Paxil appointment. Paxil - instructions for the use of tablets, composition, indications, side effects, analogues and price. Side effects and overdose

Abbott Nutrition Ltd SMITHKLINE BEECHAM PHARMACEUTIKALS Glaxo Wellcome Production GlaxoSmithKline Pharmaceuticals S.A. Laboratory GlaxoSmithKline/Glaxo Wellcome Production S.C.Europharm S.A.

Country of origin

Poland Romania United Kingdom France

Product group

Nervous system

Antidepressant

Release form

  • Tablets of 20 mg - 100 pieces per pack. Tablets 20mg - 30pcs per pack.

Description of the dosage form

  • White, film-coated, oval, biconvex tablets, debossed with "20" on one side and a break line on the other.

pharmachologic effect

Antidepressant. It belongs to the group of selective serotonin reuptake inhibitors. The mechanism of action of Paxil is based on its ability to selectively block the reuptake of serotonin (5-hydroxytryptamine /5-HT/) by the presynaptic membrane, which is associated with an increase in the free content of this neurotransmitter in the synaptic cleft and an increase in serotonergic action in the central nervous system responsible for the development of thymoanaleptic (antidepressive) effect. Paroxetine has a low affinity for m-cholinergic receptors (has a weak anticholinergic effect), alpha1-, alpha2- and beta-adrenergic receptors, as well as dopamine (D2), 5-HT1-like, 5-HT2-like and histamine H1 receptors. Behavioral and EEG studies show that paroxetine exhibits weak activating properties when given at doses above those needed to inhibit serotonin uptake. Paroxetine does not affect the cardiovascular system, does not disrupt psychomotor functions, and does not depress the central nervous system. In healthy volunteers, it does not cause a significant change in the level of blood pressure, heart rate and EEG. The main components of the psychotropic activity profile of Paxil are antidepressant and anti-anxiety effects. Paroxetine may cause mild activating effects at doses in excess of those required to inhibit serotonin reuptake. In the treatment of depressive disorders, paroxetine has shown efficacy comparable to that of tricyclic antidepressants. There is evidence that paroxetine is therapeutically effective even in patients who have not responded adequately to prior standard antidepressant therapy. Patients' condition improves as early as 1 week after the start of treatment, but outperforms placebo only at 2 weeks. Taking paroxetine in the morning does not adversely affect the quality and duration of sleep. In addition, with effective therapy, sleep may improve. During the first few weeks of taking paroxetine, patients with depression and suicidal thoughts improve. The results of studies in which patients took paroxetine for 1 year showed that the drug effectively prevents relapses of depression. In panic disorder, the use of Paxil in combination with drugs that improve cognitive function and behavior turned out to be more effective than monotherapy with drugs that improve cognitive-behavioral function, which is aimed at correcting them.

Pharmacokinetics

Absorption After oral administration, paroxetine is well absorbed from the gastrointestinal tract. Eating does not affect absorption. The distribution of Css is established by 7-14 days from the start of therapy. The clinical effects of paroxetine (side effects and efficacy) do not correlate with its plasma concentration. Paroxetine is extensively distributed in tissues, and pharmacokinetic calculations show that only 1% of it is present in plasma, and at therapeutic concentrations, 95% is in protein-bound form. Paroxetine has been found to be excreted in small amounts in breast milk and also crosses the 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 the therapeutic efficacy of the drug is unlikely. Since the metabolism of paroxetine includes a "first pass" stage through the liver, its amount determined in the systemic circulation is less than that absorbed from the gastrointestinal tract. With an increase in the dose of paroxetine or with repeated dosing, when the load on the body increases, there is a partial absorption of the "first pass" effect through the liver and a decrease in the plasma clearance of paroxetine. As a result, an increase in the concentration of paroxetine in plasma and fluctuations in pharmacokinetic parameters are possible, which can only be observed in those patients in whom low plasma levels of the drug are achieved when taking low doses. Withdrawal Excreted in the urine (unchanged - less than 2% of the dose and in the form of metabolites - 64%) or bile (unchanged - 1%, in the form of metabolites - 36%). T1 / 2 varies, but averages 16-24 hours. The elimination of paroxetine is biphasic, including primary metabolism (first phase) followed by systemic elimination. With prolonged continuous use of the drug, pharmacokinetic parameters do not change. Pharmacokinetics in special clinical situations In elderly patients, the plasma concentration of paroxetine is increased, and the range of plasma concentrations in them almost coincides with the range of healthy adult volunteers. In patients with severely impaired renal function (CC less than 30 ml / min) and in patients with impaired liver function, the plasma concentration of paroxetine is increased.

Special conditions

Young patients, especially those with major depressive disorder, may be at increased risk of suicidal behavior during paroxetine therapy. An analysis of placebo-controlled studies in adults with mental illness indicates an increase in the incidence of suicidal behavior in young patients (aged 18-24 years) while taking paroxetine compared with the placebo group (2.19% to 0.92%, respectively), although this difference not considered statistically significant. In patients of older age groups (from 25 to 64 years old and over 65 years old), there was no increase in the frequency of suicidal behavior. In adults of all age groups with major depressive disorder, there was a statistically significant increase in the incidence of suicidal behavior during treatment with paroxetine compared with the placebo group (the incidence of suicide attempts 0.32% to 0.05%, respectively). However, most of these cases while taking paroxetine (8 out of 11) were registered in young patients aged 18-30 years. Data obtained in a study in patients with major depressive disorder may indicate an increase in the incidence of suicidal behavior in patients under 24 years of age with various mental disorders. Patients with depression may experience exacerbation of symptoms and/or the emergence of suicidal thoughts and behavior (suicidality) regardless of whether they are receiving antidepressants. This risk persists until a marked remission is achieved. There may be no improvement in the patient's condition in the first weeks of treatment or more, therefore, the patient must be carefully monitored for the timely detection of a clinical exacerbation of suicidal tendencies, especially at the beginning of the course of treatment, as well as during periods of dose changes (increase or decrease). Clinical experience with all antidepressants indicates that the risk of suicide may increase in the early stages of recovery. Other psychiatric disorders treated with paroxetine may also be associated with an increased risk of suicidal behavior. In addition, these disorders may be comorbid conditions associated with major depressive disorder. Therefore, in the treatment of patients with other psychiatric disorders, the same precautions should be observed as in the treatment of major depressive disorder. Patients with a history of suicidal behavior or suicidal thoughts, younger patients, and patients with severe suicidal thoughts prior to treatment are at greatest risk of suicidal thoughts or suicidal attempts, and therefore all of them need to be given special attention during treatment.

Compound

  • paroxetine hydrochloride hemihydrate 22.8 mg, which corresponds to the content of paroxetine 20 mg Excipients: calcium dihydrophosphate dihydrate, sodium carboxystarch type A, magnesium stearate. Shell composition: hypromellose, titanium dioxide, macrogol 400, polysorbate 80

Paxil indications for use

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

Paxil contraindications

  • - simultaneous administration of MAO inhibitors and a period of 14 days after their withdrawal (MAO inhibitors cannot be prescribed within 14 days after the end of treatment with paroxetine); - simultaneous reception of thioridazine; - concomitant use of pimozide; - age up to 18 years (controlled clinical studies of paroxetine in the treatment of depression in children and adolescents have not proven its effectiveness, therefore the drug is not indicated for the treatment of this age group). Paroxetine is not prescribed to children under the age of 7 years due to the lack of data on the safety and efficacy of the drug in this category of patients. - hypersensitivity to paroxetine and other components of the drug.

Paxil dosage

  • 20 mg 20 mg

Paxil side effects

  • The frequency and intensity of some side effects may decrease with continued therapy and usually do not lead to discontinuation of treatment. Determination of the frequency of side effects: very often (> 1/10), often (> 1/100, 1/1000, 1/10 000,

drug interaction

The use of paroxetine concomitantly with serotonergic drugs (including L-tryptophan, triptans, tramadol, selective serotonin reuptake inhibitors, fentanyl, lithium, and herbal remedies containing St. John's wort) can cause serotonin syndrome. The use of paroxetine with MAO inhibitors (including linezolid, an antibiotic that transforms into a non-selective MAO inhibitor) is contraindicated. In a study of the possibility of co-administration of paroxetine and pimozide at a low dose (2 mg once), an increase in the level of pimozide was recorded. This fact is explained by the property of paroxetine to inhibit the CYP2D6 isoenzyme. Due to the narrow therapeutic index of pimozide and its known ability to prolong the QT interval, the combined use of pimozide and paroxetine is contraindicated. When using these drugs in combination with paroxetine, care must be taken and careful clinical monitoring should be carried out.

Overdose

an increase in the side effects described above, as well as vomiting, fever, changes in blood pressure, involuntary muscle contractions, anxiety, tachycardia. Patients usually do not develop serious complications even with a single dose of up to 2 g of paroxetine.

