Asentra (Sertraline) tablets - Instructions for Use, Dosage, Side Effects, Reviews

Synonyms: Alprax Forte (Sertraline and Alprazolam), Alprax Plus (Sertraline and Alprazolam), Andep, Ansium, Antipres, Anxit Forte (Sertraline and Alprazolam), Anxit Plus (Sertraline and Alprazolam), Ariale, Asentra, Asertin, Atenix, Atralin, Bellsert, Bicromil, Chear, Chemmart Sertraline, Cimicile, Cratular, Daxid, Debitum-Sanovel, Deprax, Deprecalm, Depsert, Doc Sertraline, Dominium, Eleval, Episod, Garmisch Setrax, GenRX Sertraline, Halea, Implicane, Inosert, Lesefer, Lustral, Luxeta, Mapron, Netral, Nudep, Optibel, Pandomil, Repose, Resert, Restyl Forte (Sertraline and Alprazolam), Restyl Plus (Sertraline and Alprazolam), Sedoran, Serdep, Serenata, Serimel, Serjet, Serlift, Serlin, Serolux, Sertagen, Sertal, Sertin, Sertiva, Sertrac, Sertralin - 1 A Pharma, Sertralin Actavis, Sertralin Arrow, Sertralin ICP, Sertralin Mylan, Sertralin Sandoz, Sertralin Stada, Sertralin Teva, Sertralina Biogalenica, Sertralina Bluepharma, Sertralina Chemopharma, Sertralina Dr. Reddy’s, Sertralina Genfar, Sertralina Itf, Sertralina L.CH., Sertralina La Santé, Sertralina Mepha, Sertralina MK, Sertralina Pharmakern, Sertralina ratiopharm, Sertralina Somidal, Sertralina Tetrafarma, Sertralina, Sertraline Actavis, Sertraline Arrow, Sertraline Aurobindo, Sertraline EG, Sertraniche, Sertrax, Serval, Setalin, Setaloft, Setra, Sidata, Solotik, Tragal, Tralin, Traser, Xsert, Zapline, Zerlin, Zert-OD, Zetral, Zolof, Zoloft, Zortral, Zosert, Zotral, Adco-Zerta, Adjuvin, Aleval, Alpraser (Sertraline and Alprazolam), Alpraser Simple, Altisben, Altruline, Anilar, Apo-Sertral, Apo-Sertraline, Aremis, Arrow Sertraline, Asentra, Aserin, Bei Yu, Besitran, Celonfex, Cenzoft, Certorun, Cloridrato de Sertralina, CO Sertraline, Concorz, Conexine, Deprax, Deprefolt, Depreger, Diticone, Doc Sertraline, Eleva, Emergen, Enidap, Epilyd, Exulten, Fatral, Fridep, Gen-Sertraline, Gerotralin, Gladem, Halea, Iglodep, Insertec, Irradial, JinDeSi, Jzoloft, Kinloft, Kuai Wu You, Leyuan, Lomaz, Lowfin, Lusedan, Lusert, Lustral, Lustraline, Luxeta, Misol, Neurosedine, Novativ, Novo-Sertraline, Nu-Sertraline, Onirux, Oralin, Pharmacor Sertraline, Pi Mai Le, PMS-Sertaline, PMS-Sertraline, Prosertin, Purtraline, ratio-Sertraline, Resperal, Sandoz Sertraline, Satil, Selectra, Seltra, Seralin, Seralin-Mepha, Serdep, Serenada, Serenata, Seretral, Serivo, Serlain, Serlan, Serlife, Serlift, Serlin, Serlina, Serline GMP, Serlo, Serlof, Sernade, Serolux, Serolux Sandoz, Seronex, Serotin, Serotop, Serotyp, Serta, Sertac, Sertadepi, Sertagen, Sertex, Sertiva, Sertra TAD, Sertra, Sertrabrain, Sertragen, Sertral, Sertralin - 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Active substance: Sertraline.

ATC - N06AB06 Sertraline

Pharmacological group - Antidepressants.

Generic Name: sertraline

Brand Name: Zoloft

What is Sertraline?

Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Sertraline affects chemicals in the brain that may be unbalanced in people with depression, panic, anxiety, or obsessive-compulsive symptoms. You can buy Asentra.

Sertraline is used to treat depression, obsessive-compulsive disorder, panic disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

What is the most important information I should know about sertraline?

You should not use sertraline if you also take pimozide, or if you are being treated with methylene blue injection.

Do not use sertraline if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Post Traumatic Stress Disorder - Signs, Symptoms and Solutions

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not give sertraline to anyone younger than 18 years old without the advice of a doctor. Sertraline is FDA-approved for children with obsessive-compulsive disorder (OCD). It is not approved for treating depression in children.

Nosological classification (ICD–10)

F32 Depressive episode;

F41.0 Panic disorder [episodic paroxysmal anxiety];

F41.2 Mixed anxiety and depressive disorder;

F42 Obsessive-compulsive disorder;

F43.1 Post-Traumatic Stress Disorder.

Sertraline (Asentra) Composition, structure and packing

Tablets, film-coated white, round, with bevelled edges and a notch on the one hand; on a break - white lumpy mass.

Other ingredients: magnesium stearate, hydroxypropyl cellulose, sodium starch glycolate, calcium dihydrogen phosphate, microcrystalline cellulose, talc.

Cover structure: Opadry 03H28758 (hypromellose, titanium dioxide, talc, propylene glycol).

Pharmacological action

Antidepressant. A specific inhibitor of the reuptake of serotonin (5-HT) reuptake in neurons. In the metabolism of norepinephrine and dopamine affects slightly. At therapeutic doses, sertraline blocks serotonin uptake in human platelets. The drug has no stimulating, sedative or anticholinergic action. No affinity for serotonin, dopamine, histamine, benzodiazepine, GABA, choline and adrenoceptors.

The antidepressant effect was observed by the end of the second week of the regular admission of Asentra, while the maximum effect is achieved only after 6 weeks.

Unlike tricyclic antidepressants in the appointment of Asentra no increase in body weight; in some cases, marked its decline.

The drug does not cause mental or physical drug dependence.

Pharmacokinetics

Absorption

After oral administration of sertraline is slowly absorbed from the gastrointestinal tract, C max in plasma is reached after 4.5–8.4 h.

Distribution

Css is set within a week with a daily intake of 1 times/day. Sertraline binding to plasma proteins is 98%. Vd > 20 l/kg.

Sertraline is excreted in breast milk. Data on its ability to cross the placental barrier is not.

Metabolism and excretion

Sertraline undergoes intense biotransformation in the “first pass” through the liver by N-demethylation. The main metabolite - N-desmethylsertraline - less active than the parent compound. Metabolites are excreted in urine and faeces in equivalent amounts. Approximately 0.2% of sertraline excreted by the kidneys in unchanged form. T 1/2 drug is 22–36 hours and is independent of the age or sex of the patients. For N-desmethylsertraline T 1/2 - 62–104 hours.

Pharmacokinetics in special clinical situations

T 1/2 and AUC in plasma increases with abnormal liver function.

Pharmacokinetic parameters of sertraline in patients with both mild and moderate renal impairment (creatinine clearance 20–50 ml/min), and with severe renal impairment (creatinine clearance <20 ml/min) did not change when it is used consistently.

Sertraline is not output during dialysis.

Sertraline (Asentra) Dosage

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

For panic disorders and PTSD Asentra initial dose is 25 mg 1 time/day, in the morning or in the evening. After a week, you can increase the dose to 50 mg 1 time/day, and then gradually, not a week before, to raise up to a maximum daily dose of 200 mg.

Initial dose of Asentra for children aged 6 to 12 years is 25 mg sertraline 1 time/day, in the morning or in the evening. After a week, you can increase the dose to 50 mg 1 time/day. For children between the ages of 12 to 17 years starting 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 increase from 50 mg up to a maximum daily dose of 200 mg. To avoid overdose should take into account the smaller body weight in children compared with adults, and with increasing doses above 50 mg/day should be carefully monitored for this category of patients: the first signs of an overdose of the drug should be discontinued.

