Index of drugs

Treatment of major depressive episodes. Prevention of recurrence of major depressive episodes. Treatment of panic disorder with accompanying (or not) agoraphobia. Treatment of obsessive-compulsive disorder (ZO-K) in adult patients and children and adolescents aged 6-17. Treatment of social anxiety disorder. Treatment of post-traumatic stress disorder (PTSD).

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

Antidepressant - a selective serotonin reuptake inhibitor (SSRI). Has a slight effect on the reuptake of norepinephrine and dopamine. At therapeutic doses, sertraline inhibits serotonin uptake in platelets. It has been shown that it has no stimulating, sedative, cholinolytic or cardiotoxic effects, it does not affect psychomotor performance. Sertraline does not affect catecholaminergic transmission and does not show affinity for muscarinic, serotonin, dopaminergic, adrenergic, histaminergic, GABA-ergic or benzodiazepine receptors. Sertraline has not been shown to be prone to abuse. After an oral dose of 50-200 mg once daily for 14 days, the maximum serum concentration of sertraline occurred 4.5-8.4 h after daily administration. Food has no significant effect on bioavailability. Approx. 98% of the drug is associated with plasma proteins. Sertraline undergoes extensive metabolism during the first pass through the liver. It is metabolised by numerous pathways, including CYP3A4, CYP2C19 and CYP2B6. Sertraline and its major metabolite, desmethylsertraline, are also substrates of P-glycoprotein underin vitro. Medium T_0,5 sertraline is approx. 26 h (range 22-36 h). According to the final elimination half-life, approximately 2-fold accumulation to steady-state concentrations occurs, which are achieved after 1 week of once daily administration. T_0,5 N-desmethylsertraline remains in the range of 62-104 h. Both sertraline and N-desmethylsertraline are extensively metabolised, and the resulting metabolites are excreted in the faeces and in the urine in equal amounts. Only a small amount (<0.2%) of unchanged sertraline is excreted in the urine.

Hypersensitivity to the active substance or any of the excipients. The simultaneous use of irreversible MAO inhibitors is contraindicated due to the risk of serotonin syndrome. Sertraline should not be started for at least 14 days after stopping treatment with an irreversible MAO inhibitor. Sertraline should be discontinued at least 7 days before treatment with an irreversible MAO inhibitor. Simultaneous use of pimozide.

In patients taking SSRIs (including sertraline) there is a risk of developing potentially life-threatening syndromes, such as serotonin syndrome (SS) or neuroleptic malignant syndrome (NMS); the risk increases when serotonergic drugs (including triptans) are used concurrently with drugs that impair serotonin metabolism (including MAO inhibitors), antipsychotics and other Dopamine antagonists. The patient should be monitored for signs and symptoms of SS or NMS syndromes. Due to limited experience, caution should be exercised when switching from SSRI, antidepressants or antiobsession drugs to sertraline, especially when changing from long-acting drugs such as fluoxetine. The concomitant administration of sertraline with other drugs that potentiate the effects of serotoninergic neurotransmission, such as tryptophan or fenfluramine or 5-HT agonists or preparations containing St. John's wort, should be undertaken with caution; if possible, concomitant use with sertraline should be avoided. The drug should be used with caution in patients with a history of mania and / or hypomania, it is necessary to closely observe the doctor. Sertraline should be discontinued in any patient entering the manic phase. In patients with schizophrenia, psychotic symptoms may get worse. The use of sertraline in patients with unstable epilepsy should be avoided; Patients with controlled epilepsy should be carefully monitored. Sertraline should be discontinued in any patient who develops seizures. Depression is associated with an increased risk of suicidal thoughts, self-mutilation and suicide (behavior related to suicide). This risk persists until full remission is achieved.Patients should be closely monitored until improvement occurs and at an early stage of recovery (increased risk of suicide). In patients treated for other psychiatric disorders, the same precautions should be taken as in patients with severe depressive disorder. Patients with a history of suicide-related events or patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment are considered to be at increased risk of suicidal thoughts or suicide attempts and should be closely monitored during treatment, particularly in patients below 25 years of age. During treatment, especially at the beginning of therapy and when the dose is changed, patients should be closely monitored, particularly those at high risk. Sertraline should not be used to treat children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorders aged 6-17 years. In the course of clinical trials, suicidal behaviors (suicidal thoughts and attempts) and hostility (especially aggression, rebel behavior and anger) were more frequently observed in children and adolescents treated with antidepressants than in the placebo group. If, however, as a result of an existing clinical need, a decision to treat is made, the patient should be carefully monitored for signs of suicide. In addition, there are no long-term data on the safety of children and adolescents regarding growth, maturation and cognitive development and behavioral development. The health condition of children treated for a long time should be controlled by a physician in order to detect abnormalities in these organ systems. Due to the risk of abnormal bleeding, caution is advised in patients taking SSRIs, particularly when co-administered with drugs known to have an adverse effect on platelet function (eg anticoagulants, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acid Acetylsalicylic acid and NSAIDs) as well as in patients with a history of bleeding disorders. Elderly patients and patients taking diuretics or other medicines that reduce plasma volume may be at greater risk of developing hyponatraemia. In patients with symptomatic hyponatraemia, discontinuation of sertraline and appropriate medical management should be considered. In patients who develop symptoms of akathisia, increasing the dose may be harmful. Severe caution should be used when treating sertraline in patients with liver disease. In patients with hepatic impairment, dose reduction or less frequent dosing should be considered. Sertraline should not be used in patients with severe hepatic impairment. In patients with diabetes, treatment with SSRIs may change glycemic control; if necessary, adjust the dose of insulin and / or concomitantly used oral antidiabetic agents. No clinical studies have been conducted to determine the risks or benefits of electroconvulsive therapy and sertraline. The use of sertraline with grapefruit juice is not recommended. Caution should be exercised when using sertraline in patients with closed-angle glaucoma or history of glaucoma.

