Index of drugs

Treatment: severe depressive episode, obsessive-compulsive disorder, anxiety disorder with anxiety attacks without agoraphobia or with agoraphobia, social phobia, generalized anxiety disorder, post-traumatic stress disorder.

1 tabl powl. contains 20 mg of paroxetine in the form of a hydrochloride semiplatelet.

Antidepressant - a strong and selective serotonin reuptake inhibitor in brain neurons. Paroxetine has little affinity for muscarinic, adrenergic receptors (α₁, α₂ and ß), dopaminergic (D.₂), serotonergic (5HT₁, 5HT₂) and histaminergic (H₁). researchin vivo showed no inhibitory properties o.u.n. and antihypertensive properties. After oral administration, paroxetine is well absorbed from the gastrointestinal tract and undergoes first-pass metabolism. The steady state drug concentration is reached 7-14 days after the start of therapy. The drug is extensively distributed to the tissues, only 1% is in the plasma. About 95% is bound to plasma proteins. The main metabolites of paroxetine have a polar structure and are conjugated oxidation and methylation products, they are inactive. Approx. 64% of the dose is excreted in the urine in the form of metabolites (less than 2% - unchanged), the remaining 36% excreted in the faeces (less than 1% - unchanged). Excretion of metabolites is two-phase; initially it is the result of the first pass metabolism followed by the systemic elimination of paroxetine. T_0,5 in the elimination phase it is variable, usually about 1 day.

Hypersensitivity to paroxetine or other ingredients of the preparation. Paroxetine is contraindicated for concomitant use with MAO inhibitors (treatment with paroxetine may be initiated 2 weeks after discontinuation of irreversible MAO inhibitors, or at least 24 hours after the end of reversible MAO inhibitors, e.g. moclobemide, MAO inhibitors should not be initiated before at least one week after stopping treatment with paroxetine). Do not use with thioridazine. Do not use simultaneously with pimozide.

Due to the increased risk of suicidal thoughts and attempts, as well as self-injury, patients should be carefully monitored for a clear remission of depressive symptoms and in the initial stages of the healing process (increased risk of suicide). Patients with other psychiatric disorders, patients with behavior or suicidal ideation should be carefully monitored in patients who had significant suicidality and patients aged 18-25 before starting treatment. In patients with symptoms of akathisia, increasing the dose may be harmful. Use with caution in combination with other serotonergic and / or neuroleptics, due to the risk of serotonin syndrome or neuroleptic malignant syndrome (if symptoms of any of these syndromes should be discontinued). Due to the risk of serotonin syndrome, paroxetine should not be used in combination with serotonin precursors (such as L-tryptophan, oxytryptan). Caution should be exercised when using the preparation in patients with a history of mania; paroxetine treatment should be discontinued in any patient who begins the manic phase. Caution is advised in patients with severe renal failure or hepatic failure, epilepsy - should be discontinued if a seizure occurs, with narrow-angle glaucoma or glaucoma, with cardiac abnormalities, in patients at risk for hyponatraemia (e.g. concomitant medications and cirrhosis of the liver). In diabetic patients, treatment with SSRIs may affect glycemic control - adjustment of insulin dose and / or oral antidiabetic agents may be required. The clinical experience of concurrent use and treatment with electroconvulsive therapy is very low. Caution should be exercised when administering SSRIs with oral anticoagulants, platelets or other drugs that increase the risk of bleeding (eg atypical antipsychotics - clozapine, phenothiazine derivatives, most tricyclic antidepressants, Acetylsalicylic acid, NSAIDs, inhibitors) COX-2) as well as in patients with a history of bleeding or conditions that predispose to bleeding. The drug should not be used to treat children and adolescents under 18 years of age.In clinical trials, suicidal behavior and hostility (aggression, rebellious behavior, anger) were more frequently observed in children and adolescents treated with antidepressants than in the placebo group. If a decision to treat is made based on an existing clinical need, the patient should be carefully monitored for signs of suicide. There are no long-term studies on the safety of children and adolescents regarding growth, maturation, cognitive development and behavioral development. The use of paroxetine has not been studied in children under 7 years of age - do not use the drug in this age group.

The drug can be used in pregnancy only in the case of strict indications. When prescribing a medicine to a pregnant woman or pregnancy planner, the possibility of alternative treatment should be considered. Avoid sudden paroxetine treatment during pregnancy. Newborns should be observed whose mothers took paroxetine in late pregnancy, especially in the third trimester. A small amount of the drug is excreted into breast milk - breastfeeding may be considered if the expected benefit to the mother outweighs the potential risk to the child.