Storage conditions

  • store at room temperature 15-25 degrees
  • keep away from children
Information provided


Paxil analogs are presented, in accordance with medical terminology, called "synonyms" - drugs that are interchangeable in terms of effects on the body, containing one or more identical active substances. When choosing synonyms, consider not only their cost, but also the country of origin and the reputation of the manufacturer.

Description of the drug

Paxil- Paroxetine is a potent and selective 5-hydroxytryptamine (5-HT, serotonin) reuptake inhibitor. It is generally accepted that its antidepressant activity and effectiveness in the treatment of obsessive-compulsive disorder (OCD) and panic disorder are due to the specific inhibition of serotonin reuptake in brain neurons.

In terms of its chemical structure, paroxetine differs from tricyclic, tetracyclic and other well-known antidepressants.

Paroxetine has a weak affinity for muscarinic acetylcholine receptors, and animal studies have shown that it has only weak anticholinergic properties.

In accordance with the selective action of paroxetine, in vitro studies have shown that, unlike tricyclic antidepressants, it has a weak affinity for α 1 -, α 2 - and β-adrenergic receptors, as well as for dopamine (D 2), 5-HT 1 -like, 5HT 2 - and histamine (H 1) receptors. This lack of interaction with postsynaptic receptors in vitro is confirmed by the results of in vivo studies, which demonstrated that paroxetine does not have the ability to depress the central nervous system and cause arterial hypotension.

Pharmacodynamic effects

Paroxetine does not disrupt psychomotor functions and does not enhance the inhibitory effect of ethanol on the central nervous system.

Like other selective serotonin reuptake inhibitors, paroxetine causes symptoms of 5-HT receptor overstimulation when administered to animals that have previously received MAO inhibitors or tryptophan. Behavioral and EEG studies have demonstrated that paroxetine produces weak activating effects at doses in excess of those required to inhibit serotonin reuptake. Its activating properties are not "amphetamine-like" in nature.

Animal studies have shown that paroxetine does not affect the cardiovascular system.

In healthy individuals, paroxetine does not cause clinically significant changes in blood pressure, heart rate and ECG.

Studies have shown that, unlike antidepressants that inhibit norepinephrine reuptake, paroxetine has a much lower ability to inhibit the antihypertensive effects of guanethidine.

List of analogues

Note! The list contains Paxil synonyms that have a similar composition, so you can choose a replacement yourself, taking into account the form and dose of the medicine prescribed by your doctor. Give preference to manufacturers from the USA, Japan, Western Europe, as well as well-known companies from Eastern Europe: Krka, Gedeon Richter, Actavis, Egis, Lek, Geksal, Teva, Zentiva.


Release form(by popularity)price, rub.
Tab 20mg N30 (Glaxo Wellcome Production (France)753.10
20mg №30 tab (GlaxoSmithKline Pharmaceuticals (Poland)807.10
Tab 20mg N100 (Glaxo Wellcome Production (France)2288.40
20mg No. 100 tab.2302.90
Tab 20mg №30 (Veropharm JSC (Russia)638
Tab 20mg №30 (ACTAVIS Group Malta (Malta)470
Tab 20mg №30 (Actavis Ltd (Malta)487
Tab 30mg N30 (ACTAVIS Group Malta (Malta)545
Tab 30mg N30 (Actavis Ltd (Malta)600.50
Tab p / pl.o 30mg N30 w / k5690528143126 (Actavis JSC (Iceland)647.40
Tablets 20 mg, 30 pcs. (Apotex, Canada)616
20mg No. 30 tab.327.50
20mg №30 tab.346.50
Tablets 20 mg, 30 pcs. (Teva, Israel)365
Film-coated tablets 20 mg 30 pcs. (Teva, Israel)405
Tablets 20 mg, 30 pcs.764
Tablets 30 mg, 30 pcs.873

Reviews

Below are the results of surveys of visitors to the site about the drug Paxil. They reflect the personal feelings of the respondents and cannot be used as an official recommendation for treatment with this drug. We strongly recommend that you consult a qualified medical specialist for a personalized course of treatment.

Visitor survey results

Nine visitors reported effectiveness


Your answer about side effects »

Eleven visitors reported a value estimate

Members%
Expensive9 81.8%
not expensive2 18.2%

Your answer about the cost estimate »

21 visitors reported the frequency of admission per day

How often should I take Paxil?
Most of the respondents most often take this drug once a day. The report shows how often the other participants in the survey take this drug.
Members%
1 per day17 81.0%
2 times a day3 14.3%
4 times a day1 4.8%

Your answer about the frequency of intake per day »

Thirteen visitors reported dosage

Members%
11-50mg8 61.5%
6-10mg4 30.8%
51-100mg1 7.7%

Your answer about dosage »

Seven visitors reported a start date

How long does it take to take Paxil to feel an improvement in the patient's condition?
Survey participants in most cases felt an improvement in their condition after 1 month. But this may not correspond to the period after which you will improve. Talk to your doctor about how long you need to take this medicine. The table below shows the results of the survey on the beginning of an effective action.
Your answer about the start date »

Ten visitors reported reception time

When is the best time to take Paxil: on an empty stomach, before or after food?
Site users most often report taking this medication with meals. However, your doctor may recommend a different time for you. The report shows when the rest of the interviewed patients take their medicine.
Your answer about the appointment time »

61 visitors reported patient age


Your answer about the age of the patient »

Visitor reviews


There are no reviews

Official instructions for use

There are contraindications! Before use, read the instructions

Paxil (PAXIL)

Registration number:

P No. 016238/01
Trade name of the drug: Paxil

International non-proprietary name:

Paxil

Dosage form:

film-coated tablets 20 mg
The composition of the drug:
Active substance: paroxetine hydrochloride hemihydrate - 22.8 mg (equivalent to 20.0 mg paroxetine base).
Excipients: calcium dihydrogen phosphate dihydrate, sodium carboxymethyl starch type A, magnesium stearate.
Tablet shell: hypromellose, titanium dioxide, macrogol 400, polysorbate 80.
Description:
White, biconvex, film-coated tablets, oval, debossed with "20" on one side of the tablet and a break line on the other side.

Pharmacotherapeutic group:

Antidepressant
ATC code:

Pharmacological properties

Pharmacodynamics
Mechanism of action
Paxil is a potent and selective 5-hydroxytryptamine (5-HT, serotonin) reuptake inhibitor. It is generally accepted that its antidepressant activity and effectiveness in the treatment of obsessive-compulsive disorder (OCD) and panic disorder are due to the specific inhibition of serotonin reuptake in brain neurons. In its chemical structure, Paxil differs from tricyclic, tetracyclic and other well-known antidepressants. Paxil has a weak affinity for muscarinic cholinergic receptors, and animal studies have shown that it has only weak anticholinergic properties.
According to the selective action of paroxetine, studies in vitro showed that, unlike tricyclic antidepressants, it has a weak affinity for α-1, α-2 and (β-drenoreceptors, as well as for dopamine (D 2), 5-HT 1-like, 5HT 2 and histamine (H 1) receptors This lack of interaction with postsynaptic receptors in vitro is supported by the results of in vivo studies, which demonstrated that paroxetine does not have the ability to depress the central nervous system and cause arterial hypotension.
Pharmacodynamic effects
Paxil does not disrupt psychomotor functions and does not enhance the inhibitory effect of ethanol on the central nervous system.
Like other selective serotonin reuptake inhibitors, Paxil causes symptoms of 5-HT receptor overstimulation when administered to animals that have previously received monoamine oxidase (MAO) inhibitors or tryptophan.
Behavioral and EEG studies have demonstrated that Paxil produces weak activating effects at doses in excess of those required to inhibit serotonin reuptake. Its activating properties are not "amphetamine-like" in nature.
Animal studies have shown that Paxil does not affect the cardiovascular system.
In healthy individuals, Paxil does not cause clinically significant changes in blood pressure, heart rate and ECG. Studies have shown that, unlike antidepressants that inhibit norepinephrine reuptake, Paxil has a much lower ability to inhibit the antihypertensive effects of guanethidine.

