Is Paxilla with a hormonal drug. Paksil - instructions for use of tablets, composition, indications, side effects, analogues and price

Content

The drug Paxil from the pharmacological group of serotonin inverse seizure inhibitors has anti-time and antidepressant action. The tool is used to treat depressions of all types and other psyche disorders, accompanied by an increased level of anxiety, panic attacks, severe apathy and the despair, the feeling of despair and unfortunate fear, other typical symptoms.

Packel drug refers to the pharmacological group of antidepressants. It is used to treat mental disorders accompanied by depression, including reactive and severe forms, increased anxiety. Assigns within the framework of complex supporting therapy and as a means of preventing obsessive-compulsive disorder. It can be used to treat children over the age of seven years suffering:

• panic disorders, including accompanied by agoraphobia;
• generalized disturbing disorders;
• post-traumatic disorders against the background of stress.

Structure

Paxilla is produced in the form of tablets for receiving inside, white, double-screwed shape covered with shell. The content of the actively active substance of the steamsetin is 20 mg per tablet. It is fusing a blister in 10 pieces in each, one package contains 1, 3 or 10 blisters (i.e. 10, 30 or 100 tablets) and instructions for the use of the drug. The full composition of the medicinal product:

The mechanism of action of the drug

The antidepressant action of Paxil tablets is based on the mechanism of a specific oppression by the method of reverse seizure of serotonin in the brain neurons. The active active ingredient of paroxetine has a weak affinity for α1-, α2 and β-adrenoreceptors, to dopamine, serotonin, histamine receptors. It does not interact with postsynaptic receptors, does not oppress the central nervous system (CNS), does not cause arterial hypotension.

Reception of the drug does not have an active influence on the functionality of the work of the cerebral cortex, does not cause violations of psychomotor functions. In healthy persons, when using funds, blood pressure jumps were not observed, changes in the readings of the electrocardiogram, heart rate disorders. Low affinity with muscarinic cholinergic receptors causes an activating effect in doses exceeding the slowdown of serotonin reverse capture. The mechanism of action is not amphetami-like.

The pharmacokinetic metrics of the Paxilla reception are not stable, the kinetics is nonlinear (steamsetin is metabolized by the liver "at the first passage" - less substance falls into the blood plasma than the gastrointestinal tract). After absorption is distributed in the tissues of the organism. Falling in the structure of the central nervous system through the hematorecephalic barrier. The metabolite half-life time is 16-20 hours, 64% is removed from the urine, the rest is with the feces and unchanged.

When Pakshil begins to act

According to the reviews of practitioners, the meaningful effect of the drug Paksil on the patient's body, causing a stable improvement in its condition and expressed positive life results, occurs 14-16 days after the start of therapy. The rate of occurrence of a positive effect largely depends on the individual characteristics of the body and additional funds taken within the framework of integrated therapy. In some cases, a stable improvement in the state week after the start of reception was noted.

Indications for use

Antidepressant Paxil is used to treat a number of pathological conditions of the central nervous system, psychotic disorders in adult patients and children over 7 years old. The main indications of use are:

• treatment and prevention of obsessive-compulsive disorder (OCD);
• depression of jet and heavy forms;
• panic disorder;
• generalized anxiety disorder;
• social phobias.

Instructions for the use of Paksil

Tablets are taken inside once a day during meals, in the morning. The dosage depends on the diagnosis, the severity of symptoms and individual patient features is determined by the attending physician. The following drug reception schemes are possible:

• Depression: The daily dose is 20 mg per day. In the presence of indications, it is possible for a daily increase in the dosage by 10 mg every day to a maximum daily dose of 50 mg. After 15-25 days of reception, the dosage is adjusted depending on the clinical picture.
• OCP, Panic disorders: 40 mg per day; Weekly, the daily dose increases by 10 mg (the maximum dose is 60 mg / day). The duration of therapeutic therapy ranges from 3 to 6 weeks.
• Generalized alarmed disorder, social phobias, post-traumatic disorder against the background of stress: 20 mg per day, if necessary, it is possible to increase the dosage by 10 mg every 7 days to a maximum dose of 50 mg.

Cancellation syndrome Paksil

In order to avoid recurrence of the disease, the abolition of the drug Paksil is produced gradually, reducing the daily dosage by 10 mg every seven days. If the cancellation syndrome occurs (sharp deterioration of the state and return of initial symptoms), the drug reception is renewed with the possible adjustment of the daily dosage. Therapy continues for 5-21 days, then a decrease in daily doses at a lower rate (dose is reduced by 10 mg times in 14-20 days). Cancellation syndrome may be accompanied by the following symptoms:

• insomnia;
• anxiety;
• increased emotional arousal;
• dizziness;
• confusion of consciousness.

special instructions

The drug Paksil in some cases may cause a violation of psychomotor functions, so during the reception it is recommended to abandon activities related to increased concentration of attention, for example, from driving vehicles. Caution is prescribed to patients with liver and kidney dysfunctions, it is possible in these cases a dose reduction is required. An independent reception or a change in the dosage without appointing a doctor is excluded.

Packsil and pregnancy

During pregnancy, Paksil can be assigned only if there are sharp testimony, in cases where the expected benefit for the mother exceeds the potential risk for the child. Significant data on the safety of the pregnant woman of the drug Paksil is missing (the corresponding clinical trials were not conducted), so the reception is possible strictly for its intended purpose and under the control of the attending physician.

In childhood

Paxil is contraindicated for children under 7 years old. At the age of 7 to 15, the purpose is made in accordance with the diagnosis, while the course duration and daily dosage decrease as follows: 10 mg per day, it is possible a weekly increase by 10 mg to a maximum dose of 50 mg. In some cases, during therapy in children and adolescents, suicidal thoughts were observed, especially those with a burdened suicidal anamnesis.

Medicinal interaction

Paksil is not recommended for a joint reception with monoaminoxidase inhibitors and within 2 weeks after the end of the course. Co-use with thiuridazine increases the concentration of thiuridazine in the plasma (the dosage adjustment is required). The drug enhances the effect of ethanol-containing means and beverages, reduces the effectiveness of digoxin, tamoxifen. Cimetidine increases the activity of paroxetine. The reception of Paksil together with coagulants and antithrombic means increases the intensity of bleeding.

Paksil and alcohol

The use of alcohol on the eve of the reception of the Paksil means causes a decrease in its effectiveness. Theoretically compatible with ethanol, but regular drinking of alcoholic beverages during therapy changes the action of the drug and provokes the occurrence of side effects (there are registered cases of death). Doctors recommend to refrain from the use of alcohol during the course of treatment.

Side effects

The course of treatment with antidepressant Paxil may cause side effects and negative reactions from the endocrine, immune, reproductive, cardiovascular and central nervous systems, digestive disorders. In these cases, observed:

• decline in appetite;
• metabolism disorders - diarrhea, constipation, nausea;
• from the side of the respiratory authorities - yawning;
• raising the level of hepatic enzymes (in rare cases is accompanied by the development of hepatitis or jaundice);
• drowsiness or insomnia;
• clouding consciousness;
• sinus tachycardia;
• asthenia;
• violations, development of glaucoma;
• reducing the secretion of ADG (antidiuretic hormones);
• internal hemorrhages in the skin and mucous membranes;
• reduced or enhance arterial pressure;
• increased sweating, skin rashes, urticaria, in rare cases - an increase in lymph nodes, angioedema edema;
• sexual dysfunction;
• hyperprolactinemia;
• galactere;

Overdose

The dosage exceeding is accompanied by tachycardia, nausea and vomiting, a setting and increased excitability, a change in blood pressure, convulsive syndrome, the expansion of pupils, fever. Registered cases of imposition in whom. With a joint reception with psychotropic agents and alcohol, a fatal outcome is possible (very rarely). When establishing an overdose, stomach washing, activated carbon receiving, supporting therapy. Specific antidote does not exist.

