Instructions Emoton film-coated tablets 100 mg blister No. 30
Composition
active ingredient: sertraline;
1 film-coated tablet contains sertraline hydrochloride 50 mg or 100 mg;
excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silicon dioxide, magnesium stearate.
The film coating contains: polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol 300, talc.
Dosage form
Film-coated tablets.
Main physicochemical properties: white, round, convex tablets, with a score.
Pharmacotherapeutic group
Antidepressants. Selective serotonin reuptake inhibitors. ATX code N06A B06.
Pharmacological properties
Pharmacodynamics
Sertraline is a potent and specific inhibitor of neuronal serotonin (5-HT) reuptake in vitro, which in animals leads to potentiation of the effects of 5-HT. Sertraline has only a very weak effect on the neuronal reuptake of noradrenaline and dopamine. At clinical doses, sertraline blocks the reuptake of serotonin in human platelets. The drug does not exhibit stimulant, sedative, anticholinergic or cardiotoxic effects in animal experiments. During the use of the drug, sertraline did not have a sedative effect and did not affect psychomotor functions. In accordance with its inherent selective inhibition of serotonin reuptake, sertraline does not stimulate catecholaminergic activity. The drug has no affinity for muscarinic (cholinergic), serotonergic, dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine receptors.
Sertraline is not addictive. In a comparative study of the abuse potential of sertraline, alprazolam, and d-amphetamine in humans, sertraline did not produce positive subjective effects indicative of abuse potential. In contrast, subjects taking both alprazolam and d-amphetamine had statistically significantly higher rates of abuse potential, euphoria, and drug dependence potential than subjects taking placebo. Sertraline does not produce the stimulant or anxiety effects of d-amphetamine or the sedative and psychomotor impairments of alprazolam.
Pharmacokinetics
Absorption
The pharmacokinetics of sertraline in the dose range of 50 to 200 mg are dose-dependent. During 14 days of oral administration of sertraline at a dosage of 50-200 mg 1 time per day, peak plasma concentrations are reached 4.5-8.4 hours after daily administration. Food does not significantly alter the bioavailability of sertraline in tablet form.
Distribution
Approximately 98% of circulating sertraline is bound to plasma proteins.
Biotransformation
Sertraline undergoes extensive first-pass metabolism in the liver.
Elimination
The mean elimination half-life of sertraline is approximately 26 hours (range 22 to 36 hours). In accordance with the terminal elimination half-life, accumulation of the drug (with an increase in its level by approximately twofold) is observed when reaching equilibrium concentrations, which are observed after once-daily administration for 1 week. The elimination half-life for N-desmethylsertraline is 62-104 hours. Sertraline and N-desmethylsertraline are extensively metabolized in the human body, their final metabolites are excreted in feces and urine in equal amounts. Only a very small part (
Pharmacokinetics in specific patient groups
Children with OCD
The pharmacokinetics of sertraline were studied in 29 children aged 6-12 years and 32 adolescents aged 13-17 years. Patients were titrated to a daily dose of 200 mg over 32 days, starting with either 25 mg or 50 mg. Tolerability was similar between the 25 mg and 50 mg doses. At steady state, plasma sertraline concentrations in children aged 6-12 years at a dose of 200 mg were approximately 35% higher than in patients aged 13-17 years and 21% higher than in the adult reference group. There were no significant differences in clearance between boys and girls. Therefore, a low starting dose and titration in 25 mg increments are recommended for children, especially those with low body weight. The same doses as adults can be used for adolescents.
Adolescents and elderly patients
The pharmacokinetic profile of sertraline in adolescents and the elderly does not differ significantly from that in adults aged 18-65 years.
Liver dysfunction
In patients with liver damage, the half-life of sertraline is prolonged and the area under the pharmacokinetic concentration-time curve increases threefold.
Kidney dysfunction
No significant accumulation of sertraline was observed in patients with moderate or severe renal impairment.
Indication
– Major depressive episodes. Prevention of recurrence of major depressive episodes.
– Panic disorders with or without agoraphobia.
– Obsessive-compulsive disorder (OCD) in adults and children aged 6-17 years.
– Post-traumatic stress disorder (PTSD).
Contraindication
Hypersensitivity to sertraline or to any of the other ingredients of the drug. Severe liver dysfunction; uncontrolled epilepsy. Concomitant use of monoamine oxidase inhibitors (MAOIs). Concomitant use of sertraline and pimozide is contraindicated.