Pharmacokinetics

Absorption. After oral administration, Paxil is well absorbed and undergoes first pass metabolism.
Due to first pass metabolism, less paroxetine enters the systemic circulation than is absorbed from the gastrointestinal tract. As the amount of paroxetine in the body increases with a single dose of large doses or with multiple doses of conventional doses, the first pass metabolic pathway is partially saturated and the clearance of paroxetine from plasma decreases. This leads to a disproportionate increase in plasma concentrations of paroxetine. Therefore, its pharmacokinetic parameters are not stable, resulting in non-linear kinetics. It should be noted, however, that non-linearity is usually mild and occurs only in patients who achieve low plasma levels of paroxetine with low doses of the drug.
Stable plasma concentrations are reached 7-14 days after the start of treatment with paroxetine, its pharmacokinetic parameters are likely not to change during long-term therapy.
Distribution. Paxil is widely distributed in tissues, and pharmacokinetic calculations show that only 1% of the total amount of paroxetine present in the body remains in plasma. At therapeutic concentrations, approximately 95% of plasma paroxetine is protein bound.
No correlation was found between plasma concentrations of paroxetine and its clinical effect (i.e., with adverse reactions and efficacy).
It has been established that Paxil in small amounts passes into the breast milk of women, as well as into embryos and fetuses of laboratory animals Metabolism. The main metabolites of paroxetine are polar and conjugated products of oxidation and methylation, which are easily eliminated from the body. Given the relative lack of pharmacological activity of these metabolites, it can be argued that they do not affect the therapeutic effects of paroxetine.
Metabolism does not impair the ability of paroxetine to selectively inhibit the reuptake of serotonin.
Elimination. Less than 2% of the dose is excreted in the urine as unchanged paroxetine, while excretion of metabolites reaches 64% of the dose. About 36% of the dose is excreted in the feces, probably entering it with bile; faecal excretion of unchanged paroxetine is less than 1% of the dose. Thus, Paxil is eliminated almost entirely through metabolism.
The excretion of metabolites is biphasic: initially it is the result of first pass metabolism, then it is controlled by the systemic elimination of paroxetine.
The half-life of paroxetine varies, but is usually about 1 day (16-24 hours).

Indications for use

  • Depression
    Depression of all types, including reactive and severe depression, as well as depression accompanied by anxiety. In the treatment of depressive disorders, Paxil has about the same effectiveness as tricyclic antidepressants. There is evidence that Paxil may provide good results in patients who have failed standard antidepressant therapy. Taking paroxetine in the morning does not adversely affect the quality and duration of sleep. In addition, as the effect of treatment with paroxetine appears, sleep may improve. When using short-acting hypnotics in combination with antidepressants, additional side effects did not occur. In the first few weeks of therapy, Paxil effectively reduces symptoms of depression and suicidal thoughts.
    The results of studies in which patients took Paxil for up to 1 year showed that the drug effectively prevents relapses of depression.

  • Paxil is effective in the treatment of obsessive-compulsive disorder (OCD), including as a supportive and preventive therapy.
    In addition, Paxil was effective in preventing OCD recurrences.
  • panic disorder
    Paxil is effective in the treatment of panic disorder with and without agoraphobia, including as a supportive and preventive therapy.
    In the treatment of panic disorder, the combination of paroxetine and cognitive behavioral therapy has been found to be significantly more effective than the isolated use of cognitive behavioral therapy. In addition, Paxil was effective in preventing relapses of panic disorder.
  • social phobia
    Paxil is an effective treatment for social phobia, including as a long-term maintenance and preventive therapy.

  • Paxil is effective in generalized anxiety disorder, including as a long-term maintenance and preventive therapy.
    Paxil is also effective in preventing relapses in this disorder.

  • Paxil is effective in the treatment of post-traumatic stress disorder.

    Contraindications

  • Hypersensitivity to paroxetine and its components.
    Combined use of paroxetine with monoamine oxidase (MAO) inhibitors. Paxil should not be used simultaneously with MAO inhibitors or within 2 weeks after their withdrawal. MAO inhibitors should not be prescribed within 2 weeks after the end of treatment with paroxetine.
  • Combined use with thioridazine. Paxil should not be administered in combination with thioridazine because, like other drugs that inhibit the activity of the hepatic enzyme CYP450 2D6, Paxil can increase plasma concentrations of thioridazine, which can lead to prolongation of the QT interval and associated arrhythmias "pirouette" (torsades de pointes ) and sudden death.
  • Combined use with pimozide.
  • Use in children and adolescents under 18 years of age. Controlled clinical studies of paroxetine in the treatment of depression in children and adolescents have not proven its effectiveness, therefore the drug is not indicated for the treatment of this age group. The safety and efficacy of paroxetine have not been studied in younger patients (less than 7 years of age).

    Dosage and administration

    Paxil is recommended to be taken once a day in the morning with meals. The tablet should be swallowed whole without chewing.
  • Depression
    The recommended dose in adults is 20 mg per day. If necessary, depending on the therapeutic effect, the daily dose may be increased weekly by 10 mg per day up to a maximum dose of 50 mg per day. As with any antidepressant treatment, the effectiveness of therapy should be evaluated and, if necessary, the dose of paroxetine should be adjusted 2-3 weeks after the start of treatment and thereafter depending on clinical indications.
    To stop depressive symptoms and prevent relapses, it is necessary to observe an adequate duration of stopping and maintenance therapy. This period may be several months.
  • Obsessive Compulsive Disorder
    The recommended dose is 40 mg per day. Treatment begins with a dose of 20 mg per day, which can be increased weekly by 10 mg per day. If necessary, the dose can be increased to 60 mg per day. It is necessary to observe an adequate duration of therapy (several months or longer).
  • panic disorder
    The recommended dose is 40 mg per day. Patients should be treated at a dose of 10 mg daily and increased weekly by 10 mg daily based on clinical response. If necessary, the dose can be increased to 60 mg per day.
    A low initial dose is recommended to minimize the possible increase in panic disorder symptoms that may occur at the start of treatment with any antidepressant.
    It is necessary to observe adequate terms of therapy (several months and longer).
  • social phobia
  • generalized anxiety disorder
    The recommended dose is 20 mg per day. If necessary, the dose can be increased weekly by 10 mg per day, depending on the clinical effect, up to 50 mg per day.
  • Post Traumatic Stress Disorder
    The recommended dose is 20 mg per day. If necessary, the dose can be increased weekly by 10 mg per day, depending on the clinical effect, up to 50 mg per day.
    general information
    Withdrawal of paroxetine
    As with other psychotropic drugs, abrupt discontinuation of paroxetine should be avoided. The following withdrawal regimen may be recommended: reduce the daily dose by 10 mg per week; after reaching a dose of 20 mg per day, patients continue to take this dose for 1 week, and only after that the drug is completely canceled.
    If withdrawal symptoms develop during dose reduction or after discontinuation of the drug, it is advisable to resume taking the previously prescribed dose. Subsequently, the doctor may continue to reduce the dose, but more slowly.
    Separate groups of patients
    Elderly patients
    In elderly patients, plasma concentrations of paroxetine may be increased, but the range of its plasma concentrations is similar to that in younger patients.
    In this category of patients, therapy should begin with the dose recommended for adults, which can be increased to 40 mg per day.
    Patients with impaired renal or hepatic function
    Plasma paroxetine concentrations are elevated in patients with severely impaired renal function (creatinine clearance less than 30 ml/min) and in patients with impaired liver function. Such patients should be prescribed doses of the drug that are in the lower part of the therapeutic dose range.

    The use of paroxetine in this category of patients is contraindicated.

