Paroxetine | Paxil tablets 20 mg, 30 pcs.

Release form

Coated tablets

Packing

30 pcs.

Pharmacological action

Paxil - antidepressant. Selectively blocks the reuptake of serotonin, increases its concentration in the synaptic cleft and causes an antidepressant effect.

Has 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.

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 administration. During treatment, there is a decrease in anxiety, depression, and normalization of sleep.

Indications

- Depression of all types, including reactive depression, severe endogenous depression and anxiety depression (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 prophylactic therapy) of obsessive-compulsive disorder (OCD) in adults, as well as in children and adolescents aged 7-17 years (it has been shown that the drug remains effective in treating OCD for at least 1 years and in the prevention of relapse of OCD).

- Treatment (including supportive and preventive therapy) of a panic disorder with agoraphobia and without it (the effectiveness of the drug persists for 1 year, preventing relapse of panic disorder).

- Treatment (including maintenance and prophylactic therapy) of social phobia in adults, as well as in children and adolescents aged 8-17 years (the effectiveness of the drug persists with prolonged treatment of this disorder).

- Treatment (including maintenance and prophylactic therapy) of generalized anxiety disorder (the effectiveness of the drug persists with prolonged treatment of this disorder, preventing relapse of this disorder).

- Treatment for post-traumatic stress disorder.

Contraindications

- Concomitant use 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).

- Concomitant use of thioridazine.

- Hypersensitivity to paroxetine and other components of the drug.

Use during pregnancy and lactation

In experimental studies, no teratogenic or embryotoxic effects of paroxetine were detected. Data on a small number of women who took paroxetine during pregnancy indicate the absence of an increased risk of congenital malformations 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 potential risk associated with taking the drug.

It is necessary to monitor the health status of newborns whose mothers took paroxetine in late pregnancy, as there are reports of complications in children (however, a causal relationship with the drug has not been established).

Respiratory distress syndrome, cyanosis, apnea, seizures, temperature instability, feeding difficulties, vomiting, hypoglycemia, arterial hyper- or hypotension, hyperreflexia, tremor, irritability, lethargy, constant crying, drowsiness. In some reports, symptoms have been described as neonatal manifestations of withdrawal.

In most cases, the described complications occurred immediately after childbirth or shortly after (within 24 hours). Paroxetine in small amounts is excreted in breast milk. Therefore, the drug should not be used during lactation, unless the potential benefit of the treatment exceeds the possible risk associated with taking the drug.

Special instructions

Should be used with caution in case of kidney and liver failure, angle-closure glaucoma, prostatic hyperplasia, mania, cardiac pathology, epilepsy, convulsive states, in combination with electropulse therapy, in patients receiving drugs that increase the risk of bleeding, with a factor risk of increased bleeding. During treatment, it is necessary to refrain from taking alcoholic beverages.

Use with caution while working 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. Caution should be exercised when administered in combination with lithium preparations.

For the duration of treatment should refrain from the use of ethanol.

Composition

1 tablet contains:

paroxetine hydrochloride hemihydrate 22.8 mg, which corresponds to paroxetine 20 mg.

Excipients:

calcium dihydrogen phosphate dihydrate,

sodium carboxy starch type A,

magnesium stearate.

Shell composition:

hypromellose,

titanium dioxide,

macrogol 400,

polysorbate 80.

Dosage and administration

Inside, in the morning - 20 mg.

If the effect is insufficient, a dose increase of 10 mg / day is possible with an interval of at least 1 week (maximum dose is 50 mg / day). In elderly, emaciated patients, as well as in case of impaired renal and hepatic function, the initial dose is 10 mg / day, and the maximum dose is 40 mg / day.

Side effects

Drowsiness or insomnia, tremor, nervousness, increased irritability of the central nervous system, impaired concentration, emotional lability, amnesia, dizziness, paresis of accommodation, pain in the eye, dilated pupil, eye pain , increase or decrease in blood pressure, fainting, tachycardia or bradycardia, impaired cardiac conduction and peripheral circulation, cough, rhinitis, dipnoea, tachypnea, nausea, decreased appetite, dyspepsia, increased activity of hepatic t Ransaminase, stomatitis, arthralgia, arthritis, dysuria, polyuria, urinary incontinence, urinary retention, amenorrhea, dysmenorrhea, miscarriage, mastitis, ejaculation disturbance, decreased libido and potency, peripheral edema, decreased or increased body weight, anemia, leukopenia, allergic reactions (itching, urticaria, chills).

Rarely - impaired thinking, akinesia, ataxia, convulsions, hallucinations, hyperkinesia, manic or paranoid reactions, delirium, euphoria, major epileptic seizures, aggressiveness, nystagmus, stupor, autism, decreased visual acuity, cataract, conjunctivitis, glaucoma, stenocardia , myocardial infarction, cerebrovascular accident, cardiac arrhythmias, eosinophilia, leukocytosis, lymphocytosis, monocytosis, hematuria, nephrourolithiasis, impaired renal function, dermatitis, erythema nodosum, depigmentation.

Drug Interactions

Inductors of microsomal oxidation (phenobarbital, phenytoin) decrease blood concentration and activity, inhibitors (cimetidine) increase.

Increases plasma procyclidine. Incompatible with MAO inhibitors.

Co-administration with indirect anticoagulants may cause increased bleeding with unchanged prothrombin time. Enhances the effect of alcohol.



overdose Available information on paroxetine overdose indicates a wide range of safety.

Symptoms: increased side effects described above, vomiting, pupil enlargement, fever, change in blood pressure, involuntary muscle contractions, agitation, anxiety, tachycardia.

Patients usually do not develop serious complications, even with a single intake of up to 2 g of paroxetine. In some cases, coma and changes in the EEG develop, very rarely a lethal outcome with the combined use of paroxetine with psychotropic drugs or alcohol.

Treatment: standard measures used in the overdose of antidepressants (gastric lavage by artificial vomiting, administration of 20-30 mg of activated charcoal every 4-6 hours during the first day after overdose).

The specific antidote is unknown. Supportive therapy and control of vital functions of an organism are shown.

Storage conditions

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

Shelf life

3 years.

Deystvuyushtee substance

Paroxetine

dosage form

tablets

Possible product names

PAXIL 0.02 N30 TABLE P / O

Paxil 20 mg No. 30

Paxil 20 mg Tab. p / o X30 (R)

Paxil 20mg Tab. p / o X30 (R) $

Paxil 20mg Tab. p / pl / rev X30 (R)

GlaxoSmithKline Pharmaceuticals SA, UK