Index of drugs

Treatment of major depressive episodes. Prevention of recurrence of major depressive episodes. Treatment of panic disorder with agoraphobia or without agoraphobia. Treatment of obsessive-compulsive disorders (ZO-K) in adults, children and adolescents aged 6-17. Treatment of social anxiety disorder. Treatment of post-traumatic anxiety 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 to any of the excipients. Concomitant use of sertraline with 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. The concurrent use of pimozide is contraindicated.

The occurrence of potentially life-threatening syndromes such as serotonin syndrome (SS) or neuroleptic malignant syndrome (NMS) has been observed in people taking SSRIs, including those taking sertraline. The risk of developing SS or NMS increases when other serotonergic drugs (including other serotoninergic drugs with antidepressant activity, triptans) are used simultaneously with drugs that interfere with serotonin metabolism (including MAO inhibitors, eg methylene blue), antipsychotic drugs, other antagonists Dopamine and opioid drugs. Patients should be monitored for signs and symptoms of SS or NMS syndrome. There is limited data from controlled trials regarding the optimal timing of treatment with SSRIs, antidepressants or antiobsessives for treatment with sertraline. During this change, caution and reasonable medical judgment should be used, especially when changing from long-acting drugs such as fluoxetine. Co-administration of sertraline with other drugs that potentiate the effects of serotonergic neurotransmission, such as tryptophan or fenfluramine or 5-HT agonists, or herbal preparations containing St. John's wort, should be undertaken with caution or where possible avoided. Sertraline should be used with caution in patients with a history of mania and / or hypomania. Close supervision of the doctor is necessary. In patients entering the manic phase, treatment with sertraline should be discontinued. In patients with schizophrenia, psychotic symptoms may get worse. The use of sertraline in patients with unstable epilepsy should be avoided, and 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 (suicidal behavior). This risk persists until full remission is achieved. Patients should be closely monitored until recovery occurs 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 observed, particularly those at increased risk. Sertralin should not be used to treat children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder aged 6-17. During 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 suicidal tendencies. 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 to detect abnormalities in these organ systems. Because of the risk of abnormal bleeding, it is recommended to be cautious in patients receiving SSRI, particularly when co-administered with drugs known to have an adverse effect on platelet function (eg anticoagulants, atypical antipsychotics and phenothiazines, most tricyclic antidepressants) , Acetylsalicylic acid and NSAIDs) as well as in patients with a history of bleeding disorders. In elderly patients and in patients receiving diuretic therapy or for other reasons that are at risk of reducing plasma volume, the risk of hyponatremia with SSRIs or SNRIs may be greater. 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. When sertraline is administered to patients with hepatic impairment, dose reduction or less frequent dosing should be considered. Sertralin should not be used in patients with severe hepatic impairment. In patients with diabetes, treatment with SSRIs may change glycemic control. insulin and / or oral hypoglycemic agents may need to be adjusted. 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.

