Index of drugs

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

1 tabl contains 20 mg of paroxetine as anhydrous hydrochloride.

Antidepressant - a strong and selective serotonin reuptake inhibitor in brain neurons. Paroxetine has little affinity for muscarinic, adrenergic receptors (α₁, α₂ and β), 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 a first-pass effect. 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. 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). T_0,5 in the elimination phase it is variable, usually about 1 day.

Hypersensitivity to paroxetine or other ingredients of the preparation. Do not use simultaneously with MAO inhibitors. Treatment with paroxetine can be started 2 weeks after the end of irreversible MAO inhibitors or at least 24 hours after the end of the use of reversible MAO inhibitors (eg moclobemide). At least one week should be discontinued from treatment with paroxetine until initiation of MAO inhibitor therapy. Do not use with thioridazine. Do not use simultaneously with pimozide.

In exceptional circumstances, in combination with paroxetine, linezolid (an antibiotic which is a reversible, non-selective MAO inhibitor) can be administered, provided that it is possible to closely monitor the patient for serotonin syndrome symptoms and monitor blood pressure. 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. Patients with other psychiatric disorders, patients with a history of suicidal behavior or thoughts, patients who exhibited significant suicidality and patients below 25 years of age, especially at the beginning of therapy and when the dose was changed, should be closely monitored. In patients with symptoms of akathisia, increasing the dose may be harmful. Cautiously used in combination with other serotoninergic and / or neuroleptics, due to the risk of serotonin syndrome or neuroleptic malignant syndrome. 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 insufficiency or hepatic insufficiency, epilepsy - the drug should be discontinued in case of seizures, with closed-angle glaucoma or glaucoma, with cardiac abnormalities, in patients at risk for hyponatraemia (eg due to 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 concomitant use of SSRIs with oral anticoagulants, platelets or other agents that increase the risk of bleeding (eg atypical antipsychotics - clozapine, phenothiazines, most tricyclic antidepressants, Acetylsalicylic acid, NSAIDs, COX inhibitors) -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 paroxetine is excreted into human milk, but no effects of the drug on the infant have been observed. Because no effects on the baby are anticipated, breastfeeding can be considered.

Very common: nausea, sexual dysfunction. Common: cholesterol increase, decreased appetite, sleepiness, insomnia, agitation, unusual dreams (including nightmares), dizziness, tremor, headache, concentration disorders, blurred vision, yawning, constipation, diarrhea, vomiting, dryness of the mucous membrane of the cavity oral, sweating, weakness, weight gain. Uncommon: confusion, hallucinations, extrapyramidal symptoms, pupil dilation, sinus tachycardia, transient decrease or increase in blood pressure, orthostatic hypotension, urinary retention, urinary incontinence, rash, pruritus, abnormal bleeding (most commonly affecting the skin and mucous membranes - ecchymosis). Rare: mania, agitation, anxiety, depersonalization, panic attacks, akathisia, convulsions, restless legs syndrome, bradycardia, increased liver enzymes, joint pain, muscle pain, hyperprolactinemia and / or milk clotting, hyponatremia (mostly in the elderly, sometimes associated with the syndrome of inappropriate secretion of ADH). Very rare: thrombocytopenia, serotonin syndrome (agitation, confusion, sweating, hallucinations, hyperreflexia, myoclonus, chills, tachycardia, tremor), acute glaucoma, gastrointestinal bleeding, liver dysfunction (ie hepatitis sometimes associated with jaundice and ( or) liver failure), severe cutaneous side effects (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), priapism, photosensitivity, peripheral edema, inappropriate antidiuretic hormone (SIADH) syndrome, allergic reactions (including urticaria and angioneurotic edema). There are reports of extrapyramidal symptoms (oro-facial dystonias) in patients with concomitant musculoskeletal diseases or in patients who have used neuroleptics. There were reports of suicidal thoughts and behavior and tinnitus during treatment with the preparation.
Symptoms observed during withdrawal (especially sudden) of paroxetine: often - pain and dizziness, disturbances in sensation, sleep disorders, anxiety; uncommon - agitation, nausea, tremors, confusion, sweating, emotional instability, visual disturbances, palpitations, diarrhea, irritability. Epidemiological studies, mainly in patients aged 50 and older, indicate an increased risk of bone fractures in patients taking SSRIs and tricyclic TLDD antidepressants.
In short-term clinical trials in children and adolescents the following side effects were observed (at least 2% of patients and twice as often as in the placebo group): increased suicidal behaviors (including suicide attempts and suicidal thoughts), self-mutilations, 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.Depressive episode. The recommended dose is 20 mg a day. Usually, the improvement of the patients' condition occurs after one week of treatment, but it becomes visible only from the second week of therapy. Dosage of the preparation should be verified and if necessary adjusted to the clinical needs after 3-4 weeks from the beginning of treatment and in the later period, if it is clinically justified. In some patients in which a 20 mg dose response is insufficient, the dose may be gradually increased by 10 mg, up to a maximum of 50 mg per day, depending on the patient's response. Treatment for depression should last at least 6 months to ensure relief of symptoms.Obsessive-compulsive disorder. The recommended dose is 40 mg a day. Treatment should be started with 20 mg daily. This dose can be gradually increased by 10 mg up to the recommended dose. If, after several weeks of using the recommended dose, the response to treatment is insufficient, in some patients it may be beneficial to continue increasing the dose gradually, up to a maximum of 60 mg daily. Treatment of obsessive-compulsive disorder can last several months or longer.Panic disorder. The 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. If, after several weeks of using the recommended dose, the response to treatment is insufficient, in some patients it may be beneficial to continue increasing the dose gradually, up to a maximum of 60 mg daily. Treatment of panic disorder may last for several months or longer.Social phobia, generalized anxiety disorder, post-traumatic stress disorder. The recommended daily dose is 20 mg. If, after several weeks of using the recommended dose, the response to treatment is insufficient, in some patients it may be beneficial to continue to gradually increase the dose by 10 mg to a maximum of 50 mg daily. Long-term therapy should be evaluated regularly. In patients with severe renal impairment (creatinine clearance less than 30 ml / min) or in patients with hepatic impairment, the dosage should be limited to the lower dose range. In the elderly, the starting dose of the drug should be the same as in adults, some patients may need to increase the dose, the maximum daily dose should not exceed 40 mg.Way of giving. It is recommended to administer the preparation once a day, in the morning, during a meal; tablets should be swallowed whole without chewing.