Stimuloton film-coated pills 50mg N10
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Active ingredients
Sertraline
Release form
Pills
Composition
Table 1 contains: active ingredient: 50 mg sertraline (as 55.95 mg sertraline hydrochloride, respectively). excipients: magnesium stearate, hyprolose (hydroxypropylcellulose), sodium carboxymethyl starch (type A), calcium hydrogen phosphate dihydrate, microcrystalline cellulose. shell: macrogol 6000, titanium dioxide, hypromellose.
Pharmacological effect
Antidepressant. Selective serotonin reuptake inhibitor. It has little effect on the reuptake of norepinephrine and dopamine. In therapeutic doses, sertraline also blocks the seizure of serotonin by human platelets. It has no stimulating, sedative or anticholinergic effects. Sertralin has no affinity for the m-choline, serotonin, dopamine, histamine, adreno, GABA, and benzodiazepine receptors. With the use of Stimuloton there is no increase in body weight. The drug does not cause mental or physical drug dependence. The antidepressant effect is noted by the end of the second week of regular use of the drug, while the maximum effect is achieved only after 6 weeks.
Indications
- depression of various etiologies, incl. accompanied by anxiety (treatment and prevention). - obsessive-compulsive disorders, including in children over 6 years old. - panic disorders (with agoraphobia or without). - posttraumatic stress disorders.
Contraindications
- simultaneous use of MAO inhibitors and a period of 14 days after their cancellation. - unstable epilepsy. - age up to 18 years (due to the lack of sufficient clinical experience), with the exception of patients with obsessive-compulsive disorders. - pregnancy. - lactation period (breastfeeding). - hypersensitivity to the drug.
Use during pregnancy and lactation
Controlled results of the safety of using Stimuloton in pregnant women do not, therefore, the appointment during pregnancy is contraindicated. Women of reproductive age who are supposed to prescribe Stimoton. Should be advised to use effective contraceptive methods. Sertralin is excreted in breast milk.There is no reliable data on the safety of its use during lactation. If necessary, the appointment of Stimuloton during lactation breastfeeding should be discontinued.
Dosage and administration
The drug is administered orally, 1 time / day (morning or evening). Adults with depression and obsessive-compulsive disorders drug is prescribed in a dose of 50 mg 1 time / day. For panic disorders and post-traumatic stress disorders, to reduce the frequency and severity of side effects, it is recommended to start treatment with a dose of 25 mg 1 time / day and after a week increase it to 50 mg 1 time / day. With an unsatisfactory therapeutic response and good tolerability, the daily dose can be increased by 50 mg over several weeks to a maximum daily dose of 200 mg. Therapeutic effect is usually achieved within 7 days. However, for the full manifestation of the antidepressant action requires regular intake of the drug for 2-4 weeks. With obsessive-compulsive disorder, the therapeutic effect develops even more slowly. For maintenance therapy, a minimum effective dose should be prescribed. When obsessive-compulsive disorders in children aged 13 to 18 years, the drug is prescribed in the initial dose of 50 mg 1 time / day. For children aged 6 to 12 years, the drug is prescribed in an initial dose of 25 mg 1 time / day, after a week the daily dose can be increased to 50 mg. With an unsatisfactory therapeutic response, further dose can be increased weekly at 50 mg / day to a maximum daily dose of 200 mg. In order to avoid overdose with increasing doses of more than 50 mg / day, it should be borne in mind that the body weight in children is less than in adults. With prolonged maintenance therapy, the drug should be prescribed in the minimum effective dose. Elderly patients do not require dose adjustment. In patients with severely impaired liver function, the dose should be reduced or extended between intakes. In patients with impaired renal function, a special dose selection is not required.
Side effects
From the side of the central nervous system and peripheral nervous system: rarely - drowsiness, fatigue, dizziness, headache, tremor, insomnia, irritability, akathisia, hypomania, mania.As with the treatment with other antidepressants, reactions can be observed that are difficult to differentiate from the symptoms of the underlying disease, including paresthesia, hypesthesia, depression, hallucinations, agitation, aggressiveness, agitation, anxiety, psychosis. On the part of the digestive system: dry mouth, decreased appetite or increased appetite (possibly due to the elimination of depression). rarely - anorexia, stomach cramps, flatulence, or pain, unstable stools, diarrhea, dyspepsia, nausea, vomiting. Since the cardiovascular system: rarely - the heartbeat. On the part of metabolism: weight loss. From the hemopoietic system: bleeding (including epistaxis). From the senses: rarely - visual impairment (including blurred vision). On the part of the reproductive system: rarely - dysmenorrhea, impaired sexual function (delayed ejaculation, decreased potency and / or libido, anorgasmia). Dermatological reactions: rarely - hyperemia of the skin or "flushing" of blood to the face, increased sweating. On the part of laboratory parameters: in some cases (0.8%) - asymptomatic increase in ACT and ALT (these changes were observed during the first 9 weeks of taking the drug and stopped immediately after it was canceled). there are reports of reversible hyponatremia (presumably this phenomenon is associated with the syndrome of insufficient secretion of ADH, since it was observed mainly in elderly patients receiving concomitant diuretics simultaneously or other drugs). Other: rarely - allergic reactions, yawning. in some cases, discontinuation of the drug causes withdrawal syndrome. Sometimes (causation with the drug has not been reliably established) - motor disorders (extrapyramidal symptoms and gait disturbances), convulsions, menstrual disorders, hyperprolactinemia, galactorrhea, skin rash (rarely - erythema multiforme), itching. In most cases, motor impairment was observed in patients taking concomitant antipsychotics (neuroleptics), as well as with a long history of motor impairment.
special instructions
From the side of the central nervous system and peripheral nervous system: rarely - drowsiness, fatigue, dizziness, headache, tremor, insomnia, irritability, akathisia, hypomania, mania.As with the treatment with other antidepressants, reactions can be observed that are difficult to differentiate from the symptoms of the underlying disease, including paresthesia, hypesthesia, depression, hallucinations, agitation, aggressiveness, agitation, anxiety, psychosis. On the part of the digestive system: dry mouth, decreased appetite or increased appetite (possibly due to the elimination of depression). rarely - anorexia, stomach cramps, flatulence, or pain, unstable stools, diarrhea, dyspepsia, nausea, vomiting. Since the cardiovascular system: rarely - the heartbeat. On the part of metabolism: weight loss. From the hemopoietic system: bleeding (including epistaxis). From the senses: rarely - visual impairment (including blurred vision). On the part of the reproductive system: rarely - dysmenorrhea, impaired sexual function (delayed ejaculation, decreased potency and / or libido, anorgasmia). Dermatological reactions: rarely - hyperemia of the skin or "flushing" of blood to the face, increased sweating. On the part of laboratory parameters: in some cases (0.8%) - asymptomatic increase in ACT and ALT (these changes were observed during the first 9 weeks of taking the drug and stopped immediately after it was canceled). there are reports of reversible hyponatremia (presumably this phenomenon is associated with the syndrome of insufficient secretion of ADH, since it was observed mainly in elderly patients receiving concomitant diuretics simultaneously or other drugs). Other: rarely - allergic reactions, yawning. in some cases, discontinuation of the drug causes withdrawal syndrome. Sometimes (causation with the drug has not been reliably established) - motor disorders (extrapyramidal symptoms and gait disturbances), convulsions, menstrual disorders, hyperprolactinemia, galactorrhea, skin rash (rarely - erythema multiforme), itching. In most cases, motor impairment was observed in patients taking concomitant antipsychotics (neuroleptics), as well as with a long history of motor impairment.