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Asentra (Sertralinum, Sertraline) - Antidepressant. A specific inhibitor of serotonin reuptake (5-HT) neurons. On noradrenaline and dopamine metabolism affects slightly. At therapeutic doses, sertraline blocks uptake of serotonin in human platelets. The drug has no stimulating, sedative or anticholinergic action. It has no affinity for serotonin, dopamine, histamine, benzodiazepine, of GABA, choline and adrenoceptor.

Antidepressant effect was seen at the end of the second week of the regular reception Asentry, while the maximum effect is achieved only after 6 weeks.

Unlike tricyclic antidepressants when assigning Asentry no increase in body weight; in some cases it observed decrease.

The drug does not cause mental or physical drug dependence.

Testimony:

  • Treatment and prevention of depression of different etiology.
  • Treatment of obsessive-compulsive disorder (OCD).
  • Treatment of panic disorder.
  • Post-traumatic stress disorder (PTSD).

Contraindications:

  • Simultaneous reception of MAO inhibitors in the 14 days after their cancellation.
  • Concomitant use of tryptophan or fenfluramine.
  • The unstable epilepsy.
  • Children under 6 years of age.
  • Pregnancy.
  • Lactation (breastfeeding).
  • Hypersensitivity to the drug.

Precautions: prescribe the drug for neurological disorders (including mental retardation), manic states, epilepsy, liver and / or kidney failure, reduction of body weight, children over 6 years.

Pregnancy and breast-feeding:

Adequate and well-controlled clinical safety trials of sertraline during pregnancy was conducted. Appointment of the drug is only possible if the intended benefits to the mother outweighs the potential risk to the fetus.

Women of childbearing age during treatment should be advised to use effective contraception.

Sertraline is found in breast milk. If necessary, the appointment during lactation should stop breastfeeding due to lack of reliable data on the safety of sertraline in this period.

Special instructions:

According to clinical studies the drug sertraline is effective and safe in the treatment of depression in patients with myocardial infarction, and in patients with unstable angina. Placebo-controlled studies have demonstrated the efficacy and safety of sertraline in patients with diabetes.

Sertraline not administered jointly with inhibitors and for 14 days after cessation of treatment MAO inhibitors; after the abolition of sertraline for 14 days did not prescribe MAOIs.

C Patients with depression are at risk for suicide attempts. This risk persists until the development of remission. Therefore, from the beginning of the treatment and to achieve optimal clinical response should be to establish a permanent medical supervision of the patient. Currently, there is no sufficient experience in the application of sertraline in patients undergoing electroconvulsive therapy. The possible success or the risk of such combined treatment has not been studied.

Effects on ability to drive vehicles and management mechanisms

Appointment of sertraline is not accompanied by violation of psychomotor functions. However, its use in conjunction with other drugs may impair attention and motor coordination. Therefore during therapy with sertraline driving vehicles or engaged, associated with an increased risk of the activity is not recommended.

Side effects:

From the central and peripheral nervous system: dry mouth, increased sweating, drowsiness, headache, dizziness, tremors, anxiety, agitation, hypomania, mania, insomnia, decreased appetite (rarely - increased) up to anorexia, weakness, restlessness .

From the digestive system: flatulence, nausea, vomiting, diarrhea, abdominal pain; rare (0.8%) with long-term use - asymptomatic increase of transaminases in serum (is normalized to remove the drug).

Other: visual disturbances, flushing, ejaculation disorder, decreased libido, weight loss.

From the laboratory parameters: reversible hyponatremia (usually in the elderly, as well as when taking diuretics or some other drugs) related to the syndrome of inappropriate secretion of ADH.

In applying the drug in a few cases it was noted extrapyramidal disorder, dyskinesia, tremor, cramps, menstrual disorders, hyperprolactinemia, galactorrhea, skin rash; rarely - erythema multiforme. Movement disorders were more common in patients with indications of their presence in the history or concomitant use of antipsychotics.

Upon termination of the drug withdrawal syndrome is rare. There may be paresthesia, hypoesthesia, depressive symptoms, hallucinations, aggressive reaction, agitation, anxiety or psychotic symptoms. These manifestations are difficult to distinguish from the main symptoms of the disease, and may occur in the application and other antidepressants.

Suggested Use:

For depression and OCD in adults: The average starting dose is 50 mg 1 time / day, morning or evening. The daily dose can be gradually, not earlier than one week increased to a maximum of 50 mg daily dose of 200 mg.

When panic disorder and PTSD: Asentra initial dose is 25 mg 1 time / day, morning or evening. After a week, you can increase the dose to 50 mg 1 time / day, and then gradually, not earlier than a week, increase to a maximum daily dose of 200 mg.