Contraindications

The main contraindications for the reception of Paksil is children's age up to 7 years and individual intolerance to the main or auxiliary components of the drug. Share reception with monoaminoxidase inhibitors is not recommended. Packing treatment can be started not earlier than two weeks after completion of therapy with the use of these drugs.

Terms for sale and storage

Vacation of drug from pharmacies is made according to the doctor's prescription. Store the drug is necessary in an inaccessible to children, a dark place at a temperature not higher than 25 ° C. Shelf life - 3 years from the date indicated on the package. Upon expiration of the storage period, the use is contraindicated.

Analogs

When identifying low effectiveness of therapy or pronounced side effects, the analogues of Paxil are prescribed. Replacing the drug can be carried out only by the attending physician if there are sufficient grounds, an independent reception of another drug without receiving a specialist about the possibility of replacement is invalid. Possible replacement means are:

• Paroksetin;
• Adepress.
• Paroxin;
• Rexetin.

Paksil Price

The drug Paksil can be purchased at the drug recipe pharmacy. Price range for all forms of discharge of the drug:

Video

Paxiel is an antidepressant, selectively reducing the neuronal reverse grip of 5-hydroxytriptamine. It affects the pathogenetic link of the emergence of depression, eliminating serotonin deficiency in brain neurons synapses.

The drug can be used both a separate means for treatment and as part of comprehensive therapy, complementing other drugs. Paksil is prescribed for the treatment of acute state, and as a supportive drug during remission.

The mechanism of action is based on the ability of the drug selectively block the reverse seizure of serotonin (5-hydroxitriptatamine / 5-NT / 5-HT /) presynaptic membrane, with which the increase in the free content of this neurotiator in the synaptic slit and amplification of serotonergic action in the central nervous system is responsible for the development of the Timoyanalenic .

Paroksetin has a low affinity to m-cholinoreceptors (has a weak anticholinergic effect) ,? 1-,? 2- and? -Adrenoreceptors, as well as to dopamine (D2), 5-HT1-like, 5-HT2-like and histamine H1- receptors.

Paksil is released in the form of tablets coated with film shell: white, bicon-like, oval, on one side - engraving "20", on the other - risk (10 pcs. In blisters, 1, 3 or 10 blisters in a cardboard pack).

The 1 tablet includes:

• Active substance: Paroksetin - 20 mg (in the form of hemihydrate Paroksetina hydrochloride - 22.8 mg);
• Auxiliary components: calcium hydrophosphate dihydrate - 317.75 mg; magnesium stearate - 3.5 mg; Carboxymethyl starch sodium type A - 5.95 mg;
• Shell: Opadry white - 7 mg (hypimloose - 4.2 mg; macrogol 400 - 0.6 mg; titanium dioxide - 2.2 mg; polysorbate 80 - 0.1 mg).

According to Paxile's reviews, he, in contrast to some other antidepressants (amitriptyline, imipramine), does not cause an increase in blood pressure and does not affect the CNS.

The reception of Paksil in the morning does not adversely affect the quality and duration of sleep. In addition, as the treatment effect manifests itself, sleep can improve. When using short-acting sleeping agents in combination with antidepressants, additional side effects did not occur.

Indications for use

What does Pakshil help? Prescribe the drug in the following cases \\ states:

• Depression of all types, including reactive depression and severe depression, depression accompanied by anxiety (results of studies in which patients received the drug for 1 year, show that it is effective in preventing depression relapses);
• Treatment (including supporting and prophylactic therapy) of obsessive-compulsive disorder (OCD). In addition, paroxetine is effective in preventing the recurrence of OCC;
• Treatment of panic disorder with agoraphobia and without it. In addition, steamsetin is effective in preventing the recurrence of panic disorder;
• Treatment of social phobia;
• Treatment (incl. Supporting and preventive therapy) of generalized alarmed disorder. In addition, the drug is effective in the prevention of recurrence of this disorder;
• Treatment of post-traumatic stress disorder.

There is evidence that anti-infertion therapy of anxiety and phobic states is effective. There are positive results of therapy in patients, the treatment of standard antidepressants of which turned out to be unsatisfactory. The reception of Paxil in patients with a steight disorder in the post-trap period is shown. The drug can be used for a long time, as well as with a preventive purpose.

Instructions for use Paxil and dosage

Paksil tablets should be taken inside, not chewing, completely, preferably - in the morning at the same time with meals.

For adults with depression - 20 mg (initial dose). If necessary, a phased increase in the dose is possible (10 mg 1 time in 7 days) before reaching the maximum - 50 mg. Evaluate the effectiveness of the passenger in order to correct the dose follows 2-3 weeks of therapy. The course duration is determined by the testimony (up to several months).

For adults with panic disorders, the average therapeutic dose is 40 mg / day. Therapy should be started with the use of the drug at a dose of 10 mg / day. Subsequent dose increases by 10 mg weekly until the effect is obtained. With insufficient efficiency, the dose can be increased to 60 mg / day. The drug is used in a low initial dose to minimize the possible risk of exacerbation of panic symptoms, which can be observed at the initial stage of therapy.

OCP - 20 mg (initial dose). If necessary, a phased increase in the dose is possible (10 mg 1 time in 7 days) to the recommended or maximum (40/60 mg). The duration of the course is several months and longer.

Social phobia, generalized anxiety and post-traumatic stress disorders: 20 mg (initial dose). If necessary, a phased increase in the dose is possible (10 mg 1 time in 7 days) to 50 mg.

For adults with post-traumatic stress disorder, the average therapeutic dose is 20 mg / day. With an insufficient clinical effect, the dose can be increased gradually by 10 mg weekly maximum to 50 mg / day.

After the end of therapy, in order to reduce the likelihood of cancellation syndrome, the dose of the drug to reach 20 mg should be reduced in gradually - 10 mg per week. After 7 days, the paxil can be completely canceled. If the symptoms of cancellation are observed with a decrease in the dose or after the discharge of the drug, it is advisable to resume therapy in a prescribed dose, and then reduce the dose more slowly.

Patients in old age therapy need to start with the recommended initial dose, which can be gradually increased to 40 mg per day. In patients with severe disorders of liver and kidney function (QC less than 30 ml / min), the dose of the drug should be reduced to the lower limit of the dose range.

Controlled clinical studies Paxilla in the treatment of depression in children and adolescents (7-17 years) did not prove its effectiveness, therefore the drug is not shown to treat the specified age group.

special instructions

The use of Paksil can provoke the occurrence of suicidal thoughts, aggression and hostility in the case of his adolescent adolescents under 18.

Sometimes combined medication with other drugs that increase serotonin concentration can cause the development of serotonin syndrome, which is manifested by such symptoms:

• increasing body temperature;
• excessive muscle tone and their involuntary shudder;
• irritability;
• the strongest emotional excitement up to the "white hotness".

During the period of therapy, this drug is necessary with extreme caution to engage in potentially unsafe activities (work at the production, driving of the car).

Side effect

When appointing Paxil, the following side effects are possible:

• formation of hematomas on the skin and mucous membranes;
• disruption of appetite;
• increasing blood cholesterol;
• somnological disorders (insomnia and the drowsiness developing on this basis, nightmarish dreams), emotional arousal;
• inhibition, hallucinations;
• dizziness, headaches;
• involuntary muscle cuts;
• fucetitude view, expansion of the pupil;
• cardiac rhythm;
• dyspeptic symptoms (nausea, diarrhea or constipation, hypospalivation);
• yawn;
• hyperhydrosis;
• rash;
• reducing libido;
• the appearance of overweight.

The drug has the so-called cancellation syndrome, when the cessation of admission is accompanied by a number of undesirable symptoms: dizziness, tinnitus, paresthesia, sleep disorders, hyperhydrosis, nausea, anxiety.

The manifestations of this complex of symptoms does not exceed the reasonable limits and over time everything passes spontaneously. However, the decrease in the daily dosage of Paksil should be produced smoothly, without breaking the sharp therapeutic course.

