Asentra
Asentra: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Asentra
ATX code: N06AB06
Active ingredient: sertraline (sertraline)
Manufacturer: Krka (Slovenia)
Description and photo update: 2019-23-08
Prices in pharmacies: from 522 rubles.
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Asentra is a drug with an antidepressant effect.
Release form and composition
Asentra dosage form - film-coated tablets: round, white, on one side have beveled edges and a notch; at the break - a rough white mass (7 pieces in blisters, 4 blisters in a cardboard box).
Composition of 1 tablet:
- active substance: sertraline - 50 or 100 mg (sertraline hydrochloride - 55.95 or 111.9 mg);
- auxiliary components: hydroxypropyl cellulose, magnesium stearate, calcium dihydrogen phosphate, sodium starch glycolate, talc, microcrystalline cellulose;
- shell: Opadry 03H28758 (talc, hypromellose, titanium dioxide, propylene glycol).
Pharmacological properties
Pharmacodynamics
The active ingredient of Asentra is sertraline, an antidepressant, a specific inhibitor of serotonin (5-HT) reuptake in neurons. In therapeutic doses, it blocks the seizure of serotonin in human platelets. The antidepressant effect develops by the end of the second week of daily intake of Asentra, the maximum effect is observed only after 6 weeks.
Asentra, unlike tricyclic antidepressants, does not cause an increase in body weight. In some cases, on the contrary, it contributes to its reduction.
It has no affinity for GABA, histamine, dopamine, serotonin, benzodiazepine, adrenergic and cholinergic receptors. It does not have a sedative, stimulating and anticholinergic effect. Does not cause physical and mental drug dependence.
The effect on the metabolism of dopamine and norepinephrine is negligible.
Pharmacokinetics
After oral administration of Asentra, sertraline is slowly absorbed from the gastrointestinal tract. The maximum concentration of the drug in the blood is reached after 4.5-8.4 hours.
With daily intake of Asentra 1 time per day, the equilibrium concentration of sertraline is established within about a week. The connection with plasma proteins is 98%, the volume of distribution is more than 20 l / kg. Sertraline passes into breast milk. The ability to penetrate the placental barrier has not been established.
Sertraline is extensively metabolized by N-demethylation during the first passage through the liver. The main metabolite resulting from biotransformation is the less active compound N-desmethylsertraline. About 0.2% of sertraline is excreted unchanged by the kidneys. Metabolites are excreted in approximately equal parts with feces and urine. The half-life does not depend on the gender and age of the patient, it is about 22–36 hours, for N-desmethylsertraline - 62–104 hours.
In patients with impaired liver function, the half-life of the drug and the area under the concentration-time curve increase.
The pharmacokinetic parameters of sertraline in patients with impaired renal function (both mild and severe) do not change with constant administration of Asentra.
The drug is not excreted during dialysis.
Indications for use
- depression of various etiologies (therapy and prevention);
- obsessive-compulsive disorder (OCD);
- post-traumatic stress disorder (PTSD);
- panic disorder.
Contraindications
Absolute:
- unstable epilepsy;
- combined therapy with tryptophan or fenfluramine, as well as with monoamine oxidase (MAO) inhibitors and for 2 weeks after their withdrawal;
- age up to 6 years;
- pregnancy and the period of breastfeeding;
- hypersensitivity to the components of the drug.
Relative (Asentra tablets should be used with caution in the presence of the following conditions / diseases):
- epilepsy;
- neurological disorders, including mental retardation;
- hepatic / renal failure;
- manic states;
- weight loss;
- children's age from 6 years.
Instructions for use of Asentra: method and dosage
Asentra tablets are taken orally. The daily dose is taken in 1 dose (morning or evening).
Recommended dosing regimen for adults:
- OCD, depression: initial average daily dose - 50 mg in 1 dose. The dose increase is carried out gradually (not earlier than after 7 days). Maximum - 200 mg per day;
- panic disorder and PTSD: the initial daily dose is 25 mg. After 7 days, the dose can be doubled, after which gradually (not earlier than after 7 days) it can be increased to a maximum of 200 mg per day.
