Serenata - Instructions For The Use Of Tablets, Price, Analogs, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Serenata

Serenata: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Serenata

ATX code: N06AB06

Active ingredient: sertraline (sertraline)

Manufacturer: Torrent Pharmaceuticals Ltd. (Torrent Pharmaceuticals, Ltd.) (India)

Description and photo update: 2018-21-11

Prices in pharmacies: from 495 rubles.

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Serenata is an antidepressant, psychotropic drug.

Release form and composition

Dosage form Serenates - coated tablets: biconvex, capsule-shaped, on one side there is a dividing line, the color of the shell and the color at the break - from white to almost white (in blisters of 10 pcs., In a cardboard box of 3 or 5 blisters).

Composition for 1 tablet:

• active substance: sertraline (in the form of hydrochloride) - 50 or 100 mg;
• auxiliary components: microcrystalline cellulose, sodium carboxymethyl starch, calcium hydrogen phosphate dihydrate, polysorbate, hydroxypropyl cellulose, magnesium stearate;
• shell: propylene glycol, hypromellose, titanium dioxide.

Pharmacological properties

Pharmacodynamics

Serenata is an antidepressant drug that selectively inhibits the reuptake of serotonin (5-HT), which has a weak effect on the reuptake of dopamine and norepinephrine. The use of therapeutic doses of sertraline ensures the blocking of serotonin uptake by human platelets. At the same time, it does not have an affinity for adrenergic, serotonin, histamine, dopamine, muscarinic, GABA- or benzodiazepine receptors, does not have a sedative, anticholinergic or stimulating effect.

The antidepressant effect of Serenata is observed by the end of the second week of therapy, provided that sertraline is taken regularly, and the maximum effectiveness of treatment can be achieved only after six weeks.

The use of sertraline, in contrast to therapy with tricyclic antidepressants, does not contribute to an increase in body weight. Sertraline does not cause physical or mental drug dependence.

Pharmacokinetics

The main pharmacokinetic characteristics of sertraline:

• absorption: absorption from the gastrointestinal tract (GIT) after oral administration of Serenata is significant, but prolonged. The maximum concentration of the substance in plasma (C _max) is reached in 4.5–8.4 hours. When taken simultaneously with food, its bioavailability increases by 25%, and the time to reach C _{max is} reduced;
• distribution: as a result of a single daily intake of Serenata, the equilibrium plasma concentration (C _ss) of sertraline is achieved within one week, while its binding to plasma proteins is up to 98%, and the volume of distribution (V _d) is more than 20 l / kg. Sertraline passes into breast milk, there is no data on its passage through the placental barrier;
• metabolism and excretion: being extensively metabolized during the first passage through the liver, sertraline undergoes N-demethylation with the formation of the main metabolite - N-desmethylsertraline (less active in comparison with the parent compound). About 0.2% of the substance is excreted unchanged by the kidneys, metabolites are excreted in equal volumes with urine and feces. The half-life (T _1/2) is from 22 to 36 hours, the value does not depend on age or gender. For N-desmethylsertraline, the rate increases to 62-104 hours. Sertraline is not dialyzed.

In patients with impaired liver function, the T _1/2 and AUC values (area under the concentration-time curve) increase.

In patients with renal failure, regardless of its severity, the pharmacokinetic parameters of sertraline do not change (subject to constant use).

Indications for use

According to the instructions, Serenate is recommended for the treatment and prevention of depression of various etiologies, as well as in the treatment of OCD (obsessive-compulsive disorders), panic disorder (with or without agoraphobia), PTSD (post-traumatic stress disorder) and social anxiety disorders (social phobias).

Contraindications

Absolute:

• unstable epilepsy;
• pregnancy and the period of breastfeeding (lactation);
• children under 6 years of age;
• use in conjunction with fenfluramine or tryptophan;
• use in conjunction with monoamine oxidase inhibitors (MAO) - the break between their use and taking Serenata should be at least 2 weeks;
• increased individual sensitivity to sertraline and (or) auxiliary components of the drug.

Relative contraindications in which Serenat tablets should be used with caution: organic brain diseases (including mental retardation), manic conditions, epilepsy, hepatic and / or renal failure, weight loss.

Instructions for use of Serenata: method and dosage

Serenat tablets are taken orally, 1 time per day, in the morning or evening, regardless of the diet.

Recommended dosage for adult patients:

• depression and OCD: the initial dose is 50 mg, gradually (not earlier than after 1 week) can be increased to a maximum of 200 mg;
• panic disorder and PTSD: the initial dose is 25 mg, after a week it can be increased to 50 mg, and then gradually (not earlier than 1 week) increase to a maximum of 200 mg.

A satisfactory clinical effect is usually achieved after 1 week from the start of the course. Serenate takes 2 to 4 weeks regularly to achieve a full therapeutic response, and OCD may take 8 to 12 weeks to be highly effective. The minimum dose providing the therapeutic effect of the drug is further retained as a maintenance dose.

Recommended dosage for OCD in children by age:

• 6-12 years: initial dose - 25 mg, after a week can be increased to 50 mg;
• 12-17 years: the initial dose is 50 mg, it can be gradually (not earlier than 1 week) increased to a maximum of 200 mg.

It is required to take into account that children have less body weight in comparison with adult patients. Therefore, with an increase in the dose of more than 50 mg per day in pediatric practice, it is required to carefully monitor patients and cancel Serenate at the first signs of an overdose.

Side effects

• digestive system: decreased appetite up to anorexia (less often - increase), dry mouth, abdominal pain, dyspeptic disorders (in the form of flatulence, nausea, vomiting, diarrhea); with prolonged use in 0.8% of cases - an asymptomatic increase in the serum activity of hepatic transaminases (if Serenate is canceled, their content normalizes independently);
• central and peripheral nervous system: dizziness, headache, weakness, insomnia, drowsiness, tremors, anxiety, hypomania, mania, agitation, gait disturbances; when using sertraline, convulsions, dyskinesias, extrapyramidal disorders, tremors, and visual impairments were noted. Movement disorders were more common in patients with a history of their presence or with concomitant use of antipsychotic drugs;
• endocrine system: decreased libido, ejaculation disorders, menstrual irregularities, galactorrhea, hyperprolactinemia;
• metabolism: weight loss, hyperhidrosis; in 0.8% of cases (more often in elderly patients and with the concomitant use of diuretics or some other drugs) - transient hyponatremia [this side reaction is associated with SIADH - syndrome of inappropriate secretion of antidiuretic hormone (ADH) or vasopressin];
• dermatological reactions: rash / redness of the skin; in rare cases - erythema multiforme (exudative);
• reactions to discontinuation of therapy: in rare cases - withdrawal syndrome, manifested by paresthesias, hyposthesias, signs of depression, hallucinations, aggressive reactions, psychomotor agitation, anxiety or psychosis symptoms that are indistinguishable from the symptoms of the underlying disease.

Overdose

Severe symptoms of sertraline overdose were not detected even when taken in high doses. But when taken simultaneously with ethanol or other drugs, severe poisoning is possible. The result of such an overdose may be serotonin syndrome with agitation, psychomotor agitation, drowsiness, nausea / vomiting, tachycardia, dizziness, diarrhea, increased sweating, hyperreflexia, myoclonus.

To normalize the condition, intensive supportive treatment and constant monitoring of vital body functions are carried out. Sertraline has no specific antidotes. It is also not recommended to induce vomiting in the patient. Taking activated charcoal may be more effective than gastric lavage. The airway should be kept clear. Due to the large V _{d of} sertraline, hemoperfusion, dialysis or blood transfusion, as well as increased urine output, may be ineffective.

special instructions

There are insufficient data from studies of the use of Serenate in patients receiving ECT (electroconvulsive therapy), and therefore the possible success or risk of such a combination has not been studied.

Patients with depression represent a risk group for suicidal intentions and attempts. This danger persists until the phase of remission and requires constant medical monitoring of patients from the beginning of the course until an acceptable clinical effect is achieved.