Satisfactory therapeutic results achieved typically after 7 days of starting treatment. However, to achieve full therapeutic effect requires regular use 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.

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

In hepatic dysfunction 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 regimen is not required.

Asentra (Sertraline) Overdose

Symptoms: may cause serotonin syndrome with nausea, vomiting, drowsiness, tachycardia, agitation, dizziness, agitation, diarrhea, sweating, myoclonus, hyperreflexia. Severe symptoms are observed, even when using the drug in high doses. However, when taken with other drugs or ethanol may occur severe poisoning, sometimes fatal.

Treatment: There are no specific antidotes. If necessary - intensive supportive therapy and monitoring of vital body functions. Injection of activated carbon can be more effective than gastric lavage, artificial cause vomiting is not recommended. Necessary to maintain an open airway. Forced diuresis, dialysis, hemoperfusion, or blood transfusions may be unsuccessful (due to the large volume of distribution of sertraline).

Drug Interactions

With simultaneous use of sertraline and MAO inhibitors (including selective MAO inhibitors acting reversible type of action - selegiline and moclobemide) may develop serotonin syndrome: hyperthermia, rigidity, myoclonus, and the lability of the autonomic nervous system (rapid fluctuations of parameters of the respiratory and cardiovascular system), changes mental status, including increased irritability, marked agitation, confusion, which in some cases may go into delirious state or coma (this combination is contraindicated). Similar complications (sometimes fatal) arise 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 200 mg/day did not affect the effect of ethanol, carbamazepine or haloperidol, as well as mental activity and psychomotor activity (though the combined purpose of sertraline and drugs which depress the central nervous system, requires careful attention, and the simultaneous use of with ethanol and ethanol-containing drugs are contraindicated).

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

Sertraline Pharmacokinetic interactions

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

Simultaneous use of the drug cimetidine significantly reduces the clearance of sertraline.

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

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

Plasma concentrations of tolbutamide, phenytoin and warfarin for long-term administration of sertraline 200 mg/day does not change, therefore, it can be concluded that sertraline does not inhibit the isoenzyme CYP2C9.

Sertraline does not affect the concentration of diazepam in serum, suggesting the lack of inhibition of isoenzyme CYP2C19.

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

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

When replacing one inhibitor of neuronal uptake on the other there is no need for a “washout period.” However, caution is required when changing the course of treatment. Avoid co-administration of tryptophan or fenfluramine with sertraline.

In clinical studies have shown that sertraline causes minimal induction of liver enzymes. Simultaneous with the appointment of sertraline 200 mg of antipyrine and leads to a significant decrease in T 1/2 antipyrine (this change is detected only 5% of cases).

When co-administered sertraline has no effect on beta-adrenoceptor blocking effect of atenolol.

When administered in a daily dose of sertraline 200 mg drug interactions with glibenclamide and digoxin have been identified.

Pregnancy and lactation

Adequate and well-controlled clinical studies on the safety of sertraline during pregnancy was conducted. Use of the drug is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Women of childbearing age in the period of the drug should be advised to use effective contraceptive methods.

Sertraline is found in breast milk. The appointment during lactation should stop breastfeeding because of the lack of reliable data on the safety of sertraline in this period.

Sertraline (Asentra) Side effects

CNS and peripheral nervous system: dry mouth, increased sweating, drowsiness, headache, dizziness, tremor, anxiety, agitation, hypomania, mania, insomnia, loss of appetite (rarely - increased) until anorexia, weakness, restlessness.

From the digestive system: flatulence, nausea, vomiting, diarrhea, abdominal pain; rare (0.8%) with prolonged use - asymptomatic increase of transaminases in serum (normal upon drug discontinuation).

Miscellaneous: blurred vision, redness of the skin, ejaculation disorders, decreased libido, weight loss.

From the laboratory parameters: reversible hyponatremia (more common in the elderly, as well as when taking diuretics or some other drugs) associated with the syndrome of inappropriate secretion of ADH.

When using the drug in a few cases have been marked extrapyramidal disorder, dyskinesia, tremor, convulsions, menstrual disorders, hyperprolactinemia, galactorrhea, skin rash; rarely - erythema multiforme. Movement disorders were more common in patients with indications of their presence in history or concomitant use of antipsychotic drugs.