There are no adequately controlled studies on the use of the drug in pregnant women. In experimental studies conducted, no congenital malformations induced by sertraline were observed. The use of sertraline during pregnancy causes symptoms consistent with withdrawal symptoms in some newborns whose mothers have taken sertraline. It is not recommended during pregnancy unless the clinical condition of the woman justifies this need, and the potential benefits of treatment outweigh the potential risks. If the mother continues to use sertraline during late periods of pregnancy, especially in the third trimester, the newborn should be observed. After the use of sertraline by the mother during late periods of pregnancy, the following symptoms may occur in the newborn: acute respiratory failure, cyanosis, apnea, seizures, fluctuations in body temperature, difficulty in taking food, vomiting, hypoglycaemia, increased muscle tone, decreased muscle tone, excessive temperature reflexes, muscle tremors, muscle cramps, irritability, hypothermia, constant crying, drowsiness and sleep disorders. These symptoms may result from either serotonergic effects or withdrawal symptoms. In most cases, complications occur immediately or soon after delivery (within less than 24 hours). The use of SSRIs during pregnancy, especially in the late period, may increase the risk of persistent pulmonary hypertension syndrome in the newborn (PPHN).Small amounts of sertraline and its metabolite penetrate into breast milk. In breast-fed infants, very low or undetectable serum concentration values ​​were found, with a single exception of the infant with a concentration of sertraline corresponding to about 50% of the value found in the mother (but without a noticeable effect on the infant's health). This medicine is not recommended for mothers who are breastfeeding, unless the doctor believes that the benefits outweigh the risks. From the case reports of the use of certain SSRIs in humans, the effect on sperm quality is transient. No effects on human fertility have been observed so far.

