It is necessary to monitor the main life functions (respiration, pulse, blood pressure). Specific antidote is. It is not recommended to apply patients with epilepsy (can provoke the development of epileptic seizures).

Interaction:

In order to avoid possible medicinal interactions with diazepam, apply other drugs can only after agreeing with the doctor .

The inhibitory effect of diazepam on the central nervous system amplifies everything medicinal productsWith a similar action: Psychotropic drugs, narcotic analgesics, drugs for general anesthesia, sleeping pills, sedatives, anti-epileptic, antihistamines, neuroleptics, antidepressants, opioids, sympathic and cholinolitic drugs.

The use of alcohol during diazepam treatment enhances the inhibitory effect on the central nervous system and can lead to the development of paradoxical reactions such as: psychoding excitement, aggressive behavior, inhibition of breathing and even coma.

When used with minelaxants, they can increase their action.

Smoking weakens the effect of diazepam, as it accelerates its metabolism.

Microsomal oxidation inhibitors (including oral contraceptives, propoxyphen,) lengthen the half-life and increase the effect of the drug.

The inductors of microsomal liver enzymes () accelerate the metabolism of diazepam and reduce its effectiveness.

Narcotic analgesics strengthen the euphoria, leading to increasing psychological dependence. The depressing effect on the central nervous system is also enhanced. Hypotensive tools can enhance the severity of reduction in blood pressure.

With the joint application of diazepam with clozapine, it is possible to strengthen the oppression of breathing.

With simultaneous use with low-polar cardiac glycosides, it is possible to increase the concentration of the last in the serum and the development of digitalistic intoxication (as a result of competition for communication with plasma proteins).

Reduces the effectiveness of Levodopa in patients with Parkinsonism.

Preparations that block the channel secretion can prevent the process of conjugation of diazepam in the liver, which leads to a faster suction or an increase in the duration of action.

Monoaminoxidase inhibitors, anagetti, psychostimulants change the activity of the drug.

It is potentially possible to increase the toxicity of Zidovudine.

Theophylline (used in low doses) can reduce or even change drug.

Pharmaceutically incompatible in one syringe with other drugs.

Premedication of diazepam allows you to reduce the dose of fentanyl requiring input anesthesia, and reduce the time required for "shutdown" of consciousness Using induction doses.

special instructions:

- unacceptably sharp cessation of treatment due to the risk of "cancellation syndrome" (head and muscle pain, anxiety, tension, confusion, irritability; In severe cases - dramatization, depersonalization, hyperactus, light-friendly, tactile hypersensitivity, paresthesia in limbs, hallucinations and epileptic seizures). However, due to the slow period of the semi-university diazepam, its manifestation is expressed much weaker than that of other benzodiazepines;

- in case of patients, such unusual reactions occur as an increased aggressiveness, acute states of excitement, anxiety, feeling of fear, thoughts on suicide, hallucinations, enhancing muscle seizures, difficult falling asleep, superficial sleep, treatment should be discontinued;

- when prescribing the drug in severe depressions, it is necessary to observe special cautionbecause The preparation can be used for suicidal intent;

- the beginning of treatment with diazepam or its sharp cancellation in patients with epilepsy or with epileptic seizures In the history I can accelerate the development of seizures or epileptic status;

- the multiple use of diazepam leads to a gradual weakening of its action as a result of the development of tolerance;

- the drug must be administered intravenously slowly. The rapid administration of the drug can lead to a decrease in blood pressure, respiratory impairment, and even to stopping cardiac activity;

- greater caution is recommended for intravenous administration of the drug, especially in children in mind the increase in the probability of development. side phenomena on the components of the drug, as well as an increase in the risk of developing acute respiratory failure;

- using (especially in / m or in / c) in doses above 30 mg for 15 hours before delivery or during childbirth can cause a newborn inhibition of respiration (up to apnea), a decrease in muscle tone, decrease in blood pressure, hypothermia, weak act sucking (the so-called "sluggish baby syndrome") and a violation of metabolism in response to cold stress;