Overdose

Symptoms of overdose Packels are as follows:

• vomiting, nausea,
• asthenia or excessive excitement
• drowsiness,
• dizziness,
• convulsions
• urine delay,
• heart rhythm disturbances
• fainting and confusion confusion
• coma,
• change hell
• manic reactions and aggression.

Symptoms of liver failure (jaundice, signs of cirrhosis, hepatitis) can also develop. With joint admission of overpriced doses with psychotropic drugs, an ethanol is possible.

Treatment - the stomach washing, provoking artificial vomiting, acceptance of adsorbents. In the hospital, disintellation is prescribed by intravenous drugs. It is necessary to observe the physician for the patient's life indicators, maintaining the functions of breathing, cardiac activity. No specific antidote.

Contraindications

The appointment of Paxil is contraindicated in the following cases:

• The simultaneous reception of Mao inhibitors and a period of 14 days after their cancellation (MAO inhibitors cannot be prescribed within 14 days after the end of the treatment with paroxetine);
• Simultaneous reception of thiuridazine;
• Increased sensitivity to paroxetine and other components of the drug.

Analogs Paksil, list of drugs

If necessary, replace Paxiel, use the analogues on the ATX code. List of drugs:

1. ActApacksetin,
2. Adepress
3. Plisil,
4. Paroksetin,
5. Rexetin.

Choosing analogues It is important to understand that the instructions for use Paksil, the price and reviews for drugs of similar action do not apply. It is important to obtain a doctor's advice and not to produce an independent replacement of the drug.

The average cost of Paksil tablets in pharmacies depends on the number of tablets in the package. 30 tablets - 717-723 rubles. 100 tablets - 2157-2165 rubles.

The drug should be stored in the original factory packaging, dark, dry, inaccessible to children at air temperature not higher than + 30 ° C. Shelf life - 3 years.

Paroxetine hydrochloride hemihydrate 22.8 milligrams (equivalent to 20.0 milligrams pAROKSETHINA ), as auxiliary substances: calcium dihydrophosphate dihydrate , carboxymethyl starch sodium type A Magnesium stearic shell Tablets - Opadry white YS - 1R - 7003 (macrogol 400, titanium dioxide, hypimosellose, polysorbate 80).

Form release

The drug is produced in the pills of the double-screw form, packed in blisters of 10 pcs., In one package can be one, three or ten blisters.

pharmachologic effect

Renders antidepressive action According to the mechanism of a specific oppression by reverse capture in the functional cells of the brain - neuronah .

Pharmacodynamics and pharmacokinetics

Has low affinity with muscarinic cholinergic receptors . As a result of research, they received data that:

• On animals anticholinergic properties There are weak.
• Paroxetine research in vitro - weak affinity for α1-, α2 and β-adrenoreceptors , including dopaminov (D2), serotonin subtype 5-nT1- and 5-NT2- , including histamine receptors (H1) .
• In vivo studies confirmed in vitro results - does not interact with postsynaptic receptors and does not oppress CNS and does not cause arterial hypotension .
• Not broken psychomotor functions Paroxetine does not increase the oppressive action ethanol on the central nervous system .
• The study of behavioral changes and showed that paroxetine is able to cause a weak activating effect in a dose that exceeds the slowdown of serotonin reverse capture, while the mechanism is not amphetami-like .
• The healthy body of PAKSETHIN does not have significant changes to hell (), Heart rate and ECG.

As for pharmacokinetics, after admission to the drug absorbed and metabolized with the "first passage" of the liver, as a result of which there is less steamsetin, which is absorbed from the gastrointestinal tract. By increasing the number of paroxetine in the body (one-time reception of large doses or multiple reception of ordinary doses) achieve partial saturation metabolic path and reducing the clearance of paroxetine, leading to a disproportionate increase in plasma paroxetine concentration. This means that the pharmacokinetic parameters are unstable and the kinetics is nonlinear. However, non-linearity is usually expressed weakly and is observed in patients taking low doses of the drug, which cause low plasma paroxetine. It is possible to achieve an equilibrium concentration in plasma in 1-2 weeks.

Paroxetine is distributed in the tissues, and the plasma pharmacokinetic calculations remains 1% of the total number of paroxetine, which is present in the body. In therapeutic concentrations of approximately 95% of the plasma paroxetine is associated with proteins . The dependences between the concentration of parkset in plasma and clinical effects, side reactions are not revealed. He is able to penetrate breast milk and B. embos .

Biotransformation occurs in 2 phases: including primary and systemic elimination before inactive polar and conjugated products as a result of the process oxidation and. Half-life varies in the range of 16-24 hours. Approximately 64% are removed with urine as metabolites, 2% - in non-modified form; the rest - with the feces like metabolites and 1% - in not a changed form.

Indications for use

The drug is used for all kinds in adults, including reactive and severe, accompanied by anxiety, for supporting and preventive therapy. Children and adolescents are 7-17 years old with panic disorders with agoraphobia and without social phobias, generalized disturbing disorders, post-traumatic stress disorders.

Contraindications

Increased sensitivity K. parksetius or other components.

Side effects

Reducing the frequency and intensity of individual side effects of paroxetine occurs as treatment flows, therefore they do not require cancellation of the destination. Frequency gradation is as follows:

• very often (≥1 / 10);
• often (≥1 / 100,<1/10);
• sometimes happens (≥1 / 1000,<1/100);
• rarely (≥1 / 10,000,<1/1000);
• rarely (<1/10 000), учитывая отдельные случаи.

Frequent and very frequent occurrence is determined on the basis of generalized data about the safety of the drug in more than 8 thousand patients. Clinical trials It was carried out to calculate the differences in the frequency of side effects in a group with Paxil and the second placebo group. The occurrence of side effects of paxing rare or very rare is determined on the basis of postmarketing information on the frequency of messages, and not the true frequency of these effects.

Side effects are stratified by organs and frequency:

• Blood and lymphatic system: rarely happen anomalous (hemorrhage into the skin and mucous). It is very rare thrombocytopenia .
• Endocrine system: Very rare - violation of secretion.
• The immune system: very rarely happen allergic reactions Type and.
• Metabolism: "Often" cases of decline, sometimes in elderly patients in violation of the adg secretion - hyponatremia .
• CNS.: often arises or, convulsive seizures ; seldom - perpudence consciousness , maniacal reactions As possible symptoms of the disease itself.
• Vision: very rarely arises exacerbation However, "often" is a fuzziness of vision.
• The cardiovascular system: "Rarely" was noted sinus , as well as transient decrease or increased blood pressure
• Respiratory system, chest and mediastinal: "Often" was noted yawn .
• Zhkt. : "Very often" fixed nausea ; Often - or when dry mouth ; Gastrointestinal bleeding is very rarely recorded.
• Hepatobiliary system: Rarely "rarely" noted increase production level hepatic ; very rare cases accompanied by jaundice and / or hepatic insufficiency .
• Epidermis: often registered; rare case skin rashes and very rare - reactions photosensitivity .
• urinary system: rarely recorded.
• Reproductive system: Very often - cases sexual dysfunction ; Rarely - I. galactorei .
• Among the general disorders: often fixed asthenia , and very rarely - peripheral edema.

An approximate list of symptoms that may occur after the course is completed. paroxetine : "Often" noted and other sensory violations , sleep mode disorders, the presence of anxiety,; sometimes - strong emotional arousal , nausea , sweating , as well as diarrhea . Most often, these symptoms in patients are lightweight and weakly pronounced, pass without interference. Not registered groups of patients who were at increased risk of side effects, but if there is no greater need for steamsetin treatment, the dose is reduced smoothly to complete cancellation.

Packel pills, instructions for use (method and dosage)

Tablets take orally, swallowed entirely and not chewing. Take one time a day in the morning during meals.

