Serenata pills 100mg №30

Indications

- Depression of various etiologies (treatment and prevention);

- obsessive compulsive disorder (OCD);

- panic disorder (with or without agoraphobia);

- posttraumatic stress disorder (PTSD).

Dosage and administration

For adults at depression and OCD the drug is prescribed in the initial dose of 50 mg 1 time per day in the morning or in the evening. The daily dose can be gradually increased, not earlier than in a week, from 50 mg to a maximum daily dose of 200 mg.

At panic disorders and PTSD the initial dose is 25 mg 1 time per day in the morning or evening. After a week, you can increase the dose to 50 mg 1 time / day, and then gradually, not earlier than in a week, the daily dose can be increased from 50 mg to a maximum daily dose of 200 mg.

A satisfactory therapeutic result is usually achieved after 7 days from the start of treatment. However, to achieve the full therapeutic effect requires regular intake of the drug for 2-4 weeks. At OCD treatment it may take 8-12 weeks to achieve a good result. The minimum dose that provides a therapeutic effect is further maintained as a maintenance.

For children at OCD drug is prescribed depending on age. For children aged 6 to 12 years the initial dose is 25 mg 1 time per day in the morning or evening.A week later, the dose can be increased to 50 mg 1 time / day. For children and adolescents aged 12 to 17 years the initial dose is 50 mg 1 time / day, in the morning or in the evening. The daily dose can be gradually increased, not earlier than in a week, from 50 mg to a maximum daily dose of 200 mg. To avoid overdose, you should take into account the lower body weight in children compared with adults and with increasing doses of more than 50 mg / day, it is necessary to carefully monitor this category of patients and at the first sign of overdose to cancel the drug.

Have elderly patients no special dose selection is required.

At severe liver dysfunction dose of the drug should be reduced or increased the intervals between doses.

Have patients with impaired renal function no special dose selection is required.

Side effect

Gastrointestinal: dry mouth, decreased appetite (rarely, increased), up to anorexia, dyspeptic disorders (flatulence, nausea, vomiting, diarrhea), abdominal pain; with prolonged use in 0.8% of cases - asymptomatic increase in the activity of transaminases in the blood serum (with the abolition of the drug, the activity of enzymes normalizes).

Nervous system: drowsiness, headache, dizziness, tremor, insomnia, anxiety, agitation, hypomania, mania, gait disturbances, weakness. During sertraline treatment extrapyramidal disorders, dyskinesias, tremors, convulsions, visual disturbances were noted.Movement disorders were more frequently observed in patients with indications of their presence in history or with the concomitant use of antipsychotics.

On the part of the endocrine system: ejaculation disorders, decreased libido, menstrual disorders, hyperprolactinemia, galactorrhea.

Metabolism: increased sweating, weight loss; 0.8% (more often in elderly patients, as well as when taking diuretics or a number of other drugs) - transient hyponatremia (this side effect is associated with the syndrome of inadequate secretion of ADH).

Dermatologic: skin redness, skin rash; rarely erythema multiforme.

When discontinuing treatment: rarely, withdrawal syndrome: paresthesia, hypostezia, depression symptoms, hallucinations, aggressive reactions, psychomotor agitation, anxiety or psychosis symptoms that cannot be distinguished from the symptoms of the underlying disease are possible.

Contraindications

- unstable epilepsy;

- children's age up to 6 years;

- pregnancy;

- lactation period;

- the combined use of sertraline and MAO inhibitors (when replacing one drug with another one should refrain from taking antidepressants for 14 days);

- combined use of sertraline with tryptophan or fenfluramine;

- hypersensitivity to the drug.

WITH caution should use the drug for organic brain diseases (includingwith mental retardation), manic states, epilepsy, liver and / or kidney failure, weight loss.

Use during pregnancy and lactation

Adequate and strictly controlled clinical studies of the safety of the drug Serenat during pregnancy were not conducted. Administration of the drug to pregnant women is contraindicated.

Women of reproductive agewho are supposed to undergo treatment with Serenata should use effective methods of contraception.

Sertralin is excreted in breast milk. Reliable data on the safety of sertraline during lactation are not available. Therefore, if necessary, the appointment of the drug breastfeeding should be discontinued.

Application for violations of the liver

At severe liver dysfunction dose of the drug should be reduced or increased the intervals between doses.

Application for violations of kidney function

Have patients with impaired renal function no special dose selection is required.

Use in children

The drug is contraindicated in children under 6 years.

The drug should be used with caution in children over the age of 6 years.

For children at OCD drug is prescribed depending on age. For children aged 6 to 12 years the initial dose is 25 mg 1 time per day in the morning or evening. A week later, the dose can be increased to 50 mg 1 time / day. For children and adolescents aged 12 to 17 years the initial dose is 50 mg 1 time / day, in the morning or in the evening. The daily dose can be gradually increased, not earlier than in a week, from 50 mg to a maximum daily dose of 200 mg. To avoid overdose, you should take into account the lower body weight in children compared with adults and with increasing doses of more than 50 mg / day, it is necessary to carefully monitor this category of patients and at the first sign of overdose to cancel the drug.

