Pharmacological properties
Pharmacodynamics. Sertraline is a potent and specific inhibitor of serotonin uptake in vitro, which in the animal body leads to potentiation of the effects of 5-nt. Sertraline has only a very weak effect on the processes of noradrenaline and dopamine reuptake. In therapeutic doses, sertraline blocks the uptake of serotonin in human platelets. The drug does not have a stimulating, sedative, anticholinergic or cardiotoxic effect in animal experiments. During the use of the drug, sertraline did not have a sedative effect and did not affect psychomotor functions. Due to the 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 does not cause drug dependence. In human studies of the comparative abuse potential of sertraline, alprazolam, and D-amphetamine, sertraline did not produce positive subjective effects indicative of abuse potential. In contrast, subjects treated with both alprazolam and D-amphetamine had statistically significantly higher rates of abuse, euphoria, and drug dependence than subjects treated with 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 50-200 mg is dose-dependent. During 14 days of oral administration of sertraline 50-200 mg (orally 1 time per day), the peak concentration of sertraline in the blood plasma is reached 4.5-8.4 hours after daily administration of the drug. Food does not significantly change the bioavailability of sertraline in capsules / tablets.
Distribution: Approximately 98% of circulating sertraline is bound to plasma proteins.
Biotransformation: Sertraline undergoes extensive first-pass metabolism in the liver.
Elimination. The average T ½ of sertraline is about 26 hours (in the range of 22-36 hours). According to the terminal T ½, cumulation of the drug (with an increase in its level by about 2 times) is noted when reaching equilibrium concentrations, which are detected after using the drug in a dose of 1 time per day for 1 week. T ½ of N-desmethylsertraline is 62-104 hours. Sertraline and N-desmethylsertraline are intensively metabolized in the human body, their final metabolites are excreted in feces and urine in equal amounts. Only a very small part (0.2%) of sertraline is excreted in urine in unchanged form.
Pharmacokinetics in specific patient groups
Children with obsessive-compulsive disorder (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 a dose of 25 or 50 mg. Tolerability was similar at 25 and 50 mg. At steady state, plasma sertraline concentrations in children aged 6-12 years 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. Thus, for the use of the drug in children, especially those with low body weight, a low initial dose is recommended and its increase during titration in 25 mg increments. The same doses as for adults can be used for adolescents.
Adolescents and elderly patients: The pharmacokinetic profile of sertraline in adolescents and elderly patients does not differ significantly from that in adults aged 18-65 years.
Hepatic impairment: In patients with hepatic impairment, sertraline T½ is prolonged and AUC is increased 3-fold (see Dosage and Administration and Precautions).
Renal impairment: No significant accumulation of sertraline was observed in patients with moderate or severe renal impairment.
Indication
Major depressive episodes (MDEs). Preventing recurrence of MDEs;
panic disorders with or without agoraphobia;
OCD in adults and children aged 6-17 years;
social anxiety disorder; post-traumatic stress disorder (PTSD).
Application
Emoton is used once a day inside in the morning or evening. Capsules / tablets are taken regardless of meals.
start of treatment
Depression and OCD: Sertraline treatment should be initiated at a dose of 50 mg/day.
Panic disorder, PTSD and social anxiety disorder. Treatment should be initiated at a dose of 25 mg/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.
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 started no earlier than after 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/day. Dose adjustment should be carried out no more often than once a week, taking into account the T ½ of sertraline, which is 24 hours.
The first signs of a therapeutic effect may be observed within 7 days of treatment. However, a longer period is usually required to achieve a therapeutic response, especially in patients with OCD.
Maintenance dose. The dose during long-term therapy should be maintained at the minimum effective level, after which it is prescribed depending on the therapeutic response.
Depression. Long-term therapy may also be used to prevent relapse of BDE. In most cases, the recommended dose for the prevention of relapse of BDE is the same as the dose used during treatment for the current 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 in patients with panic disorder and OCD, regular evaluation of therapy should be carried out, as the drug has not been shown to be effective in preventing relapse of such disorders.