The simultaneous use of Serenate and drugs that depress the central nervous system should be carried out with extreme caution and under close monitoring of the patient's condition.

Drinking alcohol during treatment is prohibited.

Influence on the ability to drive vehicles and complex mechanisms

Sertraline, as a rule, does not cause impairment of psychomotor functions. However, when used in combination with other drugs, it is possible to impair concentration of attention and coordination of movements. In this regard, it is not recommended to engage in potentially hazardous activities and drive vehicles, special equipment.

Application during pregnancy and lactation

Adequate, strictly controlled clinical studies on the safety of using Serenata during pregnancy have not been conducted. It is contraindicated to prescribe the drug to pregnant women.

Patients of childbearing age who are expected to receive sertraline therapy need to use effective contraception.

There is no reliable data on the safety of using Serenate during lactation. It is known that sertraline is excreted in breast milk. If necessary, taking the drug should stop breastfeeding.

Pediatric use

• children under 6 years of age - the use of Serenata is contraindicated;
• children over 6 years old - the drug is used with caution.

With impaired renal function

Patients with impaired renal function do not require a special dose adjustment.

For violations of liver function

Patients with severely impaired liver function need to reduce or increase the time between doses of Serenata.

Use in the elderly

In old age, no special dose adjustment is required.

Drug interactions

Contraindicated combinations:

• MAO inhibitors: sertraline is contraindicated to be used simultaneously, 1 week before and 2 weeks after the end of the course of treatment with MAO inhibitors; MAO inhibitors can be prescribed 2 weeks after discontinuation of sertraline;
• pimozide: the combined use of sertraline (200 mg per day) and pimozide (2 mg once) led to an increase in the concentration of pimozide; due to insufficient data on the mechanism of such interaction and the narrow therapeutic index of pimozide, their simultaneous administration is contraindicated.

Possible interactions of Serenate with other substances / drugs:

