Index of drugs

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

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

A potent and selectively acting serotonin reuptake inhibitor in brain neurons. Paroxetine has a low affinity for muscarinic, adrenergic receptors (α₁, α₂ and β), dopaminergic (D.₂), serotonergic (5HT₁, 5HT₂) and histamine (H₁). After oral administration, paroxetine is well absorbed from the gastrointestinal tract and undergoes a first-pass effect. Steady-state levels are obtained 7-14 days after starting treatment. About 95% of the drug is bound to plasma proteins. Approximately 64% of the dose is excreted in the urine as metabolites, with less than 2% of the dose excreted unchanged. About 36% are excreted in faeces, mainly in the form of metabolites, and less than 1% in unchanged form. T_0,5 most often it is about 24 hours.

Hypersensitivity to the active substance or to any of the excipients. Concomitant use with MAO inhibitors is contraindicated. Under exceptional circumstances, linezolid (an antibiotic that is a reversible, non-selective MAO inhibitor) can be given in combination with paroxetine provided that it is possible to follow closely the symptoms of serotonin syndrome and monitor blood pressure. 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, linezolid, methylthionin chloride (methylene blue: preoperatively used to visualize the structures; is a reversible selective MAO inhibitor.) At least 1 week of dosing with paroxetine should be discontinued prior to initiating treatment with any MAOI inhibitor Paroxetine should not be used concomitantly with thioridazine (paroxetine may increase thioridazine plasma concentrations). QTc and associated severe ventricular arrhythmias such astorsades de pointes and sudden death. Paroxetine should not be used together with pimozide.

The drug should not be used to treat children and adolescents under 18 years of age due to the increased risk of suicidal behavior (suicide attempts, suicidal thoughts) and hostility (especially aggression, rebellious behavior and anger) observed in clinical trials. In addition, paroxetine has not been shown to be effective. If, based on the existing clinical need, however, a decision to treat is made, the patient should be carefully monitored for signs of suicide. There are no studies on children under the age of 7 - paroxetine should not be used in this age group. All patients who use the drug should be monitored for signs of suicidal ideation and behavior (especially in early recovery and after a change in the dose); this applies especially to patients under the age of 25 years and patients with a history of suicidal behavior or thoughts. When treating patients with other mental disorders, the same precautions should be taken as when treating patients with major depressive disorder. Increasing the dose in patients with akathisia may be harmful. Caution should be exercised when using paroxetine in patients with a history of mania (treatment should be discontinued if a mania episode occurs). Caution is advised in patients with severe renal failure and / or hepatic failure, diabetes, epilepsy (should be discontinued if seizures occur), narrow-angle glaucoma or a history of glaucoma, cardiac dysfunction, and patients at risk for hyponatraemia ( e.g. due to concomitant medications and cirrhosis of the liver).Clinical experience regarding the simultaneous use of paroxetine and electroconvulsive therapy is very low. Use with caution in patients with a history of bleeding or conditions that predispose to bleeding.

Some epidemiological studies suggest an increased risk of congenital malformations, in particular of the cardiovascular system (eg, ventricular septal defect or intra-aortic septal space) associated with the use of paroxetine during the first trimester of pregnancy. The mechanism of these changes is unknown. Paroxetine may be used during pregnancy only when there are strict indications for its use. In pregnant women or women who plan to become pregnant, the doctor should consider an alternative treatment option. Avoid sudden paroxetine treatment during pregnancy. Newborns should be observed whose mothers continued to take paroxetine in late pregnancy, especially in the third trimester. In newborns whose mothers used paroxetine in late pregnancy, the following symptoms may occur: respiratory distress syndrome, cyanosis, apnea, convulsions, body temperature instability, difficulty in feeding, vomiting, hypoglycaemia, hypotonia, hypertonia, hyperreflexia, tremor, jitter of nervousness , irritability, lethargy, constant crying, drowsiness and difficulty sleeping. The above symptoms may be caused by serotoninergic effects or may be withdrawal symptoms. In the majority of cases, complications started immediately or soon (<24 h) after delivery. Epidemiological data suggest that the use of SSRIs during pregnancy, in particular at a later stage, may increase the risk of persistent neonatal hypertension (PPHN). A small amount of paroxetine is excreted into milk. In the published studies, the serum concentration of paroxetine in breastfed infants was undetectable (<2 ng / ml) or very low (<4 ng / ml) and no signs of drug effects were observed in these infants. If no symptoms are anticipated, breast-feeding may be considered. Animal studies have shown that paroxetine may have a transient effect on sperm quality. No effects on human fertility have been observed so far.