The use of sertraline is not recommended during pregnancy except when the clinical condition of the woman justifies the administration of the drug, and the potential benefits of treatment outweigh the potential risks. There are no adequate controlled studies on the use of sertraline in pregnant women. Analysis of the significant amount of collected data does not indicate that sertraline caused congenital malformations. If the mother continues her treatment with sertraline later in pregnancy (especially in the third trimester), the newborn baby needs to be observed. In newborns whose mothers took sertraline later in pregnancy, the following symptoms were noted: respiratory failure, cyanosis, apnea, seizures, fluctuations in body temperature, difficulty in taking food, vomiting, hypoglycaemia, increased muscle tone, decreased muscle tone, increased reflexes, tremors muscular cramps, irritability, hypothermia, continuous crying, drowsiness and sleep disorders. These symptoms may be due to serotonergic effects or symptoms of withdrawal. In most cases, complications develop immediately or in a short time (less than 24 hours) after delivery.The use of SSRIs during pregnancy, especially in late pregnancy, may increase the risk of persistent pulmonary hypertension in newborns (PPHN). This medicine is not recommended for mothers who are breastfeeding, except when the doctor believes that the benefits of taking the medicine outweigh the risks. Small amounts of sertraline and its metabolite N-desmethylsertraline pass into breast milk. Normally, very low to undetectable levels of serum drug were found in infants. The only exception was an infant, in whom the concentration of sertraline corresponded to approx. 50% of the value of the concentration marked in the mother (but without a noticeable effect on the child's health). There have been no reports of side effects in breastfed infants from mothers receiving sertraline, however, the risk of such effects can not be excluded. Animal studies have shown no evidence of sertraline effects on fertility. 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 (14%), fatigue (10%). Common: pharyngitis, anorexia, increased appetite, depression, depersonalization, nightmares, anxiety, agitation, nervousness, decreased libido, bruxism, sensory disturbances, tremor, increased tension, taste disorders, concentration disorders, visual disturbances, tinnitus, palpitations , hot flushes, yawning, abdominal pain, vomiting, constipation, indigestion, bloating, rash, excessive sweating, muscular pain, sexual dysfunction, erectile dysfunction, chest pain. Uncommon: upper respiratory tract infections, rhinitis, hallucinations, euphoria, apathy, abnormal thinking, seizures, involuntary muscle movements, coordination disorders, hyperkinesia, memory problems, hypoaesthesia, speech disorders, orthostatic dizziness, migraine, tachycardia, hypertension arterial, flushing, bronchospasm, dyspnea, nosebleeds, esophagitis, dysphagia, hemorrhoids, salivary glands, tongue disorders, belching, periorbital edema, purpura, alopecia, cold sweat, dry skin, urticaria, osteoarthritis, 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, lymphadenopathy, hypercholesterolemia, hypoglycaemia, conversion disorders, drug addiction, psychiatric disorders, aggression, madness, thoughts and / or suicidal behavior, sleepwalking, premature ejaculation, coma, choreoathetosis, dyskinesia, hyperaesthesia, impaired sensation, glaucoma, tear disorders, visual field defects, double vision, photophobia, intracameral bleeding, mydriasis, ear pain, myocardial infarction, bradycardia, heart disease, peripheral ischemia , laryngeal spasm, hyperventilation, hypoventilation, larynx, dysphonia, hiccups, tarry stools, presence of fresh blood in the stool, stomatitis, tongue ulcer, tooth disorder, tongue inflammation, mouth ulcer, liver dysfunction, dermatitis, bullitis skin, papular rash, abnormal st hair growth, abnormal skin odor, bone disorders, oliguria, urinary incontinence, delayed urination, menorrhagia, atrophic vulvovaginitis, glans and foreskin inflammation, vaginal discharge, painful penile erection, galactorrhea, hernia, reduction of tolerance to drugs, impaired gait, increased ALT, AST, abnormal semen, injuries, vasodilatation. Not known: leukopenia, thrombocytopenia, hypersensitivity reactions, hyperprolactinemia, hypothyroidism and vasopressin syndrome, hyponatraemia, diabetes, hyperglycemia, nightmares, movement disorders (including extrapyramidal disorders such as hyperkinesia,hypertonia, dystonia, teeth grinding and gait disturbances), syncope, signs and symptoms of the serotonin syndrome or malignant neuroleptic syndrome (eg agitation, confusion, profuse sweating, diarrhea, fever, hypertension, stiffness, tachycardia; concomitant use of other serotonergic drugs), akathisia and psychomotor anxiety, cerebral vasospasm (including transient cerebrovascular spasms and Calla-Fleming syndrome), abnormal vision, pupils of unequal size, abnormal bleeding (eg from the nose, from the gastrointestinal tract, blood in the urine), pulmonary fibrosis, pancreatitis, severe liver disease (including hepatitis, jaundice and hepatic failure), severe skin reactions (e.g., Stevens-Johnson syndrome, epidermal necrosis), angioneurotic edema, swelling of the face, sensitivity to light, pruritus, joint pain, pain muscle wounds, gynecomastia, irregular menstruation, peripheral edema, abnormal laboratory tests, platelet dysfunction, increased cholesterol. In patients ≥ 50 years of age, there is an increased risk of falls and fractures in patients receiving selective serotonin reuptake inhibitors or tricyclic antidepressants (mechanism is not known). Elderly patients have an increased risk of clinically significant hyponatraemia. Children and adolescents: very common: headache (22%), insomnia (21%), diarrhea (11%), 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, suicide attempts, convulsions, extrapyramidal disorder, paraesthesia, depression, hallucinations, purpura, hyperventilation, anemia, liver dysfunction, increased ALAT, cystitis, herpes, external otitis, ear pain, pain eyes, mydriasis, malaise, hematuria, pustular rash, rhinitis, injuries, weight loss, muscle cramps, abnormal dreams, apathy, proteinuria, pollakiuria, polyuria, breast pain, menstrual disorders, alopecia, dermatitis, skin disorders, abnormal skin smell, hives, bruxism, hot flushes. Withdrawal of sertraline (especially sudden) often causes withdrawal symptoms: dizziness, sensory disturbances (including paraesthesia), sleep disorders (including insomnia and intense dreams), agitation or anxiety, nausea and / or vomiting, muscle tremor, headache .

Orally.The beginning of treatment. Depression and ZO-K: treatment should start at 50 mg daily. Panic disorder, PTSD and social anxiety disorder: treatment should start with a dose of 25 mg per day. After a week the dose should be increased to 50 mg daily. This dosage regimen reduces the frequency of side effects characteristic of the initial phase of treatment of an anxiety disorder with anxiety attacks.Increasing the dose. Depression, ZO-K, panic disorder, social anxiety disorder and PTSD: in patients who do not respond to a dose of 50 mg, the dose should be increased. 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 the elimination half-life of sertraline (24 h), do not change the dosage more frequently than once a week. The onset of the therapeutic effect may occur within 7 days, however, more time is usually needed to achieve full effect (especially in the case of ZO-K).Maintenance treatment. During long-term maintenance therapy, the dosage should be set at the lowest level to ensure therapeutic effect and then 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 episode. Patients with depression should be treated for at least 6 months, respectively, to ensure that their symptoms disappear.Panic disorders and ZO-K: the need to continue treatment should be regularly assessed, because in these disorders the prevention of relapse has not been proven.Children and adolescents with ZO-K. 13-17 years old: 50 mg per day initially. Age 6-12 years: initially 25 mg per day. After a week, the dose can be increased to 50 mg a day. If no effect is expected after 50 mg daily, subsequent doses may be higher in subsequent weeks, depending on the need. The maximum dose is 200 mg a day. Increasing the daily dose of over 50 mg should take into account the lower body weight in children compared to adults. Do not change the dosage more often than once a week. The effectiveness of the drug in cases of severe depression in children has not been demonstrated. In patients with hepatic impairment, lower doses or longer intervals between doses are recommended. Sertralin should not be used in case of severe hepatic insufficiency. In case of renal dysfunction, no dosage adjustment is necessary. Sertralin should be given once a day, in the morning or in the evening, regardless of meals.