DR. DOPING

Instructions

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Instructions / Instruction for use: Paxil

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Dosage form: coated tablets

Active substance: Paroxetine*

ATX

N06AB05 Paroxetin

Pharmacological groups:

Antidepressant

The nosological classification (ICD-10)

F32 Depressive episode: Adynamic subdepression; Astheno-adynamic subdepressive states; Asthenoadressive disorder; Astheno-depressive disorder; Asthenodepressive state; Astheno-depressive state; Major Depressive Disorder; Vyaloapatichesky depression with retardation; Double Depression; Depressive pseudodement; Depressive illness; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive disorders; Depressive syndrome; Depressive syndrome larviated; Depressive syndrome in psychoses; Depressed masks; Depression; Depression Depletion; Depression with the phenomena of inhibition within the framework of cyclothymia; Depression is smiling; Involutional depression; Involutionary melancholy; Involutional depression; Manic-depressive disorder; Masked Depression; Melancholic Attack; Neurotic depression; Neurotic depression; Shallow Depression; Organic depression; Organic depressive syndrome; Simple depression; Simple melancholic syndrome; Psychogenic depression; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Reactive depression; Recurrent depression; Seasonal depressive syndrome; Severostatic depression; Senile Depression; Symptomatic Depression; Somatogenic depression; Cyclotymic depression; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F33 Recurrent depressive disorder: Major depressive disorder; Secondary depression; Double Depression; Depressive pseudodement; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive syndrome; Depressed masks; Depression; Depression is smiling; Involutional depression; Involutional depression; Masked Depression; Melancholic Attack; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F40.0 Agoraphobia: Fear of open space; Fear of being in a crowd

F40.1 Social phobia: Social isolation; Social detachment; Social phobia; Social Anxiety Disorder / Social Phobia; Sociophobia; Sociopathy

F41.0 Panic disorder [episodic paroxysmal anxiety]: Panic state; Panic attack; Panic; Panic disorders

F41.1 Generalized anxiety disorder: Generalized anxiety disorders; Generalized alarm; Phobic neurosis; Anxiety reaction; Anxious neurosis

F41.9 Unspecified anxiety disorder: Neurotic disorders with anxiety syndrome; Severe anxiety; Neurosis-like symptoms; Neuro-like disorders; Neuro-like conditions; Neuroses with anxiety symptoms; Neuroses with a sense of anxiety; Acute situational and stress anxiety; Acute attack of anxiety; Abrupt anxiety; Situational Anxiety Disorder; State of anxiety; Anxious-delirious component; Alarming state; Anxiety; Anxiety Disorders; Anxiety syndrome; Sense of anxiety; Alarm states; Chronic neurotic anxiety; Susto; Psychopathy with a predominance of anxiety and anxiety; Anxiety disorders in neurotic and neurosis-like states; Anxious neuroses; Anxious and delusional state; Acute situational stress alarm; Depressed mood with elements of anxiety

F43.1 Post-traumatic stress disorder: Combat fatigue; Catastrophe Syndrome; The survivor's syndrome; Traumatic isolation; Traumatic neurosis; Traumatic syndrome; Post-Traumatic Stress Disorder

Composition and release form

Tablets 1 table.

paroxetine hydrochloride hemihydrate 22.8 mg

(equivalent to 20.0 mg of paroxetine)

auxiliary substances: calcium dihydrogen phosphate dihydrate; sodium carboxymethyl starch type A; magnesium stearate

tablet shell: Opadry white YS-1R-7003 (hypromellose, titanium dioxide, macrogol 400, polysorbate 80)

in a blister of 10 pcs .; in the box 1, 3 or 10 blisters.

Description of dosage form

White biconvex tablets covered with a shell, oval in shape with an engraving "20" on one side and a fault line on the other.

Characteristic

Selective serotonin reuptake inhibitor.

Pharmachologic effect

Mode of action - antidepressant.

Antidepressant activity is due to the specific inhibition of reuptake of serotonin in neurons of the brain.

Pharmacodynamics

Has a low affinity for muscarinic cholinergic receptors, and studies in animals have shown that anticholinergic properties are poorly expressed. In vitro studies have shown that paroxetine has a weak affinity for alpha1, alpha2 and beta adrenoreceptors, as well as for dopamine (D2), serotonin 5-HT1 and 5-HT2 and histamine (H1) receptors. The lack of interaction with postsynaptic receptors in vitro is confirmed by the results of in vivo studies, which demonstrated the absence of the ability of paroxetine to oppress the CNS and cause arterial hypotension. Does not violate psychomotor functions and does not enhance the inhibitory effect of ethanol on the central nervous system.