For children aged 6 to 12 years: initial dose Asentra is 25 mg sertraline, 1 time / day, morning or evening. After a week, you can increase the dose to 50 mg 1 time / day. For children aged 12 to 17 years: The initial dose is 50 mg 1 time / day in the morning or in the evening. If necessary, the daily dose can be gradually, not earlier than one week, to raise to a maximum of 50 mg daily dose of 200 mg. To avoid overdose should take into account the smaller body weight in children than adults, and by increasing the dose of 50 mg / day should be carefully monitored for this category of patients: the drug should be discontinued at the first sign of overdose.

Satisfactory therapeutic results achieved typically after 7 days of starting treatment. However, to achieve full therapeutic effect requires the regular intake of the drug for 2-4 weeks. In patients with OCD in order to achieve a good result may require 8-12 weeks. The minimum dose providing therapeutic effect is maintained in the future as a support.

Elderly patients: there is no need a special dose adjustment.

If abnormal liver function: the drug should be used with caution. In severe hepatic dysfunction dose should be reduced or increased intervals between doses.

In patients with impaired renal function: a special correction dosing regime is not required.

Drug interactions:

With simultaneous use of sertraline and MAO inhibitors (including the selective MAO inhibitors with a reversible type of action - selegiline and moclobemide) may develop serotonin syndrome: hyperthermia, rigidity, myoclonus, lability of the autonomic nervous system (rapid fluctuations in the parameters of the respiratory and cardiovascular system), change mental status, including increased irritability, marked agitation, confusion, which in some cases can go into delirious state or coma (this combination is contraindicated). Similar complications (sometimes fatal) occur in the appointment of MAO inhibitors during treatment with antidepressants, depressing neuronal uptake of monoamines or immediately after their withdrawal.

In healthy volunteers the use of sertraline at a dose of 200 mg / day does not influence the effect of ethanol, carbamazepine or haloperidol, and also on mental performance and psychomotor activity (though the combined purpose of sertraline and drugs which depress the central nervous system requires careful attention, as the simultaneous use of ethanol and ethanol-containing drugs is contraindicated).

The joint appointment of indirect anticoagulants (coumarin derivatives) with sertraline showed a significant increase in prothrombin time (prothrombin time monitoring is required at the beginning of the use of sertraline and after its cancellation).

Pharmacokinetic interactions

In a joint application Sertraline can interact with other drugs that bind to plasma proteins (diazepam, tolbutamide and warfarin).

The simultaneous use of the drug cimetidine significantly reduces the clearance of sertraline.

Long-term use of sertraline at a dose of 50 mg / day with desipramine (drug metabolizing isoenzyme CYP2D6) accompanied by an increase desipramine plasma concentration.

In in vitro experiments revealed that carried isoenzyme CYP3A3 / 4 betagidroksilirovanie endogenous cortisol, as well as the metabolism of carbamazepine and long-term administration of terfenadine with sertraline at a dose of 200 mg / day does not change.

plasma concentrations of tolbutamide, phenytoin and warfarin in long-term appointment of sertraline at a dose of 200 mg / day does not change, therefore, it can be concluded that sertraline does not inhibit isoenzyme CYP2C9.

Sertraline not affect the diazepam concentration in the serum, indicating no inhibition of isozyme CYP2C19.

According to in vitro studies, sertraline has virtually no effect or minimally inhibits isoenzyme CYP1A2.

The pharmacokinetics of lithium were not significantly changed by concomitant administration of sertraline; but the tremor occurs more frequently, which suggests the possibility of a pharmacodynamic interaction (such a combination requires caution). Also, caution should be prescribed sertraline with other drugs that affect the serotonergic transmission.

When replacing a neuronal uptake inhibitor on the other there is no need to "washout period". However, caution is required when changing the course of treatment. Avoid concomitant administration of tryptophan or fenfluramine with sertraline.

In clinical studies have shown that sertraline causes minimal induction of liver enzymes. Co-administration of sertraline at a dose of 200 mg and antipyrine leads to a significant decrease in T1 / 2 of antipyrine (this change is detected only 5% of cases).

If co-administration of sertraline has no effect on the beta-adrenoceptor blocking action of atenolol.

With the introduction of sertraline in a daily dose of 200 mg drug interactions with glibenclamide and digoxin have been identified.

Packaging:

  • Comes in original packaging. Item is brand new and unopened.

Storage:

  • Keep away from direct sunlight.
  • Keep locked and away from children.
  • Store in dry place at room temperature.
  • Do not exceed storage temperature higher than 25 C

Important notice- the outer box design may vary before prior notice!

 

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