Interaction

Paroxetine is not recommended to apply with inhibitors of MAO , as well as for 2 weeks after the completion of the course; in combination with, because, like other drugs that oppress the activity enzyme CYP2 D6. cytochrome P450. , increases the concentration of thiuridazine in plasma. Paxil is able to strengthen the effect of alcohol-containing agents and reduce efficiency and T.amoxiphen . Inhibitors of microsomal oxidation and Cimetidine increase the activity of paroxetine. Using indirect coagulants or antithrombic means there is an increase in bleeding.

Terms of sale

On prescription.

Storage conditions

In the dry inaccessible for children, a place protected from light. Permissible temperature no more than 30 ° Celsius.

Shelf life

Stored for up to three years.

Paksil and alcohol

As a result of clinical studies, data were obtained that the absorption and pharmacokinetics of the active substance - paroxetine does not depend or almost independently dependent (that is, the dependence does not require changes doses) from alcohol. It is not established that Paroksetin enhances the negative effect of ethanol on psychomotoric However, it is not recommended to take it together with alcohol, as it is mainly alcohol suppresses the effect of the drug - reducing the effectiveness of treatment.

Paksil (Tablep.O..20mg N10) France Glaxo Lelkom Production

Trade name: Paksil

International title: Paroksetin

Manufacturer: Glaxo Walcome Production

Country: France

Information about registered packages:

1. Packing tablets covered with a shell 20 mg 10 pcs., Packaging Cell contour (10) - Putures cardboard

Registration date 05/27/2005

ND ND 42-13469-05

EAN code 4602233002217

2. Packing tablets covered with shell 20 mg 10 pcs., Packaging Cell contour (1) - Cardboard packs

Registration number P N016238 / 01

Registration date 05/27/2005

ND ND 42-13469-05

EAN code 4602233002194.

3. Packing tablets covered with a shell 20 mg 10 pcs., Packaging Cell contour (3) - Cardboard packs

Registration number P N016238 / 01

Registration date 05/27/2005

ND ND 42-13469-05

EAN code 4602233002200.

Total packs: 3

Description (Vidal 2008):

Paxil (Paxil)

Representation:

Glasosmitklein ATX code: N06AB05 Registration certificate owner:

Laboratoire GlaxosmithKline,

produced Glaxo Wellcome Production,

Release form, composition and packaging

White tablets covered with shell, oval, double-screw, with engraving "20" on one side and a linte of faults to another.

paroxetina hydrochloride Gemihydrate 22.8 mg,

corresponds to steamsetin 20 mg

Auxiliary substances: calcium dihydrophosphate dihydrate, sodium carboxycharmal type A, magnesium stearate.

The composition of the shell: hypimloose, titanium dioxide, macrogol 400, polysorbate 80.

10 pieces. - Blister (1) - packs cardboard.

10 pieces. - Blister (3) - Cardboard packs.

10 pieces. - Blister (10) - packs cardboard.

Clinical and Pharmacological Group: Antidepressant

Registration No.:

# tab. 20 mg: 10, 30 or 100 pcs. - P №016238 / 01, 05/27/05

The description of the drug is based on officially approved instructions for use and approved by the manufacturer to publish 2008.

Pharmacological action | Pharmacokinetics | Indications | Dosing mode | Side effect | Contraindications | Pregnancy and lactation | Special instructions | Overdose | Medicinal interaction | Pharmacies leave | Storage conditions and shelf life

pharmachologic effect

Antidepressant. Refers to a group of selective inhibitors of serotonin reverse seizure.

The mechanism of the accumulation mechanism is based on its ability to selectively block the reverse seizure of serotonin (5-hydroxytriptamin / 5-NT /) presynaptic membrane, with which the increase in the free content of this neurotiator in the synaptic slit and the enhancement of serotonergic action in the central nervous system is responsible for the development of Timanalente (antidepressive) Effect.

Paroxetine has a low affinity to m-cholinoreceptors (has a weak anticholinergic effect) ,? 1-,? 2- and? -Adrenororeceptors, as well as to dopamine (D2), 5HT1-like, 5HT2-like and histamine H1 receptors.

According to the study of behavior and EEG in Paroksetin, weak activating properties are identified when it is prescribed in doses above those necessary to inhibit serotonin capture. Paroxetine does not affect the cardiovascular system, does not violate psychomotor functions, does not oppress the CNS. Healthy volunteers have a significant change in the level of blood pressure, heart rate and EEG.

The main components of the profile of psychotropic activity of Paksil are anti-depressive and anti-time effect. Paroxetine can cause weak activating effects in doses exceeding those required to inhibit serotonin injecting.

In the treatment of depressive disorders, Paroxetine has demonstrated effectiveness comparable to the effectiveness of tricyclic antidepressants. Paroxetine has the therapeutic efficiency even in those patients who did not respond adequately to the previous standard therapy. The patient's condition is improved after 1 week after the start of treatment, but exceeds placebo efficiency only on week 2. Morning Reception of Paroksetina does not have a negative impact on the quality and duration of sleep. Moreover, with effective therapy, sleep should improve. During the first few weeks of reception, paroxetine improves the condition of patients with depression and suicidal thoughts.

The results of studies in which patients accepted Paroxetine for 1 year showed that the drug effectively prevents depression relapses.

With panic disorder, the prescription of the pasxil in combination with drugs that improve cognitive functions and behavior turned out to be more efficient than monotherapy with drugs that improve the cognitive behavioral function that is aimed at correction.

Pharmacokinetics

Suction

After receiving inside, the steamsette is well absorbed from the gastrointestinal tract. Meal does not affect absorption.

Distribution

CSS is installed by 7-14 days from the moment of the start of therapy. The clinical effects of paroxetine (side effect and efficiency) are not correlated with its plasma concentration.

Paroxetine is extensively distributed in the tissues, and pharmacokinetic calculations show that only 1% is present in the plasma, and in the therapeutic concentrations of 95% - in the associated with protein form.

It has been established that paroxetine in small quantities is released with breast milk, and also penetrates a placental barrier.

Metabolism

The main metabolites of paroxetine are polar and conjugated oxidation and methylation products. Due to the low pharmacological activity of metabolites, their effect on therapeutic efficacy of the drug is unlikely.

Since Paroksetin metabolism includes the stage of the "first passage" through the liver, its number defined in the system circulation, less than that is absorbed from the gastrointestinal tract. With an increase in the dose of paroxetine or with multiple dosing, when the load on the body increases, there is a partial absorption of the effect of the "first passage" through the liver and a decrease in plasma clearance of paroxetine. As a result, it is possible to increase the concentration of parkset in plasma and fluctuations in pharmacokinetic parameters, which can only be observed in those patients who, when taking low doses, low levels of the drug in plasma are reached.

Election

It is derived from the urine (unchanged - less than 2% dose and in the form of metabolites - 64%) or with bile (unchanged - 1%, in the form of metabolites - 36%).

T1 / 2 varies, but the average is 16-24 hours.

Paroxetine removal is biphaste, comprising primary metabolism (first phase) and the following systemal elimination.

With long-term continuous reception of the drug, pharmacokinetic parameters do not change.

Pharmacokinetics in special clinical cases

In the elderly patients, as well as in pronounced violations of the liver and kidney function, the plasma paroxetine concentration is increased, and they almost coincide with the range of healthy adult volunteers with the range of plasma concentrations.

Indications

Depression of all types, including reactive depression, severe endogenous depression and depression, accompanied by anxiety (research results in which patients received the drug for 1 year, show that it is effective in preventing depression relapses);

Treatment (including supportive and preventive therapy) of obsessive-compulsive disorder (OCD) in adults, as well as in children and adolescents aged 7-17 years (it has been proven to preserve the effectiveness of the drug in the treatment of OCD for at least 1 year and with the prevention of recurrence of OCC);

Treatment (including supporting and prophylactic therapy) of a panic disorder with agoraphobia and without it (the effectiveness of the drug is preserved for 1 year, preventing the recurrence of panic disorder);

Treatment (including supportive and preventive therapy) of social phobia in adults, as well as children and adolescents aged 8-17 years (the effectiveness of the drug is preserved with long-term treatment of this disorder);

Treatment (including supportive and prophylactic therapy) of generalized anxiety disorder (the effectiveness of the drug is preserved with long-term treatment of this disorder, preventing the relapse of this disorder);

Treatment of post-traumatic stress disorder.