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

Studies of EEG behavior and changes have demonstrated that paroxetine causes mild activating effects at doses in excess of those required to inhibit serotonin reuptake. By its nature, its activating properties are not amphetamine-like.

Studies in animals have shown that paroxetine does not affect the cardiovascular system.

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

Pharmacokinetics

When ingested, it is well absorbed and metabolized at the "first pass" through the liver. Due to the metabolism of the "first passage", less paroxetine is delivered to the systemic bloodstream than that absorbed from the digestive tract. As the amount of paroxetine increases in the body with a single intake of large doses or with repeated intake of usual doses, the partial metabolism of the "first passage" occurs and the clearance of paroxetine from the plasma decreases. This leads to a disproportionate increase in the concentrations of paroxetine in the plasma. Therefore, its pharmacokinetic parameters are unstable, resulting in nonlinear kinetics. It should be noted, however, that the nonlinearity is usually poorly expressed and is observed only in those patients who, when taking low doses of the drug in the plasma, achieve low levels of paroxetine. The equilibrium concentration in plasma is reached after 7-14 days. Paroxetine is widely distributed in tissues, and pharmacokinetic calculations show that only 1% of the total amount of paroxetine present in the body remains in the plasma. At therapeutic concentrations, approximately 95% of paroxetine in the plasma is associated with proteins. There was no correlation between paroxetine concentrations in plasma and its clinical effect (adverse reactions and efficacy). It was found that paroxetine penetrates into breast milk of women in small amounts, as well as in embryos and fruits of laboratory animals.

Biotransformed into inactive polar and conjugated products (oxidation and methylation processes). T1 / 2 varies, but usually is about one day (16-24 hours). About 64% is excreted in urine in the form of metabolites, less than 2% - in unchanged form; the rest of the amount is excreted with feces (probably getting into it with bile) in the form of metabolites, less than 1% - in unchanged form. Excretion of metabolites is biphasic, including primary metabolism (first phase) and systemic elimination.

Clinical Pharmacology

Taking paroxetine in the morning does not adversely affect the quality and duration of sleep. In addition, as the effect of paroxetine treatment manifests, sleep can improve. When using short-acting hypnotic drugs in combination with antidepressants, no additional side effects occurred.

In the first few weeks of therapy, paroxetine effectively reduces 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.

Controlled clinical studies of paroxetine in the treatment of depression in children and adolescents (7-17 years) have not proven its effectiveness, so the drug is not indicated for treatment of this age group.

Paroxetine is effective in treating obsessive-compulsive disorder (OCD) in adults, as well as in children and adolescents aged 7-17 years.

It has been established that in the treatment of panic disorder in adults, the combination of paroxetine and cognitive-behavioral therapy is significantly more effective than one cognitive-behavioral therapy.

Studies have shown that paroxetine has little ability to inhibit the antihypertensive effects of guanethidine.

Depression of all types in adults, including reactive and severe depression, and depression accompanied by anxiety; OCD in adults (including as a means of supportive and preventive therapy), as well as in children and adolescents 7-17 years; panic disorder in adults, with and without agoraphobia (including as a means of supporting and prophylactic therapy, social phobia in adults (including as a means of supporting and prophylactic therapy), as well as in children and adolescents in age 8-17 years, generalized anxiety disorder in adults (including as a means of supporting and prophylactic therapy), post-traumatic stress disorder in adults.

Contraindications

Hypersensitivity to paroxetine and the components of the drug.

Combined use of paroxetine with MAO inhibitors (paroxetine should not be used simultaneously with MAO inhibitors or within 2 weeks after their withdrawal, MAO inhibitors can not be administered within 2 weeks after discontinuing paroxetine treatment).

Combined use with thioridazine (paroxetine should not be given in combination with thioridazine, since, like other drugs that inhibit the activity of the cytochrome P450 enzyme CYP2D6, paroxetine can increase the thioridazine concentrations in the plasma).

Application in pregnancy and lactation

Pregnancy

Studies in animals have not revealed teratogenic or selective embryotoxic activity in paroxetine, and data on a small number of women who took paroxetine during pregnancy indicate that there is no increased risk of congenital anomalies in newborns. There are reports of premature birth in women who received paroxetine or other SSRIs during pregnancy, but a causal relationship between these drugs and preterm delivery has not been established. Paroxetine should not be used during pregnancy if its potential benefit does not exceed the potential risk.