- children, especially in the younger age, are very sensitive to the oppressive central nervous system by the action of benzodiazepines;

- the drug contains in its composition a benzyl alcohol (15.5 mg in 1 ml), so care must be taken when it is administered due to the possibility of the appearance of hypersensitivity. In infants and children under 3 years old, the benzyl alcohol may cause the development of toxic or allergic reactions;

- newborn is not recommended to prescribe drugs containing benzyl alcohol due to the possibility of developing a deadly toxic syndrome, manifested by metabolic acidosis, inhibition of the central nervous system, difficulty breathing, renal failure, hypotension, and possibly epileptic seizures, as well as intracranial hemorrhages;

- the preparation contains ethyl alcohol (100 mg per 1 ml). Should be remembered about it Applying the drug in children or patients from a risk group, i.e. from hepatic insufficiency, epilepsy or alcoholism;

- sodium benzoate, which is part of the drug (49 mg per 1 ml), can increase the risk of jaundice in newborns;

- incoming propylene glycol may be caused by allergies;

- benzoic acid is part of the drug may cause skin irritation, mucous membranes and eye conjunctivities. Can also cause allergies or an attack of asthma in patients with bronchial asthma;

- it is not recommended to use benzodiazepines and similar preparations in patients with severe liver failure, as they can accelerate the development of liver encephalopathy. Liver failure can also lead to increased side effects of benzodiazepines;

- it is necessary to use the drug in patients with chronic respiratory failure;

- diazepam must be used in patients with porphyria. The use of diazepam can cause the symptoms of this disease;

- patients in old age (over 65 years) recommended a dose reduction. It is necessary to avoid long-term use of the drug in connection with the strengthening of undesirable phenomena in this age group;

- prolonged use of diazepam may cause a psychophysical drug dependence and the appearance of an abstineent syndrome in the case of a sharp cancellation of diazepam. An abstitent syndrome is characterized by psychomotor excitation, expressed irritability, insomnia and worsening of the mood;

- benzodiazepines and similar preparations are necessary with great care in patients with alcohol and drug dependence (including narcotic dependence) in history. These patients during the reception of diazepam should be under strict control, because are in the risk of addiction and mental dependence;

- during long-term therapy, periodic blood tests are shown (Morphology with a smear) and functional tests Liver.

During the treatment period and 3 days after its end, it is impossible to use any alcoholic beverages.

Impact on the ability to control the transc. cf. And Meh.:

During treatment with the drug, the religation and within 3 days after its completion can not be managed by road and engage in other potentially hazardous species activities , requiring increased concentration of attention and speed of psychomotor reactions.

Release form / Dosage:

Solution for intravenous and intramuscular administration, 5 mg / ml.

Packaging:

2 ml of the drug in an ampoule of colorless glass of hydrolytic class I (Heb. Farm). 5 ampoules are placed in the pallet from PVC.

5 ampoules (1 pallet), or 10 ampoules (2 pallets), or 50 ampoules (10 pallets) with instructions for use are placed in a cardboard box equipped with first autopsy control stickers.

Storage conditions:Store in the light-protected place at a temperature not higher than 25 ° C.

The drug refers to the list of psychotropic substances (List III).

Store in places inaccessible to children.

Shelf life:

3 years.

Do not use after the expiration date indicated on the package.

Conditions of vacation from pharmacies:On prescription Registration number:N015047 / 01 Registration date:13.08.2008 Registration Certificate Owner:Tarhominsky Pharmaceutical Plant "Polafa", A.O.