Dosing mode

For adults with depression, the average therapeutic dose is 20 mg / day. In case of insufficient efficiency, the dose can be increased to the maximum 50 mg / day. The increase in the dose should be carried out gradually - by 10 mg with an interval of 1 week. The dose of Paxilla should be reviewed and, if necessary, change within 2-3 weeks from the start of therapy and later until an adequate clinical effect is obtained.

For adults with an obsessive-compulsive disorder, the average therapeutic dose is 40 mg / day. Begin treatment follows from 20 mg / day, then gradually dose rises by 10 mg every week. With an insufficient clinical effect, the dose can be increased to 60 mg / day. For children aged 7-17 years, the drug is prescribed in the initial dose of 10 mg / day, gradually raising by 10 mg every week. If necessary, the dose can be increased to 50 mg / day.

For adults with panic disorders, the average therapeutic dose is 40 mg / day. Treatment should be started with the use of the drug at a dose of 10 mg / day. The drug is used in a low initial dose to minimize the possible risk of exacerbation of panic symptoms, which can be observed at the initial stage of therapy. Subsequent dose increases by 10 mg weekly until the effect is obtained. With insufficient efficiency, the dose can be increased to 60 mg / day.

For adults with social phobia, the average therapeutic dose is 20 mg / day. With an insufficient clinical effect, the dose can be increased gradually by 10 mg weekly up to 50 mg / day. For children aged 8-17 years, the drug is prescribed in the initial dose of 10 mg / day, gradually raising by 10 mg every week. If necessary, the dose can be increased to 50 mg / day.

For adults with a generalized anxious disorder, the average therapeutic dose is 20 mg / day. With an insufficient clinical effect, the dose can be increased gradually by 10 mg weekly to the maximum dose of 50 mg / day.

For adults with post-traumatic stress disorder, the average therapeutic dose is 20 mg / day. With an insufficient clinical effect, the dose can be increased gradually by 10 mg weekly maximum to 50 mg / day.

In elderly patients, treatment should be started with a dose for adults, in the future, the dose can be increased to 40 mg / day.

In patients with severe disorders of liver and kidney function (QC less than 30 ml / min), the dose of the drug should be reduced to the lower limit of the dose range.

The course of treatment should be sufficiently long. Patients with depression or OCD should receive treatment over a period of time sufficient to disappear all symptoms. This period can occupy several months when depressed, and with OCC and panic disorder - even longer period.

Paksil takes 1 time / day in the morning along with food intake. The tablet should be swallowed entirely, not chewing, drinking water.

Cancellation of the drug

It should be avoided by a sharp cancellation of the drug. The daily dose should be reduced by 10 mg weekly. After reaching a daily dose of 20 mg in adults or 10 mg in children and adolescents, patients continue to take this dose during the week and after that the drug is completely canceled.

If the symptoms of cancellation develop during a dose reduction or after the discharge of the drug, it is advisable to resume the reception of the previously prescribed dose. Subsequently, a decrease in the dose of the drug should be continued, but more slowly.

Side effect

Side effects are usually moderately expressed. In continuation of therapy, side effects decrease in the intensity and frequency of occurrence and usually do not lead to discontinuation of treatment. The following criteria for evaluating the frequency of occurrence of unwanted phenomena are used: often (? 1% and<10%), нечасто (?0.1% и <1%), редко (?0.01% и <0.1%), очень редко (<0.01%), включая отдельные случаи. Встречаемость частых и нечастых побочных эффектов была определена на основании обобщенных данных о безопасности применения препарата более чем у 8000 человек, участвовавших в клинических испытаниях (ее раcсчитывали по разнице между частотой побочных эффектов в группе пароксетина и в группе плацебо). Встречаемость редких и очень редких побочных эффектов определяли на основании постмаркетинговых данных (касается скорее частоты сообщений о таких эффектах, чем истинной частоты самих эффектов).

From the digestive system: very often - nausea, decrease in appetite; Often - dry mouth, constipation, diarrhea; rarely - increase the level of hepatic enzymes; Very rarely - gastrointestinal bleeding, hepatitis (sometimes with jaundice), liver failure (with the development of side effects from the liver side, the question of the feasibility of termination of therapy should be solved in cases where a long-term increase in functional test indicators is noted).

From the CNS: often - drowsiness, tremor, asthenia, insomnia, dizziness; Infrequently confidence, hallucinations, extrapyramidal symptoms; rarely - mania, convulsions, acatia; Very rare - serotonin syndrome (assesting, confusion of consciousness, diaphoresis, hallucinations, hyperreflexia, myoclone, tachycardia, tremor). In patients with motor disorders or taking neuroleptics - extrapyramidal disorders with orofacial dystonia.

By the body of the vision: often - a blurredness; Very rarely - acute glaucoma.

From the cardiovascular system: infrequently - transient increase or decreased blood pressure (usually in patients with arterial hypertension and anxiety), sinus tachycardia; Very rarely - peripheral edema.

From the urinary system: rarely - urine delay.

From the side of the blood coagulation system: infrequently - hemorrhages in the skin and mucous membranes, bruises; Very rarely thrombocytopenia.

From the endocrine system: rarely - hypopronlactinemia / galactere and hyponatremia (mainly in elderly patients), which is sometimes due to the syndrome of insufficient secretion of antidiuretic hormone.

Allergic reactions: very rarely angium edema, urticaria; Rarely skin rash.

Others: Very often - sexual dysfunction; Often - strengthening sweating, yawning; Very rarely - photosensitivity reactions.

Unwanted symptoms observed during clinical trials in children

In clinical trials in children listed below the side effects occurred in 2% of patients and met 2 times more often than in the placebo group: emotional lability (including damage to himself, suicidal thoughts, suicidal attempts, plasticity, mood lability) , hostility, reducing appetite, tremor, increased sweating, hyperkinosis and assessment. Suicidal thoughts, suicidal attempts were mainly observed in clinical trials in adolescents with a pronounced depressive disorder, in which the effectiveness of paroxetine has not been proven. Hostility was noted in children (especially at the age of 12 years) with obsessive-compulsive disorder.

Contraindications

The simultaneous reception of Mao inhibitors and a period of 14 days after their cancellation (MAO inhibitors cannot be prescribed within 14 days after the end of the treatment with paroxetine);

Simultaneous reception of thiuridazine;

Increased sensitivity to paroxetine and other components of the drug.

Application in pregnancy and breastfeeding

In experimental studies, the teratogenic or embryotoxic action of paroxetine is not detected. Data on the small number of women who took stepssetin during pregnancy, indicate the absence of increased risk of congenital anomalies in newborns.

There are reports of premature births in women who received Paroksetin during pregnancy, but the causal relationship with the reception of the drug is not established. Paksil should not be used during pregnancy, except when the potential benefits of treatment exceed the possible risk associated with the reception of the drug.

It is necessary to observe the state of the health of newborns whose mothers took stepsset in late pregnancy, because there are reports of complications in children (however, the causal relationship with the reception is not established). Described respiratory distress syndrome, cyanosis, apnea, convulsive seizures, temperature instability, feeding difficulties, vomiting, hypoglycemia, arterial hyper-or hypotension, hyperreflexia, tremor, irritability, lethargy, permanent crying, drowsiness. In some messages, the symptoms have been described as neonatal manifestations of cancellation syndrome. In most cases, the complications described occur immediately after childbirth or shortly after them (within 24 hours).

Paroxetine in minor quantities stands out with breast milk. Therefore, it should not be applied to the drug during lactation, unless the potential benefits of treatment exceed the possible risk associated with the reception of the drug.