It is necessary to closely monitor the health of those newborns whose mothers were taking paroxetine in late pregnancy, as there are reports of complications in newborns exposed to paroxetine or other SSRI drugs in the third trimester of pregnancy. It should be noted, however, that in this case the cause-and-effect relationship between these complications and this drug therapy has not been established. The clinical complications described included: respiratory distress, cyanosis, apnea, convulsive seizures, instability of body temperature, difficulty with feeding, vomiting, hypoglycemia, hypertension, hypotension, hyperreflexia, tremor, tremor, irritability, lethargy, constant crying and drowsiness. In some reports, the symptoms have been described as neonatal manifestations of withdrawal syndrome. In most cases, the described complications occurred immediately after birth or shortly after birth (<24 h).

Lactation

In breast milk penetrates a small amount of paroxetine. However, paroxetine should not be taken during breastfeeding, except when its benefit to the mother exceeds the potential risk to the child.

Side effects

The frequency and intensity of some of the following side effects of paroxetine may decrease as the treatment continues, and such effects usually do not require withdrawal of the drug. Side effects are stratified by organ systems and frequency. The frequency gradient is the following: very often (≥1 / 10), often (≥1 / 100, <1/10), sometimes (≥1 / 1000, <1/100), rarely (≥1 / 10,000, <1 / 1000) and very rarely (<1/10 000), including individual cases. The occurrence of frequent and infrequent side effects was determined based on general safety data of the drug in more than 8000 patients participating in clinical trials and was calculated from the difference between the frequency of side effects in the paroxetine group and placebo group. The occurrence of rare and very rare side effects was determined on the basis of postmarketing data, and it relates more often to the frequency of reports of such effects than to the true frequency of the effects themselves.

Disturbances from the blood and lymphatic system: sometimes - abnormal bleeding, mainly hemorrhage into the skin and mucous membranes (most often bruising); very rarely - thrombocytopenia.

Impaired immune system: very rarely - allergic reactions (including hives and angioedema).

Endocrine disorders: very rarely - syndrome of ADH secretion.

Metabolic disorders: often - decreased appetite; rarely - hyponatremia (occurs mainly in elderly patients and may be due to the syndrome of ADH secretion).

Mental disorders: often - drowsiness, insomnia; sometimes confusion, hallucinations; rarely - manic reactions. These symptoms can also be caused by the disease itself.

Disturbances from the organs of vision: often - blurred vision; very rarely - exacerbation of glaucoma.

Disturbances from the heart: sometimes - sinus tachycardia.

Vascular disorders: sometimes - transient increase or decrease in blood pressure, incl. in patients with pre-existing arterial hypertension or anxiety.

Disorders from the respiratory, thorax and mediastinal organs: often - yawning.

Disturbances from the nervous system: often - convulsive seizures.

Gastrointestinal disorders: very often - nausea; often - constipation, diarrhea, dry mouth; very rarely - gastrointestinal bleeding.

Hepatobiliary disorders: rarely - increased levels of hepatic enzymes; very rarely - hepatitis, sometimes accompanied by jaundice and / or liver failure.

Sometimes there is an increase in levels of hepatic enzymes. Postmarketing reports of liver damage such as hepatitis, sometimes with jaundice, and / or liver failure are very rare. The question of the advisability of discontinuing paroxetine treatment should be addressed in cases where there is a prolonged increase in the performance of functional hepatic samples.

Disturbances from the skin and subcutaneous tissues: often - sweating; rarely - skin rashes; very rarely photosensitivity reactions.

Disorders from the kidney and urinary tract: rarely - urinary retention.

Disorders from the reproductive system and mammary glands: very often - sexual dysfunction; rarely - hyperprolactinaemia / galactorrhea.

Common disorders: often - asthenia; very rarely - peripheral edema.

Symptoms arising from discontinuation of paroxetine treatment: often - dizziness, sensory disturbances, sleep disorders, anxiety, headache; sometimes - agitation, nausea, tremor, confusion, sweating, diarrhea.

As with the abolition of many psychotropic drugs, discontinuing paroxetine treatment (especially severe) can cause symptoms such as dizziness, sensory disturbances (including paresthesia and a feeling of discharge of electric current), sleep disturbances (including bright dreams), agitation or anxiety, nausea, headache pain, tremors, confusion, diarrhea and sweating. In most patients, these symptoms are mild or moderate and go away spontaneously. There is no known group of patients who would be at an increased risk of such symptoms, but if paroxetine is no longer needed, the dose should be reduced slowly until the drug is completely discontinued.