Recommended dosage regimen for children:
- 6–12 years old: initial daily dose is 25 mg. After 7 days, the dose can be doubled;
- 12-17 years: initial daily dose - 50 mg.
If necessary, a gradual increase in the dose is carried out (no earlier than after 7 days). The maximum is 200 mg per day.
It is necessary to take into account the lower weight in children compared to adults (in order to avoid overdose). When prescribing daily doses above 50 mg, careful monitoring is required; at the first symptoms of an overdose, therapy is canceled.
As a rule, a satisfactory therapeutic effect is observed 7 days after the start of the use of Asentra, a complete one - after 2-4 weeks. With OCD, good outcomes may take 8 to 12 weeks. The smallest dose that provides a therapeutic effect is subsequently retained as a maintenance dose.
With functional disorders of the kidneys and elderly patients, the dosage regimen should not be adjusted. Patients with severely impaired liver function are prescribed Asentra with caution, while it is necessary to reduce the dose or increase the interval between doses.
Side effects
- digestive system: diarrhea, flatulence, vomiting, nausea, abdominal pain; rarely (with prolonged therapy) - an asymptomatic increase in the activity of transaminases in the blood serum (is of a transient nature, disappears after discontinuation of treatment);
- central and peripheral nervous system: insomnia, drowsiness, motor restlessness, dry mouth, increased sweating, hypomania, headache, tremor, dizziness, agitation, anxiety, weakness, mania, decreased appetite (in rare cases, increased) up to anorexia;
- laboratory parameters: reversible hyponatremia (in most cases in elderly patients, as well as during therapy with diuretics or some other drugs), associated with a syndrome of inappropriate secretion of antidiuretic hormone (ADH);
- others: decreased libido, skin redness, visual disturbances, ejaculation disorders, weight loss.
In isolated cases during therapy, the development of the following adverse reactions was noted: skin rash, convulsions, extrapyramidal disorders, tremors, dyskinesias, menstrual irregularities, galactorrhea, hyperprolactinemia; rarely - erythema multiforme. Movement disorders were more often observed in patients with a burdened history or in the combined use of Asentra with antipsychotic drugs.
Withdrawal symptoms after stopping treatment are usually rare. Symptoms: aggressive reactions, psychomotor agitation, paresthesia, symptoms of depression / psychosis, hypesthesia, hallucinations, anxiety. These disorders are difficult to differentiate from the symptoms of the underlying disease, and they can develop with the use of other antidepressant drugs.
Overdose
In case of an overdose, it is possible to develop serotonin syndrome, accompanied by symptoms such as nausea and vomiting, diarrhea, agitation, dizziness, drowsiness, psychomotor agitation, tachycardia, increased sweating, hyperreflexia, myoclonus. Severe signs of intoxication were not detected even when taking Asentra in high doses. However, in the case of the simultaneous use of other drugs or ethanol, severe poisoning can occur, up to and including death.
There is no specific antidote to sertraline. Taking activated charcoal may be more effective than gastric lavage. Induction of vomiting is not recommended. It is shown that intensive supportive therapy is carried out, as well as monitoring of the state of vital body functions. The airway must be kept clear. Dialysis, forced diuresis, hemoperfusion, and blood transfusion are unlikely to be beneficial due to the large volume of distribution of sertraline.
special instructions
According to clinical studies, Asentra is safe and effective in treating depression in patients who have suffered myocardial infarction, as well as in patients with unstable angina pectoris and diabetes mellitus.
From the beginning of the use of Asentra and until the optimal clinical effect is achieved, constant medical monitoring of the patient's condition is necessary, since patients with depression are at risk of suicidal attempts (the danger exists before remission develops).
