Serenata pills 50mg, 30pcs

Composition

1 coated tablet contains:

Active ingredient:

sertraline hydrochloride in terms of sertraline 50 or 100 mg;

excipients:

microcrystalline cellulose,

sodium carboxymethyl starch,

calcium hydrophosphate dihydrate,

polysorbate,

magnesium stearate;

hypromellose,

propylene glycol,

titanium dioxide.

Pharmacological action

Serenata is an antidepressant.

Sertraline is a selective serotonin reuptake inhibitor (5-HT). It has very little effect on the reuptake of norepinephrine and dopamine. In therapeutic doses, sertraline blocks the uptake of serotonin by human platelets. It does not have a stimulating, sedative or anticholinergic effect. Sertraline has no affinity for muscarinic (cholinergic), serotonergic, dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine receptors.

The antidepressant effect is noted by the end of the second week of regular sertraline intake, while the maximum effect is achieved only after 6 weeks. Unlike tricyclic antidepressants, sertraline does not cause weight gain. Sertraline does not cause mental or physical drug dependence.

Pharmacokinetics

Absorption of sertraline from the gastrointestinal tract is significant, but occurs slowly. The maximum concentration in blood plasma is reached in 4.5-8.4 hours after oral use of the drug. The equilibrium concentration of sertraline in blood plasma is reached within a week with a single daily intake. Bioavailability during food intake increases by 25%, while the time to reach the maximum concentration is shortened.

Distribution. The total binding of sertraline to plasma proteins is 98%. Volume of distribution >20 l/kg.

Metabolism and elimination. Sertraline undergoes intensive metabolism during its first passage through the liver, undergoing N-demethylation. Its main metabolite, N-desmethylsertraline, is less active than the parent compound. Metabolites are excreted in the urine and feces in equal amounts. About 0.2% of sertraline is excreted unchanged by the kidneys. The half-life of the drug is 22-36 hours and does not depend on age or gender. For N-desmethylsertraline, this indicator is 62-104 hours.

The half-life of sertraline and the area under the plasma concentration curve (AUC) increase with impaired liver function. Regardless of the severity of renal insufficiency, the pharmacokinetics of sertraline do not change with its constant use.

Sertraline passes into breast milk. There is no data on its ability to pass through the hematoplacental barrier. Sertraline is not dialyzed.

Indications

• Depression of various etiologies (treatment and prevention),
• Obsessive-compulsive disorder (OCD)
• Panic disorders (with or without agarophobia).
• Post-traumatic stress disorder (PTSD).

Use during pregnancy and lactation

There are no controlled results of sertraline use in pregnant women, so they should only be prescribed the drug if the expected benefit to the mother exceeds the potential risk to the fetus.

Women of reproductive age who are supposed to be prescribed sertraline should be advised to use effective contraceptives.

Sertraline is found in breast milk, and therefore treatment with this drug during breastfeeding is not recommended.

There is no reliable data on the safety of its use in this case.

If treatment is still necessary, then it is better to stop breastfeeding.

Contraindications

• Hypersensitivity to the Active ingredient or other ingredients included in the preparation Serenata,
• combined use of sertraline and MAO inhibitors. When replacing one drug with another, you should refrain from taking antidepressants for 14 days,
• co-use of sertraline with tryptophan or fenfluramine
• unstable epilepsy,
• children under 6 years of age;
• pregnancy and lactation.

With caution: organic brain diseases (including mental retardation), manic states, epilepsy, liver and / or kidney failure, weight loss, in children over 6 years of age.

Side effects

Dry mouth, increased sweating, drowsiness, headache, dizziness, tremor, insomnia, anxiety, agitation, hypomania, mania, decreased appetite (rarely increased), up to anorexia, dyspeptic disorders (flatulence, nausea, vomiting, diarrhea), abdominal pain, weight loss, gait disorders.

Weakness, redness of the skin, visual disturbances, ejaculation disorders, and decreased libido are also possible.

Extrapyramidal disorders, dyskinesia, tremor, convulsions, menstrual disorders, hyperprolactinemia, galactorrhea, skin rash, and occasionally erythema multiforme have been reported during sertraline treatment. Motor disorders were more often observed in patients with a history of motor disorders or with concomitant use of antipsychotic drugs.

When sertraline treatment is discontinued, rare cases of withdrawal syndrome have been described. Paresthesia, hyposthesia, symptoms of depression, hallucinations, aggressive reactions, psychomotor agitation, anxiety, or symptoms of psychosis that cannot be distinguished from the symptoms of the underlying disease may occur.

Laboratory data: rarely – in 0.8% of cases, with prolonged use-there is an asymptomatic increase in the activity of transaminases in the blood serum. Withdrawal of the drug in this case leads to normalization of enzyme activity. Transient hyponatremia may occur during sertraline treatment. This is more common in elderly patients, as well as when taking diuretics or a number of other medications. This side effect is associated with the syndrome of inadequate secretion of antidiuretic hormone.

Interaction

Monoamine oxidase inhibitors (MAOIs). There are severe complications with the simultaneous use of sertraline and MAOIs (including selectively acting (selegiline) MAOIs and reversible type of action (moclobemide). Serotonin syndrome may develop. Similar complications, sometimes fatal, occur when MAOI is prescribed during treatment with antidepressants that inhibit the neuronal uptake of monoamines or immediately after their withdrawal.

With the simultaneous use of selective inhibitors of neuronal reuptake of serotonin and MAO, the following symptoms occur: 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, pronounced agitation, confusion, which in some cases can go into a delirious state or coma.