Use in elderly patients

Have elderly patients no special dose selection is required.

special instructions

Sertralin should not be prescribed for 14 days after stopping treatment with MAO inhibitors. MAO inhibitors are not prescribed for 14 days after discontinuation of sertraline.

Patients receiving electroconvulsive therapy lack sufficient experience with the use of the drug Serenat. The possible success or risk of such a combination treatment has not been studied.

Depressed patients are at risk of suicidal attempts. This danger persists until the development of remission. Therefore, from the start of treatment and until the optimum clinical effect is achieved, patients should be provided with constant medical supervision.

With the simultaneous use of the drug Serenat and drugs that have a depressant effect on the central nervous system, special care and careful monitoring of the patient’s condition are required.

Use in pediatrics

The drug should be used with caution in children over the age of 6 years.

Alcohol is prohibited during treatment.

Influence on ability to drive motor transport and control mechanisms

The purpose of sertraline, as a rule, is not accompanied by a violation of psychomotor functions. However, its use simultaneously with other drugs can lead to impaired attention and coordination of movements. Therefore, it is not recommended to drive vehicles, special equipment or engage in activities associated with increased risk during treatment with sertraline.

Overdose

Symptoms: severe symptoms of sertraline overdose have not been identified even with the administration of the drug in high doses. However, when taken with other drugs or ethanol, severe poisoning can occur. An overdose can cause serotonin syndrome with nausea, vomiting, drowsiness, tachycardia, agitation, dizziness, psychomotor agitation, diarrhea, sweating, myoclonus and hyperreflexia.

Treatment: there are no specific antidotes. Requires intensive supportive care and constant monitoring of vital body functions. Vomiting is not recommended. The introduction of Activated carbon may be more effective than gastric lavage. It is necessary to maintain airway patency. Sertraline big v_dtherefore, an increase in diuresis, dialysis, hemoperfusion, or blood transfusion may be ineffective.

Drug interaction

With simultaneous use of the drug Serenat and MAO inhibitors, both selectively acting (selegilin) ​​and with a reversible type of action (moclobemide), serious complications may develop, including serotonin syndrome. Similar complications, sometimes fatal, occur when prescribing MAO inhibitors during treatment with antidepressants that suppress the neuronal uptake of monoamines or immediately after their withdrawal. With simultaneous use of selective serotonin reuptake neuronal inhibitors and MAO inhibitors, hyperthermia, rigidity, myoclonus, lability of the autonomic nervous system (rapid fluctuations in the parameters of the respiratory and cardiovascular systems), changes in mental status, including increased irritability, marked arousal, confusion, which in some cases can go into a delirious state or to whom.

With the joint appointment of coumarin derivatives and sertraline, a significant increase in prothrombin time is noted (it is recommended to monitor the prothrombin time at the beginning of treatment with Serenata and after its withdrawal).

Pharmacokinetic interaction

Sertralin binds to plasma proteins . Therefore, it is necessary to consider the possibility of its interaction with other drugs that bind to proteins (for example, diazepam, tolbutamide and warfarin).

With simultaneous use with cimetidine, a significant decrease in sertraline clearance is observed. With prolonged treatment with sertraline at a dose of 50 mg / day in the case of simultaneous use, an increase in plasma concentration of desipramine is observed, which is metabolized with the participation of the CYP2D6 isoenzyme.

In experimental studies on the study of drug interactions in vitro, it was shown that metabolic processes occurring with the participation of CYP3A3 / 4 isoenzymes - beta-hydroxylation of endogenous cortisol and Carbamazepine and terfenadine metabolism - do not change with long-term administration of sertraline at a dose of 200 mg / day. The concentration in plasma of tolbutamide, phenytoin and Warfarin with the prolonged administration of sertraline in the same dose also does not change. Thus, it can be concluded that sertraline does not inhibit the activity of the CYP2C9 isoenzyme.

Sertralin does not affect the concentration of diazepam in the serum, which indicates the absence of inhibition of the CYP2C19 isoenzyme.

According to in vitro studies, sertraline has virtually no effect or is minimally inhibited by the CYP1A2 isoenzyme.

The pharmacokinetics of lithium do not change with simultaneous use of sertraline, but in such cases tremor is more common. As well as the appointment of other selective serotonin reuptake neuronal inhibitors, the combined use of sertraline with drugs that affect serotonergic transmission (for example, with lithium) requires increased caution. When replacing one inhibitor of neuronal seizure of serotonin with another, there is no need for a “laundering period”.However, care is required when changing the course of treatment.

Co-administration of tryptophan or fenfluramine with sertraline should be avoided.

Sertralin causes minimal induction of liver microsomal enzymes. The simultaneous appointment of sertraline and antipyrine at a dose of 200 mg leads to a significant decrease in T_1/2 antipyrine, although it occurs in just 5% of cases.

With simultaneous use of sertraline does not alter the beta-adrenoceptor blocking effect of Atenolol .

With simultaneous use of sertraline at a dose of 200 mg / day with glibenclamide or Digoxin , drug interaction was not detected.

Terms and conditions of storage

The drug should be kept out of the reach of children, at a temperature below 25 ° C.