There is no sufficient experience in using Asentra in patients undergoing electroconvulsive therapy (the safety / efficacy profile of combination therapy has not been studied).
Influence on the ability to drive vehicles and complex mechanisms
The combined use of Asentra with other drugs can cause the development of disorders of attention and coordination of movements, and therefore, during the period of therapy, it is not recommended to perform work associated with an increased risk and to drive vehicles.
Application during pregnancy and lactation
Strictly controlled and adequate clinical studies regarding the safety of taking sertraline by pregnant women have not been carried out, therefore, it is not recommended to use Asentra during this period. The physician can only make a decision to prescribe a medicine in cases where the expected benefit is definitely higher than the potential risks.
Women of reproductive age are advised to use reliable contraceptive methods during treatment.
Sertraline passes into breast milk. There are no data available on the safety of sertraline in infants. In this regard, breastfeeding should be discontinued if antidepressant therapy is required during lactation.
Pediatric use
According to the instructions, Asentra is contraindicated in children under 6 years of age. For the treatment of children from 6 years of age, the drug should be used with caution.
With impaired renal function
Antidepressant for renal failure must be used with caution.
For violations of liver function
In case of mild and moderate liver dysfunctions, Asentra should be used with caution. In severe hepatic dysfunction, it is recommended to reduce the dose of the drug or increase the intervals between doses.
Use in the elderly
There is no need to adjust the dose of Asentra in elderly patients.
Drug interactions
With the combined use of Asentra with certain drugs / substances, the following effects may develop:
- drugs that depress the central nervous system: development of interaction (combined use requires caution);
- MAO inhibitors: the occurrence of serotonin syndrome: myoclonus, rigidity, hyperthermia, lability of the autonomic nervous system, changes in mental status, including severe agitation, increased irritability, confusion, which in some cases can go into a delirious state or to whom (combined use is contraindicated). Similar disorders (in some cases fatal) develop with the appointment of MAO inhibitors during treatment with antidepressants that inhibit the neuronal uptake of monoamines, or immediately after their withdrawal;
- indirect anticoagulants (coumarin derivatives): a significant increase in prothrombin time (at the beginning of therapy and after discontinuation of Asentra, prothrombin time control is necessary);
- ethanol and ethanol-containing drugs: development of interaction (combined use is contraindicated);
- cimetidine: significant decrease in sertraline clearance;
- drugs that bind to blood plasma proteins (diazepam, tolbutamide and warfarin): development of interaction;
- lithium and other drugs that affect serotonergic transmission: development of interaction (combined use requires caution);
- desipramine (long-term use of sertraline in a daily dose of 50 mg): an increase in its plasma concentration;
- antipyrine: a significant decrease in its half-life;
- tryptophan, fenfluramine: development of interaction (combined use should be avoided).
Analogs
The analogs of Asentra are: Aleval, Zoloft, Serenata, Serlift, Stimuloton, Torin, Adepress, Azafen, Actaparoxetine, Alventa, Amitriptyline, Anafranil, Brintellix, Valdoxan, Velaksin, Velafax, Venlaxor, Venulloxentafaxin, People Mirtazonal, Paxil, Paroxetine, Plizil, Prozac, Remeron, Selektra, Trittico, Fluoxetine, Tsipralex, Acipe, etc.
Terms and conditions of storage
Keep out of reach of children at temperatures up to 25 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Acenter
Reviews about Asentre are mostly positive. Patients describe a good tolerance of the drug and a significant improvement in their condition during therapy, however, they note that at least 2-3 weeks are required to achieve an antidepressant effect.
Price for Asentra in pharmacies
The price for Asentra is 657–748 rubles. for a pack of 28 film-coated tablets, 50 mg each.
Asentra: prices in online pharmacies
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Drug name Price Pharmacy |
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Asentra 50 mg film-coated tablets 28 pcs. 522 RUB Buy |
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Asentra tablets 50mg 28 pcs. 798 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, 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!
