Setra
Generic Name
Sertraline
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
setra 50 mg tablet | ৳ 7.00 | ৳ 70.00 |
Description
Overview of the medicine
Sertraline is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, premenstrual dysphoric disorder, and social anxiety disorder.
Uses & Indications
Dosage
Adults
Initial 50 mg once daily, may be increased up to 200 mg once daily. Dosage adjustments should be made at intervals of at least one week.
Elderly
Similar to adult dosage, but titration should be done more cautiously due to potential for reduced clearance.
Renal_impairment
No dosage adjustment needed for mild to moderate renal impairment. Use with caution in severe impairment due to lack of data.
How to Take
Oral. May be taken with or without food. Should be taken consistently at the same time each day.
Mechanism of Action
Sertraline selectively inhibits the reuptake of serotonin (5-HT) by the presynaptic neuron, leading to increased serotonin concentration in the synaptic cleft and enhanced serotonergic neurotransmission.
Pharmacokinetics
Onset
Therapeutic effects may take 2-4 weeks to become apparent.
Excretion
About 40-45% excreted in urine and 40-45% in feces as metabolites.
Half life
Approximately 26 hours (range 22-36 hours).
Absorption
Well absorbed orally, peak plasma concentrations typically reached 4.5-8.4 hours after administration.
Metabolism
Extensively metabolized in the liver, primarily by CYP2C19, CYP2B6, CYP2D6, CYP3A4, CYP2C9 to an inactive metabolite, N-desmethylsertraline.
Side Effects
Contraindications
- Concomitant use with MAOIs (Monoamine Oxidase Inhibitors) or within 14 days of discontinuing an MAOI
- Concomitant use with pimozide
- Hypersensitivity to sertraline or any component of the formulation
Drug Interactions
MAOIs
Concurrent use can lead to serious, sometimes fatal, reactions including serotonin syndrome (e.g., hyperthermia, rigidity, mental status changes).
Pimozide
Increased pimozide levels, leading to QT prolongation and cardiac arrhythmias.
Warfarin
May increase prothrombin time; monitor INR.
Other serotonergic drugs (e.g., Triptans, Fentanyl, Lithium, Tramadol, St. John's Wort)
Increased risk of serotonin syndrome.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms include somnolence, vomiting, tachycardia, nausea, dizziness, agitation, tremor, and coma. Management is supportive and symptomatic; maintain airway, monitor cardiac and vital signs, gastric lavage, activated charcoal.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies the potential risk to the fetus. Small amounts excreted in breast milk; use with caution.
Side Effects
Contraindications
- Concomitant use with MAOIs (Monoamine Oxidase Inhibitors) or within 14 days of discontinuing an MAOI
- Concomitant use with pimozide
- Hypersensitivity to sertraline or any component of the formulation
Drug Interactions
MAOIs
Concurrent use can lead to serious, sometimes fatal, reactions including serotonin syndrome (e.g., hyperthermia, rigidity, mental status changes).
Pimozide
Increased pimozide levels, leading to QT prolongation and cardiac arrhythmias.
Warfarin
May increase prothrombin time; monitor INR.
Other serotonergic drugs (e.g., Triptans, Fentanyl, Lithium, Tramadol, St. John's Wort)
Increased risk of serotonin syndrome.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms include somnolence, vomiting, tachycardia, nausea, dizziness, agitation, tremor, and coma. Management is supportive and symptomatic; maintain airway, monitor cardiac and vital signs, gastric lavage, activated charcoal.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies the potential risk to the fetus. Small amounts excreted in breast milk; use with caution.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA and DGDA (for generic Sertraline)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated efficacy and safety of sertraline in major depressive disorder, OCD, panic disorder, PTSD, SAD, and PMDD.
Lab Monitoring
- Monitor for hyponatremia, especially in elderly and those on diuretics.
- Monitor coagulation parameters if co-administered with warfarin.
Doctor Notes
- Counsel patients on delayed onset of action (2-4 weeks) and the importance of adherence to therapy.
- Monitor patients for signs of serotonin syndrome, especially with concomitant use of other serotonergic agents.
- Warn patients about the Black Box Warning regarding suicidal ideation, particularly in pediatric and young adult populations. Closely monitor for clinical worsening and emergence of suicidal thoughts or unusual changes in behavior.
Patient Guidelines
- Take as directed by your doctor, usually once daily.
- Do not stop taking the medicine suddenly without consulting your doctor, as withdrawal symptoms may occur.
- It may take several weeks to feel the full effects of the medicine.
- Report any worsening depression or suicidal thoughts immediately to your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
May cause dizziness or drowsiness; use caution when driving or operating machinery until you know how it affects you.
Lifestyle Advice
- Avoid alcohol consumption.
- Engage in regular exercise and maintain a healthy diet.
- Seek therapy or counseling if recommended by your doctor.
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