Setra
Generic Name
Sertraline
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| setra 25 mg tablet | ৳ 4.00 | ৳ 40.00 |
Description
Overview of the medicine
Sertraline is an antidepressant used to treat various mood and anxiety disorders including major depressive disorder, obsessive-compulsive disorder, panic disorder, and post-traumatic stress disorder.
Uses & Indications
Dosage
Adults
Initial: 25-50 mg once daily. For MDD/OCD, usually 50 mg/day. Max: 200 mg/day. Doses should be titrated gradually.
Elderly
Start with lower doses (e.g., 25 mg/day) and titrate carefully, considering potential for decreased clearance and increased sensitivity.
Renal_impairment
No dosage adjustment required for mild to moderate renal impairment. Use with caution in severe renal impairment.
How to Take
Oral, usually once daily, with or without food. To be swallowed whole with water.
Mechanism of Action
Sertraline selectively inhibits the reuptake of serotonin (5-HT) in the brain, leading to increased serotonin concentrations in the synaptic cleft, thereby enhancing serotonergic neurotransmission.
Pharmacokinetics
Onset
Antidepressant effects usually observed after 2-4 weeks of treatment; full effect may take 6-8 weeks.
Excretion
Excreted primarily via feces (approx. 40-45%) and urine (approx. 40-45%) as metabolites.
Half life
Approximately 26 hours for sertraline, and 62-104 hours for its active metabolite desmethylsertraline.
Absorption
Well absorbed orally, peak plasma concentration after 4.5-8.4 hours. Bioavailability is enhanced with food.
Metabolism
Primarily hepatic metabolism via CYP2C19, CYP2B6, CYP2D6, CYP3A4, CYP2C9, and CYP1A2 into an active N-desmethyl metabolite.
Side Effects
Contraindications
- Concomitant use with MAOIs (Monoamine Oxidase Inhibitors) or within 14 days of discontinuing an MAOI (risk of serotonin syndrome).
- Concomitant use with pimozide.
- Hypersensitivity to sertraline or any component of the formulation.
Drug Interactions
Lithium
Increased risk of tremor and other serotonergic effects.
Diazepam
May reduce the clearance of diazepam.
Pimozide
Concomitant use is contraindicated due to increased pimozide levels and potential for QT prolongation.
Warfarin
Potentiation of anticoagulant effect, requiring careful INR monitoring.
NSAIDs, Aspirin
Increased risk of bleeding, especially gastrointestinal bleeding.
Tricyclic Antidepressants (TCAs)
May increase TCA plasma levels, requiring dose adjustment.
MAOIs (Monoamine Oxidase Inhibitors)
Concomitant use is contraindicated due to increased risk of serotonin syndrome.
Storage
Store in a cool, dry place below 30°C, protected from light and moisture. Keep out of reach and sight of children.
Overdose
Symptoms of overdose include somnolence, vomiting, tachycardia, tremor, agitation, dizziness, and rarely, seizures or coma. Management is primarily supportive, involving maintaining an open airway, monitoring cardiac and vital signs, and symptomatic treatment. Gastric lavage and activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit outweighs the potential risk to the fetus. Sertraline is excreted in breast milk; caution advised, and a risk/benefit assessment should be performed before use during lactation.
Side Effects
Contraindications
- Concomitant use with MAOIs (Monoamine Oxidase Inhibitors) or within 14 days of discontinuing an MAOI (risk of serotonin syndrome).
- Concomitant use with pimozide.
- Hypersensitivity to sertraline or any component of the formulation.
Drug Interactions
Lithium
Increased risk of tremor and other serotonergic effects.
Diazepam
May reduce the clearance of diazepam.
Pimozide
Concomitant use is contraindicated due to increased pimozide levels and potential for QT prolongation.
Warfarin
Potentiation of anticoagulant effect, requiring careful INR monitoring.
NSAIDs, Aspirin
Increased risk of bleeding, especially gastrointestinal bleeding.
Tricyclic Antidepressants (TCAs)
May increase TCA plasma levels, requiring dose adjustment.
MAOIs (Monoamine Oxidase Inhibitors)
Concomitant use is contraindicated due to increased risk of serotonin syndrome.
Storage
Store in a cool, dry place below 30°C, protected from light and moisture. Keep out of reach and sight of children.
Overdose
Symptoms of overdose include somnolence, vomiting, tachycardia, tremor, agitation, dizziness, and rarely, seizures or coma. Management is primarily supportive, involving maintaining an open airway, monitoring cardiac and vital signs, and symptomatic treatment. Gastric lavage and activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit outweighs the potential risk to the fetus. Sertraline is excreted in breast milk; caution advised, and a risk/benefit assessment should be performed before use during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, specific details on packaging.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Patent expired, available as generics
WHO Essential Medicine
YesClinical Trials
Sertraline has been extensively studied in numerous randomized, placebo-controlled clinical trials, demonstrating significant efficacy in the treatment of major depressive disorder, OCD, panic disorder, PTSD, social anxiety disorder, and PMDD across various patient populations.
Lab Monitoring
- Monitor for worsening depression, suicidal ideation, and unusual changes in behavior, especially at the initiation of therapy or after dose changes.
- Electrolyte levels (especially sodium) in at-risk patients (e.g., elderly, those on diuretics) for hyponatremia.
- Liver function tests in patients with hepatic impairment.
- INR monitoring for patients concomitantly taking warfarin.
Doctor Notes
- Counsel patients on the delayed onset of action (2-4 weeks) and the importance of continued adherence for optimal therapeutic outcomes.
- Monitor patients closely for worsening depression, suicidal ideation, and unusual behavioral changes, especially during initial therapy or dose adjustments.
- Emphasize the need for gradual dose tapering when discontinuing treatment to minimize withdrawal symptoms.
- Consider potential drug interactions, especially with MAOIs, pimozide, and drugs affecting serotonin levels.
Patient Guidelines
- Do not stop taking this medication suddenly, as it can cause withdrawal symptoms. Consult your doctor for gradual tapering.
- It may take several weeks to feel the full therapeutic effects of the medication. Continue taking it as prescribed.
- Report any worsening mood, suicidal thoughts, unusual behavior changes, or new symptoms to your doctor immediately.
- Avoid driving or operating heavy machinery until you know how this medicine affects you.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at once.
Driving Precautions
Sertraline may cause dizziness, drowsiness, or visual disturbances. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that sertraline therapy does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- Avoid alcohol consumption while taking sertraline, as it can worsen side effects and depressive symptoms.
- Engage in regular physical activity and maintain a balanced diet for overall well-being.
- Practice good sleep hygiene; aim for a consistent sleep schedule to aid mood regulation.
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