Interaction with other medicinal products and other types of interactions
Contraindicated
Irreversible (non-selective) MAO inhibitors (selegiline).
Sertraline should not be used in combination with irreversible (non-selective) MAO inhibitors such as selegiline. Sertraline treatment may be initiated at least 14 days after discontinuation of irreversible (non-selective) MAO inhibitors. Sertraline treatment should be discontinued 7 days before treatment with irreversible (non-selective) MAO inhibitors.
Selective reversible MAO inhibitors (moclobemide).
Due to the risk of serotonin syndrome with concomitant treatment with sertraline and reversible selective MAO inhibitors such as moclobemide, this combination is not recommended. Sertraline treatment can be started at least 14 days after discontinuation of reversible (selective) MAO inhibitors. Sertraline treatment should be discontinued 7 days before treatment with reversible (selective) MAO inhibitors.
Non-selective reversible MAO inhibitors (linezolid)
The antibiotic linezolid is a weak, non-selective, reversible MAO inhibitor that should not be used in patients taking sertraline.
Serious adverse reactions have been reported in patients who have recently discontinued MAO inhibitors (e.g. methylene blue) and started taking sertraline or who have discontinued sertraline shortly before starting MAO inhibitors. The following adverse reactions have been observed: tremor; myoclonus; profuse sweating; nausea; vomiting; flushing; dizziness; hyperthermia, particularly similar to neuroleptic malignant syndrome; convulsions; and death.
Pimozide
In a single low-dose pimozide (2 mg) study, an increase in pimozide levels of approximately 35% was observed. This increase was not accompanied by any changes in ECG parameters. Although the mechanism of this interaction is unknown, concomitant use of sertraline and pimozide is contraindicated due to the narrow therapeutic range of pimozide.
Concomitant use with sertraline is not recommended.
CNS depressants, alcohol
Co-administration of sertraline 200 mg/day did not potentiate the effects of alcohol, carbamazepine, haloperidol, or phenytoin on cognitive and psychomotor performance in healthy subjects, but co-administration of sertraline with alcohol is not recommended.
Other serotonergic drugs
Caution is required when prescribing sertraline concomitantly with fentanyl (used primarily during general anesthesia and in the treatment of chronic pain), other serotonergic drugs (including other serotonergic antidepressants, triptans), and other opioids.
Special precautions for use
Lithium
In a study in healthy volunteers, co-administration of sertraline and lithium did not significantly alter the pharmacokinetics of lithium, but resulted in increased tremor compared to placebo, suggesting a possible pharmacodynamic interaction. Appropriate monitoring should be provided when sertraline and lithium are used concomitantly.
Phenytoin
Studies in healthy volunteers have shown that long-term administration of sertraline at a dose of 200 mg/day does not result in clinically significant inhibition of phenytoin metabolism. There is evidence of high phenytoin exposure in patients receiving sertraline; monitoring of phenytoin plasma concentrations is recommended during the initial phase of sertraline therapy with appropriate adjustment of the phenytoin dose. In addition, concomitant use of the drug with phenytoin may lead to a decrease in sertraline plasma concentrations. The possibility of a decrease in sertraline plasma levels under the influence of other CYP3A4 inducers, including phenobarbital, carbamazepine, St. John's wort, and rifampicin, cannot be excluded.
Triptans
There have been isolated reports of weakness, hyperreflexia, incoordination, confusion, anxiety and agitation when sertraline and sumatriptan are used concomitantly. Symptoms of serotonin syndrome may also occur with other drugs of the same class (triptans). If concomitant treatment with sertraline and triptans is clinically necessary, appropriate monitoring of the patient should be ensured.
Warfarin
Interaction with other drugs. Formal studies of the interaction of sertraline with other drugs have been conducted. Concomitant use of sertraline 200 mg per day and diazepam or tolbutamide resulted in minor but statistically significant changes in some pharmacokinetic parameters. Concomitant use with cimetidine causes a significant decrease in sertraline clearance. The clinical significance of this phenomenon is unknown. Sertraline does not affect the β-blocking properties of atenolol. No interaction was found with concomitant use of sertraline 200 mg per day and glibenclamide or digoxin.
Electroconvulsive therapy (ECT): There have been no studies on the risks or benefits of concomitant use of ECT and sertraline.
Drugs that affect platelet function
The risk of bleeding may be increased when selective serotonin reuptake inhibitors (SSRIs), including sertraline, are used concomitantly with medicinal products that affect platelet function (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid and ticlopidine) or other medicinal products that may increase the risk of bleeding.
