Zotral

Zotral

sertraline

Manufacturer:

Micro Labs

Distributor:

Zizawa Healthcare
Full Prescribing Info
Contents
Sertraline HCl.
Action
Antidepressant.
Pharmacology: Serotonin is 5-hydroxytryptamine (5-HT), the mechanism of which is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin (5-HT). Sertraline hydrochloride blocks the uptake of serotonin into human platelets.
Pharmacokinetics: In man, following oral once-daily dosing over the range of 50-200 mg for 14 days, mean peak plasma concentrations (Cmax) of sertraline hydrochloride occurred between 4.5-8.4 hrs post-dosing. The average terminal elimination half-life of plasma sertraline is about 26 hrs. Based on this pharmacokinetic parameter, steady-state sertraline plasma levels should be achieved after approximately 1 week of once-daily dosing. The effects of food on the bioavailability of sertraline hydrochloride on subjects administered with a single dose showed AUC slightly increased. The Cmax was 25% greater, while the time to reach peak plasma concentration decreased from 8 hrs post-dosing to 5.5 hrs.
Indications/Uses
Treatment of major depressive disorder; obsessive-compulsive disorder; and panic disorder.
Dosage/Direction for Use
Treatment and Prevention of Recurrence of Depression: Initial Dosage: 50 mg once daily is recommended. Upward titration (in 50-mg increments at intervals of at least 1 week) to a maximum daily dosage of 200 mg may be advised in patients who do not respond to 50 mg daily.
Same dosage regimen is effective for treatment of patients with obsessive-compulsive disorder (OCD).
Although dosage adjustments are not required in elderly patients, sertraline should be administered with caution in patients with renal or hepatic impairment.
Overdosage
Symptoms: Somnolence, nausea, vomiting, tachycardia, ECG changes, anxiety and dilated pupils.
Treatment: Treatment included monitoring and use of activated charcoal, gastric lavage or cathartics and hydration.
Contraindications
Patients with known hypersensitivity to sertraline.
Special Precautions
The concomitant use of sertraline and monoamine oxidase inhibitors (MAOIs) should be avoided. Based on the experience of tricyclic antidepressants at least 14 days should elapse between discontinuation of MAOIs and initiation of sertraline. In patients taking ECT, sertraline administration should be avoided because of lack of experience.
Use in pregnancy: As there are no adequate and well-controlled studies in pregnant women, Zotral should be used in pregnancy only if clearly needed.
Use in lactation: It is not known whether, and if so in what amount, sertraline or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sertraline is given to lactating mothers.
Use in children: Safety and effectiveness in children has not been established.
Use In Pregnancy & Lactation
Use in pregnancy: As there are no adequate and well-controlled studies in pregnant women, Zotral should be used in pregnancy only if clearly needed.
Use in lactation: It is not known whether, and if so in what amount, sertraline or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sertraline is given to lactating mothers.
Adverse Reactions
Sertraline is generally well tolerated. Adverse reactions are usually dose related, mild and transient in nature and decrease in frequency as treatment is continued.
Side Effects
The common side effects include nausea, diarrhoea, dry mouth, headache, insomnia, dizziness, tremors, fatigue and somnolence. As with other serotonin re-uptake inhibitors, sertraline causes lower incidence of anticholinergic, cardiovascular and sedative effects.
Drug Interactions
There are potential effects of co-administration of drugs bound to plasma proteins. Because sertraline hydrochloride is tightly bound to plasma protein, the administration of Zotral to patients taking another drug which is tightly bound to plasma proteins (eg, warfarin, digitoxin) may cause a lift in plasma concentration resulting in adverse effects.
Storage
Store below 25°C, in a dry place. Protect from direct sunlight.
MIMS Class
ATC Classification
N06AB06 - sertraline ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Presentation/Packing
FC tab 50 mg x 10 x 10's. 100 mg x 10 x 10's.
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