Very common: nausea, sexual dysfunction. Common: drowsiness, insomnia, agitation, abnormal dreams (including nightmares), dizziness, tremor, headache, concentration disorders, blurred vision, yawning, constipation, diarrhea, dry mouth, sweating, increased cholesterol, decreased appetite, weakness, weight gain. Uncommon: confusion, hallucinations, extrapyramidal symptoms, mydriasis, sinus tachycardia, transient increase or decrease in blood pressure (usually in patients with pre-existing hypertension or anxiety), urinary retention, urinary incontinence, abnormal bleeding, mostly affecting the skin and mucous membranes (most often ecchymosis), rash, pruritus. Rarely: convulsions, restless legs syndrome, manic reactions, anxiety, depersonalization, panic attacks, akathisia, bradycardia, hyponatremia (mostly in elderly people and sometimes associated with inappropriate secretion of ADH), increased liver enzymes, hyperprolactinemia, mellitus, pain joints, muscle pain. Very rare: serotonin syndrome, acute glaucoma, gastrointestinal bleeding, inappropriate ADH syndrome, severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), liver dysfunction (hepatitis, sometimes associated with jaundice and / or liver failure), hypersensitivity to light, priapism, peripheral edema, thrombocytopenia, allergic reactions (including urticaria and angioedema). Frequency unknown: tinnitus. There have been cases of suicidal thoughts and behavior during and shortly after discontinuation of treatment. Withdrawal symptoms observed after discontinuation of paroxetine: common - dizziness, sensory disturbances, sleep disturbances, anxiety, headache; uncommon - agitation, nausea, tremor, confusion, sweating, emotional instability, blurred vision, palpitations, diarrhea, irritability. Discontinuation of paroxetine treatment (especially sudden) often leads to withdrawal symptoms. In short-term clinical trials in children and adolescents, the following side effects were observed (at least 2% of patients and twice as likely as placebo): increased suicidal behaviors (including suicide attempts and suicidal thoughts), self-harming, increased hostility. In addition, the following were observed: decreased appetite, tremor, sweating, hyperkinesia, agitation, emotional instability (including crying, mood swings). Symptoms observed during discontinuation of paroxetine or after discontinuation of administration in children and adolescents (at least 2% of patients and twice as much as in the placebo group): emotional instability (including: crying, mood swings, self-harming, suicidal thoughts and attempts), nervousness , dizziness, nausea and abdominal pain.

Orally. Adults.Severe episode of depressionThe recommended daily dose is 20 mg. Improvement of the patient's condition begins after 1 week, but becomes visible from the second week of therapy. Dosage should be reviewed and if necessary adjusted to clinical needs within 3-4 weeks of starting treatment, and then re-evaluated and modified based on the results of treatment.In some patients with a 20 mg reaction, the dose may be increased by 10 mg depending on the patient's response, up to a maximum dose of 50 mg per day. Patients with depression should be treated for a sufficiently long period of at least 6 months to ensure relief of symptoms.Obsessive-compulsive disorderThe recommended daily dose is 40 mg. Treatment should be started with 20 mg daily. The dose may be increased by 10 mg in steps up to the recommended dose. If, after several weeks of using the recommended dose, the observed response to treatment is inadequate, some patients may benefit from a gradual increase in the dose up to a maximum dose of 60 mg per day. Patients with obsessive-compulsive disorder should be treated for a sufficiently long period to ensure relief of symptoms. This period can last several months or even longer.Anxiety disorder with anxiety attacksThe recommended daily dose is 40 mg. Treatment should start with a dose of 10 mg a day and increase it by 10 mg increments depending on the patient's response to the recommended dose. Starting treatment with a low initial dose is recommended to minimize the potential exacerbation of panic disorder symptoms that occurs during the initial treatment period. If, after several weeks of using the recommended dose, the observed response to treatment is inadequate, some patients may benefit from a gradual increase in the dose up to a maximum dose of 60 mg per day. Patients with anxiety disorder with anxiety attacks should be treated for a sufficiently long period to ensure relief of symptoms. This period can last several months or even longer.Social phobiaThe recommended daily dose is 20 mg. If, after several weeks of using the recommended dose, the response observed is insufficient, some patients may benefit from a gradual increase in the dose by 10 mg up to a maximum dose of 50 mg per day. Long-term therapy should be evaluated regularly.Generalized anxiety disorderThe recommended daily dose is 20 mg. If, after several weeks of using the recommended dose, the response observed is insufficient, some patients may benefit from a gradual increase in the dose by 10 mg up to a maximum dose of 50 mg per day. Long-term therapy should be evaluated regularly.Post-traumatic stress disorderThe recommended daily dose is 20 mg. If, after several weeks of using the recommended dose, the response observed is insufficient, some patients may benefit from a gradual increase in the dose by 10 mg up to a maximum dose of 50 mg per day. Long-term therapy should be evaluated regularly.Special groups of patients. In elderly people, dosing should be started with the starting dose recommended in adults; some people may benefit from increasing the dose; the maximum dose should not exceed 40 mg daily. In patients with severe renal impairment (creatinine clearance <30 ml / min) or with hepatic impairment, the dosage should be limited to the lower dose range.Way of giving. It is recommended that the preparation be administered once a day, in the morning, with a meal; tablets should be swallowed without chewing.