Index of drugs

Treatment and prevention of major depressive episodes, treatment of obsessive-compulsive disorder (ZO-K) in adults and children (from 6 years), panic disorder with or without associated agoraphobia, post-traumatic anxiety disorder (PTSD), social anxiety disorder.

1 tabl powl. contains 50 mg or 100 mg of sertraline in the form of a hydrochloride.

Antidepressant - a strong, selective inhibitor of serotonin reuptake in nerve cells. It has a slight influence on the reuptake of norepinephrine and dopamine. In therapeutic doses, it blocks the uptake of serotonin in blood platelets. In animal studies, it has been shown that the drug has no stimulant, sedative, cholinolytic or cardiotoxic effects. Sertraline does not cause sedation, does not affect psychomotor performance and does not affect the catecholaminergic transmission. It does not show affinity for muscarinic, serotonin, dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine receptors. After oral administration at doses of 50-200 mg for 14 days, the maximum blood concentration was reached after 4.5-8.5 hours. Approximately 98% of the drug is bound to plasma proteins. The average half-life is 22-36 h. Sertraline is extensively metabolised in the liver. The main metabolite - N-desmethylsertraline is about 20 times less active (in vitro) than the parent substance. T_0,5 metabolite is 62-104 h. Metabolites of sertraline and N-desmethylsertraline are excreted in equal parts with urine and faeces.

Hypersensitivity to the components of the preparation. It should not be used concurrently with MAO inhibitors or with pimozide.

Due to the risk of suicidal thoughts and attempts, patients should be closely monitored, especially in the initial stages of the healing process (the highest risk of suicide). The increased risk applies especially to young adults (under 25 years of age) and patients with history of suicidal behavior or thoughts. Caution should be exercised when treating patients with a history of mania or hypomania. In patients entering the mania phase, treatment with sertraline should be discontinued. In patients with schizophrenia, psychotic symptoms may be aggravated. Especially cautiously use in patients with impaired liver function (it may be necessary to reduce the doses or to prolong the intervals between doses). Use with caution in patients with renal insufficiency. Sertraline may compromise glycemic control - adjustment of insulin dose and / or oral hypoglycemic agents may be required. The use of sertraline in patients with unstable epilepsy should be avoided. Patients with controlled epilepsy should remain under constant control, and if the incidence of epilepsy attacks increases, the drug should be discontinued. In every patient who has seizures, treatment should be discontinued. Caution use in patients with inappropriate antiduretic hormone secretion, taking diuretics and in the elderly (risk of hyponatraemia). Caution is advised during concomitant use of sertraline and electroconvulsive therapy because clinical experience with such treatment is minor. Due to the risk of abnormal skin bleeds (ecchymosis, purpura), caution should be used in patients taking drugs that affect platelet function (eg atypical antipsychotics and phenothiazine derivatives, most tricyclic antidepressants, Acetylsalicylic acid and NSAIDs) and in patients with bleeding disorders in interview. Caution should be exercised when using sertraline in patients with a history of closing glaucoma in the course of glaucoma or glaucoma.
It is not recommended for children under 6 years of age. The drug should not be used to treat children and adolescents from 6 to 18 years of age, except for patients with obsessive-compulsive disorder. In clinical trials, suicidal behavior and hostility (aggression, oppositional 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 safety in children and adolescents with regard to growth, maturation, cognitive development and behavioral development.

It can only be used during pregnancy and breastfeeding if the expected benefit to the mother outweighs the potential risk to the fetus and the baby.