Application with violations of liver function

In patients with pronounced violations of the liver function, the dose of the drug should be reduced to the lower limit of the dose range.

Application with violations of the kidney function

In patients with pronounced disorders of the kidney function (QC less than 30 ml / min) dose of the drug should be reduced to the lower limit of the dose range.

special instructions

In patients with depression, exacerbation of the symptoms of the disease and / or the appearance of suicidal thoughts and suicidal behavior (suicidality) may be observed regardless of whether they receive antidepressants. This risk is preserved until pronounced remission is achieved. Improving the patient's condition may be absent in the first weeks of treatment or more, so the patient needs to be carefully observed for the timely identification of clinical exacerbation of the tendency to suicide, especially at the beginning of the course of treatment, as well as during periods of change of doses (increase or decrease). The clinical experience of applying all antidepressants shows that the risk of suicide may increase in the early stages of recovery.

Other mental disorders, for the treatment of which paroxetine, can also be associated with an increased risk of suicidal behavior. In addition, these disorders may be comorbid states accompanying a large depressive disorder. Therefore, in the treatment of patients suffering from other mental disorders, the same precautions should be observed as in the treatment of a large depressive disorder.

Patients who have a history of suicidal behavior or suicidal thoughts, patients of young age, as well as patients with severe suicidal thoughts before treatment, are exposed to the greatest risk of suicidal thoughts or suicidal attempts, and therefore all of them need to pay special attention during treatment. Patients (and service personnel) need to be prevented about the need to follow the deterioration of their condition and / or the emergence of suicidal thoughts / suicidal behavior or thoughts on damage to themselves and in the event of these symptoms immediately apply for medical care.

Sometimes the treatment of steamsetine is accompanied by the occurrence of acatius, which is manifested by a sense of internal concern and psychomotor arousal when the patient cannot sit quietly or stand; In the acatisy, the patient usually experiences a subjective distress. The probability of the occurrence of acatius is highest in the first few weeks of treatment.

In rare cases, a serotonin syndrome or symptomology, similar to malignant neuroleptic syndrome (hyperthermia, muscle rigidity, myoclone, vegetative disorders, may occur, can occur with a paroxetine, similar to malignant neuroleptic syndrome (hyperthermia, which Progressing to delirium and coma), especially if paroxetine is used in combination with other serotonergic preparations and / or neuroleptics. These syndromes represent a potential threat to life, so in the event of their occurrence, the treatment with steamsetin must be discontinued and start supporting symptomatic therapy. Given this, paroxetine should not be prescribed in combination with serotonin precursors (such as L-tryptophan, oxitriptan) due to the risk of developing serotonin syndrome.

A large depressive episode can be the initial manifestation of bipolar disorder. It is considered (although it has not been proven by controlled clinical trials) that the treatment of such an episode alone with an antidepressant can increase the likelihood of the accelerated development of a mixed / manic episode in patients exposed to the risk of bipolar disorder.

Before starting treatment with antidepressant, it is necessary to conduct a thorough screening to assess the risk of occurrence of bipolar disorder in this patient; Such screening should include the collection of detailed psychiatric history, including data on the presence of suicide cases in the family, bipolar disorder and depression. Like all antidepressants, paroxetine is not registered for the treatment of bipolar depression. Paroxetine should be used with caution in patients having a history of mania.

Paroxetine treatment should be started carefully, no earlier than 2 weeks after the cessation of therapy inhibitors of MAO; The dose of paroxetine needs to be raised gradually until the optimal therapeutic effect is achieved.

The frequency of convulsive seizures in patients taking paroxetin is less than 0.1%. In the event of a convulsive seizure, steamsetine must be discontinued.

There is only a limited experience of simultaneous use of paroxetine and electrosalproof therapy.

Heoters were reported in leather and mucous membranes (including gastrointestinal bleeding) in patients taking paroxetine. Therefore, paroxetine should be used with caution in patients who simultaneously receive drugs that increase the risk of bleeding, in patients with a known inclination for bleeding and in patients with diseases predisposing to bleeding.

After canceling the drug (especially sharp), dizziness, sensory disorders (paresthesia), sleep disorders (bright dreams), anxiety, headache, infrequently - assessment, nausea, tremor, confusion, increased sweating, diarrhea. Most patients have these symptoms with mild or moderately pronounced, but some patients can be severe. Usually, the symptoms of cancellation occur in the first few days after the cancellation of the drug, but in rare cases - after accidental passing of one dose. As a rule, these symptoms take place independently for two weeks, but some patients - up to 2-3 months or more. Therefore, it is recommended to gradually reduce the dose of paroxetine (for several weeks or months before its complete cancellation, depending on the needs of the patient).

The emergence of symptoms of cancellation does not mean that the drug causes addiction.

In children, the symptoms of the abolition of paroxetine (emotional lability, suicidal thoughts, suicidal attempts, mood changes, plasticity, nervousness, dizziness, nausea, abdominal pain) were celebrated in 2% of patients against the background of a dose of paroxetine or after its complete cancellation and met 2 times More often than in the placebo group.

The drug should be used with caution in hepatic insufficiency, renal failure, clotted glaucoma, heart disease, epilepsy.

If observed against the background of the use of Paksil, the increase in the level of hepatic enzymes is stored for a long time, the drug should be discontinued.

Pakshil does not potentiate the effect of alcohol on psychomotor functions, nevertheless patients receiving paxil, it is recommended to refrain from alcohol consumption.

Use in pediatrics

Paroxetine is not prescribed to children under the age of 7 due to the lack of data on the safety and efficiency of the drug in this category of patients.

Controlled clinical studies on the use of paroxetine for the treatment of depression in children and adolescents aged 7 to 18 years have not proved its effectiveness, therefore the drug is not shown to use this age group.

In clinical trials, undesirable phenomena associated with suicidality (suicidal attempts and suicidal thoughts) and hostility (mainly aggression, deviant behavior and anger) were more often observed in children and adolescents who received paroxetine than those of the patients of this age group that were received by placebo. There is currently no long-term security data for children and adolescents that would concern the effect of drug on growth, ripening, cognitive and behavioral development.

Impact on the ability to driving vehicles and control mechanisms

Packing therapy does not cause cognitive disorders or psychomotor inhibition. Nevertheless, as in the treatment with any psychotropic drugs, patients must be careful when driving a car and working with moving mechanisms.

Overdose

Available information about overdose by paroxetine indicates a wide range of security.

Symptoms: Strengthening the side effects described above, as well as vomiting, expansion of pupils, fever, change of blood pressure, involuntary muscle contractions, assessment, anxiety, tachycardia. Patients usually do not develop serious complications even at one time to 2 g of paroxetine. In some cases, coma and changes on EEG are developing, very rarely becomes a fatal outcome with a combined application of paroxetine with psychotropic drugs or alcohol.

Treatment: Standard measures used in overdose of antidepressants (stomaching by artificial vomiting, Purpose 20-30 mg of activated carbon every 4-6 hours during the first day after overdose). Specific antidote is unknown. Supporting therapy and control of vital functions of the body is shown.

Medicinal interaction

Absorption and pharmacokinetics of paroxetine do not change at all or change only partially under the influence of food, antacids, digoxin, propranolol and ethanol.

With the simultaneous use of Paxiel with Mao inhibitors, L-tryptophan, triptans, tramadol, linesolid, the drugs of selective inhibitors of serotonin reverse seizure, lithium, the drugs of the juggie can develop serotonin syndrome.

The metabolism and pharmacokinetic parameters of the paxyl may vary with the simultaneous use of drugs inducing or inhibiting protein metabolism. With the simultaneous use of pasxil with drugs that inhibit the metabolism of enzymes, the doses used should be limited to the lower boundary of the usual level. With combined use with drugs induced by the metabolism of enzymes (carbamazepine, phenytoin, rifampicin, phenobarbital), no change in the initial doses of Paksil is not required. Subsequent correction of doses should be carried out depending on the clinical effect.