    Side effects

    The frequency and intensity of some of the side effects of paroxetine listed below may decrease with continued treatment, and such effects usually do not require discontinuation of the drug. Side effects are stratified below by organ system and frequency. The frequency gradation is as follows: very frequent (> 1/10), frequent (> 1/100,<1/10) нечастые (>1/1000, <1/100), редкие (>1/10 000, <1/1000) и очень редкие (<1/10 000), включая отдельные случаи. Встречаемость частых и нечастых побочных эффектов была определена на основании обобщенных данных о безопасности препарата на более чем 8000 пациентов, участвовавших в клинических испытаниях, ее рассчитывали 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, и она касается скорее частоты сообщений о таких эффектах, чем истинной частоты самих эффектов.
    Blood and lymphatic system disorders
    Infrequent: abnormal bleeding, predominantly c. skin and mucous membranes (most often bruises).
    Very rare: thrombocytopenia. Violations from the side. immune system:
    Very rare: allergic reactions (including urticaria and angioedema).
    Endocrine disorders
    Very rare: Syndrome of impaired secretion of antidiuretic hormone. Metabolic and nutritional disorders
    Frequent: decreased appetite, increased cholesterol levels.
    Rare: hyponatremia. Hyponatremia occurs predominantly in elderly patients and may be due to a syndrome of impaired secretion of antidiuretic hormone.
    Mental disorders:
    Frequent: drowsiness, insomnia, agitation, unusual dreams (including nightmares).
    Infrequent: confusion, hallucinations.
    Rare: manic reactions. These symptoms may also be caused by the disease itself.
    Nervous System Disorders
    Frequent: dizziness, tremor, headache.
    Infrequent: extrapyramidal disorders.
    Rare: convulsions, akathisia, restless legs syndrome.
    Very rare: serotonin syndrome (symptoms may include agitation, confusion, increased sweating, hallucinations, hyperreflexia, myoclonus, tachycardia with shivering, and tremor). Extrapyramidal symptoms, including orofacial dystonia, have rarely been reported in patients with impaired motor function or treated with antipsychotics.
    Visual disturbances
    Frequent: blurred vision.
    Infrequent: mydriasis
    Very rare: acute glaucoma.
    Heart disorders:
    Infrequent: sinus tachycardia
    Vascular disorders
    Infrequent: postural hypotension
    Respiratory, thoracic and mediastinal disorders
    Frequent: yawn.
    Gastrointestinal disorders
    Very common: nausea.
    Frequent: constipation, diarrhea, vomiting, dry mouth.
    Very rare: gastrointestinal bleeding.
    Hepatobiliary disorders
    Rare: increased levels of liver enzymes.
    Very rare: hepatitis, sometimes accompanied by jaundice, and / or liver failure. Sometimes there is an increase in the levels of liver enzymes. Post-marketing reports of liver damage (such as hepatitis, sometimes with jaundice, and/or liver failure) are very rare. The question of the advisability of discontinuing treatment with paroxetine must be addressed in cases where there is a prolonged increase in liver function tests.
    Skin and subcutaneous tissue disorders
    Frequent: sweating.
    Infrequent: skin rashes.
    Very rare: photosensitivity reactions.
    Renal and urinary tract disorders
    Rare: urinary retention, urinary incontinence.
    Reproductive system and mammary gland disorders
    Very common: sexual dysfunction.
    Rare: hyperprolactinemia/galactorrhea.
    General violations
    Frequent: asthenia, weight gain.
    Very rare: peripheral edema.
    Symptoms that occur when treatment with paroxetine is stopped:
    Frequent: dizziness, sensory disturbances, sleep disturbances, anxiety, headache.
    Infrequent: agitation, nausea, tremor, confusion, sweating, diarrhea:
    As with the withdrawal of many psychotropic drugs, discontinuation of paroxetine treatment (especially abruptly) may cause symptoms such as dizziness, sensory disturbances (including paresthesia, electric shock and tinnitus), sleep disturbances (including vivid dreams), agitation, or anxiety, nausea, headache, tremors, confusion, diarrhea and sweating. In most patients, these symptoms are mild or moderate and resolve spontaneously. No group of patients is known to be at increased risk for such symptoms; therefore if. treatment with paroxetine is no longer necessary, its dose should be reduced slowly until the drug is completely discontinued.
    Adverse events observed in clinical trials in children
    In pediatric clinical trials, the following side effects occurred in 2% of patients and were twice as common in the paroxetine group than in the placebo group: emotional lability (including self-harm, suicidal thoughts, suicidal attempts, tearfulness, and mood swings), hostility, decreased appetite, tremor, sweating, hyperkinesia and agitation.
    Suicidal ideation and suicide attempts have mostly been observed in clinical trials in adolescents with major depressive disorder, for which paroxetine has not been shown to be effective. Hostility has been reported in children with obsessive-compulsive disorder, especially in children younger than 12 years of age.
    Symptoms of paroxetine withdrawal (emotional lability, nervousness, dizziness, nausea and abdominal pain) were recorded in 2% of patients on the background of a reduction in the dose of paroxetine or after its complete withdrawal and occurred 2 times more often than in the placebo group.

    Overdose

    Objective and subjective symptoms
    Available information on overdose of paroxetine suggests its wide range of safety. In case of an overdose of paroxetine, in addition to the symptoms described in the "Side Effects" section, fever, changes in blood pressure, involuntary muscle contractions, anxiety and tachycardia are observed.
    The condition of patients usually returned to normal without serious consequences, even with a single dose of up to 2000 mg. A number of reports describe symptoms such as coma and ECG changes. deaths were very rare, usually in situations where patients took Paxil along with other psychotropic drugs or with alcohol.
    Treatment
    There is no specific antidote for paroxetine. Treatment should consist of the general measures used for overdose of any antidepressant. Supportive therapy and frequent monitoring of key physiological parameters are indicated. The patient should be treated according to the clinical picture or according to the recommendations of the national poison control center.