Very common: insomnia, dizziness, drowsiness, headache, diarrhea, dry mouth, nausea, ejaculation problems, fatigue. Common: pharyngitis, anorexia, increased appetite, depression, depersonalization, nightmares, anxiety, agitation, nervousness, decreased libido, bruxism, sensory disorder, tremor, increased tension, taste disorders, concentration disorders, visual disturbances, tinnitus, palpitations , hot flushes, yawning, abdominal pain, vomiting, constipation, flatulence, indigestion, rash, excessive sweating, muscle pain, joint pain, erectile dysfunction, chest pain, feeling unwell. Uncommon: inflammation of the upper respiratory tract, rhinitis, hypersensitivity, hypothyroidism, hallucinations, euphoria, aggression, apathy, abnormal thinking, convulsions, involuntary muscle movements, coordination disorders, hyperkinesia, impaired memory, hypoesthesia, speech disorders, post-dizziness, migraine, fainting, mydriasis, earache, tachycardia, hypertension, flushing, bronchospasm, shortness of breath, nosebleeds, esophagitis, dysphagia, tumors, salivary gland hyperplasia, tongue disorders, belching, periorbital edema, edema face, purpura, baldness, cold sweat, dry skin, urticaria, pruritus, osteoarthritis, muscular weakness, backache, muscle tics, urination at night, urinary incontinence, urinary retention, polyuria, pollakiuria, urinary disorders, bleeding from the vagina, sexual dysfunction in women, irregular menstruation, peripheral edema, chills, fever, asthenia, thirst, increased alanine aminotransferase, increased aspartic aminotransferase, weight loss, weight gain. Rarely: diverticulitis, gastroenteritis, otitis media, tumors, lymphadenopathy, anaphylactic reactions, hypercholesterolemia, hypoglycaemia, diabetes, conversion disorders, drug addiction, psychiatric disorders, paranoia, suicidal thoughts / behaviors, cougarence, premature ejaculation, coma, choreoathetosis, dyskinesia, hyperaesthesia, sensory disturbances, glaucoma, tear disorders, visual field defects, double vision, photophobia, frontal eye hemorrhage, myocardial infarction, bradycardia, heart disease, peripheral ischemia, hematuria, laryngospasm, hyperventilation, hypoxia, laryngeal hypnosis, dysphonia, hiccups, tar-like stools, fresh blood in the stool, stomatitis, tongue ulcer, dental disease, tongue inflammation, mouth ulceration, abnormal liver function, dermatitis, bullous dermatitis, follicular rash, abnormal hair structure, ni abnormal skin smell, bone disorders, oliguria, delay in passing urine, menorrhagia, atrophic vulvovaginitis, glans and foreskin inflammation, vaginal discharge, painful erection, galactorrhea, hernia, decreased drug tolerance, impaired gait, abnormal semen, increased concentration cholesterol, trauma, vasodilation treatment. In addition: leukopenia, thrombocytopenia, allergy, hyperprolactinemia, abnormal secretion of antidiuretic hormone, hyponatremia, hyperglycemia, sleep experiences, movement disorders (including extrapyramidal disorders such as hyperkinesia, hypertonia, dystonia, teeth grinding and gait disturbances), symptoms associated with serotonin syndrome or a neuroleptic malignant syndrome such as: agitation, convulsion, profuse sweating, diarrhea, fever, hypertension, stiffness, tachycardia (in some cases this was associated with the simultaneous use of serotonergic drugs), akathisia and psychomotor anxiety, cerebral vasospasm (including transient cerebral vasospasm and Calla-Fleming syndrome), abnormal vision, uneven pupils,abnormal bleeding (gastrointestinal bleeding), pulmonary fibrosis, pancreatitis, severe liver problems (including hepatitis, jaundice and hepatic failure), rare reports of serious side effects on the skin (CDNS): e.g. Stevens-Johnson syndrome and epidermal necrolysis, angioneurotic edema, sensitivity to light, skin reaction, muscle spasms, gynecomastia, abnormal laboratory tests, platelet dysfunction. Withdrawal of the drug (especially sudden) may lead to withdrawal symptoms such as agitation, anxiety, pain and dizziness, nausea. Epidemiological studies conducted mainly among people aged over 50 showed an increased risk of bone fractures in patients taking SSRIs and TCAs. The mechanism leading to such a risk is unknown.

Orally.Adults. Major depression and prevention of her relapse: the starting dose as well as the usual therapeutic dose is 50 mg per day.Obsessive-compulsive disorder: the starting dose is 50 mg, the therapeutic dose range is 50-200 mg.Panic disorder, post-traumatic stress disorder and social anxiety disorder: the starting dose is 25 mg, after one week of treatment the dose should be increased to 50 mg daily. In all of the above indications some patients may require doses greater than 50 mg per day. At this time, the dose should be increased once by 50 mg for a period of several weeks up to a maximum daily dose of 200 mg. After obtaining the optimal therapeutic response, the dose should be reduced to the lowest effective dose. Treatment effects may occur within the first 7 days of therapy, although a period of 2-4 weeks (or even longer in obsessive-compulsive disorder) is usually needed. In the treatment of post-traumatic stress disorder a longer period of therapy may be necessary - even over 12 weeks. Patients suffering from depression should be treated for at least 6 months. In the case of panic disorder and obsessive-compulsive disorder, the need to continue treatment should be regularly assessed because the ability to prevent their relapse has not been proven.Children and adolescents from 6 to 17 years old. Obsessive-compulsive disorder. Patients aged 13-17: the starting dose is 50 mg per day. Children 6-12 years: initially 25 mg per day, after a week the dose may be increased to 50 mg per day. If you do not respond to treatment, the dose can be increased once by 50 mg up to a maximum dose of 200 mg per day. Dose changes should not be made at intervals of less than 1 week. Lower doses or reduced frequency of administration in patients with hepatic impairment should be used. Way of giving. The drug should be taken once a day, regardless of meals.