Use in children
Children with OCD. The safety and efficacy of sertraline have been established for children aged 6 years and older. In children aged 6-12 years with OCD, Emoton is used in an initial dose of 25 mg/day, 13-18 years - 50 mg/day, which is increased if necessary under the supervision of a physician, 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.
Elderly patients: The drug should be used with caution in elderly patients, given the increased risk of developing hyponatremia.
Hepatic impairment. Sertraline should be used with caution in patients with liver disease. In cases of impaired liver function, the dose or frequency of administration should be reduced. Sertraline should not be used in patients with severe hepatic impairment, as there are no clinical data on the use of the drug in such patients.
Renal failure. In case of impaired renal function, dose adjustment of the drug is not required.
Withdrawal symptoms observed when stopping sertraline therapy. Abrupt discontinuation of the drug should be avoided. When stopping treatment with sertraline, in order to reduce the risk of developing withdrawal reactions, the dose should be gradually reduced over at least 1-2 weeks. If severe symptoms appear after reducing the dose of the drug or discontinuing its use, resuming the drug at the previously prescribed dose may be considered. In the future, the doctor may continue to reduce the dose, but more gradually.
Contraindication
Hypersensitivity to sertraline or to any of the other ingredients of the drug. Severe liver dysfunction; Uncontrolled epilepsy. Concomitant use of MAO inhibitors. Concomitant use of sertraline and pimozide is contraindicated.
Side effects
The most common side effect is nausea. Sexual dysfunction (ejaculation disorders) has been reported in men treated with sertraline for social anxiety disorder. These side effects are dose-dependent and often resolve on their own with continued therapy.
Infections and infestations: pharyngitis, upper respiratory tract infections, rhinitis, diverticulitis, gastroenteritis, otitis media.
Neoplasms benign and malignant (including cysts and polyps): neoplasm (one case reported in one patient receiving sertraline compared to no such cases in the placebo group).
From the blood system: lymphadenopathy, leukopenia, thrombocytopenia.
Immune system disorders: hypersensitivity reactions, anaphylactoid reaction, allergy.
On the part of the endocrine system: hyperprolactinemia, hypothyroidism and syndrome of inappropriate secretion of antidiuretic hormone.
Metabolic: decreased appetite, increased appetite, hypercholesterolemia, hypoglycemia, hyponatremia, hyperglycemia.
Nervous system: dizziness, drowsiness, headache, paresthesia, tremor, hypertonia, dysgeusia, disturbance in attention, convulsions, involuntary muscle contractions, impaired coordination of movements, hyperkinesia, amnesia, hypoesthesia, speech disorders, postural dizziness, fainting, headache, coma, choreoathetosis, dyskinesia, hypoesthesia, sensory disturbances, movement disorders (including extrapyramidal symptoms, including hyperkinesia, hypertonia, jaw spasms or gait disturbances). Symptoms of serotonin syndrome or neuroleptic malignant syndrome have also been reported, in some cases associated with concomitant use of serotonergic agents, including agitation, confusion, hyperhidrosis, diarrhea, fever, hypertension, rigidity, tachycardia, akathisia, psychomotor agitation, and cerebral vasospasm (including transient cerebral vasoconstriction syndrome or Coll-Fleming syndrome).
From the organ of vision: visual impairment, glaucoma, lacrimation disorders, scotoma, diplopia, photophobia, hyphema, mydriasis, visual impairment, pupils of different sizes.
On the part of the organ of hearing: ringing in the ears, ear pain.
Cardiovascular system: palpitations, tachycardia, myocardial infarction, bradycardia, cardiac disorders, hot flashes, hypertension, hyperemia, peripheral ischemia, hematuria, pathological hemorrhagic phenomena (such as gastrointestinal bleeding).
From the respiratory system: yawning, bronchospasm, dyspnea, epistaxis, laryngospasm, hyperventilation, hypoventilation, stridor, dysphonia, hiccups, interstitial lung disease.