Undesirable effects observed in clinical trials in children

In clinical trials in children, the following side effects occurred in 2% of patients and met in the paroxetine group 2 times more often than in the placebo group: emotional lability (including self-harm, suicidal ideation, suicidal attempts, tearfulness and mood swings), hostility, decreased appetite, tremor, sweating, hyperkinesia and agitation. Suicidal ideation and suicidal attempts were mainly observed in clinical trials in adolescents with major depressive disorder, in which the efficacy of paroxetine has not been proven. Hostility was noted in children with OCD, especially at the age of 12 years.

Symptoms of paroxetine withdrawal (emotional lability, nervousness, dizziness, nausea, and abdominal pain) were recorded in 2% of patients on the background of a decrease in the dose of paroxetine or after its complete withdrawal and met twice as often as in the placebo group.

Interaction

Serotonergic drugs. The use of paroxetine, as well as other SSRI drugs, along with serotonergic drugs (including MAO inhibitors, L-tryptophan, triptans, tramadol, linezolid, other SSRI drugs, lithium and plant products containing St. John's wort) can be accompanied by the development of effects caused by serotonin . When using these drugs in combination with paroxetine, care must be taken and careful clinical monitoring performed.

Enzymes involved in the metabolism of drugs. Metabolism and pharmacokinetics of paroxetine can change under the influence of induction or inhibition of enzymes that participate in the metabolism of drugs. When paroxetine is used concomitantly with inhibitors of enzymes involved in the metabolism of drugs, one should evaluate the feasibility of using a dose of paroxetine, located in the lower part of the therapeutic dose range. The initial dose of paroxetine should not be adjusted if it is used concomitantly with a drug that is a known inducer of enzymes involved in the metabolism of drugs (eg carbamazepine, rifampicin, phenobarbital, phenytoin). Any subsequent adjustment of the dose of paroxetine should be determined by its clinical effects (tolerability and efficacy).

CYP3A4. Investigation of the interaction in vivo with the simultaneous application in the equilibrium state of paroxetine and terfenadine, which is the substrate of the enzyme CYP3A4, showed that paroxetine does not affect the pharmacokinetics of terfenadine. In a similar study of the interaction in vivo, no effect of paroxetine on the pharmacokinetics of alprozalam was observed, and vice versa. The simultaneous use of paroxetine with terfenadine, alprozalam and other drugs that serve as a substrate for the enzyme CYP3A4, is unlikely to cause harm to the patient.

The ability of paroxetine to inhibit the enzyme CYP2D6 (see also "Contraindications"). Like other antidepressants, including other SSRI drugs, paroxetine inhibits the hepatic enzyme CYP2D6, which belongs to the cytochrome P450 system. The inhibition of the enzyme CYP2D6 can lead to an increase in plasma concentrations of concomitantly used drugs that are metabolized by this enzyme. These drugs include tricyclic antidepressants (eg, amitriptyline, nortriptyline, imipramine and desipramine), phenothiazine-type antipsychotics, risperidone, some anti-arrhythmic drugs such as 1C (eg, propafenone and flecainide), and metoprolol.

Protsiklidin. Daily intake of paroxetine significantly increases the concentration in the plasma of procyclidine. When anticholinergic effects occur, the dose of procyclidine should be reduced.

Anticonvulsants: carbamazepine, phenytoin, sodium valproate. Simultaneous use of paroxetine and these drugs does not affect their pharmacokinetics and pharmacodynamics in patients with epilepsy.

Clinical studies have shown that the absorption and pharmacokinetics of paroxetine are independent or virtually independent (that is, the existing dependence does not require a dose change) from food intake, antacids, digoxin, propranolol, alcohol.

Dosing and Administration

Inside (the tablet should be swallowed whole, not liquid), 1 time per day (in the morning, during a meal).

Depression. The recommended dose for adults is 20 mg / day, if necessary, depending on the therapeutic effect, the dose can be increased weekly by 10 mg / day to a maximum daily dose of 50 mg. 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 in the future, depending on the clinical indications. To relieve depressive symptoms and prevent relapses, adequate duration of stopping and maintenance therapy should be observed. The use of paroxetine in children and adolescents (7-17 years) for the treatment of depression is not recommended due to the lack of data on the effectiveness of therapy.