    special instructions

    Children and teenagers (under 18)
    Antidepressant treatment of children and adolescents with major depressive disorder and other psychiatric illnesses is associated with an increased risk of suicidal thoughts and behavior. In clinical studies, adverse events associated with suicidal attempts and suicidal thoughts, hostility (mainly aggression, deviant behavior and anger) were more frequently observed in children and adolescents treated with Paxil than in patients of this age group who received placebo. Currently, there are no data on the long-term safety of paroxetine in children and adolescents regarding the effect of this drug on growth, maturation, cognitive and behavioral development.
    Clinical deterioration and suicidal risk in adults
    Young patients, especially those with major depressive disorder, may be at increased risk of suicidal behavior during paroxetine therapy. An analysis of placebo-controlled studies in adults with mental illness indicates an increase in the frequency of suicidal behavior in young patients (aged 18-24 years) while taking paroxetine compared with the placebo group (2.19% to 0.92%, respectively). ), although this difference is not considered statistically significant. In patients of older age groups (from 25 to 64 years old and over 65 years old), no increase in the frequency of suicidal behavior was observed. In adults of all age groups with major depressive disorder, there was a statistically significant increase in the incidence of suicidal behavior during treatment with paroxetine compared with the placebo group (incidence of suicide attempts: 0.32% to 0.05%, respectively). However, most of these cases while taking paroxetine (8 out of 11) were registered in young patients aged 18-30 years. Data obtained in a study in patients with major depressive disorder may indicate an increase in the incidence of suicidal behavior in patients under 24 years of age suffering from various mental disorders. In patients with depression, exacerbation of symptoms of this disorder and / or the appearance of suicidal thoughts and suicidal behavior (suicidality) can be observed regardless of whether they receive antidepressants. This risk persists until a marked remission is achieved. There may be no improvement in the patient's condition in the first weeks of treatment or more, and therefore the patient must be carefully monitored for the timely detection of clinical exacerbation and suicidality, especially at the beginning of the course of treatment, as well as during periods of changing doses, whether it is an increase or decrease. Clinical experience with all antidepressants indicates that the risk of suicide may increase in the early stages of recovery. Other psychiatric disorders treated with Paxil may also be associated with an increased risk of suicidal behavior. In addition, these disorders may be comorbid conditions associated with major depressive disorder. Therefore, in the treatment of patients suffering from other mental disorders, the same precautions should be observed as in the treatment of major depressive disorder. Patients with a history of suicidal behavior or suicidal thoughts, younger patients, and patients with severe suicidal thoughts before treatment are at greatest risk of suicidal thoughts or suicidal attempts, and therefore all of them need to be given special attention during treatment. Patients (and their caregivers) should be warned to watch for worsening of their condition and/or the appearance of suicidal thoughts/suicidal behavior or thoughts of harming themselves during the entire course of treatment, especially at the beginning of treatment, when changing the dose of the drug. (increase and decrease). If these symptoms occur, seek immediate medical attention. It must be remembered that symptoms such as agitation, akathisia or mania may be associated with the underlying disease or be a consequence of the therapy used. If symptoms of clinical worsening (including new symptoms) and/or suicidal thoughts/behaviours occur, especially if they appear suddenly, increase in severity, or if they were not part of the patient's previous symptom complex, it is necessary to reconsider the therapy regimen up to drug withdrawal.
    Akathisia Occasionally, treatment with paroxetine or another drug of the selective serotonin reuptake inhibitors (SSRIs) group is accompanied by the occurrence of akathisia, which is manifested by a feeling of internal restlessness and psychomotor agitation when the patient cannot sit or stand still; with akathisia. the patient usually experiences subjective discomfort. The chance of akathisia occurring is highest in the first few weeks of treatment.
    Serotonin syndrome/Neuroleptic malignant syndrome
    In rare cases, during treatment with paroxetine, serotonin syndrome or neuroleptic malignant syndrome-like symptoms may occur, especially if Paxil is used in combination with other serotonergic drugs and / or antipsychotics. These syndromes are potentially life-threatening and therefore treatment with paroxetine should be discontinued if they occur (they are characterized by clusters of symptoms such as hyperthermia, muscle rigidity, myoclonus, autonomic disturbances with possible rapid changes in vital signs, changes in mental status, including confusion, irritability, extremely severe agitation progressing to delirium and coma), and start supportive symptomatic therapy. Paxil should not be administered in combination with serotonin precursors (such as L-tryptophan, oxytriptan) due to the risk of developing a serotonergic syndrome.
    Mania and Bipolar Disorder A major depressive episode may be the initial manifestation of bipolar disorder. It is generally accepted (although not proven by controlled clinical trials) that treating such an episode with an antidepressant alone may increase the likelihood of an accelerated mixed/manic episode in patients at risk for bipolar disorder. Before initiating antidepressant treatment, a thorough screening should be performed to assess the patient's risk of developing bipolar disorder; such screening should include a detailed psychiatric history, including family history of suicide, bipolar disorder, and depression. Paxil is not approved for the treatment of a depressive episode in bipolar disorder. Paxil should be used with caution in patients with a history of mania.
    Monoamine oxidase (MAO) inhibitors
    Treatment with paroxetine should be started cautiously no earlier than 2 weeks after stopping therapy with MAO inhibitors; the dose of paroxetine should be increased gradually until the optimal therapeutic effect is achieved.
    Impaired kidney or liver function
    Caution is advised when treating paroxetine in patients with severe renal impairment and in patients with hepatic impairment.
    Epilepsy
    As with other antidepressants, Paxil should be used with caution in patients with epilepsy. Seizures The frequency of seizures in patients taking Paxil is less than 0.1%. If a seizure occurs, treatment with paroxetine should be discontinued.
    Electroconvulsive therapy
    There is only limited experience with the concomitant use of paroxetine and electroconvulsive therapy.
    Glaucoma
    Like other SSRIs, Paxil causes mydriasis and should be used with caution in patients with angle-closure glaucoma.
    Hyponatremia
    During treatment with paroxetine, hyponatremia occurs rarely and mainly in elderly patients and is leveled after discontinuation of paroxetine.
    Bleeding
    Skin and mucosal bleeding (including gastrointestinal bleeding) has been reported in patients treated with paroxetine. Therefore, Paxil should be used with caution in patients who are simultaneously receiving drugs that increase the risk of bleeding, in patients with a known bleeding tendency and in patients with diseases that predispose to bleeding.
    Heart disease
    When treating patients with heart disease, the usual precautions should be followed.
    Symptoms that may occur when paroxetine treatment is discontinued in adults include:
    As a result of clinical studies in adults, the incidence of adverse events with the withdrawal of paroxetine was 30%, while the incidence of adverse events in the placebo group was 20%.
    Withdrawal symptoms have been described such as dizziness, sensory disturbances (including paresthesias, electric shock and tinnitus), sleep disturbances (including vivid dreams), agitation or anxiety, nausea, tremors, confusion, sweating, headaches, and diarrhea. Usually these symptoms are mild or moderate, but in some patients they can be severe. They usually occur in the first few days after discontinuation of the drug, but in rare cases they occur in patients who accidentally missed taking just one dose. As a rule, these symptoms resolve spontaneously and disappear within 2 weeks, but in some patients they can last much longer (2-3 months or more). It is recommended to reduce the dose of paroxetine gradually over several weeks or months before completely withdrawing it, depending on the needs of the individual patient. The occurrence of withdrawal symptoms does not mean that the drug is abused or addictive, as is the case with narcotics and psychotropic substances.
    Symptoms that may occur when paroxetine treatment is stopped in children and adolescents include:
    In clinical studies in children and adolescents, the incidence of adverse events with discontinuation of paroxetine was 32%, while the incidence of adverse events in the placebo group was 24%. Symptoms of paroxetine withdrawal (emotional lability, including suicidal thoughts, suicidal attempts, mood changes and tearfulness, as well as nervousness, dizziness, nausea and abdominal pain) were recorded in 2% of patients during a reduction in the dose of paroxetine or after its complete withdrawal and occurred 2 times more often than in the placebo group.
    bone fractures
    According to the results of epidemiological studies of the risk of bone fractures, an association of bone fractures with the use of antidepressants, including the SSRI group, was revealed. The risk was observed during the course of antidepressant treatment and was maximal at the beginning of the course of therapy. The possibility of bone fractures should be considered when prescribing paroxetine.
    Interaction with other medicinal products and other forms of interaction
    Serotonergic drugs:
    The use of paroxetine, as with other SSRIs, concomitantly with serotonergic drugs (including L-tryptophan, triptans, tramadol, SSRIs, fentanyl, lithium, and herbal remedies containing St. John's wort) may cause effects associated with 5-HT (serotonin syndrome). The use of paroxetine with MAO inhibitors (including linezolid, an antibiotic that transforms into a non-selective MAO inhibitor) is contraindicated.
    Pimozide:
    In a study of the possibility of co-administration of paroxetine and pimozide at a low dose (2 mg once), an increase in the level of pimozide was recorded. This fact is explained by the known property of paroxetine to inhibit the CYP2D6 system. Due to the narrow therapeutic index of pimozide and its known ability to prolong the QT interval, the combined use of pimozide and paroxetine is contraindicated.
    When using these drugs in combination with paroxetine, care must be taken and careful clinical monitoring should be carried out.
    Enzymes involved in drug metabolism:
    The metabolism and pharmacokinetics of paroxetine may be altered by induction or inhibition of enzymes involved in drug metabolism. When using paroxetine at the same time as an inhibitor of enzymes involved in the metabolism of drugs, the advisability of using a dose of paroxetine that is in the lower part of the therapeutic dose range should be evaluated. The starting dose of paroxetine does not need to be adjusted when it is used concomitantly with a drug known to induce drug-metabolizing enzymes (eg, carbamazepine, rifampicin, phenobarbital, phenytoin). Any subsequent dose adjustment of paroxetine should be determined by its clinical effects (tolerability and efficacy).
    Fosamprenavir/ritonavir:
    Co-administration of fosamprenavir/ritonavir with paroxetine resulted in a significant decrease in paroxetine plasma concentrations. Any subsequent dose adjustment of paroxetine should be determined by its clinical effects (tolerability and efficacy).
    Procyclidine:
    Daily intake of paroxetine significantly increases the concentration of procyclidine in the blood plasma. If anticholinergic effects occur, the dose of procyclidine should be reduced.
    Anticonvulsants:
    carbamazepine, phenytoin, sodium valproate. The simultaneous use of paroxetine and these drugs does not affect their pharmacokinetics and pharmacodynamics in patients with epilepsy.
    The ability of paroxetine to inhibit the enzyme CYP2D6
    Like other antidepressants, including other drugs of the SSRI group, Paxil inhibits the hepatic enzyme CYP2D6, which belongs to the cytochrome P450 system. Inhibition of the CYP2D6 enzyme can lead to increased plasma concentrations of concomitantly used drugs that are metabolized by this enzyme. These drugs include tricyclic antidepressants (eg, amitriptyline, nortriptyline, imipramine, and desipramine), phenothiazine antipsychotics (perphenazine and thioridazine), risperidone, atomoxetine, some type 1c antiarrhythmics (eg, propafenone and flecainide), and metoprolol. The use of paroxetine, which inhibits the CYP2D6 system, can lead to a decrease in the concentration of the active metabolite of tamoxifen in the blood plasma, and as a result, reduce the effectiveness of tamoxifen. CYP3A4
    Interaction research in vivo with simultaneous use, under equilibrium conditions, of paroxetine and terfenadine, which is a substrate of the CYP3A4 enzyme, showed that Paxil does not affect the pharmacokinetics of terfenadine. In a similar interaction study in vivo no effect of paroxetine on the pharmacokinetics of alprazolam was found, and vice versa. The simultaneous use of paroxetine with terfenadine, alprazolam and other drugs that serve as a substrate for the CYP3A4 enzyme is unlikely to cause harm to the patient.
    Clinical studies have shown that the absorption and pharmacokinetics of paroxetine are independent or practically independent (i.e. the existing dependence does not require dose changes) from:
  • antacids
  • digoxin
  • propranolol
  • Alcohol: Paxil does not increase the negative effect of alcohol on psychomotor functions, however, it is not recommended to take Paxil and alcohol at the same time.