Drugs metabolized by cytochrome P450
Sertraline may act as a weak to moderate inhibitor of the CYP2D6 isoenzyme. Long-term administration of sertraline at a dose of 50 mg/day resulted in a moderate increase (on average by 23-37%) in the steady-state plasma concentrations of desipramine (an indicator of CYP2D6 isoenzyme activity). Clinically significant interactions are possible with other CYP2D6 substrates with a narrow therapeutic range, such as class 1C antiarrhythmics, including propafenone and flecainide, tricyclic antidepressants, and typical antipsychotics, especially when sertraline is used in higher doses.
Sertraline is not a clinically significant inhibitor of CYP3A4, CYP2C9, CYP2C19 and CYP1A2 isoenzymes. This is supported by the results of in vivo drug interaction studies using CYP3A4 substrates (endogenous cortisol, carbamazepine, terfenadine, alprazolam), CYP2C19 substrate (diazepam) and CYP2C9 substrates (tolbutamide, glibenclamide and phenytoin). The results of in vitro studies indicate that sertraline has very little or no potential to inhibit CYP1A2.
Daily consumption of three glasses of grapefruit juice increased sertraline plasma levels by almost 100% in a cross-over study in healthy Japanese volunteers. Interactions with other CYP3A4 inhibitors have not been studied. Therefore, grapefruit juice should be avoided while taking sertraline.
Based on the results of the grapefruit juice interaction study, the possibility of a significantly greater increase in sertraline exposure cannot be excluded when co-administered with potent CYP3A4 inhibitors, including the protease inhibitors ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin and nefazodone. This also applies to moderate CYP3A4 inhibitors, such as aprepitant, erythromycin, fluconazole, verapamil and diltiazem. Potent CYP3A4 inhibitors should be avoided during sertraline therapy.
In CYP2C19 poor metabolizers, plasma levels of sertraline are increased by 50% compared to CYP2C19 extensive metabolizers. Drug interactions with potent CYP2C19 inhibitors such as omeprazole, lansoprazole, pantoprazole, rabeprazole, fluoxetine, fluvoxamine cannot be excluded.
Application features
Symptoms such as restlessness, agitation, panic attacks, insomnia, irritability, hostility, aggression, impulsivity, psychomotor restlessness, hypomania and mania have been observed in adults and children treated with antidepressants. These symptoms may precede the onset of suicidality. Consideration should be given to changing the therapeutic regimen or discontinuing Emoton if symptoms of depression worsen steadily, suicidality or symptoms of worsening suicidality occur. If a decision is made to discontinue treatment, the drug should be discontinued gradually as quickly as possible, but it should be remembered that abrupt discontinuation of treatment may be accompanied by a withdrawal syndrome. Before starting treatment, the patient should be examined to determine the risk of developing bipolar disorder. For this, a careful psychiatric history is collected, which includes a family history of suicide, bipolar disorder and depression. Emoton is not intended for the treatment of bipolar depression.
Syndromes that may be life-threatening, such as SSRIs or NMS, have been reported with SSRIs, including sertraline. The risk of SSRIs or NMS with SSRIs is increased by concomitant use of other serotonergic agents (including other serotonergic antidepressants, triptans and fentanyl) with agents that disrupt serotonin metabolism (including MAO inhibitors such as methylene blue), antipsychotics and other dopamine antagonists and opiates. Serotonin syndrome may include mental status changes (e.g. agitation, hallucinations, coma), autonomic nervous system disorders (tachycardia, blood pressure fluctuations, hyperthermia), neuromuscular disorders (hyperreflexia, incoordination) and/or gastrointestinal disorders (nausea, vomiting, diarrhoea). Some manifestations of serotonin syndrome, including hyperthermia, muscle rigidity, autonomic changes, and mental status changes, are similar to those of neuroleptic malignant syndrome. Patients should be monitored for symptoms of SS or CNS.
Switching from SSRIs, antidepressants, or anti-obsessional medications
There are limited data on the optimal timing of switching from SSRIs, antidepressants, or antiobsessional drugs to sertraline. Caution should be exercised when changing treatment, especially when switching to sertraline from long-acting drugs such as fluoxetine.
Other serotonergic agents, such as tryptophan, fenfluramine, and 5-HT agonists
The concomitant use of sertraline and other agents that enhance serotonergic neurotransmission, including tryptophan, fenfluramine, fentanyl, 5-HT agonists or herbal preparations containing St. John's wort (Hypericum perforatum), should be undertaken with caution and such combination therapy should be avoided (if possible) due to possible pharmacodynamic interactions.