Gastrointestinal tract: diarrhea, nausea, dry mouth, abdominal pain, vomiting, constipation, dyspepsia, flatulence, esophagitis, dysphagia, hemorrhoids, hypersalivation, language changes, belching, melena, hematochezia, stomatitis, tongue ulcers, dental pathology, glossitis, oral mucosal ulcers, pancreatitis.
Hepatobiliary system: liver dysfunction, hepatic failure, which can rarely be fatal, fulminant hepatitis, necrotizing hepatitis, cholestatic jaundice.
Skin: rash, hyperhidrosis, periorbital edema, purpura, alopecia, cold sweat, dry skin, urticaria, dermatitis, bullous dermatitis, vesicular eruptions, abnormal hair texture, unusual skin odor; isolated cases of severe skin adverse reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, angioedema, facial edema, photosensitivity, skin reactions have been reported.
Musculoskeletal system: myalgia, osteoarthritis, muscle weakness, back pain, muscle twitching, bone lesions, arthralgia, muscle spasms.
From the urinary system: nocturia, urinary retention, polyuria, pollakiuria, urination disorders, oliguria, urinary incontinence, difficulty starting urination.
Reproductive system: ejaculation disorder, sexual dysfunction, vaginal bleeding, female sexual dysfunction, menorrhagia, atrophic vulvovaginitis, balanoposthitis, genital discharge, priapism, galactorrhea, gynecomastia.
General disorders: increased fatigue, chest pain, general malaise, peripheral edema, chills, pyrexia, asthenia, thirst, hernia, decreased drug tolerance, gait disturbance.
Laboratory indicators: increased ALT and AST levels, weight loss/gain, impaired sperm quality, abnormal clinical laboratory test results, changes in platelet function, increased cholesterol levels in the blood.
Injury and poisoning: trauma.
Surgical interventions and medical procedures: vasodilation.
If an adverse event was reported in patients with depression, OCD, panic disorder, PTSD, and social anxiety disorder, the terms used to describe the adverse event were reclassified according to the terms used for patients with depression.
Withdrawal syndrome that occurs when sertraline therapy is discontinued. Discontinuation of sertraline therapy (especially if the drug is discontinued abruptly) usually leads to the development of withdrawal symptoms. The most commonly reported adverse reactions are dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and vivid dreams), agitation or anxiety, nausea and/or vomiting, tremor and headache. These adverse reactions are usually mild to moderate and self-limiting, but may be severe and/or persistent in some patients. Therefore, when sertraline therapy is no longer required, gradual discontinuation by dose tapering is recommended.
Use in children: In over 600 children treated with sertraline, the overall adverse reaction profile was generally similar to that observed in studies involving adult patients. The following adverse reactions have been reported in studies: headache, insomnia, diarrhea, nausea, chest pain, mania, pyrexia, vomiting, loss of appetite, affective lability, aggression, agitation, nervousness, disturbance in attention, dizziness, hyperkinesia, migraine, drowsiness, tremor, visual disturbances, dry mouth, dyspepsia, nightmares, fatigue, urinary incontinence, rash, acne, epistaxis, flatulence, prolongation of the QT interval on the ECG, suicide attempts, seizures, extrapyramidal disorders, paresthesia, depression, hallucinations, purpura, hyperventilation, anemia, abnormal liver function, increased ALT levels, cystitis, herpes simplex, otitis externa, ear pain, eye pain, mydriasis, malaise, hematuria, pustular rashes, rhinitis, trauma, weight loss, muscle twitching, unusual dreams, apathy, albuminuria, pollakiuria, polyuria, breast pain, menstrual irregularities, alopecia, dermatitis, skin lesions, unusual skin odor, urticaria, bruxism, flushing, enuresis.
Class-specific effects. Epidemiological studies, mainly conducted in patients aged 50 years and older, have shown an increased risk of bone fractures in patients treated with SSRIs and tricyclic antidepressants. The mechanism underlying the increased risk of cancer is unknown.
