Serenata, 100 mg 30 pcs

An antidepressant. Selective serotonin reuptake inhibitor (5-NT).

Serenata has a weak effect on norepinephrine and dopamine reuptake.

In therapeutic doses, sertraline blocks serotonin uptake by human platelets.

Sertraline has no affinity for muscarinic, serotoninic, dopamine, adrenergic, histamine, GABA- or benzodiazepine receptors.

Does not have stimulant, sedative or anticholinergic effects.

Indications

– depression of various etiologies (treatment and prevention);

– obsessive-compulsive disorder (OCD);

– panic disorder (with or without agoraphobia);

– post-traumatic stress disorder (PTSD).

Active ingredient

Sertraline

Composition

1 tablet contains sertraline (in hydrochloride form) 100 mg.

How to take, the dosage

Ingestion. Adults Serenata is administered in an initial dose of 50 mg once daily in the morning or evening. The daily dose may be gradually increased from 50 mg to a maximum daily dose of 200 mg, at the earliest after one week.

In children, the starting dose is 25 mg once daily in the morning or evening. After a week, the dose may be increased to 50 mg once daily.

Interaction

The concomitant use of Serenat and MAOI inhibitors, both selectively acting (selegiline) and reversible (moclobemide), may lead to severe complications, including serotonin syndrome. Similar complications, sometimes fatal, occur when prescribing MAO inhibitors during treatment with antidepressants that inhibit the neuronal capture of monoamines or immediately after their withdrawal. Concomitant use of selective serotonin reuptake inhibitors and MAO inhibitors causes: hyperthermia, rigidity, myoclonus, vegetative nervous system lability (rapid fluctuations of respiratory and cardiovascular system parameters), mental status changes, including increased irritability, marked agitation, confusion, which in some cases may progress to delirium or coma.

When coumarin derivatives and sertraline are coadministered, there is a significant increase in prothrombin time (it is recommended that prothrombin time be monitored at the start of treatment with Serenat and after discontinuation).

Pharmacokinetic interaction

Sertralin binds to plasma proteins. Therefore, the possibility of its interaction with other drugs that bind to proteins (e.g., diazepam, tolbutamide and avarfarin) must be considered.

In concomitant use with cimetidine there is a significant decrease in clearance of sertraline. During long-term treatment with sertraline at a dose of 50 mg/day, concomitant use leads to increased plasma concentrations of desipramine, which is metabolized with the participation of CYP2D6 isoenzyme.

Sertraline has no effect on the serum concentration of diazepam, indicating no inhibition of CYP2C19 isoenzyme.

In in vitro studies, Sertraline has little or no effect on the CYP1A2 isoenzyme.

The pharmacokinetics of lithium are not altered by concomitant administration of sertraline, but tremor is more commonly observed in such cases. As with the administration of other selective serotonin reuptake inhibitors, co-administration of sertraline with drugs that affect serotonergic transmission (e.g., lithium) requires increased caution. There is no need for a “washout period” when replacing one serotonin neuronal takeover inhibitor with another. However, caution is required when changing the course of treatment.

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

Sertraline causes minimal induction of microsomal liver enzymes. Concomitant administration of sertraline and antipyrine at a dose of 200 mg results in a significant decrease in the T1/2 of antipyrine, although this occurs in only 5% of observations.

Concomitant use of sertraline does not alter the beta-adrenoblocking effect of atenolol.

In concomitant use of sertraline at a dose of 200 mg/day with glibenclamide or digoxin, no drug interaction has been observed.

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Special Instructions

Sertraline should not be prescribed for 14 days after stopping treatment with MAO inhibitors. MAO inhibitors should not be prescribed for 14 days after withdrawal of Sertraline.

There is insufficient experience with Serenat in patients receiving electroconvulsive therapy. The possible success or risk of this combination treatment has not been studied.

Depressed patients are at risk for suicide attempts. This risk persists until remission develops. Therefore, ongoing medical monitoring of patients should be established from the initiation of treatment until optimal clinical effect is achieved.

Particular caution and close monitoring of the patient is required when using Serenat concomitantly with drugs that have a CNS depressant effect.

Pediatric use

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

The use of alcohol is prohibited during treatment.

Impact on ability to drive and operate machinery

The administration of Sertraline is not usually accompanied by impairment of psychomotor functions. However, its use simultaneously with other drugs may lead to impairment of attention and coordination of movements. Therefore, during treatment with sertraline it is not recommended to drive vehicles, operate special equipment or engage in activities associated with increased risk.

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Contraindications

– unstable epilepsy;

– children under 6 years of age;

– pregnancy;

– lactation period;

– concomitant use of sertraline and MAO inhibitors (if one drug is replaced with the other, refrain from taking antidepressants for 14 days);

– co-administration of Sertraline with tryptophan or phenfluramine;

– hypersensitivity to the components of Serenat.

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Side effects

Digestive system disorders: dry mouth, decreased appetite (rarely – increase), up to anorexia, dyspeptic disorders (flatulence, nausea, vomiting, diarrhea), abdominal pain; with long-term use in 0.8% of cases – asymptomatic increase in serum transaminase activity (when the drug is cancelled, enzyme activity is normalized).

CNS and peripheral nervous system disorders: drowsiness, headache, dizziness, tremor, insomnia, anxiety, agitation, hypomania, mania, gait disturbances, weakness, Extrapyramidal disorders, dyskinesias, tremors, seizures, visual disturbances were noted during Sertraline treatment. Movement disorders were more frequently noted in patients with a history of such disorders or with concomitant use of antipsychotic drugs.

Endocrine system disorders: ejaculation disorders, decreased libido, menstrual cycle disorders, hyperprolactinemia, galactorrhea.

Metabolism disorders: increased sweating, weight loss; 0.8% (more often in elderly patients and while taking diuretics or other drugs) – transient hyponatremia (this side effect is associated with ADH inadequate secretion syndrome).

Dermatological reactions: skin redness, skin rash; erythema multiforme is rare.

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Overdose

Symptoms: Severe symptoms of Sertraline overdose have not been found even when administered in high doses. However, severe poisoning may occur if concomitantly taken with other drugs or ethanol. Overdose may cause serotonin syndrome with nausea, vomiting, drowsiness, tachycardia, agitation, dizziness, psychomotor agitation, diarrhea, increased sweating, myoclonus and hyperreflexia.

Treatment: there are no specific antidotes. Intensive supportive therapy and constant monitoring of vital body functions is required. Inducing vomiting is not recommended. Ingestion of activated charcoal may be more effective than gastric lavage. Airway patency should be maintained. Sertraline has a large Vd, so increasing diuresis, performing dialysis, hemoperfusion, or blood transfusion may not be effective.

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Pregnancy use

No adequate and strictly controlled clinical safety studies of Serenat in pregnancy have been conducted.

Prescribing the drug to pregnant women is contraindicated.

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Similarities

Serlift