Worsening of hypomania or mania
Exacerbation of mania/hypomania has been reported in a small percentage of patients treated with licensed antidepressants and anti-obsessional drugs, including sertraline. Therefore, sertraline should be used with caution in patients with a history of mania/hypomania. Close medical supervision is required. Sertraline should be discontinued if signs of a manic phase develop.
Schizophrenia
While taking the drug, psychotic symptoms may worsen in patients with schizophrenia.
Convulsions
Sertraline therapy may cause seizures: sertraline should not be prescribed to patients with unstable epilepsy; the use of sertraline in patients with controlled epilepsy requires careful supervision. Patients who develop seizures should discontinue the drug.
Suicide/suicidal thoughts/suicidal attempts or clinical signs of worsening
Patients with depression are at increased risk of suicidal ideation, self-harm and suicide attempts (suicidal acts and manifestations). This risk exists until significant remission is achieved. Since improvement may occur within the first few weeks or longer of therapy, patients should be closely monitored until such improvement occurs. Clinical experience suggests that the risk of suicide may be increased in the early stages of recovery.
Other psychiatric disorders for which sertraline is prescribed may also be associated with an increased risk of suicidal behaviour and suicidal thoughts. In addition, these conditions may be co-morbid with major depressive disorder. Therefore, similar precautions to those used in the treatment of patients with major depressive disorder should be taken when treating patients with other psychiatric disorders.
It is known that patients with a history of suicidal acts and manifestations, or patients who show a significant degree of suicidal ideation prior to initiation of therapy, are at greater risk of suicidal thoughts or suicide attempts during treatment, and should receive careful monitoring while taking the drug. A meta-analysis of data from studies of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behavior in patients under 25 years of age when using antidepressants compared with placebo.
Close monitoring of patients at high risk of suicide is indicated during treatment with Emoton, especially at the beginning of therapy and after any dose changes. Patients (and caregivers of patients) should be warned about the need to monitor for any signs of clinical worsening, the emergence of suicidal behavior or suicidal thoughts, as well as any unusual changes in behavior and to seek medical advice immediately if these symptoms present.
Sertraline should not be used in children and adolescents, except for patients with obsessive-compulsive disorder aged 6-17 years. In studies, suicidal behaviour (suicidal attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in children treated with antidepressants compared to patients treated with placebo. If, based on clinical need, a decision is nevertheless made in favour of prescribing this drug, careful monitoring for suicidal symptoms is necessary. In addition, only limited clinical evidence is available on the long-term safety of the drug in children and adolescents, including effects on growth, puberty, and cognitive and behavioural development. A few cases of growth retardation and puberty retardation have been reported. The clinical significance and causality are not yet established. During long-term therapy of pediatric patients, a doctor's supervision is necessary to detect deviations from the norm of the growth and development of the body.
Abnormal bleeding/hemorrhage
Cases of pathological haemorrhagic events, including cutaneous haemorrhagic events (ecchymoses and purpura), and other haemorrhagic events such as gastrointestinal or gynaecological haemorrhages, including fatal haemorrhages, have been reported with SSRIs. Caution is advised when SSRIs are used in patients, particularly when used concomitantly with medicinal products known to affect platelet function (e.g. anticoagulants, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and NSAIDs), and in patients with a history of haemorrhagic disorders.
Hyponatremia
Hyponatraemia may occur as a result of treatment with SSRIs or serotonin norepinephrine reuptake inhibitors (SNRIs), including sertraline. In many cases, hyponatraemia is the result of the syndrome of inappropriate antidiuretic hormone secretion. Serum sodium levels below 110 mmol/L have been reported. Elderly patients may be at greater risk of developing hyponatraemia with SSRIs and SNRIs. The risk of this complication may also be increased in patients taking diuretics or in patients with hypovolaemia from any other source. In patients with symptomatic hyponatraemia, discontinuation of sertraline therapy should be considered and appropriate treatment should be initiated. Symptoms of hyponatraemia include headache, difficulty concentrating, memory impairment, confusion, weakness and loss of balance, which may lead to falls. Symptoms associated with more severe and/or acute episodes of hyponatremia include hallucinations, syncope, seizures, coma, respiratory arrest, and death.
Withdrawal symptoms observed upon discontinuation of sertraline therapy
Withdrawal symptoms are common when treatment is stopped, especially if the drug is stopped abruptly. Studies have shown that the incidence of withdrawal reactions in patients who stopped taking sertraline was 23% compared with 12% in patients who continued to receive sertraline therapy.
The risk of developing a withdrawal syndrome may depend on several factors, including the duration of therapy, dosage and rate of dose reduction. The most commonly reported reactions were dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and vivid dreams), agitation or anxiety, nausea and/or vomiting, tremor and headache. These symptoms were generally mild to moderate in severity, but may be severe in some patients. They usually occur within the first few days after discontinuation of therapy, and in very rare cases, such symptoms have been observed in patients who accidentally missed a dose of the drug. In most cases, these symptoms resolve spontaneously within 2 weeks, although in some patients they may persist longer (2-3 months or more). Therefore, it is recommended that the dose of sertraline be gradually reduced when discontinuing therapy over a period of several weeks or months, according to the patient's needs.
Akathisia/psychomotor restlessness
Sertraline has been associated with the development of akathisia, a subjectively unpleasant or insatiable restlessness and need to move, often accompanied by an inability to sit or stand still. The risk of such complications is greatest during the first two weeks of therapy. In patients who develop these symptoms, increasing the dose may be harmful.
Sertraline is extensively metabolized in the liver. A multiple-dose pharmacokinetic study in patients with stable mild cirrhosis showed a prolongation of the half-life and an increase in AUC and Cmax approximately threefold compared to those in subjects with normal liver function. No significant differences in plasma protein binding were found between the two groups of subjects. Sertraline should be used with caution in patients with liver disease. When prescribing sertraline to patients with impaired liver function, consideration should be given to reducing the dose or frequency of administration. Sertraline should not be used in patients with severe hepatic impairment.
Kidney failure
Sertraline is extensively metabolized; urinary excretion of unchanged compound is a minor route of elimination. In studies involving patients with mild to moderate renal impairment (creatinine clearance 30-60 ml/min) or moderate to severe renal impairment (creatinine clearance 10-29 ml/min), pharmacokinetic parameters (AUC0-24 and Cmax) with multiple dosing were not statistically significantly different from those in the control group. No dose adjustment is necessary based on the degree of renal impairment.
Elderly patients
Studies have included over 700 elderly patients (aged > 65 years). The nature and frequency of adverse reactions in elderly patients were similar to those observed in younger patients.
However, the use of SSRIs and SNRIs, including sertraline, has been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk of developing this adverse event (see Hyponatremia in the Precautions section).
Diabetes mellitus
New cases of diabetes mellitus have been reported in patients treated with SSRIs, including sertraline. Loss of glycemic control, including both hyperglycemia and hypoglycemia, has been reported in patients with and without diabetes. Therefore, patients should be monitored for symptoms of changes in glucose levels. Patients with diabetes should be monitored particularly closely for changes in glucose levels, as the dosage of insulin and/or other oral hypoglycemic agents may need to be adjusted in such patients.
Electroconvulsive therapy (ECT)
Clinical trials investigating the risks or benefits of combined use of ECT and sertraline have not been conducted.
Grapefruit juice
Concomitant use of sertraline with grapefruit juice is not recommended.
Interaction with urine screening test
False-positive urine immunoassays for benzodiazepine metabolites have been reported in patients taking sertraline. False-positive results are due to the low specificity of this laboratory test and may persist for several days after discontinuation of sertraline treatment. Sertraline can be differentiated from benzodiazepine derivatives in urine by confirmatory tests such as gas chromatography/mass spectrometry.
Angle-closure glaucoma
SSRIs, including sertraline, may affect pupil size with mydriasis. This effect may lead to narrowing of the angle of the eye with subsequent increase in intraocular pressure and the development of angle-closure glaucoma, especially in patients with a corresponding predisposition. Sertraline should be used with caution in patients with angle-closure glaucoma and a history of glaucoma.
Sexual dysfunction
Selective serotonin reuptake inhibitors (SSRIs) and selective serotonin norepinephrine reuptake inhibitors (SSRIs) can cause sexual dysfunction. There have been reports of long-term sexual dysfunction, in which symptoms persisted despite discontinuation of SSRIs/SSRIs.
Use during pregnancy or breastfeeding
Pregnancy
There are no well-controlled studies in pregnant women. However, a substantial amount of data does not indicate any evidence of congenital malformations of the fetus due to sertraline use. Sertraline use during pregnancy has been reported to cause withdrawal-like symptoms in some newborns born to mothers who had taken sertraline. This phenomenon has also been observed with other SSRI antidepressants. Sertraline is not recommended for use during pregnancy unless the clinical condition of the woman is such that the expected benefits outweigh the potential risks.
Newborns should be observed closely following exposure to sertraline in late pregnancy, especially in the third trimester, as the following symptoms may occur in the newborn: respiratory distress syndrome, cyanosis, apnea, seizures, temperature instability, feeding difficulties, vomiting, hypoglycemia, hypertonia, hypotonia, hyperreflexia, tremor, hyperexcitability, irritability, lethargy/apathy, constant crying, drowsiness, and difficulty falling asleep. These symptoms may be secondary to other serotonergic effects or withdrawal symptoms. In most cases, these complications develop immediately after delivery or within the first 24 hours.
Epidemiological studies suggest that the use of SSRIs during pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension of the newborn. The risk associated with SSRI use is estimated to be approximately 5 cases per 1000 pregnancies. In the general population, the incidence of persistent pulmonary hypertension of the newborn is 1-2 cases per 1000 pregnancies.
Breast-feeding
Published data on sertraline levels in breast milk indicate that sertraline and its metabolite N-desmethylsertraline are excreted in breast milk in small amounts. In general, negligible or undetectable drug concentrations were found in the serum of infants, with the exception of one case where the drug concentration in the infant's serum was approximately 50% of the maternal serum concentration (but without any noticeable effect on the health of the infant). To date, no adverse effects of the drug on the health of infants breastfed by women taking sertraline have been reported, but such a risk cannot be excluded. The use of the drug during breastfeeding is not recommended unless, in the opinion of the physician, the benefit of taking the drug outweighs the possible risk.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies have shown that sertraline has no effect on psychomotor function. However, patients should be cautious because the drug may impair mental or physical reactions required for performing potentially hazardous tasks, such as driving or operating machinery.
Method of administration and doses
The drug Emoton is taken once a day (in the morning or evening).
The tablets can be taken regardless of food intake.
Starting treatment
Depression and OCD
Sertraline treatment should be initiated at a dose of 50 mg per day.
Panic Disorder, PTSD, and Social Anxiety Disorder
Treatment should be initiated at a dose of 25 mg per day. After 1 week, the dose should be increased to 50 mg once daily. This dosing regimen has been shown to reduce the incidence of early-stage side effects typical of panic disorder.
Dose titration
Depression, OCD, panic disorder, social anxiety disorder, and PTSD
In patients who do not respond to a dose of 50 mg, the effect may be achieved by increasing the dose. Dose adjustment should be initiated no earlier than 1 week of treatment, increasing it gradually by 50 mg at intervals of at least 1 week. The maximum dose should not exceed 200 mg per day. Dose adjustment should be carried out no more than 1 time per week, taking into account the half-life of sertraline, which is 24 hours.
The first signs of a therapeutic effect can be observed within 7 days of treatment. However, a longer period of time is usually required to achieve a therapeutic response, especially in patients with OCD.
Maintenance dose
Dosage during long-term therapy should be maintained at the lowest effective level with subsequent adjustment depending on the therapeutic response.
Depression
Long-term treatment can also be used to prevent recurrence of major depressive episodes (MDEs). In most cases, the recommended dose for prevention of recurrence of MDE is the same as the dose used during the treatment of that depressive episode. Patients with depression should receive treatment for a sufficient period of time, at least 6 months, to ensure complete resolution of symptoms.
Panic Disorders and OCD
With long-term use, patients with panic disorders and OCD should undergo regular evaluation of therapy, as the drug has not been demonstrated to be effective in preventing relapse of such disorders.
Use in children
Children with obsessive-compulsive disorder
The safety and efficacy of sertraline have been established for children aged 6 years and older. For children aged 6-12 years with obsessive-compulsive disorders, Emoton is used in an initial dose of 25 mg per day, for children aged 13-18 years - 50 mg per day, which is increased if necessary under the close supervision of a doctor, but not more often than once every 7 days. The maximum daily dose for adults and children is 200 mg. The course of treatment for primary disorders should last at least 6 weeks, and for relapses - at least 3-6 months.
The drug's effectiveness for children with major depressive disorder has not been demonstrated.
There are no data on the use of the drug in children under 6 years of age.
The drug should be used with caution in elderly patients due to the increased risk of developing hyponatremia.
Liver failure
Sertraline should be used with caution in patients with liver disease. In case of impaired liver function, the dose or frequency of administration should be reduced. Sertraline should not be used in patients with severe liver failure,