Special instructions
Symptoms such as restlessness, agitation, panic attacks, insomnia, irritability, hostility, aggression, impulsivity, psychomotor agitation, hypomania and mania have been reported in adults and children taking 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 increased suicidality develop. 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 therapy may be accompanied by 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, including a family history of suicide, bipolar disorder and depression. Emoton is not intended for the treatment of bipolar depression.
Serotonin syndrome (SS) or neuroleptic malignant syndrome (NMS). With the use of SSRIs, including sertraline therapy, the development of syndromes that can be life-threatening, such as SSRIs or NMS, has been reported. The risk of developing SSRIs or NMS with SSRIs is increased by the simultaneous use of serotonergic agents (including other serotonergic antidepressants, triptans and fentanyl) with agents that disrupt serotonin metabolism (including MAO inhibitors, e.g. methylene blue), antipsychotics and other dopamine antagonists. SS may include mental status changes (e.g. agitation, hallucinations, coma), autonomic disturbances (tachycardia, blood pressure fluctuations, hyperthermia), neuromuscular disturbances (hyperreflexia, incoordination) and/or gastrointestinal disturbances (nausea, vomiting, diarrhoea). Some manifestations of SS, including hyperthermia, muscle rigidity, autonomic changes, and mental status changes, are similar to those of ALS. Patients should be monitored for signs and symptoms of SS or ALS.
Switching from SSRIs, antidepressants, or anti-obsessional drugs: There is limited research evidence on the optimal timing of switching from SSRIs, antidepressants, or anti-obsessional drugs to sertraline. Caution should be exercised when switching from SSRIs, antidepressants, or anti-obsessional drugs to sertraline, especially when switching 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, such as 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 the potential for pharmacodynamic interactions).
Exacerbation of hypomania or mania. Exacerbation of symptoms of mania/hypomania has been reported in a small number of patients treated with licensed antidepressants and antiobsessional 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.
Suicide/suicidal thoughts/suicidal attempts or clinical signs of worsening. Patients with depression are at increased risk of suicidal thoughts, self-harm and suicide attempts (suicidal acts and manifestations). This risk exists until significant remission is achieved. Since improvement may occur during 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 ideation. In addition, these conditions may coexist with major depressive disorder. Therefore, similar measures taken in the treatment of patients with major depressive disorder should be considered in the treatment of patients with other psychiatric disorders.
It is known that patients with a history of suicidal acts and manifestations, or patients who have a significant degree of suicidal thinking before the start of therapy, are at greater risk of suicidal thoughts or suicide attempts during treatment, and therefore they should be monitored while taking the drug. A meta-analysis of data obtained from studies on the use of antidepressants in adult patients with mental disorders suggests an increased risk of suicidal behavior when using antidepressants compared with placebo.
Close monitoring of patients at high risk of suicidality is indicated when using 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 help immediately if these symptoms develop.
Use in children. Sertraline should not be used in children, except for patients with OCD aged 6-17 years. In clinical trials, suicidal behaviour (suicidal attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently reported in children treated with antidepressants than in patients treated with placebo. If, based on clinical need, a decision is nevertheless made in favour of prescribing this drug, careful monitoring for signs of suicidal symptoms is necessary. In addition, long-term safety data in children regarding the effects of treatment on their growth, maturation, and cognitive and behavioural development are lacking. A few cases of delayed growth and puberty have been reported. The clinical significance and causality are not yet established. With long-term therapy of pediatric patients, a doctor's supervision is necessary to identify deviations from the norm of the growth and development of the body.
Abnormal bleeding/hemorrhages: Cases of abnormal cutaneous bleeding, such as ecchymoses and purpura, and other bleeding, such as gastrointestinal or gynaecological bleeding, 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 non-steroidal anti-inflammatory drugs), as well as in patients with a history of bleeding disorders.