Discontinuation of the drug withdrawal syndrome is rare. Possible paresthesia, hypoesthesia, symptoms of depression, 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.

Indications

Treatment and prevention of depression of various etiologies;

Treatment of obsessive-compulsive disorder (OCD);

Treatment of panic disorder;

Post-traumatic stress disorders (PTSD).

Contraindications

Concomitant use of monoamine oxidase inhibitors and for 14 days after their withdrawal;

Simultaneous use of tryptophan or fenfluramine;

Unstable epilepsy;

Children under 6 years of age;

Pregnancy;

Lactation (breastfeeding);

Hypersensitivity to the drug.

With care prescribe the drug for neurological disorders (including mental retardation), manic states, epilepsy, hepatic and/or renal failure, weight loss, children over 6 years.

Cautions

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

Sertraline is not prescribed in conjunction with MAO inhibitors, and also within 14 days after discontinuation of treatment with MAO inhibitors; after discontinuation 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 treatment and to achieve optimal clinical response should establish a permanent medical supervision of the patient.

At the moment there is no sufficient experience with sertraline in patients undergoing electroconvulsive therapy. Eventual success or 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 a violation of psychomotor functions. However, its use in conjunction with other drugs may impair attention and motor coordination. Therefore, during treatment with sertraline to drive vehicles or to engage in activities related to the increased risk is not recommended.

Sertraline (Asentra) Reviews

Other names Zoloft: Stimuloton, Asentra, certralina, Deprefolt, Seralina, Serenata, Serlift, Torin, Adyuvin.

... Zoloft - this is a wonderful drug! This is the first that I have appointed. Very strong anti-depressant! I was on it so cool ... and shivers ran, and hands numb, and it was getting dark Galaz and hallucinations were ... well I do not like this drug ...

... I took it for two days. On the first day I was so covered that I even have really thought the end ... I do not even speech center refused ... all in all instructions for antidepressants written that when a hallucination should stop taking the drug ... here ... I called the doctor - say - so and so - I have hallucinations - as she says - keep drinking ... says there is no more - and I believe it ... and the next day - my mother dear ... I was in shock and stopped short to take it ... then another read that there side effects in rare cases, death ... very interesting side effect - is not it ?? That's a good thought, it is better to kick in or live with panic attacks ... I chose panic attacks ... and began to take tranquilizers ... they are much softer, but the cause of panic attacks is not treated, but only eliminate the symptoms ... but output I have no ... that's ...

Well ... on myself and I checked what BP called Zoloft. Last night I was taken to the emergency room, because there was a very strong attack of the PA, I have all day twisted-nauseated, and in the evening caught spazm, shaking like never before, and I could not control it, cramped hands and feet, the head stopped, in short I thought I was dying, I thought a stroke happens. Mom with my brother scared exactly, and I myself was in shock!
In short a good thing in America ambulance come in 3 minutes ... we were loaded into the car and drove away. Held once a bunch of tests, to the point that thrust me into some kind of pipe and checked brain. In conclusion, I know that everything is fine on the analysis, and by the strongest attack occurred overstressed despite the fact that I spent the whole day lying in bed.
I do not want think, but after this experience with BP I get to the side of the opponents of this chemistry, and I will calm myself try more humane ways ...
Zoloft I took only 2 days, ie two tablets of 0.25

... Well that ends well ... and Zoloft - is evil itself ... 2 days only sustained, and well, he fucking - such aid ... does not cure, and cripples ...

... Hi! Zoloft - the active ingredient Sertraline ... started to drink and immediately went strong side effects, heart palpitations, anxiety began, although receiving sertraline me it was not, discomfort in the abdomen and chest, there was great excitement, dilated pupils, eyes were like a wolf ...

... As well that I have not bought a drink and did not ... I neuropathologist has written out, but somehow I'm not in a hurry with this ... right now I read the topic and pleased !!! ... I like all my life against drugs and against these pills that make me not from me ... and I want to be yourself !!! Without the intervention of my mind ...