Zosert
Generic Name
Sertraline
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zosert 25 mg tablet | ৳ 3.01 | ৳ 30.10 |
Description
Overview of the medicine
Zosert 25 mg Tablet is an antidepressant medicine that belongs to the Selective Serotonin Reuptake Inhibitor (SSRI) class. It is primarily used to treat major depressive disorder, obsessive-compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), social anxiety disorder, and premenstrual dysphoric disorder (PMDD).
Uses & Indications
Dosage
Adults
Initial dose 25 mg or 50 mg once daily. May be increased gradually over weeks to a maximum of 200 mg/day depending on the condition. For MDD and OCD, typical starting dose is 50 mg/day. For panic disorder, PTSD, social anxiety disorder, and PMDD, initial dose is 25 mg/day.
Elderly
Lower initial doses may be considered, starting with 25 mg once daily, and titrated cautiously due to potential for increased sensitivity and slower clearance.
Renal_impairment
No significant dose adjustment needed for mild to moderate renal impairment. Caution advised in severe renal impairment as sertraline metabolites may accumulate.
How to Take
Take Zosert 25 mg Tablet orally, once daily, with or without food. It is recommended to take it at the same time each day, preferably in the morning or evening.
Mechanism of Action
Sertraline works by selectively inhibiting the reuptake of serotonin by neurons in the central nervous system. This increases the concentration of serotonin in the synaptic cleft, thereby enhancing serotonergic neurotransmission and alleviating symptoms of depression and anxiety disorders.
Pharmacokinetics
Onset
Therapeutic effects usually begin within 2-4 weeks, though some patients may experience benefits sooner.
Excretion
Approximately 40-45% excreted in urine and 40-45% in feces, mainly as metabolites.
Half life
Approximately 26 hours for sertraline and 62-104 hours for its primary active metabolite, N-desmethylsertraline.
Absorption
Well absorbed orally, with peak plasma concentrations occurring between 4.5 to 8.4 hours after administration. Food slightly increases absorption.
Metabolism
Extensively metabolized in the liver, primarily via CYP2C19, CYP2B6, CYP2C9, CYP3A4, and CYP2D6 enzymes, to N-desmethylsertraline and other inactive metabolites.
Side Effects
Contraindications
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI.
- Concomitant use with pimozide.
- Known hypersensitivity to sertraline or any component of the formulation.
- Concomitant use with disulfiram (for oral solution due to alcohol content).
Drug Interactions
Alcohol
Enhances CNS depressant effects; concomitant use not recommended.
Pimozide
Increased pimozide levels, risk of QT prolongation and cardiac arrhythmias. Contraindicated.
Warfarin
Potentiation of anticoagulant effect, leading to increased bleeding risk. Monitor INR.
MAOIs (e.g., phenelzine, selegiline)
Risk of serious, sometimes fatal, serotonin syndrome. Avoid concomitant use.
Other Serotonergic Drugs (e.g., triptans, TCAs, 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 of overdose include somnolence, nausea, vomiting, tachycardia, tremor, agitation, dizziness, and rarely, coma. Management is primarily supportive; maintain an open airway, monitor cardiac and vital signs. There is no specific antidote for sertraline overdose.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SSRIs in late pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Sertraline is excreted in human breast milk; caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI.
- Concomitant use with pimozide.
- Known hypersensitivity to sertraline or any component of the formulation.
- Concomitant use with disulfiram (for oral solution due to alcohol content).
Drug Interactions
Alcohol
Enhances CNS depressant effects; concomitant use not recommended.
Pimozide
Increased pimozide levels, risk of QT prolongation and cardiac arrhythmias. Contraindicated.
Warfarin
Potentiation of anticoagulant effect, leading to increased bleeding risk. Monitor INR.
MAOIs (e.g., phenelzine, selegiline)
Risk of serious, sometimes fatal, serotonin syndrome. Avoid concomitant use.
Other Serotonergic Drugs (e.g., triptans, TCAs, 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 of overdose include somnolence, nausea, vomiting, tachycardia, tremor, agitation, dizziness, and rarely, coma. Management is primarily supportive; maintain an open airway, monitor cardiac and vital signs. There is no specific antidote for sertraline overdose.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SSRIs in late pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Sertraline is excreted in human breast milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from the date of manufacture, specific expiry date mentioned on the pack.
Availability
Available in pharmacies, hospitals and clinics
Approval Status
Approved (DGDA, FDA)
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Sertraline has undergone extensive clinical trials demonstrating its efficacy and safety in the treatment of various psychiatric disorders, including numerous placebo-controlled and active-comparator studies.
Lab Monitoring
- Monitor serum sodium levels, especially in elderly patients or those on diuretics, due to risk of hyponatremia.
- Monitor liver function tests periodically, especially in patients with hepatic impairment.
Doctor Notes
- Counsel patients on the delayed onset of therapeutic action and the importance of continuous treatment.
- Monitor for emergent suicidality, especially at the initiation of therapy or dose changes, particularly in younger patients.
- Be aware of serotonin syndrome risk when co-administered with other serotonergic agents. Warn patients about withdrawal symptoms upon abrupt discontinuation.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor. Do not stop taking it suddenly without consulting your doctor, as this may cause withdrawal symptoms.
- It may take several weeks for the full therapeutic effect to be noticed.
- Report any unusual mood changes, worsening depression, or suicidal thoughts to your doctor immediately.
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 dosing schedule. Do not double the dose to catch up.
Driving Precautions
Zosert may cause dizziness, drowsiness, or impaired judgment. Patients should be cautious when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Avoid alcohol consumption while taking Zosert, as it may enhance CNS depressant effects.
- Engage in regular physical activity and maintain a healthy diet to support overall well-being.
- Consider psychotherapy or counseling in conjunction with medication for better outcomes in depression and anxiety disorders.
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