Hyponatraemia. Hyponatraemia may develop as a result of treatment with SSRIs or SNRIs, including sertraline. In many cases, hyponatraemia is the result of the syndrome of inappropriate antidiuretic hormone secretion. Plasma sodium levels of 110 mmol/L have been reported. Elderly patients may be at greater risk of developing hyponatraemia when taking SSRIs and SNRIs. The risk of this complication may also be increased in patients taking diuretics or in those 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 physical balance, which may lead to falls. Symptoms associated with more severe and/or acute episodes of hyponatremia include hallucinations, fainting, seizures, coma, respiratory arrest, and death.
The risk of developing a withdrawal syndrome may depend on several factors, including the duration of therapy, the dose and the 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. In general, these symptoms were mild to moderate in severity, but in some patients they may be severe. They usually occur within the first few days after discontinuation of therapy, and very rarely such symptoms have been observed in individuals 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 with the drug 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, which is characterized by 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 highest during the first 2 weeks of therapy. In patients who develop these symptoms, increasing the dose may be harmful.
Hepatic impairment. Sertraline is extensively metabolized in the liver. In a multiple-dose pharmacokinetic study, patients with stable mild cirrhosis had a prolonged T½ and an approximately three-fold increase in AUC and Cmax compared to those with normal liver function. There was no significant difference in plasma protein binding between the two groups. 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.
Renal impairment. 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 (AUC 0-24 and C max) after 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: Clinical 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 higher 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 individuals with and without diabetes. Therefore, patients should be monitored for signs and symptoms of changes in blood glucose levels. Patients with diabetes mellitus should be closely monitored for changes in glucose levels, as their dose of insulin and/or other oral hypoglycemic agents may need to be adjusted.
Electroconvulsive therapy (ECT): There have been no clinical studies investigating the risks or benefits of the combined use of ECT and sertraline.
Grapefruit juice. Concomitant use of sertraline with grapefruit juice is not recommended.
Interaction with urine screening tests. 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 occur for several days after discontinuation of sertraline treatment. Sertraline can be differentiated from benzodiazepines in urine by performing confirmatory tests such as gas chromatography/mass spectrometry.
Glaucoma. SSRIs, including sertraline, may affect pupil size with the development of mydriasis. This effect may lead to narrowing of the angle of the eye with subsequent increase in intraocular pressure and the development of glaucoma, especially in individuals with a corresponding predisposition. Sertraline should be used with caution in patients with angle-closure glaucoma and a history of glaucoma.
Pregnancy. There are no well-controlled studies in pregnant women. However, a large body of data does not provide evidence of congenital malformations 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 reported 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.
Women of reproductive age should use appropriate contraception when using sertraline.
Newborns should be observed if the mother continues to use sertraline late in pregnancy, especially in the third trimester. After the use of sertraline in late pregnancy, the following symptoms may occur in newborns: respiratory distress syndrome, cyanosis, apnea, seizures, temperature instability, feeding difficulties, vomiting, hypoglycemia, hypertonia, hypotonia, hyperreflexia, tremor, hyperexcitability syndrome, irritability, lethargy/apathy, constant crying, drowsiness and difficulty falling asleep. These symptoms may be due to other serotonergic effects or withdrawal symptoms. In most cases, these complications develop immediately after delivery or in the near future (within less than 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.
Breastfeeding. 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 plasma of newborns, with the exception of one case where the plasma concentration of the newborn was about 50% of the concentration of the drug in the mother's serum (but without any noticeable health effects for this newborn). To date, adverse effects on the health of children 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 doctor, the benefits of taking the drug outweigh the possible risks.
Children: Sertraline should not be used to treat children, except for children 6 years of age and older with OCD.
Ability to influence the reaction rate when driving vehicles or operating other mechanisms. Studies indicate that sertraline has no effect on psychomotor functions. However, patients should be careful, as the drug may impair mental or physical reactions required for performing potentially dangerous tasks, such as driving vehicles or operating other mechanisms.
Interactions
contraindicated
Irreversible MAO inhibitors (e.g. 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 inhibitor (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 MAO inhibitors of reversible action (linezolid). The antibiotic linezolid is a weak non-selective MAO inhibitor of reversible action, should not be used