Obsessive-compulsive disorder. The recommended adult dose is 40 mg / day. Treatment begins with a dose of 20 mg / day, which can be increased weekly by 10 mg / day. If necessary, the dose can be increased to 60 mg / day. It is necessary to observe adequate duration of therapy. For children and adolescents (7-17 years old), the initial dose is 10 mg / day, it can be weekly increased by 10 mg / day. If necessary, the dose may be increased to 50 mg / day.

Panic disorder. The recommended adult dose is 40 mg / day. Treatment of patients should begin with a dose of 10 mg / day and weekly increase the dose by 10 mg / day, focusing on the clinical effect. If necessary, the dose may be increased to 60 mg / day. A low initial dose is recommended to minimize the possible increase in symptoms of panic disorder, which may occur at the beginning of treatment with any antidepressant. Adequate treatment times should be observed.

Social phobia. The recommended adult dose is 20 mg / day. If necessary, the dose may be increased weekly by 10 mg / day, depending on the clinical effect - up to 50 mg / day. Treatment of children and adolescents (8-17 years) should begin with a dose of 10 mg / day and weekly increase the dose by 10 mg / day, focusing on the clinical effect. If necessary, the dose may be increased to 50 mg / day.

Generalized anxiety disorder. The recommended adult dose is 20 mg / day. If necessary, the dose may be increased weekly by 10 mg / day, depending on the clinical effect - up to 50 mg / day.

Post-traumatic stress disorder. The recommended adult dose is 20 mg / day. If necessary, the dose may be increased weekly by 10 mg / day, depending on the clinical effect - up to 50 mg / day.

Overdose

The available information on paroxetine overdose testifies to its wide range of safety.

Symptoms: In addition to the symptoms described in the section "Side effects", there is vomiting, dilated pupils, fever, changes in blood pressure, involuntary muscle contractions, agitation, anxiety, tachycardia.

The condition of patients usually normalized without serious consequences, even with a single dose of up to 2000 mg. A number of reports describe such symptoms as coma and ECG changes; cases of death were very rare, usually in those situations where patients took paroxetine along with other psychotropic drugs or with alcohol.

Treatment: general measures used for an overdose of any antidepressant; if necessary - gastric lavage, the appointment of activated charcoal (20-30 mg every 4-6 hours during the first day after an overdose), maintenance therapy and frequent monitoring of basic physiological indicators.

There is no specific antidote of paroxetine.

Precautionary measures

Paroxetine withdrawal. Describing withdrawal symptoms such as dizziness, sensory disturbances (including paresthesia and electric shock), sleep disturbances (including bright dreams), agitation and anxiety, nausea, tremors, confusion, sweating, headaches and diarrhea are described. Usually these symptoms are mild or moderate, but in some patients they can be severe. Usually they occur in the first few days after the drug is discontinued, but in rare cases they occur in patients who accidentally missed only one dose. As a rule, these symptoms pass spontaneously and disappear within 2 weeks, but in some patients they can last much longer (2-3 months or more).

As in the treatment of other psychotropic drugs, avoid abrupt withdrawal of paroxetine. The following cancellation schedule can be recommended: reduction of the daily dose by 10 mg at weekly intervals; After reaching a dose of 20 mg / day (or 10 mg / day in children and adolescents), patients continue to take this dose for 1 week and only then the drug is canceled completely. If withdrawal symptoms develop during dose reduction or after drug withdrawal, it is advisable to resume taking the previously prescribed dose. In the future, the doctor may continue to reduce the dose, but more slowly.

The onset of withdrawal symptoms does not mean that the drug is abused or addictive, as is the case with drugs and psychotropic substances.

Symptoms that may occur when paroxetine is discontinued in children and adolescents. 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 on the background of a decrease in the dose of paroxetine or after its complete withdrawal and were 2 times more common than in the placebo group.

Individual patient groups.

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

Patients with impaired renal or hepatic function. Paroxetine concentrations in plasma are elevated in patients with severe renal impairment (Cl creatinine less than 30 mL / min) and in patients with impaired liver function. Such patients should be given doses of the drug that are in the lower part of the therapeutic dose range.

Children under 7 years. The use of paroxetine is not recommended due to the lack of safety and efficacy studies in this group of patients.

Children and adolescents 7-17 years. In clinical trials, adverse events associated with suicidal (suicidal attempts and suicidal ideation) and hostility (mainly aggression, deviant behavior and anger) were more common in children and adolescents receiving paroxetine than in those patients of this age group who received a placebo. At present, there is no data on the long-term safety of paroxetine for children and adolescents, which would affect the effect of this drug on growth, maturation, cognitive and behavioral development.

