Sertal
Generic Name
Sertraline
Manufacturer
ACME Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sertal 25 mg tablet | ৳ 3.00 | ৳ 30.00 |
Description
Overview of the medicine
Sertal 25 mg tablet contains Sertraline, an antidepressant used to treat depression, obsessive-compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), social anxiety disorder, and premenstrual dysphoric disorder (PMDD). It helps to restore the balance of a natural substance (serotonin) in the brain.
Uses & Indications
Dosage
Adults
Initial dose 25-50 mg once daily, may be increased gradually up to 200 mg daily as tolerated. For OCD, initial dose 50 mg once daily.
Elderly
Similar to adult dosage, but initiate at a lower dose (e.g., 25 mg daily) and titrate slowly, monitoring for adverse effects.
Renal_impairment
No dosage adjustment generally required for mild to moderate renal impairment. Use with caution in severe renal impairment.
How to Take
Take orally once daily, in the morning or evening, with or without food. To minimize gastrointestinal upset, it is often recommended to take it with food.
Mechanism of Action
Sertraline selectively inhibits 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 typically observed within 1-4 weeks, full effect may take 6-12 weeks.
Excretion
Approximately 40-45% excreted in urine and 40-45% in feces as metabolites; less than 0.2% excreted unchanged in urine.
Half life
Approximately 26 hours (22-36 hours) for sertraline; 62-104 hours for the active metabolite, N-desmethylsertraline.
Absorption
Well absorbed after oral administration, peak plasma concentrations reached in 4.5-8.4 hours.
Metabolism
Extensively metabolized in the liver, primarily via CYP2C19, CYP2B6, CYP2D6, CYP3A4, and CYP2C9, to an active metabolite (N-desmethylsertraline) and other inactive metabolites.
Side Effects
Contraindications
- 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
Concurrent use may lead to serious, sometimes fatal, reactions including serotonin syndrome.
Pimozide
Increased pimozide levels and potential for cardiac effects.
Warfarin
May prolong prothrombin time (INR); monitor closely.
Serotonergic drugs
Increased risk of serotonin syndrome (e.g., triptans, fentanyl, tramadol, lithium, St. John's Wort).
Other CNS depressants
Additive effects with alcohol and other CNS depressants.
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 rarely, coma. