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Active Ingredient: Paroxetine

Paxil is used for treating depression or obsessive-compulsive disorder (OCD). It may be used to treat panic disorder or posttraumatic stress disorder (PTSD). It may also be used to treat generalized anxiety disorder or social anxiety disorder. Paxil is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems.

Mechanism of action

Paroxetine is a potent and selective inhibitor of the reuptake of 5-hydroxytryptamine (5-HT, serotonin). It is believed that its antidepressant activity and effectiveness in the treatment of obsessive-compulsive (OCD) and panic disorder is due to the specific inhibition of serotonin reuptake in brain neurons. In its chemical structure, paroxetine is different from tricyclic, tetracyclic and other known antidepressants. Paroxetine has a weak affinity for muscarinic cholinergic receptors, and animal studies have shown that it has only weak anticholinergic properties.

In accordance with the selective effect of paroxetine, in vitro studies have shown that, unlike tricyclic antidepressants, it has a weak affinity for ɑ-1,-2, and (β-drenoreceptors, as well as for dopamine (D2), 5-НТ1- similar, 5HT2 and histamine (H1) receptors. This lack of interaction with postsynaptic receptors in vitro is confirmed by in vivo studies, which demonstrated the lack of paroxetine ability to inhibit the central nervous system and cause arterial hypotension.

Pharmacodynamic effects

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

Like other selective serotonin reuptake inhibitors, paroxetine causes symptoms of excessive stimulation of 5-HT receptors when administered to animals that have previously received monoamine oxidase inhibitors (MAO) or tryptophan.

Studies on behavior and EEG changes have demonstrated that paroxetine causes weak activating effects at doses higher than those required to inhibit serotonin reuptake. By nature, its activating properties are not "amphetamine-like".

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 the reuptake of norepinephrine, paroxetine has a much lower ability to inhibit the antihypertensive effects of guanethidine.


Absorption. After oral administration, paroxetine is well absorbed and undergoes first-pass metabolism.

Due to the metabolism of the first passage, a smaller amount of paroxetine than the one that is absorbed from the gastrointestinal tract enters the systemic circulation. As the amount of paroxetine in the body increases, with a single dose of large doses or with multiple doses of usual doses, the metabolic pathway of the first passage 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 nonlinearity is usually weakly expressed and is observed only in those patients who, while receiving low doses of the drug in plasma, achieve low levels of paroxetine.

Stable plasma concentrations are achieved 7-14 days after the start of treatment with paroxetine, its pharmacokinetic parameters most likely do not change during long-term therapy.

Distribution. Paroxetine is widely distributed in tissues, and pharmacokinetic calculations show that only 1% of the total amount of paroxetine in the body remains in plasma. At therapeutic concentrations, approximately 95% of paroxetine in plasma is associated with proteins.

No correlation was found between plasma concentrations of paroxetine and its clinical effect (i.e., adverse reactions and efficacy).

It is established that paroxetine in small quantities penetrates into the breast milk of women, as well as into the embryos and fruits of laboratory animals.

Metabolism. The main metabolites of paroxetine are polar and conjugated oxidation and methylation products, 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 serotonin reuptake.

Elimination. With urine in the form of unchanged paroxetine, less than 2% of the accepted dose is excreted, while the excretion of metabolites reaches 64% of the dose. About 36% of the dose is excreted in the feces, probably getting into it with bile; excretion of feces of unchanged paroxetine is less than 1% of the dose. Thus, paroxetine is eliminated almost entirely through metabolism. The excretion of metabolites is biphasic: first it is the result of first-pass metabolism, then it is controlled by systemic elimination of paroxetine.

The half-life of paroxetine varies, but is usually about 1 day (16-24 hours).

Indications for use


Depression of all types, including reactive and severe depression, as well as depression, accompanied by anxiety. When treating depressive disorders, paroxetine has about the same efficacy as tricyclic antidepressants. There is evidence that paroxetine may give good results in patients in whom standard antidepressant therapy has been ineffective. 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 hypnotic drugs in combination with antidepressants, additional side effects did not occur. In the first few weeks of treatment, paroxetine effectively reduces the symptoms of depression and suicidal thoughts.

The results of studies in which patients took paroxetine for up to 1 year showed that the drug effectively prevents relapses of depression.

Obsessive compulsive disorder

Paroxetine is effective in treating obsessive-compulsive disorder (OCD), including as a means of supportive and prophylactic therapy.

In addition, paroxetine effectively prevented relapses of OCD.

Panic disorder

Paroxetine is effective in treating panic disorder with and without agoraphobia, including as a means of supportive and prophylactic therapy.

It has been established that in the treatment of panic disorder, the combination of paroxetine and cognitive-behavioral therapy is significantly more effective than isolated application of cognitive-behavioral therapy. In addition, paroxetine effectively prevented the recurrence of panic disorder.

Social phobia

Paroxetine is an effective treatment for social phobia, including as a long-term supportive and prophylactic therapy.

Generalized anxiety disorder

Paroxetine is effective in generalized anxiety disorder, including as a long-term supportive and prophylactic therapy.

Paroxetine also effectively prevents relapses in this disorder.

Post traumatic stress disorder

Paroxetine is effective in treating post-traumatic stress disorder.


Hypersensitivity to paroxetine and its components.

Combined use of paroxetine with monoaminooxidase inhibitors (MAO). Paroxetine should not be used simultaneously with MAO inhibitors or for 2 weeks after their withdrawal. MAO inhibitors should not be prescribed for 2 weeks after treatment with paroxetine.

Combined use with thioridazine. Paroxetine should not be prescribed in combination with thioridazine, because, like other drugs that inhibit the activity of the liver enzyme CYP450 2D6, paroxetine may increase plasma thiordidine concentrations, which can lead to a prolongation of the QT interval and the associated pirouette arrhythmia (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, so the drug is not indicated for the treatment of the specified age group. The safety and efficacy of paroxetine has not been studied when used in patients of younger age group (younger than 7 years).

Dosage and administration

Paroxetine is recommended to be taken once a day in the morning with meals. The tablet should be swallowed whole, without chewing.


The recommended dose in adults is 20 mg per day. If necessary, depending on the therapeutic effect of the daily dose may be increased weekly by 10 mg per day to a maximum dose of 50 mg per day. As with treatment with any antidepressants, 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 further depending on the clinical indications.

To relieve depressive symptoms and prevent recurrence, it is necessary to observe adequate duration of stopping and supporting 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. Adequate duration of therapy (several months or longer) must be observed.

Panic disorder

The recommended dose is 40 mg per day. Treatment of patients should begin with a dose of 10 mg per day and weekly increase the dose of 10 mg per day, focusing on the clinical effect. If necessary, the dose can be increased to 60 mg per day.

A low initial dose is recommended to minimize the possible increase in the symptoms of panic disorder, which may occur at the beginning of treatment with any anti-depressants. It is necessary to observe adequate terms of therapy (several months and longer).

Social phobia

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.

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.

Cancel paroxetine

As with other psychotropic drugs, the abrupt withdrawal of paroxetine should be avoided. The following withdrawal regimen may be recommended: a daily dose reduction of 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 canceled completely.

If withdrawal symptoms develop during dose reduction or after discontinuation of the drug, it is advisable to resume taking the previously prescribed dose. In the future, the doctor may continue to reduce the dose, but more slowly.

Selected patient groups

Elderly patients

In elderly patients, plasma concentrations of paroxetine may be increased, but the range of its plasma concentrations coincides with those 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 concentrations of paroxetine are increased in patients with severe impairment of 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 range of therapeutic doses.

Children and teenagers (under 18)

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


Objective and subjective symptoms

Available information about paroxetine overdose indicates its wide range of safety. With 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 paroxetine with other psychotropic drugs or with alcohol.


The specific antidote paroxetine does not exist. Treatment should consist of general measures applied in case of overdose of any antidepressants. Shown maintenance therapy and frequent monitoring of basic physiological parameters. Treatment of the patient should be carried out in accordance with the clinical picture or in accordance with the recommendations of the National Toxicological Center.



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