General information regarding the observed effects after treatment with benzodiazepines and other drugs of this action, which should be taken into account when appointing diazepam. Tolerance: Regular use of benzodiazepines (including diazepama), can lead to a weakening of their action. Drug addiction: The use of benzodiazepines can lead to the development of mental and physical drug addiction. The risk of drug dependence is increased together with the dose and the duration of treatment, and increases in patients with alcohol addiction, as well as in patients with drug addiction in history. "Sidrom Cancellation": a sharp discontinuation of the application of diazepam can lead to the occurrence of "cancellation syndrome", characteristic manifestations of which are: head and muscle pain, anxiety, tension, confusion, irritability, insomnia, and in severe cases - Derealization, depersonalization, hyperactusia. Svetubyaznny, tactile hypersensitivity, parrestzia limbs, hallucinations and seizures of seizures. Insomnia according to the type "Ricochlet": after the end of treatment, there may be a transitional recurrence of symptoms in more pronounced formThan those who were the cause of the initial treatment (the so-called insomnia in the type of "ricochet"). These symptoms often accompany changes in mood, anxiety, anxiety, sleep disorders and insomnia. The patient must be informed about the possibility of insomnia on the type of "ricochet". This information will reduce its concern if such symptoms appear after the termination of the drug. The probability of the development of cancellation syndrome or the appearance of insomnia in the type of "ricochet" increases with a sharp discontinuation of the use of the drug. To reduce the risk of developing these symptoms, a gradual reduction in dose is recommended. Anterograd amnesia: diazepam, as well as other benzodiazepines and similar drugs, can cause anterograd amnesia. Such a state occurs most often a few hours after taking the drug, especially in a large dose. Amnesia's symptoms may be accompanied by inadequate to the situation by behavior. To reduce the risk of anchorograd amnesia, it is recommended to take the drug for half an hour before sleep and provide conditions for continuous sleep for 7-8 hours. Mental and paradoxical reactions. The use of diazepam may cause incorrect (opposite expected) mental and paradoxical reactions, such as: anxiety, excitement, irritability, aggressiveness, angry, nightmares, hallucinations, psychosis, somnambulism, personality violations and others behavioral disorders . These reactions are significantly more often observed in elderly patients and in patients with alcohol addiction. In the event of such symptoms, it is necessary to immediately stop taking the drug. Specific groups of patients: Elderly patients are encouraged to prescribe less doses due to the possible strengthening of side effects, mainly orientation disorders and coordination of movements (fall, injury). It is not recommended to use benzodiazepines in patients with severe hepatic insufficiency, as they can accelerate the development of hepatic encephalopathy. It is necessary to use the drug in patients with chronic respiratory failure, as it is established that benzodiazepines can be inhibitory effects on the respiratory center. The beginning of treatment with diazepam or its sharp cancellation in patients with epilepsy or with epileptic seizures can accelerate the development of seizures or epileptic status. It is not recommended to use benzodiazepines and similar preparations in patients with psychosis. Diazepam should be used with great caution in patients with depression symptoms. Suicidal inclinations may appear in these patients. In connection with the possibility of intentional overdose, these patients should be prescribed benzodiazepines as far as possible in the smallest doses. Benzodiazepines should not be applied in depression monotherapy or anxiety associated with depression. Monotherapy with these drugs can enhance suicidal trends. In the event of a loss of loved ones or mourning, benzodiazepines can slow the psychological awareness and the adoption of the situation. Benzodiazepines and similar drugs must be used in patients with alcohol, medicinal and drug addiction in patients with alcoholic, medicinal and drug dependence. Such patients during treatment should be under strict control, because Participated with the risk of addiction and mental dependence. Diazepam must be used in patients with porphyria. The use of diazepam can cause the symptoms of this disease. With caution, diazepams should be used in patients with glaucoma (it is possible to use in patients with an open-hearted form of glaucoma, which prepare appropriate treatment, but contraindicated with the closed-molded form of glaucoma). During long-term therapy, periodic blood tests (morphology with smear) and functional liver tests are shown. Due to the content of lactose, the drug should not be used in patients with rarely encountered hereditary intolerance to galactose, lactase insufficiency or poor absorption of glucose-galactose. The drug can cause allergic reactions due to the content of azocracy - quinoline yellow. During the treatment with diazepam and within 3 days after its completion, it is impossible to use any alcoholic beverages. Effect of medicinal preparation for medical application On the ability to control vehicles, mechanisms: during treatment with the drug and within 3 days after its completion it is impossible to control vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.