Clinical deterioration and suicidal risk associated with mental disorders. In patients with depression, the exacerbation of symptoms of this disorder and / or the appearance of suicidal thoughts and suicidal behavior (suicidal) can be observed regardless of whether they receive antidepressants. This risk persists until a pronounced remission is achieved. Improvement of the patient's condition may be absent in the first weeks of treatment or more, so the patient should be closely monitored for the timely detection of clinical exacerbation and suicide, especially at the beginning of the course of treatment, as well as during periods of dose changes, whether they increase or decrease. Clinical experience with the use of all antidepressants shows that the risk of suicide may increase in the early stages of recovery.

Other mental disorders for which paroxetine is used may also be associated with an increased risk of suicidal behavior. In addition, these disorders can be comorbid conditions associated with a major depressive disorder. Therefore, in treating patients suffering from other mental disorders, the same precautions should be followed as in the treatment of major depressive disorder.

The greatest risk of suicidal thoughts or suicidal attempts is experienced by patients who have a history of suicidal behavior or suicidal ideation, young patients, and patients with severe suicidal thoughts prior to treatment, so all need to be given special attention during treatment.

Patients (and those who care for them) should be warned about the need to monitor their deterioration and / or the appearance of suicidal thoughts / suicidal behavior or thoughts of self-harm and, if these symptoms occur, seek medical help immediately.

Akathisia. Occasionally, treatment with paroxetine or another SSRI drug is accompanied by the appearance of akathisia, which is manifested by a feeling of internal anxiety and psychomotor agitation, when the patient can not sit or stand still; When akathisia, the patient usually experiences subjective distress. The likelihood of akathisia is highest in the first few weeks of treatment.

Serotonin syndrome / malignant neuroleptic syndrome. In rare cases, with paroxetine treatment, a serotonin syndrome or symptom similar to a malignant neuroleptic syndrome may occur, especially if paroxetine is used in combination with other serotonergic drugs and / or antipsychotics. These syndromes pose a potential threat to life, so if they occur paroxetine should be discontinued (they are characterized by a combination of symptoms such as hyperthermia, muscle rigidity, myoclonus, autonomic disorders with possible rapid changes in vital signs, changes in mental status, including confusion, irritability, extremely severe agitation, progressing to delirium and coma) and begin supporting symptomatic therapy. Paroxetine should not be given in combination with such precursors of serotonin as L-tryptophan, oxytryptane 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 can increase the chance of an accelerated development of a mixed / manic episode in patients at risk of bipolar disorder.

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

MAO inhibitors. Treatment with paroxetine should be started cautiously, not earlier than 2 weeks after discontinuation of therapy with MAO inhibitors; the dose of paroxetine should be increased gradually until an optimal therapeutic effect is achieved (see also "Contraindications").

Impaired renal or hepatic function. It is advisable to use caution when treating paroxetine with patients with severe renal dysfunction and patients with impaired hepatic function.

Epilepsy. Like other antidepressants, paroxetine should be used with caution in patients with epilepsy.

Convulsive seizures. The frequency of convulsive seizures in patients taking paroxetine is less than 0.1%. In the event of a seizure, paroxetine should be discontinued.

Electroconvulsive therapy. There is limited experience in the simultaneous use of paroxetine and electroconvulsive therapy.

Glaucoma. Like other SSRIs, paroxetine occasionally causes mydriasis, and should be used with caution in patients with closed-angle glaucoma.

Hyponatremia. In the treatment of paroxetine, hyponatremia occurs rarely and predominantly in elderly patients.

Bleeding. Hemorrhages in the skin and mucous membranes (including gastrointestinal bleeding) have been reported in patients treated with paroxetine. Therefore paroxetine should be used with caution in patients who simultaneously receive drugs that increase the risk of bleeding in patients with a known tendency to bleeding and in patients with diseases predisposing to bleeding.

Diseases of the heart. In the treatment of patients with heart disease, the usual precautionary measures should be observed.

Clinical experience with paroxetine indicates that it does not impair cognitive and psychomotor functions. However, as with any other psychotropic medications, patients should be especially careful when driving a car and working with mechanisms.

Despite the fact that paroxetine does not increase the negative effect of alcohol on psychomotor functions, it is not recommended to simultaneously use paroxetine and alcohol.

Manufacturer

SmithKleinBichem Pharmaceuticals, France.

Storage conditions for Paxil

In a dry place, at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life of Paxil

3 years.

Do not use after the expiry date printed on the package.

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