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 disorders (ZO-K) in adults and pediatric patients aged 6-17 years. Treatment of social anxiety disorder. Treatment of post-traumatic anxiety disorder (PTSD).

1 tabl powl. contains 50 mg of sertraline.

Antidepressant - a strong, selective inhibitor of neuronal reuptake of serotonin. It has a very weak effect on the reuptake of norepinephrine and dopamine. At therapeutic doses, it inhibits serotonin uptake in platelets. Sertraline does not increase catecholaminergic activity. It does not show affinity for muscarinic (cholinergic), serotonin, dopaminergic, adrenergic, histaminergic receptors, GABA receptors or benzodiazepine receptors. After an oral dose of 50-200 mg once daily for 14 days, the maximum plasma concentration occurred 4.5-8.4 h after daily administration. Plasma protein binding is approximately 98%. Sertraline undergoes extensive metabolism during the first pass through the liver. Medium T_0,5 is about 26 hours (22-36 h). In the final phase of elimination, there is an approximate double accumulation to stationary steady state concentrations, which are achieved after 1 week of once daily dosing. 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, which occurs with symptoms such as psychomotor agitation, muscular tremor and hyperthermia. 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 simultaneous use of pimozide is contraindicated.

The development of 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 serotonergic drugs (including triptans) are used concurrently with drugs that interfere with serotonin metabolism (including MAO inhibitors), antipsychotics and other Dopamine antagonists. Patients should be monitored for signs and symptoms of SS or NMS syndromes. Due to limited experience, caution and reasonable medical judgment should be used when switching from SSRIs, antidepressants or antiobsession drugs to sertraline (especially when switching 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 herbal preparations containing St. John's Wort, should be undertaken with caution and, if possible, avoided because of possible pharmacodynamic interactions. Sertraline should be used with caution in patients with a history of mania and / or hypomania. Close supervision by a doctor is necessary. Sertraline should be discontinued in any patient entering the manic phase. In patients with schizophrenia, psychotic symptoms may get worse. Patients treated with sertraline may experience seizures. 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.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 closely monitored for signs of suicidal symptoms. 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. 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. Hyponatraemia may occur during treatment. In many cases, hyponatremia appears to be the result of an inappropriate antidiuretic hormone (SIADH) syndrome. Cases of serum sodium below 110 mmol / l have been reported. There is an increased risk of hyponatraemia in elderly patients and in patients taking diuretics or for other reasons prone to reducing plasma volume. 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. Sertraline should not be used in patients with severe hepatic impairment. In diabetic patients, treatment with SSRIs may change the blood Glucose level - glycemic control should be carefully monitored in patients receiving sertraline and the dose of insulin and / or concomitant oral antidiabetic medications may need to be adjusted. No clinical trials have been conducted to determine the risks or benefits associated with the concomitant use of electroconvulsive therapy and sertraline.

Sertraline 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. There are no adequately controlled studies on the use of the drug in pregnant women. However, in the experimental studies conducted, no congenital malformations induced by sertraline were observed. 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). Epidemiological data indicate that the use of SSRI during pregnancy, especially in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).Small amounts of sertraline and its metabolite N-desmethylsertraline are excreted in breast milk. In breast-fed infants, very small or undetectable serum concentrations were generally 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). There have been no reports of any adverse reactions in breast-fed infants by mothers using sertraline, however the risk of such effects can not be excluded. This medicine is not recommended for mothers who are breastfeeding, unless the doctor believes that the benefits outweigh the risks.