    Pregnancy and lactation

    Fertility
    SSRIs (including Paxil) can affect the quality of seminal fluid. This effect is reversible after discontinuation of the drug. Changes in the properties of sperm can lead to impaired fertility.
    Pregnancy
    Animal studies have not revealed teratogenic or selective embryotoxic activity in paroxetine.
    Recent epidemiological studies of pregnancy outcomes with first-trimester antidepressants have found an increased risk of congenital anomalies, particularly of the cardiovascular system (eg, ventricular and atrial septal defects), associated with paroxetine. The reported incidence of cardiovascular defects with paroxetine during pregnancy is approximately 1/50, while the expected incidence of such defects in the general population is approximately 1/100 newborns. When prescribing paroxetine, consideration should be given to alternative treatment in pregnant women and women planning pregnancy. There are reports of preterm birth in women who received during pregnancy Paxil or other drugs of the SSRI group, but a causal relationship between these drugs and preterm birth has not been established. Paxil should not be used during pregnancy unless the potential benefit outweighs the potential risk.
    It is necessary to carefully monitor the health of those newborns whose mothers took Paxil in late pregnancy, since there are reports of complications in newborns exposed to paroxetine or other drugs of the SSRI group in the third trimester of pregnancy. It should be noted, however, that in this case, too, a causal relationship between these complications and this drug therapy has not been established. Reported clinical complications included: respiratory distress syndrome, cyanosis, apnea, seizures, temperature instability, feeding difficulties, vomiting, hypoglycemia, hypertension, hypotension, hyperreflexia, tremor, trembling, nervous excitability, irritability, lethargy, constant crying, and drowsiness . In some reports, the symptoms have been described as neonatal manifestations of the withdrawal syndrome. In most cases, the described complications occurred immediately after childbirth or shortly after them (< 24ч). По данным эпидемиологических исследований прием препаратов группы СИОЗС (включая Паксил) на поздних сроках беременности сопряжен с увеличением риска развития персистируюшей легочной гипертензии новорожденных. Повышенный риск наблюдается у детей, рожденных от матерей, принимавших СИОЗС на поздних сроках беременности, в 4-5 раз превышает наблюдаемый в общей популяции (1-2 на 1000 случаев беременности).
    Lactation
    Small amounts of paroxetine pass into breast milk. However, Paxil should not be taken while breastfeeding unless the benefit to the mother outweighs the potential risks to the baby.
    Influence on the ability to drive a car and / or other mechanisms
    Clinical experience with the use of paroxetine indicates that it does not impair cognitive and psychomotor functions. However, as in the treatment of any other psychotropic drugs, patients should be especially careful when driving a car and operating machinery.
    Despite the fact that Paxil does not increase the negative effect of alcohol on psychomotor functions, it is not recommended to use Paxil and alcohol at the same time.

    Release form

    10 tablets in a PVC / aluminum foil blister or 10 tablets in a PVC / PVDC / aluminum foil blister. 1, 3 or 10 blisters, together with instructions for use, are placed in a cardboard box.

    Best before date

    3 years.
    Do not use after the expiration date stated on the package.

    Storage conditions

    At a temperature not exceeding 30 ° C, out of the reach of children.

    Holiday conditions

    On prescription.

    Manufacturer

    1. GlaxoWellcome Production Zon Industrial du Terra. 53100. Mayenne. France / Zone Industrielle du Terras. 53100. Mayenne. France
    2. Essi. Europharm Es.A. / S.C. Europharm S.A.
    2 Panselelor Street. Brasov. Brasov district, code 500419. Romania / 2 Panselelor st Brasov. Jud. Brasov, 500419 Romania
    Organization accepting claims in the Russian Federation
    ZAO GlaxoSmithKline Trading
    121634. Moscow, st. Krylatskaya, 17, bldg. 3. fl. 5
    Business Park "Krylatsky Hills"

    The information on the page was verified by the therapist Vasilyeva E.I.

  • The drug "Paxil" is currently one of the most popular antidepressant drugs. Our life, filled with all sorts of stressful situations, needs the availability of such medications, sometimes being the only means that can relieve overstrain and put aside our fears, feelings and various phobias. Therefore, now we will analyze such main aspects regarding Paxil tablets: reviews of people, method of use, restrictions, side effects and much more.

    Compound

    The antidepressant described in this article contains the following elements:

    • Main substance: paroxetine hydrochloride hemihydrate in the amount of 22.8 mg.
    • Auxiliary components: calcium dihydrogen phosphate dihydrate, magnesium stearate, sodium carboxymethyl starch type A.

    The shell of the tablet itself consists of hypromellose, titanium dioxide, macrogol 400 and polysorbate 80.

    Implementation form

    The tool is available in the form of tablets, which are coated (it comes in various colors). The pills are oval, biconvex, engraved on one side and a break line on the other.

    Dragees are produced in blisters, 10 pieces each. Sold in a cardboard box of 10, 30 and 100 tablets.

    In what cases should it be applied?

    The drug "Paxil" can be prescribed by a doctor for the following problems:

    1. Spleen, prostration, depression.
    2. Extreme mental disorder.
    3. social phobia.
    4. post-traumatic disorder.
    5. Anxiety of the patient.
    6. Panic attacks.

    Method of application and dosage

    In what quantity and how to drink the drug "Paxil"? Instructions for use of the drug states that it is advisable to take it once a day in the morning, at the time of eating. The pill should be swallowed whole, and there is no need to chew it.

    Now consider the dosing regimen of the drug, depending on the mental state of the patient:

    Stopping the drug

    As with therapy with any other psychotropic drugs, the abolition of Paxil - tablets that are good antidepressants - should be gradual. The scheme for terminating the reception of funds can be as follows:

    Dose reduction by 10 mg every 7 days.

    After reaching the mark of taking the drug 20 mg per day, the patient should continue to take it in the same volume for 1 week. And only after that the tablets are completely canceled.

    However, if symptoms develop at the time of a dose reduction or after the drug has been completely stopped, the doctor may resume taking this medication. In the future, the specialist may continue to reduce the number of pills taken, but more slowly.

    To date, there are many similar medicines like Paxil pills. The analogues of this drug are called as follows: tablets "Adepress", "Plezil", "Reksetin", "Sirestill". These drugs have the same composition as the antidepressant described in this article. Currently, there are drugs that are similar in their action to Paxil. Analogues can be easily purchased at any pharmacy, and their composition will be similar. For example, similar drugs for the pharmacological group: Amitriptyline, Oprah, Miracitol, Deprenon, Amiksid, Negrustin, Fluoxetine, Zoloft, Prozac, Cipramil, Stimuloton, Framex, Sedopram, Noxibel, Epivel.

    Contraindications

    Patients who take MAO inhibitors such as lamizide, thioridazine, tryptophan.

    Children under 18 years old.

    Women who are breastfeeding their babies.

    With increased individual sensitivity to paroxetine and other auxiliary components of the drug.

    It is necessary to carefully apply the medication to people who have renal and hepatic insufficiency.

    Taking the drug during pregnancy

    The drug "Paxil" is prescribed to pregnant women only if the intended benefit to the mother is higher than the risk to the fetus. In any case, the doctor should consider the option of alternative treatment for pregnant women.

    Drug use in adolescents

    The antidepressant "Paxil" is not prescribed for children, even in the smallest doses. Young people from the age of 18 are prescribed this medication, however, it must be taken into account that at the beginning of such treatment, boys or girls may increase the risk of suicidal tendencies (for example, suicide attempts, thoughts about it). The characteristic hostility of the patient (aggression, anger, irritability, impulsivity) can also be observed. Currently, there is no data on the safety of this antidepressant for adolescents, on its effect on the growth, maturation and behavioral development of boys and girls.

    Third Party Effects

    None of the similar drugs can not have unwanted reactions, so Paxil is no exception. Side effects when taking this remedy can be as follows:

    1. Disorders of the lymphatic system and blood flow:

    Hemorrhages in the skin, as well as in the mucous membranes - rarely;

    Thrombocytopenia is a pathology associated with a sharp decline in the number of red blood cells (observed sporadically).

    2. Metabolic and nutritional problems:

    Increased concentration of cholesterol;

    Decreased appetite.

    3. Mental disorders:

    Drowsiness or, conversely, insomnia, nightmares;

    Agitation - emotional arousal, accompanied by anxiety, fear, anxiety (a person in this state becomes too fussy, he has a feeling of emptiness, thoughts are confused, the ability to reason is disturbed);

    hallucinations;

    Thoughts of suicide (such ideas and behaviors may occur early in treatment or after therapy is stopped).

    4. Violations of the nervous system:

    dizziness, headache, trouble concentrating;

    Cramps, restless leg syndrome;

    Very rarely - serotonin syndrome, which is characterized by confusion, increased sweating, the appearance of hallucinations, chills and tremors in the body, tachycardia and tremor.

    5. Problems with the organs of vision:

    Acute glaucoma;

    Mydriasis - pupil dilation;

    Blurred vision.

    6. Violations of the organ of hearing and heart:

    The appearance of noise in the ears;

    Aggression.

    Liver failure (signs of hepatitis and cirrhosis).

    Urinary retention.

    In case of an overdose, a specialist prescribes the following treatment:

    1. Gastric lavage.
    2. Taking activated charcoal.
    3. Artificial induction of vomiting.

    If the case is severe, then the patient can be admitted to a hospital and deal with his further treatment within the walls of the hospital. In a medical institution, he is given various detoxification measures, monitors the work of the heart, and perhaps even connects him to a ventilator (in critical moments).

    Medicine Paxil: price in Russia

    This drug is manufactured in France, so it is brought to the post-Soviet countries from there, and here its cost depends on the exchange rate, various duties at customs points, delivery and storage costs, and, of course, the mark-up of a particular pharmacy. To date, the average cost of such an antidepressant ranges from 700-730 rubles per package, in which 30 tablets, and 2000-2300 rubles for 100 pills.

    Can I drink alcohol during therapy?