• haloperidol, carbamazepine, ethanol, other CNS-depressing drugs: despite the fact that their effect on psychomotor and cognitive functions was not increased in healthy people, use with sertraline requires caution;
• fenfluramine, tryptophan, 5-HT agonists, tramadol, St. John's wort preparations, other drugs / substances that affect serotonergic neurotransmission: given the risk of pharmacodynamic interaction with sertraline, their combined use should be avoided, if possible, or caution should be exercised when administered concurrently with Serenate;
• fentanyl, other serotonergic drugs (including serotonergic antidepressants), other opioids: must be used with caution in conjunction with sertraline;
• lithium preparations: the pharmacokinetics of lithium does not change, but there is an increase in tremor, which indicates a possible pharmacodynamic interaction with sertraline; requires constant monitoring of the plasma concentration of lithium in order to adjust the dose, as well as monitoring patients;
• phenytoin: with long-term administration of sertraline (200 mg per day), the metabolism of phenytoin is not clinically significantly inhibited; in some episodes, an increase in the concentration of phenytoin was noted, and therefore it is recommended to monitor its plasma concentration, especially in patients with concomitant diseases, receiving / not receiving other therapy at the same time, and adjusting the dosage regimen, if necessary; phenytoin is able to reduce the plasma concentration of sertraline;
• carbamazepine, phenobarbital, St. John's wort preparations, rifampicin, other inducers of the CYP 3A4 isoenzyme: may reduce the plasma concentration of sertraline;
• triptans: Sumatriptan, when used with sertraline, has caused weakness, hyperreflexia, impaired coordination of movements, confusion, anxiety and agitation. Serotonergic syndrome can also develop with the combined use of sertraline with other triptans; if it is necessary to simultaneously use sertraline and triptans for medical reasons, it is important to ensure appropriate monitoring of the patient's condition;
• warfarin, other indirect anticoagulants: use with sertraline (200 mg per day) insignificantly, but statistically significantly increases the prothrombin time, which can lead to a violation of INR (international normalization rate). Therefore, at the beginning of therapy with sertraline and when it is canceled, careful monitoring of prothrombin time is required;
• atenolol: β-adrenergic blocking properties do not change under the influence of sertraline;
• digoxin: no interaction with sertraline was detected when taken at a dose of 200 mg per day;
• cimetidine: significantly reduces the clearance of sertraline, the clinical significance of such changes is unknown;
• other SSRIs (selective serotonin reuptake inhibitors), including drugs containing sertraline; agents that affect platelet function such as NSAIDs (non-steroidal anti-inflammatory drugs), acetylsalicylic acid, ticlopidine; drugs that may increase the risk of bleeding: when taken with Serenate, the likelihood of bleeding increases;
• drugs that increase the QT interval _c: the risk of lengthening the QT interval _c and the likelihood of developing a tachysystolic form of ventricular arrhythmia such as "pirouette" increases;
• diazepam, tolbutamide, warfarin, other drugs that strongly bind to plasma proteins: their interaction with sertraline is possible due to the high degree of its binding to plasma proteins, the effect must be taken into account when used together;
• desipramine (a marker of CYP 2D6 isoenzyme activity), other CYP 2D6 substrates with a narrow therapeutic index, such as class 1C antiarrhythmics (propafenone, flecainide), tricyclic antidepressants, typical antipsychotics: a clinically significant interaction with sertraline is possible, especially against the background of its use in high doses and / or long-term treatment;
• drugs metabolized by other cytochrome P ₄₅₀ isoenzymes (CYP 1A2, CYP 2C9, CYP 2C19, CYP 3A4): sertraline does not significantly inhibit these isoenzymes;
• grapefruit juice: taking 3 glasses of juice daily increases the plasma concentration of sertraline by 2 times, so this combination should be avoided;
• potent inhibitors of the CYP 3A4 isoenzyme such as itraconazole, ketoconazole, posaconazole, voriconazole, protease inhibitors, telithromycin, clarithromycin, nefazodone; moderate inhibitors of the CYP3A4 isoenzyme, such as aprepitant, erythromycin, fluconazole, verapamil, diltiazem: theoretically (based on data from studies of the interaction of sertraline with grapefruit juice), a significant increase in the exposure of sertraline can be assumed, and therefore it is recommended to avoid its simultaneous use with potent CYP inhibitors 3A4;
• tolbutamide (CYP 2C9 isoenzyme): presumably sertraline does not inhibit cytochrome P ₄₅₀ CYP 2C9 isoenzymes;
• diazepam (CYP 2C19 isoenzyme): sertraline does not affect its serum concentration, which indicates no inhibition of the CYP 2C19 isoenzyme;
• lansoprazole, omeprazole, pantoprazole, other potent inhibitors of the CYP 2C19 isoenzyme: their effect on sertraline cannot be ruled out, since patients with a slow metabolism of the CYP 2C19 isoenzyme have a more than 50% increase in its plasma concentration compared to patients with a rapid metabolism;
• isoenzyme CUR 1A2: according to the results of in vitro studies, sertraline has practically no effect on this isoenzyme or minimally inhibits it;
• antipyrine: sertraline (200 mg per day) slightly (up to 5%), but significantly reduces the T _{1/2 of} antipyrine.

Analogs

The analogues of the Serenata are: Asentra, Aleval, Stimuloton, Serlift, Zoloft, Thorin, etc.

Terms and conditions of storage

Store at 25 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Serenate

In a few reviews of Serenate, patients recommend it as an effective remedy for mild neuroses, depression, anxiety. The drug is not addictive, which is also a great advantage over other means of similar action.

Price for Serenate in pharmacies

Approximate price for Serenata (coated tablets, for 30 pcs. In a package): in a dosage of 50 mg - 570–580 rubles, in a dosage of 100 mg - 1100–1150 rubles.

Serenata: prices in online pharmacies

Drug name Price Pharmacy

Serenata 50 mg film-coated tablets 30 pcs. 495 RUB Buy

Serenata 100 mg film-coated tablets 30 pcs. 850 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!