Indus
Generic Name
Sertraline
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
indus 50 mg tablet | ৳ 5.50 | ৳ 55.00 |
Description
Overview of the medicine
Sertraline is an antidepressant belonging to the Selective Serotonin Reuptake Inhibitor (SSRI) class. It is used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, social anxiety disorder, and premenstrual dysphoric disorder.
Uses & Indications
Dosage
Adults
Initial: 50 mg once daily. May be increased at weekly intervals to a maximum of 200 mg/day.
Elderly
Lower initial doses (e.g., 25 mg/day) may be considered, with slower titration based on response and tolerability.
Renal_impairment
No significant dose adjustment generally needed for mild to moderate impairment. Use with caution in severe renal impairment.
How to Take
Administer orally once daily, in the morning or evening. May be taken with or without food. Swallow the tablet whole with water.
Mechanism of Action
Sertraline selectively inhibits the reuptake of serotonin (5-HT) by the presynaptic neuron, thereby increasing the concentration of serotonin in the synaptic cleft and enhancing serotonergic neurotransmission in the central nervous system.
Pharmacokinetics
Onset
Therapeutic effects may take 1-4 weeks to manifest.
Excretion
Approximately 40% excreted in urine and 45% in feces, primarily as metabolites.
Half life
Approximately 26 hours (parent drug), 62-104 hours (N-desmethylsertraline).
Absorption
Well absorbed orally; peak plasma levels in 4.5-8.4 hours.
Metabolism
Extensively metabolized in the liver by multiple CYP isoenzymes, primarily CYP2B6, CYP2C19, CYP2D6, CYP3A4, and CYP2C9.
Side Effects
Contraindications
- Known hypersensitivity to sertraline or any component of the formulation
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI
- Concomitant use with pimozide
Drug Interactions
MAOIs
Risk of serotonin syndrome (hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes).
Pimozide
Increased pimozide levels, QT prolongation, and cardiac arrhythmias.
Triptans
Risk of serotonin syndrome.
Warfarin
Potentiation of anticoagulant effect, increased bleeding risk.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, vomiting, tachycardia, nausea, dizziness, agitation, tremor, and coma. Management is supportive and symptomatic, with maintenance of airway, breathing, and circulation. Activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Sertraline is excreted in breast milk; caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Known hypersensitivity to sertraline or any component of the formulation
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI
- Concomitant use with pimozide
Drug Interactions
MAOIs
Risk of serotonin syndrome (hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes).
Pimozide
Increased pimozide levels, QT prolongation, and cardiac arrhythmias.
Triptans
Risk of serotonin syndrome.
Warfarin
Potentiation of anticoagulant effect, increased bleeding risk.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, vomiting, tachycardia, nausea, dizziness, agitation, tremor, and coma. Management is supportive and symptomatic, with maintenance of airway, breathing, and circulation. Activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Sertraline is excreted in breast milk; caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established sertraline's efficacy and safety for approved indications. Ongoing research explores its potential in other neuropsychiatric conditions and populations.
Lab Monitoring
- Liver function tests (in patients with hepatic impairment)
- Renal function tests (in patients with severe renal impairment)
- Serum sodium (in patients at risk of hyponatremia)
Doctor Notes
- Monitor for suicidal ideation, especially at treatment initiation or dose changes.
- Educate patients on the risk of serotonin syndrome when co-administered with other serotonergic agents.
- Emphasize gradual tapering of dose upon discontinuation to minimize withdrawal symptoms.
Patient Guidelines
- Take as directed by your doctor, do not stop abruptly without medical advice.
- It may take several weeks to feel the full benefits of the medication.
- Report any worsening depression or suicidal thoughts immediately to your doctor.
- Avoid alcohol while taking this medicine.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
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
- Engage in regular exercise and maintain a balanced diet.
- Consider psychotherapy or counseling as an adjunct to medication for better outcomes.
- Maintain a regular sleep schedule and practice stress reduction techniques.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.