With the simultaneous use of Paxil with drugs, the metabolizing isoenzyme CYP2D6 (tricyclic antidepress

Paksil is an antidepressant, which refers to the Size group (selective inhibitors of serotonin reverse seizure).

It has a pronounced anti-tesry and anxiolytic effect, it has a bicyclic structure, it distinguishes it from other widespread timoallets. Timoanleleptic effect is associated with the fact that the active substance of steamsetin is able to selectively block the reverse seizure of serotonin, due to which its effect on the CNS significantly exceeds the effect of other antidepressants.

The drug is produced in the form of tablets for intake. The active substance of the drug Paksil is paroxetine hydrochloride in the amount of 20 mg.

Clinical and Pharmacological Group

Antidepressant.

Conditions of vacation from pharmacies

Recommended by a doctor's prescription.

Prices

How much does Pakshil stand in pharmacies? The average price in 2018 is at the level of 750 rubles.

Release form and composition

The dosage form of the Paxiel is a tablet-covered tablet containing:

• 20 mg of paroxetine (in the form of hemihydrate hydrochloride);
• Auxiliary components: 317.75 mg of calcium hydrophosphate dihydrate, 5.95 mg of sodium carboxymethyl starch (type A), 3.5 mg of magnesium stearate;
• The composition of the shell: Oddraya white, including polysorbate 80, macrogol 400, titanium dioxide and hypimosellosis.

The tablets are implemented Paxilla on 10 pcs. In a blister, 1, 3 or 10 blisters in a cardboard pack.

Pharmacological effect

Paksil enters the antidepressant group. The mechanism of action of this medication consists in suppressing the inverse seizure of the mediator of serotonin neurons of the brain.

The main component of the component has a slight affinity with nutritional-type cholinoreceptors, for this reason, the tool has insignificant anticholinergic effects. Due to the fact that Paksil has a cholinolitical influence, the main component causes a rapid reduction of anxiety states, eliminates insomnia, has a weak initial activation result. In rare cases, it may cause diarrhea and vomit urge. But due to the fact that this drug has a cholinolitical influence, often during its reception there is a decrease in libido, constipation appears, the body weight increases.

Paksil has a slight impact on the capture of norepinephrine, dopamine. In addition, it has antidepressive, thymoleptic, anxiolytic influence, also has a sedative effect.

Indications for use

Paxil is shown to use in the treatment of various types of depressive states:

• reactive depression;
• severe depressions;
• depression, accompanied by anxiety.

In addition, tablets can be used when identifying the following states:

• post-traumatic stress disorders;
• generalized disturbing disorders - in this case, the drug can be used in a continuous supportive and prophylactic treatment;
• the drug is used both in treating and for the prevention of development of obsessive-compulsive disorders;
• treatment of panic disorders accompanied by agoraphobia: tablets can be used in the implementation of supporting, as well as preventive therapy; The use of the drug contributes to preventing recurrence of panic disorders;
• used to treat and prevent social phobias.

During the first few weeks of using tablets, there is a decrease in the symptoms of depressive states, suicidal thoughts pass.

Contraindications

Receiving tablets Paxilla is contraindicated in several situations to which include:

1. Individual intolerance to the active substance or auxiliary components of the drug.
2. Combined reception with thiuridazine, which can lead to significant arrhythmia (violation of the rhythm and frequency of heart cuts), which increases the risk of fatal outcome.
3. Combined use of Paksil tablets with drugs of Mao inhibitors (monoaminoxidase) and methylene blue - the drug cannot be taken within 2 weeks after taking Mao inhibitors or the use of methylene blue.
4. Children's and adolescent age up to 18 years old - Treatment of depression Tablets Paxil in children and adolescents is ineffective, data on the safety of the drug for children under 7 years old today is not.

Before the use of tablets, Paksil should be seen in the absence of contraindications.

Use during pregnancy and lactation

In the course of animal experiments, there were no negative effects of the drug on the growth and development of the fetus, as well as during pregnancy and childbirth.

However, clinical observations of women who took Paxilla during the first trimester of pregnancy (until the 12th week inclusive) showed that the drug doubles the risk of developing congenital anomalies, such as defects of interventricular and interpresentation partitions. In addition, some newborns whose mothers took Packsil in the third trimester of pregnancy (from 26 to 40 weeks), complications were identified, such as:

• hypoglycemia;
• arterial hypertension;
• hypotension;
• reinforced reflexes;
• distress syndrome;
• cyanosis;
• apnea;
• convulsive seizures;
• temperature instability;
• feeding difficulties;
• vomiting;
• tremor;
• shiver;
• excitability;
• irritability;
• lethargy;
• permanent crying;
• drowsiness.

These complications in children whose mothers took Paxilla in the third trimester of pregnancy are found at 4 - 5 times more often than on average in the population. Thus, given all these facts, women during pregnancy can be applied by paxing only if the intended benefits exceeds all possible risks. But it is better not to use the drug during pregnancy.

Paksil penetrates into breast milk, so on the background of breastfeeding the drug is also not recommended to be applied. At the time of therapy, Paxil is better to abandon breastfeeding and translate the child to artificial blends. In addition, Paksil reduces the quality of spermatozoa in men, so against the background of therapy, the drug should not be planned to conceive the child's conception. However, changes in the quality of sperm are reversible, and after some time after the abolition of Paksil, it again returns to its usual state. Therefore, it is planned to plan a pregnancy after some time after the abolition of Paksil.

Dosage and method of application

In the application instructions, it is recommended that Paksil is recommended to take 1 time / day in the morning while eating. The tablet should be swallowed entirely, not chewing.

Ossessive compulsive disorder:

• The recommended dose is 40 mg / day. Treatment begins with a dose of 20 mg / day, which can be raised weekly by 10 mg / day. If necessary, the dose can be increased to 60 mg / day. It is necessary to observe the adequate duration of therapy (several months and longer).

Depression:

• The recommended dose in adults is 20 mg / day. If necessary, depending on the therapeutic effect, the daily dose may increase weekly by 10 mg / day to a maximum dose of 50 mg / day. As in the treatment of any antidepressants, the effectiveness of therapy should be assessed and, if necessary, adjust the dose of paroxetine 2-3 weeks after the start of treatment and later depending on clinical readings. To relieve depressive symptoms and prevent recurrences, adequate duration of the stopping and supporting therapy must be observed. This period can be several months.

• The recommended dose is 40 mg / day. Treatment of patients should be started with a dose of 10 mg / day and raise a dose of 10 mg / day, focusing on the clinical effect. If necessary, the dose can be increased to 60 mg / day. Low initial dose is recommended to minimize the possible strengthening of the symptoms of a panic disorder, which can occur at the beginning of treatment with any antidepressants. It is necessary to observe adequate terms of therapy (several months and longer).

Post-traumatic stress disorder:

Generalized alarming disorder:

• The recommended dose is 20 mg / day. If necessary, the dose can be increased weekly by 10 mg / day depending on the clinical effect to 50 mg / day.

Separate groups of patients

In the elderly patients, the concentration of paroxetine in plasma can be increased, but the range of its plasma concentrations coincides with those in younger patients. This category of patients therapy should begin with a dose recommended for adults, which can be increased to 40 mg / day.

Paroxetine concentrations in plasma are elevated in patients with severe renal function (QC less than 30 ml / min) and in patients with impaired liver function. Such patients should prescribe a drug dose located at the bottom of the range of therapeutic doses.

The use of paroxetine in children and adolescents (under 18) is contraindicated.

Cancellation of the drug

As with the treatment with other psychotropic drugs, a sharp abolition of paroxetine should be avoided.

The following cancellation scheme can be recommended: a decrease in daily dose by 10 mg per week; After reaching a dose of 20 mg / day, patients continue to receive this dose for 1 week, and only after that the drug is canceled completely. If the symptoms of cancellation develop during a dose reduction or after the discharge of the drug, it is advisable to resume the reception of the previously prescribed dose. Subsequently, the doctor may continue to reduce the dose, but slower.