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, sensory disturbances, tremor, increased tension, taste disorders, concentration disorders, visual disturbances, tinnitus, palpitations , hot flushes, yawning, abdominal pain, vomiting, constipation, indigestion, bloating, rash, sweating, muscle pain, sexual dysfunction, erectile dysfunction, chest pain. Uncommon: upper respiratory tract infections, rhinitis, hallucinations, euphoria, apathy, abnormal thinking, convulsions, involuntary muscle movements, coordination disorders, hyperkinesia, memory disorders, hypoaesthesia, speech disorders, post-mortem dizziness, migraine, earache, tachycardia, hypertension, sudden redness, bronchospasm, shortness of breath, nosebleeds, oesophagitis, dysphagia, haemorrhagic tumors, salivary glands, tongue disorders, belching with reflux, periorbital edema, purpura, alopecia, cold sweat, dry skin, urticaria, osteoarthritis, muscular weakness, backache, 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, paranoia, thoughts and / or suicidal behavior, sleepwalking, premature ejaculation, coma, choreoathetosis, dyskinesia, hyperaesthesia, sensory disturbances, glaucoma, loss of tears, visual field defects, double vision, photophobia, anterior chamber gallbladder, mydriasis, myocardial infarction, bradycardia, heart disease, peripheral ischaemia, laryngeal spasm , hyperventilation, hypoxia, laryngeal hypnosis, dysphonia, hiccups, tar-like stools, presence of fresh blood in the stool, tongue ulcer, tooth disorder, tongue inflammation, mouth ulcer, abnormal liver function, dermatitis, dermatitis, follicular rash, abnormal hair structure incorrect skin smell, bone disorders, oliguria, urinary incontinence, delayed urination, menorrhagia, atrophic vulvovaginitis, glans and foreskin inflammation, vaginal discharge, painful erection, galactorrhea, hernia, fibrosis at the injection site, reduction of drug tolerance, impaired gait, increased ALT, AST, abnormal semen, injuries, vasodilatation. Frequency unknown: leukopenia, thrombocytopenia, anaphylactic reactions, allergic reactions, hyperprolactinemia, hypothyroidism, excessive vasopressin syndrome (ADH), hyponatremia, paroniria, movement disorders (including extrapyramidal disorders such as hyperkinesia, hypertonia, teeth grinding and gait disturbances) ), fainting, symptoms associated with a serotonin syndrome or a neuroleptic malignant syndrome (eg agitation, confusion, profuse sweating, diarrhea, fever, hypertension, stiffness and tachycardia), akathisia and psychomotor restlessness, abnormal vision, abnormal bleeding (nosebleeds) , from the gastrointestinal tract, blood in the urine), pancreatitis, severe liver disease (including hepatitis, jaundice and hepatic failure) and asymptomatic transaminase elevation, severe side effects on the skin (e.g.Stevens-Johnson syndrome and epidermal necrolysis), angioedema, facial edema, sensitivity to light, skin reactions, pruritus, joint pain, muscle spasms, gynecomastia, irregular menstruation, peripheral edema, laboratory abnormalities, platelet dysfunction, increased concentration cholesterol. Elderly patients may be more at risk of clinically significant hyponatraemia. Epidemiological studies conducted mainly among patients over 50 years have shown an increased risk of bone fractures in patients taking SSRIs and tricyclic antidepressants. In pediatric patients, the general adverse reaction profile was generally similar to that seen in studies involving 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 disorder, paraesthesia, depression, hallucinations, purpura, hyperventilation, anemia, liver dysfunction, elevated ALT, cystitis, herpes, external otitis, earache, aches and pains eyes, mydriasis, malaise, hematuria, pustular rash, rhinitis, injuries, weight loss, muscle cramps, abnormal dreams, apathy, proteinuria, 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, tremors and headaches.

Orally.Adults. Initial 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 1 week, the dose should be increased to 50 mg once a day. This dosing regimen reduces the frequency of side effects characteristic of the initial treatment phase of panic disorder.Increasing the dose. Depression, ZO-K, panic disorder, social anxiety disorder and PTSD: patients not responding to 50 mg may need to be increased. Dose changes should be made at intervals of at least 1 week, each time 50 mg, up to a maximum dose of 200 mg per day. Because of T_0,5 sertraline in the elimination phase (24 h), the dosage should not be changed more often than once a week. The onset of therapeutic action can take place within 7 days. In order to achieve the full therapeutic effect, especially in the treatment of patients with ZO-K, a longer treatment period is necessary.Maintenance treatmentThe dosage should be maintained at the lowest effective dose level and then adjusted depending on the patient's response to treatment. Depression: long-term treatment may also be necessary to prevent the recurrence of major depressive episodes. In most cases, the dose recommended for preventing relapse of episodes of depression is the same as the dose used to treat the current episode. Patients with depression should be treated long enough for at least 6 months to ensure that the symptoms of the disease have disappeared. Panic attack and ZO-K: the need to continue treatment should be regularly assessed because the ability to prevent relapse has not been proven in these disorders.Children and adolescents with obsessive-compulsive disorders. Age 13-17: initial dose 50 mg once a day. Age 6-12 years: starting dose of 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 / day, subsequent doses may be higher in the following weeks, depending on the need. The maximum dose is 200 mg a day.However, if you increase the daily dose above 50 mg, you 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 major depression in children has not been demonstrated. There are no data available on the use of the drug for children under the age of 6. In the elderly, the drug should be used with caution. In patients with impaired hepatic function, lower doses should be used or longer between doses, the drug should not be used in case of severe hepatic impairment. There is no need to change the dosage in patients with renal insufficiency. The preparation should be administered once a day, in the morning or evening, with or without food.