    From the point of view of therapeutic interaction, Paxil tablets and alcohol are compatible concepts, therefore, purely theoretically, it can be assumed that during treatment you can drink wine, whiskey, etc. However, in practice, doctors do not recommend doing this, since this may lead to are the following adverse effects:

    A one-time use of a strong drink on the eve of taking the medicine significantly reduces the effect of the drug.

    The systematic intake of alcohol causes an increase in both the positive results of the pills and their side effects.

    Influence on the ability to drive a car and other mechanisms

    The action of "Paxil" - a new generation antidepressant drug - in no way has a negative effect on the patient's psychomotor functions. However, in the treatment of any other psychotropic drugs, patients should be extremely prudent when driving a car and working with mechanisms.

    People evaluation

    Unfortunately, there is no unequivocal opinion of patients about the drug Paxil. Reviews are both positive and negative. Good responses were left by those patients who took pills strictly according to the doctor's prescription for the treatment of severe mental disorders. People noted that they gradually managed to achieve results: the state of asthenia disappeared, panic attacks passed, anxiety, fears - all this was eliminated. Patients had faith in the future, as well as the desire to perform some important work. The only thing is that the effect did not appear immediately, you had to wait. And this is a normal phenomenon.

    But, of course, there are also negative reviews about the Paxil drug. Reviews of a disapproving nature relate to the allegedly false therapy with this remedy. Many people on the forums write that at the very beginning of taking these pills they really had an excellent effect: a mood appeared, strength and energy increased, depression disappeared, the person felt much better. However, as soon as the drug was stopped, it became even worse, and in addition, various side effects appeared: headaches, nausea, insomnia, etc. It turns out that people developed addiction, a kind of withdrawal, like drug addicts.

    Also, the disadvantages of this medication, many people attribute its high cost, because it really is an expensive drug.

    Therefore, before thinking about whether it is worth taking these pills at all, maybe it is better to seek help from certified psychiatrists who will help to cope with the problem itself, and not dull its consequences?

    Doctors' opinions

    Doctors respond positively about the antidepressant Paxil. Reviews of this nature are not accidental: with proper use, this medication is able to cope with its task. Also, unlike many other similar drugs, Paxil is a proprietary drug, so doctors most often prescribe it.

    However, experts unanimously warn that this antidepressant must be taken correctly. It is imperative to follow all the prescriptions and prescriptions of the doctor, who sets the individual dosage of the medicine for each individual person. And if the patient turned to a specialist for help and decided to treat his nervous breakdown with this particular medication, then it is necessary, according to the rules, to finish therapy. What is meant? It is necessary to cancel the drug gradually, and not abruptly. And of course, patients should not forget about interactions with other drugs, as well as alcohol. And if the patient complies with all the doctor's prescriptions, then the positive effect of the drug will definitely be.

    Terms and conditions of storage

    The medicine should be kept out of the reach of children. The storage temperature should not exceed 30 degrees.

    The shelf life of the drug is 3 years from the date of manufacture.

    Today you have learned enough interesting and necessary information about such a drug as Paxil (price, use, analogues, reviews about it - all this is in the article). We found out that this medicine is a strong antidepressant, so you need to take it only if there are doctor's prescriptions. By the way, only for its intended purpose will a person be sold this remedy in a pharmacy, since such a serious medication is dispensed strictly by prescription.

    Release form Paxil

    Coated tablets

    Packing Paxil

    Pharmacological action Paxil

    Paxil is an antidepressant. Selectively blocks the reuptake of serotonin, increases its concentration in the synaptic cleft and causes an antidepressant effect. It has a low affinity for muscarinic cholinergic receptors, for alpha-1, alpha-2, beta-adrenergic receptors, as well as 5-HT_1-like, 5-HT_2-like and histamine (H_1) receptors. It does not violate psychomotor functions and does not potentiate the inhibitory effect of ethanol on them. The antidepressant effect appears after 7-14 days of systematic use. Against the background of treatment, there is a decrease in anxiety, depression, normalization of sleep.

    Paxil Indications

    Depression of all types, including reactive depression, severe endogenous depression and depression accompanied by anxiety (the results of studies in which patients received the drug for 1 year show that it is effective in preventing relapse of depression).
    - Treatment (including maintenance 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 that the drug remains effective in the treatment of OCD for at least 1 year and prevention of OCD relapses).
    - Treatment (including maintenance and prophylactic therapy) of panic disorder with and without agoraphobia (the effectiveness of the drug is maintained for 1 year, preventing relapse of panic disorder).
    - Treatment (including supportive and preventive therapy) of social phobia in adults, as well as in children and adolescents aged 8-17 years (the effectiveness of the drug is maintained with long-term treatment of this disorder).
    - Treatment (including maintenance and preventive therapy) of generalized anxiety disorder (the effectiveness of the drug is maintained during long-term treatment of this disorder, preventing relapse of this disorder).
    - Treatment of post-traumatic stress disorder.

    Contraindications Paxil

    Simultaneous administration of MAO inhibitors and a period of 14 days after their withdrawal (MAO inhibitors cannot be prescribed within 14 days after the end of treatment with paroxetine).
    - Simultaneous reception of thioridazine.
    - Hypersensitivity to paroxetine and other components of the drug.

    Use during pregnancy and lactation Paxil

    In experimental studies, no teratogenic or embryotoxic effects of paroxetine have been identified. Data from a small number of women who took paroxetine during pregnancy suggest no increased risk of congenital anomalies in newborns. There are reports of premature birth in women who received paroxetine during pregnancy, but a causal relationship with the drug has not been established. Paxil should not be used during pregnancy unless the potential benefit of treatment outweighs the possible risk associated with taking the drug.
    It is necessary to monitor the health of newborns whose mothers took paroxetine in late pregnancy, since there are reports of complications in children (however, a causal relationship with the drug has not been established). Respiratory distress syndrome, cyanosis, apnea, convulsive seizures, temperature instability, feeding difficulties, vomiting, hypoglycemia, arterial hyper- or hypotension, hyperreflexia, tremor, irritability, lethargy, constant crying, drowsiness are described. In some reports, the symptoms have been described as neonatal manifestations of the withdrawal syndrome. In most cases, the described complications occurred immediately after childbirth or shortly after them (within 24 hours). Paroxetine is excreted in small amounts in breast milk. Therefore, the drug should not be used during lactation, unless the potential benefit of treatment outweighs the possible risk associated with taking the drug.

    Dosage and administration of Paxil

    Inside, in the morning - 20 mg. With insufficient effect, it is possible to increase the dose by 10 mg / day with an interval of at least 1 week (maximum dose - 50 mg / day). In elderly, malnourished patients, as well as in violation of the function of the kidneys and liver, the initial dose is 10 mg / day, the maximum is 40 mg / day.

    Paxil side effects

    Drowsiness or insomnia, tremor, nervousness, increased excitability of the central nervous system, impaired concentration, emotional lability, amnesia, dizziness, accommodation paresis, pupil dilation, eye pain, noise and pain in the ears, increase or decrease in blood pressure, fainting, tachycardia or bradycardia, violation of cardiac conduction and peripheral circulation, cough, rhinitis, dipnea, tachypnea, nausea, loss of appetite, dyspepsia, increased activity of hepatic transaminases, stomatitis, arthralgia, arthritis, dysuria, polyuria, urinary incontinence, urinary retention, amenorrhea, dysmenorrhea, miscarriage, mastitis , violation of ejaculation, decreased libido and potency, peripheral edema, weight loss or increase, anemia, leukopenia, allergic reactions (itching, urticaria, chills). Rarely - thinking disorders, akinesia, ataxia, convulsions, hallucinations, hyperkinesia, manic or paranoid reactions, delirium, euphoria, grand mal seizures, aggressiveness, nystagmus, stupor, autism, decreased visual acuity, cataracts, conjunctivitis, glaucoma, exophthalmos, angina pectoris, myocardial infarction, cerebrovascular accident, heart rhythm disturbances, eosinophilia, leukocytosis, lymphocytosis, monocytosis, hematuria, nephrourolithiasis, impaired renal function, dermatitis, erythema nodosum, depigmentation.

    Special instructions Paxil

    It should be taken with caution in renal and hepatic insufficiency, angle-closure glaucoma, prostatic hyperplasia, mania, cardiac pathology, epilepsy, convulsive conditions, in combination with electrical impulse therapy, in patients receiving drugs that increase the risk of bleeding, with risk factors for increased bleeding. During treatment, you must refrain from taking alcoholic beverages. Use with caution during work for drivers of vehicles and people whose profession is associated with increased concentration of attention. With abrupt cancellation - dizziness, sensory disturbances, sleep disturbance, agitation, anxiety, nausea, sweating. Care should be taken when prescribing in combination with lithium preparations. At the time of treatment should refrain from drinking ethanol.