Side effects

Reducing the frequency and intensity of individual side effects of paroxetine occurs as treatment flows, therefore they do not require cancellation of the destination. Frequency gradation is as follows:

• very often (≥1 / 10);
• often (≥1 / 100,<1/10);
• sometimes happens (≥1 / 1000,<1/100);
• rarely (≥1 / 10,000,<1/1000);
• rarely (<1/10 000), учитывая отдельные случаи.

Frequent and very frequent occurrence is determined on the basis of generalized data about the safety of the drug in more than 8 thousand patients. Clinical trials were carried out to calculate the difference in the frequency of side effects in a group with Paxil and the second placebo group. The occurrence of side effects of paxing rare or very rare is determined on the basis of postmarketing information on the frequency of messages, and not the true frequency of these effects.

Side effects are stratified by organs and frequency:

1. Endocrine system: very rarely - violation of the secretion of ADG.
2. Urinary system: rarely recorded urine delay.
3. Respiratory organs, chest and mediastinum: "Often" marked yawning.
4. Vision: The aggravation of glaucoma is very rare, however, "often" is a fuzzyness.
5. Immune system: Allergic reactions such as urticaria and angioedema edema are very rare.
6. Reproductive system: Very often - cases of sexual dysfunction; Rarely hyperprolactinemia and galactors.
7. Cardiovascular system: "Rarely" marked sinus tachycardia, as well as a transient reduction or an increase in blood pressure.
8. Metabolism: "Often" cases of decline in appetite, sometimes in elderly patients in violation of the secretion of ADG - hyponatremia.
9. Epidermis: frequencies often recorded; A rare case of skin rashes and very rare - photosensitivity reactions.
10. PCT: "Very often" is fixed nausea; Often - constipation or diarrhea with dry mouth; Gastrointestinal bleeding is very rarely recorded.
11. Blood and lymphatic system: Anomalous bleeding (hemorrhage into skin and mucous membranes rarely occurs. Thrombocytopenia is very rare.
12. Hepatobiliary system: Rarely "rarely" was noted to increase the level of production of hepatic enzymes; Very rare cases of hepatitis accompanied by jaundice and / or liver failure.
13. CNS: often there is drowsiness or insomnia, convulsive seizures; Rarely - clouding consciousness, hallucinations, manic reactions as possible symptoms of the disease itself.
14. Among the general disorders: the asthenia is often fixed, and very rarely - peripheral edema.

An approximate list of symptoms that may occur after the past course is completed: "Often" observed dizziness and other sensory disorders, sleep disorders, the presence of alarms, headaches; Sometimes - strong emotional arousal, nausea, tremor, sweating, and diarrhea. Most often, these symptoms in patients are lightweight and weakly pronounced, pass without interference.

Not registered groups of patients who were at increased risk of side effects, but if there is no greater need for steamsetin treatment, the dose is reduced smoothly to complete cancellation.

Overdose

Under the overdose of Paxil, it is possible to strengthen unwanted adverse reactions, as well as the development of fever, violations of blood pressure, tachycardia, alarming state, involuntary muscle contraction. In most cases, the patient's well-being is normalized without serious complications.

Rarely received information on cases of coma development and changes in the ECG, one to the deaths. In most cases, such states were provoked by the combination of paxyl with alcoholic beverages or other psychotropic substances.

An overdose therapy can be carried out in accordance with its manifestations, as well as the instructions of the National Toxicological Center. Specific antidote is absent. Therapy includes general measures whose compliance is required during an overdose of antidepressant. In addition, the basic physiological indicators of the body should be monitored and maintaining supporting treatment.

special instructions

In patients at a young age, especially during the treatment of large depressive disorders, the reception of Paksil can increase the risk of suicidal behavior.

The aggravation of symptoms when depressed and / or the appearance of suicidal thoughts and suicidal behavior may occur independently of whether the antidepressant is obtained. The probability of their development remains until the onset of expressed remission. Due to the fact that the improvement of the state of patients, as a rule, occurs in a few weeks of reception of Paxil, during this period they need to be carefully monitoring the state, especially at the beginning of the medical course.

It should be borne in mind that with other mental disorders, under which Paxil is shown, there is also a high degree of risk of suicidal behavior.

In some cases, most often in the first few weeks of therapy, the use of the drug can lead to the occurrence of acatus (manifests itself in the form of internal anxiety and psychomotor excitation when the patient cannot be in calm condition - sit or stand).

There are such violations such as assets, acatius or mania, may be manifestations of the main disease or develop as a side effect of Paksil. Therefore, in cases where the available symptoms deteriorate, or when developing new, it is necessary to contact a specialist for the advice.

Sometimes, most often during combined use with other serotonergic preparations and / or neuroleptics, it is possible to develop serotonin syndrome or symptoms that are similar to malignant neuroleptic syndrome. If there are symptoms such as vegetative disorders, myoclonus, hyperthermia, muscle rigidity, accompanied by rapid changes in indicators of important functions, as well as changes in mental status, including confusion and irritability, the treatment is canceled.

Large depressive episodes in some cases are the initial manifestation of bipolar disorders. It is believed that monotherapy Paxil can increase the likelihood of accelerated development of a manic / mixed episode in patients at risk of occurrence of this state. Before appointing a drug to assess the risk of bipolar disorder, careful screening should be carried out, comprising detailed psychiatric family history with data on depression cases, suicide and bipolar disorder. For the therapy of a depressive episode within the framework of bipolar disorder, Paksil is not intended. With caution, it should be prescribed to patients with anamnestic data indicating the presence of mania. Also, the prescription of the drug requires caution against the background of epilepsy, the closed-coronal glaucoma, which predispose to bleeding diseases, including the use of substances / drugs that increase the likelihood of bleeding.

The development of symptoms of cancellation (in the form of suicidal thoughts and attempts, changeability of mood, nausea, tear, nervousness, dizziness, pain in the abdomen) does not mean that Paksil causes a dependence or what they abuse.

If convulsive seizures are developing during treatment, Paksil cancel.

Due to the existing risk of developing side effects on the part of the psyche and nervous system, while working with mechanisms and when managing motor vehicles, patients must be particularly careful.

Medicinal interaction

With the combined application of Paxil with some drugs, the following effects may be observed:

• PIMIMID: Increased its level in the blood, the elongation of the Qt interval (combination is contraindicated, if necessary, be careful and careful monitoring of the state);
• Serotoninergic preparations (including fentanyl, l-tryptophan, tramadol, triptans, preparations of a group of SSRS, lithium and vegetable agents with a dended hoody): the development of serotonin syndrome (with monoaminoxidase inhibitors, including an antibiotic transforming into a non-selective Mao inhibitor, and linoxolid application is contraindicated) ;
• FOSPRENAVIR / RITONAVIR: significant decrease in paroxetine concentration in blood plasma;
• Enzymes and inhibitors participating in the metabolism of drugs: change in metabolism and pharmacokinetics of paroxetine;
• Preparations that are metabolized by the liver enzyme CYP2D6 (phenothiazine neuroleptics, tricyclic antidepressants, atomicalsetin, risperidone, some antiarrhythmic agents of class 1 C): an increase in their plasma concentration;
• Prociklidine: an increase in its blood plasma concentration (in the case of the development of anticholinergic effects, its dose should be reduced).

Pharmacokinetics and absorption of paxille does not depend on food, digoxin, antacids, propranolol. Simultaneous use with alcohol is not recommended.

Paksil and alcohol

As a result of clinical studies, evidence was obtained that the absorption and pharmacokinetics of the active substance - paroxetine does not depend or almost independent (that is, the dependence does not require changes doses) from diet and alcohol. It is not established that Paroxetine enhances the negative effect of ethanol on the psychomotoric, however, it is not recommended to take it together with alcohol, since it is mainly alcohol suppresses the effect of the drug - reducing the effectiveness of treatment.