Very common: nausea, sexual dysfunction, peripheral edema. Common: increased cholesterol, decreased appetite, drowsiness, insomnia, agitation, abnormal dreams (including nightmares), dizziness, tremor, headache, blurred concentration, blurred vision, yawning, constipation, diarrhea, dry mouth , excessive sweating, weakness, weight gain. Uncommon: abnormal bleeding (most likely ecchymosis), changes in Glucose in patients with diabetes mellitus, confusion, hallucinations, extrapyramidal symptoms, mydriasis, sinus tachycardia, transient decrease or increase in blood pressure, orthostatic hypotension, rash, pruritus, urinary retention, urinary incontinence . Rarely: hyponatremia (especially in elderly patients, sometimes associated with inappropriate secretion of ADH), manic reactions, anxiety, depersonalization, panic attacks, akathisia, convulsions, restless legs syndrome (RLS), bradycardia, increased liver enzymes, hyperprolactinemia / mlekotok, pain in the joints, muscle pain. Very rare: thrombocytopenia, severe and potentially fatal hypersensitivity reactions (including anaphylactoid reactions and angioneurotic edema), inappropriate antidiuretic hormone (ADH) syndrome, serotonin syndrome (agitation, confusion, hyperhidrosis, hallucinations, hyperreflexia, myoclonus, chills, tachycardia and tremor), acute glaucoma, gastrointestinal bleeding, abnormal liver function (hepatitis, sometimes associated with jaundice or hepatic insufficiency), more severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), urticaria, hypersensitivity to light, priapism. Frequency unknown: suicidal thoughts, suicidal behavior and aggression, tinnitus. Epidemiological studies, mainly in patients aged 50 and over, have shown an increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants). The mechanism that triggers this risk is unknown.Withdrawal symptoms observed after discontinuation of paroxetine. Common: dizziness, sensory disturbances (including paresthesia, sensations of electric shocks and tinnitus), sleep disorders (including intense dreams), anxiety, headache. Uncommon: agitation, nausea, tremor, confusion, sweating, emotional instability, visual disturbances, palpitations, diarrhea, irritability.Children and youth. The following adverse events were observed: increased suicidal behaviors (including suicide attempts and suicidal thoughts), self-harm and increased hostility. Thoughts and suicide attempts have been observed mainly in clinical trials conducted among adolescents with severe depressive episode. Increased hostility occurred especially among children with obsessive-compulsive disorder, especially among children under 12 years of age. In addition, the following adverse events were observed: decreased appetite, tremor, sweating, hyperkinesis, agitation, emotional instability (including crying, mood swings), adverse events associated with bleeding, mainly of the skin or mucous membranes. The following adverse events were observed during the phasing-out phase or after complete cessation of paroxetine: emotional instability (including crying, mood swings, self-injury, suicidal thoughts and attempts), nervousness, dizziness, nausea and abdominal pain.

Orally. Adults.Severe episode of depression. The recommended daily dose is 20 mg. The improvement of the patient's condition begins after 1 week, but becomes visible from the second week of treatment. As with all antidepressants, dosing should be reviewed and, if necessary, adjusted within 3-4 weeks of starting treatment and then according to clinical judgment. In some patients with a 20 mg reaction, the dose can be gradually 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 time, at least 6 months, to ensure relief of symptoms.Obsessive-compulsive disorder. The recommended daily dose is 40 mg. Patients should start treatment 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 should be treated for a sufficient time to ensure relief of symptoms. This period can last several months or even longer.Anxiety disorder with anxiety attacks. The recommended daily dose is 40 mg per day. Treatment should start at a dose of 10 mg a day and increase it by 10 mg in steps, depending on the patient's response, until the recommended dose is reached. Starting treatment with a low initial dose is recommended to minimize the potential exacerbation of panic disorder symptoms, which are generally recognized as early in treatment of the disease. 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 should be treated for a sufficient period to ensure relief of symptoms. This period can last several months or even longer.Social phobia. The recommended daily dose is 20 mg per day. 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 disorder. The recommended daily dose is 20 mg per day. 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 by 10 mg up to a maximum dose of 50 mg per day. Long-term therapy should be evaluated regularly.Post-traumatic stress disorder. The recommended daily dose is 20 mg per day. 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 by 10 mg up to a maximum dose of 50 mg per day. Long-term therapy should be evaluated regularly.Stop taking paroxetine. Avoid sudden interruption of treatment. In clinical trials, a gradual withdrawal schedule was used in which the daily dose of paroxetine was reduced by 10 mg every week. If, after a dose reduction or discontinuation of treatment, intolerable symptoms appear, a return to the previous dose should be considered. The doctor may then continue to reduce the dose, but in a more gradual way.Special groups of patients. Older patients have increased plasma concentrations of paroxetine, but the range of concentrations coincides with that seen in younger subjects. Dosage should start with the initial dose recommended in adults. In some patients, it may be useful to increase the dose, however, the maximum dose should not exceed 40 mg daily. Paroxetine should not be used to treat children and adolescents. In patients with severe renal impairment (creatinine clearance <30 ml / min) or in patients with hepatic impairment, the dosage should be limited to the lower dose range.Method of administration. It is recommended that paroxetine should be given once a day, in the morning, during a meal. The tablet should be swallowed whole, it should not be chewed.