Very common: insomnia (19%), dizziness (11%). drowsiness (13%), headache (21%), diarrhea (18%), nausea (24%), dry mouth (14%), ejaculation disorders (14%), fatigue (10%). Common: pharyngitis, anorexia, increased appetite, depression, depersonalization, nightmares, anxiety, agitation, nervousness, decreased libido, bruxism, paresthesia, tremor, hypertonia, taste disturbances, impaired concentration, blurred vision, tinnitus, palpitations, blows hot, yawning, abdominal pain, vomiting, constipation, indigestion, bloating, rash, excessive sweating, muscle pain, sexual dysfunction, erectile dysfunction, chest pain. Uncommon: inflammation of the upper respiratory tract of rhinitis, hallucinations, euphoria, apathy, impaired thinking, convulsions, involuntary muscle movements, coordination disorders, hyperkinesia, amnesia, hypoesthesia, speech disorders, locomotive dizziness, migraine, earache, tachycardia, hypertension , reddening of the skin, bronchospasm, shortness of breath, nosebleeds, esophagitis, dysphagia, tumors, salivary gland hyperplasia, tongue disorder, reflux, periorbital edema, purpura, alopecia, cold sweat, dry skin, urticaria , arthritis and bones, muscle weakness, back pain, muscle tics, urination at night, urinary retention, polyuria, pollakiuria, urination disorders, vaginal bleeding, sexual dysfunction in women, malaise, chills, fever, asthenia , thirst, weight loss, weight gain. Rarely: diverticulitis, gastroenteritis, otitis media, tumors (1 case), lymphadenopathy, hypercholesterolemia, hypoglycaemia, conversion disorders, drug addiction, psychotic disorders, aggression, paranoia, thoughts and / or suicidal behavior , lunatism, premature ejaculation, coma, choreoathetosis, dyskinesia, hyperaesthesia, impaired sensation, glaucoma, impaired tear production, visual field defects, double vision, photophobia, intracameral bleeding, mydriasis, myocardial infarction, bradycardia, heart disease, ischemia peripheral, laryngeal spasm, hyperventilation, hypoxia, larynx, dysphonia, hiccups, tar-like stools, presence of fresh blood in the stool, stomatitis, tongue ulcer, tooth disease, tongue inflammation, mouth ulcer, liver dysfunction, dermatitis, bladder inflammation skin, a follicular rash, improper structure hair turn, abnormal skin smell, bone disorders, oliguria, urinary incontinence, delayed urination, menorrhagia, atrophic vulvovaginitis, glans and foreskin inflammation, vaginal discharge, painful erection, galactorrhea, hernia, reduction of drug tolerance, gait disturbance , increase in ALT and AST, abnormal semen, injuries, vasodilatation. Not known: leukopenia, thrombocytopenia, anaphylactic reactions, allergic reactions, hyperprolactinemia, hypothyroidism, excessive vasopressin syndrome, hyponatremia, diabetes, hyperglycemia, sleep disturbances, movement disorders (including extrapyramidal disorders such as hyperkinesia, hypertonia, gnashing of teeth) , gait disorders, syncope), symptoms associated with serotonin syndrome or neuroleptic malignant syndrome (such as agitation, confusion, profuse sweating, diarrhea, fever, hypertension, stiffness, tachycardia), akathisia and psychomotor restlessness, cerebral vasospasm (in including transient cerebral vasospasm and Calla-Fleming syndrome), unusual vision, unequal pupils, abnormal bleeding (nosebleeds, gastrointestinal tract, blood in the urine), interstitial pneumonitis, pancreatitis, severe liver disease (including hepatitis) , that's wheelbarrow and liver failure), rare reports of serious adverse reactions on the part of the skin (eg.Stevens-Johnson syndrome and epidermal necrolysis), angioedema, facial edema, sensitivity to light, skin reaction, pruritus, joint pain, muscle spasms, gynecomastia, irregular menstruation, peripheral edema, laboratory abnormalities, platelet dysfunction, increased plasma concentration cholesterol. Epidemiological studies, mainly in patients aged 50 years and older, have shown an increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants (the mechanism of this risk is unknown).Children and youth. The adverse reaction profile was usually similar to that seen in studies with adults. The following adverse reactions were observed in controlled studies: very common: headache (22%), insomnia (21%), diarrhea (11%), and nausea (15%); common: chest pain, mania, fever, vomiting, anorexia, emotional lability, aggression, agitation, nervousness, attention disorders, dizziness, hyperkinesia, migraine, drowsiness, tremors, blurred vision, dry mouth, indigestion, nightmares , fatigue, incontinence, rash, acne, nosebleed, bloating; uncommon: prolongation of the ECG QT interval, suicide attempts, convulsions, extrapyramidal disorders, paresthesia, depression, hallucinations, purpura, hyperventilation, anemia, liver dysfunction, elevated alanine aminotransferase, cystitis, herpes, external otitis, earache, eye pain, mydriasis, malaise, hematuria, pustular rash, runny nose, injuries, weight loss, muscle cramps, abnormal dreams, apathy, albuminuria, pollakiuria, polyuria, breast pain, menstrual disorders, alopecia, dermatitis, abnormal skin odor , hives, bruxism, hot flushes; frequency unknown: involuntary urination. Withdrawal of sertraline (especially sudden) often results in withdrawal symptoms; the most frequently reported reactions are: dizziness, sensory disturbances (including paraesthesia), sleep disorders (including insomnia and intense dreams), agitation or anxiety, nausea and / or vomiting, tremor and headache.

Orally.Adults. The beginning of treatment. Depression and ZO-K: treatment should start at 50 mg daily. Panic disorder, PTSD, social anxiety disorder: treatment should start with a dose of 25 mg per day. After 1 week, the dose can be increased to 50 mg a day. This dosage regimen reduces the frequency of side effects characteristic of the initial phase of treatment of panic disorder.Increasing the dose. Depression and ZO-K, panic disorder, social anxiety disorder, PTSD: in patients not responding to the 50 mg dose, it is beneficial to increase it. Dose changes should be made at intervals of at least 1 week, each time by 50 mg, up to a maximum dose of 200 mg per day. Considering T_0,5 sertraline (24 h), do not change the dosage more often than once a week. The onset of the therapeutic effect may occur within 7 days, however, noticeable effects are usually visible after a longer period of treatment, especially in the case of ZO-K.Maintenance treatment. In long-term therapy, the lowest possible doses should be used to ensure a therapeutic effect, adjusted as needed. Depression: long-term treatment may also be necessary to prevent the recurrence of major depressive episodes. In most cases, the recommended dose is the same as that used during the current episode. Patients with depression should be treated long enough for at least 6 months to ensure that their symptoms are gone. Panic disorder and ZO-K: the need to continue treatment should be regularly assessed because efficacy has not been demonstrated to prevent the recurrence of these diseases.Children and adolescents with ZO-K: Age 13-17: initially 50 mg per day; 6-12 years of age: initially 25 mg once a day; after 1 week, the dose may be increased to 50 mg once a day. If there is no expected effect after a dose of 50 mg daily, the Next doses may be higher in the following weeks by 50 mg, depending on the needs. The maximum dose is 200 mg a day. However, when increasing the daily dose above 50 mg, it is necessary to take into account the lower body weight in children. Do not change the dosage more often than once a week.The effectiveness of the drug in cases of major depression in children has not been demonstrated. No data are available on the use of the drug in children under the age of 6. In patients with hepatic impairment, lower doses should be used or the frequency of dosing should be reduced; should not be used in patients with severe hepatic impairment. In patients with renal insufficiency, no dose adjustment is required. The preparation should be administered once a day, in the morning or in the evening, with or without food.