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 disorders (OCD);

– panic disorders (with or without agoraphobia);

– post-traumatic stress disorder (PTSD).

Pharmacological effect

Antidepressant. Selective serotonin reuptake inhibitor (5-HT).

Serenate has a weak effect on the reuptake of norepinephrine and dopamine.

At therapeutic doses, sertraline blocks the uptake of serotonin by human platelets.

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

Does not have a stimulant, sedative or anticholinergic effect.

Special instructions

Sertraline should not be administered within 14 days of stopping treatment with MAO inhibitors. MAO inhibitors are not prescribed within 14 days after discontinuation of sertraline.

Patients receiving electroconvulsive therapy do not have sufficient experience with the use of the drug Serenata. The possible success or risk of this combination treatment has not been studied.

Patients suffering from depression are at risk for suicide attempts. This danger persists until remission develops. Therefore, from the start of treatment until the optimal clinical effect is achieved, patients should be under constant medical supervision.

When using the drug Serenata simultaneously with drugs that have a depressant effect on the central nervous system, special caution and careful monitoring of the patient’s condition are required.

Use in pediatrics

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

During the treatment period, alcohol consumption is prohibited.

Impact on the ability to drive vehicles and operate machinery

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

Active ingredient

Sertraline

Composition

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

Pregnancy

Adequate and strictly controlled clinical studies of the safety of Serenata during pregnancy have not been conducted.

Prescribing the drug to pregnant women is contraindicated.

Contraindications

– unstable epilepsy;

– children under 6 years of age;

– pregnancy;

– lactation period;

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

– combined use of sertraline with tryptophan or fenfluramine;

– hypersensitivity to the components of Serenate.

Side Effects

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

From the central nervous system and peripheral nervous system: drowsiness, headache, dizziness, tremor, insomnia, anxiety, agitation, hypomania, mania, gait disturbances, weakness. During treatment with sertraline, extrapyramidal disorders, dyskinesias, tremor, convulsions, and visual disturbances were noted. Motor disorders were more often observed in patients with indications of their presence in the anamnesis or with concomitant use of antipsychotic drugs.

From the endocrine system: ejaculation disorders, decreased libido, menstrual irregularities, 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 inappropriate ADH secretion).

Dermatological reactions: redness of the skin, skin rash; rarely – erythema multiforme.

Interaction

With the simultaneous use of the drug Serenata and MAO inhibitors, both selectively acting (selegiline) and with a reversible type of action (moclobemide), severe complications may develop, including serotonin syndrome. Similar complications, sometimes fatal, occur when MAO inhibitors are prescribed during treatment with antidepressants that inhibit the neuronal uptake of monoamines or immediately after their withdrawal. With the simultaneous use of selective neuronal reuptake inhibitors of serotonin and MAO inhibitors, the following occur: hyperthermia, rigidity, myoclonus, lability of the autonomic nervous system (rapid fluctuations in parameters of the respiratory and cardiovascular system), changes in mental status, including increased irritability, severe agitation, confusion, which in some cases can turn into a delirious state or coma.

When coumarin derivatives and sertraline are administered together, a significant increase in prothrombin time is observed (it is recommended to monitor the prothrombin time at the beginning of treatment with Serenata and after its discontinuation).

Pharmacokinetic interaction

Sertraline binds to plasma proteins. Therefore, the possibility of its interaction with other protein-binding drugs (for example, diazepam, tolbutamide and warfarin) should be taken into account.

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

Experimental studies examining drug interactions in vitro showed that metabolic processes occurring with the participation of CYP3A3/4 isoenzymes – beta-hydroxylation of endogenous cortisol and metabolism of carbamazepine and terfenadine – do not change with long-term administration of sertraline at a dose of 200 mg/day. The plasma concentrations of tolbutamide, phenytoin and warfarin also do not change with long-term administration of sertraline at the same dose. Thus, we can conclude that sertraline does not inhibit the activity of the CYP2C9 isoenzyme.

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

According to in vitro studies, sertraline has virtually no effect or minimal inhibition of the CYP1A2 isoenzyme.

The pharmacokinetics of lithium does not change with simultaneous use of sertraline, however, in such cases, tremor is more often observed. As with the administration of other selective neuronal serotonin reuptake inhibitors, the combined use of sertraline with drugs that affect serotonergic transmission (for example, lithium) requires increased caution. When replacing one neuronal serotonin uptake inhibitor with another, there is no need for a washout period. However, caution is required when changing the course of treatment.

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

Sertraline causes minimal induction of liver microsomal enzymes. The simultaneous administration of sertraline and antipyrine at a dose of 200 mg leads to a significant decrease in T1/2 of antipyrine, although this occurs in only 5% of cases.

With simultaneous use, sertraline does not change the beta-adrenergic blocking effect of atenolol.

When simultaneous use of sertraline at a dose of 200 mg/day with glibenclamide or digoxin, no drug interactions were detected.

Overdose

Symptoms: no severe symptoms of sertraline overdose were detected even when the drug was prescribed in high doses. However, when taken simultaneously with other drugs or ethanol, severe poisoning may occur. Overdose can 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 care and constant monitoring of vital body functions are required. Inducing vomiting is not recommended. The administration of activated carbon may be more effective than gastric lavage. The airway must be maintained. Sertraline has a large Vd, so increasing diuresis, dialysis, hemoperfusion, or blood transfusion may not be effective.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Manufacturer

Torrent Pharmaceuticals Ltd, India