Brand name: Zoloft

Active ingredient (generic name): Setraline

Manufacturer: Pfizer

Importer: Behestan Darou

Pharmacotherapeutic group: Antidepressant- Antianxiety

Pharmaceutical form: 50mg and 100mg film-coated tablets

Pharmacodynamic:

Sertraline is a potent and specific inhibitor of neuronal serotonin (5 HT) uptake in vitro, which results in the potentiation of the effects of 5-HT in animals. It has only very weak effects on norepinephrine and dopamine neuronal reuptake. At clinical doses, sertraline blocks the uptake of serotonin into human platelets. It is devoid of stimulant, sedative or anticholinergic activity or cardiotoxicity in animals. In controlled studies in normal volunteers, sertraline did not cause sedation and did not interfere with psychomotor performance. In accord with its selective inhibition of 5-HT uptake, sertraline does not enhance catecholaminergic activity. Sertraline has no affinity for muscarinic (cholinergic), serotonergic, dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine receptors.

Pharmacokinetic:

Sertraline exhibits dose proportional pharmacokinetics in the range of 50 to 200 mg. In man, following an oral once-daily dosage of 50 to 200 mg for 14 days, peak plasma concentrations of sertraline occur at 4.5 to 8.4 hours after the daily administration of the drug. Food does not significantly change the bioavailability of sertraline tablets. Approximately 98% of the circulating drug is bound to plasma proteins. Sertraline undergoes extensive first-pass hepatic metabolism. The mean half-life of sertraline is approximately 26 hours.

Therapeutic indication:

Sertraline is indicated for the treatment of:

Major depressive episodes. Prevention of recurrence of major depressive episodes.

Panic disorder, with or without agoraphobia.

Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years.

Social anxiety disorder.

Post traumatic stress disorder (PTSD).

Dosage and administration:

Depression and OCD

Sertraline treatment should be started at a dose of 50 mg/day.

Panic Disorder, PTSD, and Social Anxiety Disorder

Therapy should be initiated at 25 mg/day. After one week, the dose should be increased to 50 mg once daily. This dosage regimen has been shown to reduce the frequency of early treatment emergent side effects characteristic of panic disorder.

Depression, OCD, Panic Disorder, Social Anxiety Disorder and PTSD

Patients not responding to a 50 mg dose may benefit from dose increases. Dose changes should be made in steps of 50 mg at intervals of at least one week, up to a maximum of 200 mg/day. Changes in dose should not be made more frequently than once per week given the 24-hour elimination half life of sertraline.

The onset of therapeutic effect may be seen within 7 days. However, longer periods are usually necessary to demonstrate therapeutic response, especially in OCD.

Adverse reaction:

Nausea is the most common undesirable effect. In the treatment of social anxiety disorder, sexual dysfunction (ejaculation failure) in men occurred. These undesirable effects are dose dependent and are often transient in nature with continued treatment.

Insomnia, somnolence, dizziness, headache, tachycardia, psychosis, fatigue, Diarrhea and vomiting are other adverse reactions of Zoloft.

Contraindication:

Hypersensitivity to the active substance or any of the excipients.

Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome with symptoms such as agitation, tremor and hyperthermia. Sertraline must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI. Sertraline must be discontinued for at least 7 days before starting treatment with an irreversible MAOI.

Concomitant intake of pimozide is contraindicated.

Pharmacokinetic interactions:

Co-administration of sertraline 200 mg daily with warfarin resulted in a small but statistically significant increase in prothrombin time, which may in some rare cases unbalance the INR value.

Accordingly, prothrombin time should be carefully monitored when sertraline therapy is initiated or stopped.

Other drug interactions, digoxin, atenolol, cimetidine

Special warnings:

Sertraline must not be used in combination with irreversible MAOIs such as selegiline. Sertraline must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI. Sertraline must be discontinued for at least 7 days before starting treatment with an irreversible MAOI

The use of sertraline in patients with hepatic disease must be approached with caution.

Pregnancy and lactation:

Sertraline is not recommended in pregnancy, unless the clinical condition of the woman is such that the benefit of the treatment is expected to outweigh the potential risk.

Although small quantities of sertraline and its metabolite N-desmethylsertraline are excreted in milk, but no adverse effects on the health of infants nursed by mothers using sertraline have been reported, Anyway a risk cannot be excluded. Use in nursing mothers is not recommended unless, in the judgment of the physician, the benefit outweighs the risk.

Storage temperature:

Room temperature (15-25 C).

 

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