Drugs that depress the central nervous system and ethanol. The combined use of sertraline and substances that depress the central nervous system requires close attention, and the use of alcoholic beverages during treatment with sertraline is also prohibited. Coumarin derivatives – when co-administered with sertraline, there is a significant increase in prothrombin time – in these cases, it is recommended to monitor prothrombin time at the beginning of sertraline treatment and after its withdrawal.

Pharmacokinetic interaction

Sertraline 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).

Cimetidine: concomitant use significantly reduces sertraline clearance.

Drugs metabolized by cytochrome P 450 isoenzyme 2D6: long-term treatment with sertraline at a dose of 50 mg per day is accompanied by an increase in the concentration of desipramine.

Drugs that are metabolized by other cytochrome P 450 enzyme systems. In vitro interaction experiments have shown that the endogenous cortisol beta-hydroxylation carried out by the CYP 3A3 / 4 isoenzyme, as well as the metabolism of carbamazepine and terfenadine, do not change with long-term use of sertraline at a dose of 200 mg per day. The plasma concentrations of tolbutamide, phenytoin, and warfarin also do not change with long-term use of sertraline at the same dose. Thus, it can be concluded that sertraline does not inhibit the CYP 2C9 isoenzyme.

Sertraline does not affect the concentration of diazepam in the blood serum, which indicates the absence of inhibition of isoenzyme CHZ 2 with 19. According to in vitro studies, sertraline practically does not affect or minimally inhibits the CYP 1A2 isoenzyme.

Lithium. The pharmacokinetics of lithium do not change with concomitant use of sertraline. However, tremor is observed more often when they are used together. As with other selective serotonin reuptake inhibitors, the concomitant use of sertraline with drugs that affect serotonergic transmission (for example, lithium) requires increased caution.

Drugs that affect serotonergic transmission. When replacing one inhibitor of neuronal serotonin uptake with another, there is no need for a”wash-out period”. However, caution should be exercised when changing the course of treatment. Co-use of tryptophan or fenfluramine with sertraline should be avoided.

Induction of microsomal liver enzymes. Sertraline causes minimal induction of liver enzymes.Concomitant use of sertraline and antipyrine at a dose of 200 mg leads to a significant reduction in the half-life of antipyrine, although this occurs in only 5% of cases.

Atenolol: when co-administered, sertraline does not alter its beta-blocking effect. Glibenclamide and digoxin: when sertraline was administered at a daily dose of 200 mg, there was no drug interaction with these drugs.

How to take, course of use and dosage

For depression and adults, the initial dose is 50 mg of Sertraline once a day, morning or evening. The daily dose can be increased gradually, no earlier than a week later, from 50 mg, to a maximum daily dose of 200 mg.

Panic disorders and PTSD The initial dose is 25 mg of Serenate once a day, in the morning or in the evening. After a week, the doctor can increase the dose to 50 mg of sertraline once a day, and then gradually, no earlier than a week, the daily dose can be gradually increased from 50 mg to a maximum daily dose of 200 mg.

A satisfactory therapeutic result is usually achieved 7 days after the start of treatment. However, to achieve a full therapeutic effect, regular use of the drug is required for 2-4 weeks. In patients with obsessive-compulsive disorders, it may take 8-12 weeks to achieve a good result. The minimum dose that provides a therapeutic effect is maintained in the future as a maintenance dose.

Children with OCD For children from 6 to 12 years of age, the initial dose is 25 mg of sertraline once a day, in the morning or in the evening. After a week, you can increase the dose to 50 mg once a day.

For children from 12 to 17 years of age, the initial dose is 50 mg once a day, in the morning or in the evening. The daily dose can be increased gradually, no earlier than a week later, from 50 mg, to a maximum daily dose of 200 mg. To avoid overdose, the lower body weight of children compared to adults should be taken into account, and if the dose is increased more than 50 mg/day, careful monitoring of this category of patients is necessary and the drug should be discontinued at the first signs of overdose.

In elderly patients, there is no need for a special dose selection.

Patients with impaired liver function require special attention during treatment with sertraline. In severe hepatic impairment, the dose of Serenate should be reduced or the intervals between doses should be increased. In patients with impaired renal function, a special dose adjustment is not required.

Overdose

Severe symptoms of sertraline overdose were not detected even when the drug was prescribed in large doses. However, when administered concomitantly 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 maintenance therapy and constant monitoring of vital body functions are required.

It is not recommended to induce vomiting. use of activated charcoal may be more effective than gastric lavage. It is necessary to maintain the patency of the respiratory tract. Sertraline has a large volume of distribution, and therefore increased diuresis, dialysis, hemoperfusion, or blood transfusion may be ineffective.

Special instructions

Serenate should not be administered in combination with MAOI, or within 14 days of discontinuation of MAOI treatment. Similarly, after sertraline is discontinued, no MAOIs are prescribed for 14 days.

It should be noted that patients undergoing electroconvulsive therapy do not have sufficient experience with sertraline. The possible success or risk of such 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 beginning of treatment until the optimal clinical effect is achieved, patients should be constantly monitored.

Influence on the ability to drive motor vehicles and manage mechanisms:

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

Form of production

Film-coated tablets

Storage conditions

Store at temperatures below 25°C, out of the reach of children.

Shelf

life is 2 years.

Active ingredient

Sertraline

Conditions of release from pharmacies

By prescription

Dosage form

Tablets