    Paxil drug interactions

    Inducers of microsomal oxidation (phenobarbital, phenytoin) reduce blood concentration and activity, inhibitors (cimetidine) - increase. Increases the level of procyclidine in plasma. Incompatible with MAO inhibitors. Co-administration with indirect anticoagulants can cause increased bleeding with an unchanged prothrombin time. Enhances the effect of alcohol.

    Paxil overdose

    Available information on paroxetine overdose suggests a wide range of safety.
    Symptoms: increased side effects described above, vomiting, dilated pupils, fever, changes in blood pressure, involuntary muscle contractions, agitation, anxiety, tachycardia.
    Patients usually do not develop serious complications even with a single dose of up to 2 g of paroxetine. In some cases, coma and changes in the EEG develop, and very rarely, death occurs with the combined use of paroxetine with psychotropic drugs or alcohol.
    Treatment: standard measures used for an overdose of antidepressants (gastric lavage through artificial vomiting, the appointment of 20-30 mg of activated charcoal every 4-6 hours during the first day after an overdose). The specific antidote is unknown. Supportive therapy and control of vital body functions are shown.

    Paxil storage conditions

    Store in a dry place at a temperature not exceeding 30°.

    In an online pharmacy Paxil can be purchased with home delivery. The quality of all products in our online pharmacy, including Paxil, undergo quality control of goods by our trusted suppliers. You can buy Paxil on our website by clicking on the "Buy" button. We will be happy to deliver Paxil to you absolutely free of charge to any address within our delivery area.

    Paxil is a potent selective serotonin reuptake inhibitor with potent antidepressant activity.

    The drug is available in the form of tablets for oral administration. The active substance of the drug Paxil is paroxetine hydrochloride in the amount of 20 mg.

    As auxiliary elements, magnesium stearate, calcium hydrogen phosphate, titanium dioxide are used.

    The chemical structure of Paxil and other drugs from the group of tetracyclic and tricyclic antidepressants is different.

    Pharmacological effect

    The action of the drug Paxil is associated with its ability to promote selective blocking of serotonin reuptake and enhance serotonergic effects in the central nervous system, which has an antidepressant effect. The psychotropic activity of the drug is associated with its ability to:

    • eliminate depression;
    • relieve the patient of anxiety.

    No carcinogenic or mutagenic effects of the drug have been identified.

    According to research results, the drug may have a moderate activating effect when used at a dosage higher than that required to inhibit serotonin uptake. Paxil does not contribute to the impact on the cardiovascular system, disorders of psychomotor functions, as well as depression of the central nervous system.

    In the treatment of depressive conditions, Paxil demonstrates efficacy that can be compared with the effects of drugs from the group of tricyclic antidepressants. The active component of the drug demonstrates the proper therapeutic effect even during the therapy of those patients who did not respond positively to previous treatment with drugs from the antidepressant group.

    An improvement in the patient's well-being is observed after 1 week of using the tablets.

    If you use Paxil in the morning, the active ingredient of the drug does not adversely affect the duration of sleep. In addition, effective therapy can improve the quality of sleep.

    According to the results of studies, in patients who took the drug Paxil for 12 months, the risk of relapse of depressive conditions is significantly reduced.

    If the drug is used in the treatment of panic disorders in combination with drugs that improve behavior and cognitive functions, the administration of Paxil has a more pronounced therapeutic effect than mono-treatment with other groups of drugs.

    The absorption of the active substance occurs in the liver area, the achievement of a stable concentration in the blood plasma is observed after 1-2 weeks of regular tablet intake. The excretion of the active component is carried out together with excrement.

    The elimination half-life for each patient may vary, on average it takes from 15-16 hours to a day.

    Indications for admission

    Paxil is indicated for use in the treatment of various types of depressive conditions:

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

    In addition, tablets can be used to identify the following conditions:

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

    Mode of application

    Paxil tablets should be taken once a day, with meals. The drug should not be chewed. The exact dose and course of treatment are selected, taking into account the indications for admission and the patient's complaints.

    In the treatment of depression, the effectiveness of the prescribed treatment should be evaluated (a few weeks after the start of treatment) and, if necessary, the dose of the drug should be adjusted. The duration of stopping and maintenance treatment can take up to several months.

    Patients with severe liver and kidney dysfunction should take the tablets at the lowest effective dose.

    It is worth refraining from abruptly stopping the use of Paxil tablets. . If during the period of a gradual decrease in the dosage of the patient, the withdrawal syndrome is disturbed, then it is recommended to resume taking the previously used dosage. In the future, the dose should be reduced more slowly.

    Paxil is not intended for self-medication, you should always consult your doctor before taking the tablets.

    Development of an overdose

    With an overdose of Paxil, it is possible to increase unwanted side reactions, as well as the development of fever, blood pressure disorders, tachycardia, anxiety, and involuntary muscle contraction. In most cases, the patient's well-being returns to normal without serious complications.

    Rarely, there was information about cases of coma and ECG changes, and sporadically about lethal outcomes. In most cases, such conditions were provoked by the combination of Paxil with alcohol or other psychotropic substances.

    Overdose therapy can be carried out in accordance with its manifestations, as well as the instructions of the national poison control center. There is no specific antidote. Therapy includes general measures that are required in case of an overdose of an antidepressant. In addition, the main physiological parameters of the body should be monitored and supportive treatment should be carried out.

    Contraindications

    Paxil is contraindicated for use:

    • with intolerance to the active or auxiliary elements;
    • simultaneously with MAO inhibitors, thioridazine and pimozide substances;
    • Paxil is also not used in the treatment of persons under the age of 18 years.

    Use during pregnancy

    Before the appointment of Paxil during the treatment of women who are expecting a child, the possibility of using alternative methods of treatment should be considered. There is information about cases of premature birth of children whose mothers use Paxil in late pregnancy. Tablets should not be taken unless the potential risk outweighs the potential benefit.

    A certain amount of the active substance of the drug has the ability to penetrate into breast milk. For this reason, the drug is not prescribed if the potential benefit does not outweigh the likely harm to the child.

    Despite the fact that the teratogenic effects of Paxil have not been identified, tablets are used during the treatment of pregnant women only in exceptional cases.

    The active ingredient of the drug may affect the quality of sperm.

    Adverse reactions

    Paxil can cause disorders of the immune, endocrine, cardiovascular, digestive, reproductive, respiratory systems, as well as mental disorders, metabolic disorders.

    The most commonly reported were blurred vision, headache, yawning, tremors, dizziness, drowsiness, agitation, sleep disturbances, decreased appetite, nausea, stool disorders, dry mouth, sweating, sexual dysfunction, asthenia, and weight gain.

    When Paxil treatment was stopped, the most common complaints were dizziness, sensory disturbances, anxiety, headache, and sleep disturbances.

    drug interaction

    When Paxil is combined with hypnotic drugs with a short period of action, the development of additional adverse reactions is not observed.

    Paxil dosage adjustment may be required when combined with drugs from the group of tricyclic antidepressants, as well as medicines based on metoprolol, procyclidine, flecainide, encaidine, propafenone, thioridazine.

    The active substance of the tablets may increase the effect of drugs containing alcohol, as well as reduce the effectiveness of medicines, the active substance of which is tamoxifen and digoxin.

    Simultaneous use with drugs from the group of indirect anticoagulants and antithrombotic agents may lead to the risk of bleeding.

    Paxil should not be used simultaneously with drugs based on methylene blue and medicines from the group of MAO inhibitors, as well as for 14 days after stopping their use. MAO inhibitor drugs should not be taken for 14 days after completion of therapy with Paxil.

    In the course of controlled clinical trials, Paxil did not demonstrate adequate efficacy in the treatment of depressive conditions in patients of younger and adolescence (from 7 to 17 years old). For this reason, the drug is not used in the treatment of this age group of patients.

    Since the active substance of the drug can contribute to the development of mydriasis, the drug is used with extreme caution in the treatment of patients with angle-closure glaucoma.

    Experience with the use of the drug simultaneously with electroconvulsive therapy is limited.

    Paxil is used with extreme caution in the treatment of people with a history of epilepsy.

    When prescribing the drug, the risk of bone fracture should be taken into account.

    When driving vehicles and performing potentially hazardous types of work, special care must be taken.

    The drug is used with extreme caution in the treatment of patients with a history of mania.

    The combination of the active substance of the drug with alcoholic beverages is not recommended.

    Storage of the drug should be carried out in a place inaccessible to children and sunlight. Tablets are stored in compliance with the temperature regime - no more than 30 degrees.

    This medication is available in pharmacies as a prescription drug.

    Analogues, cost

    The cost of the drug Paxil for the period June 2016 is formed as follows:

    1. Tablets 30 pcs., 20 mg - 700-730 rubles.
    2. Tablets 100 pcs., 20 mg - 2130-2190 rubles.

    Analogues of the drug Paxil are: Reksetin, Plizil N, Paroxetine, Adepress, Actaparoxetine.

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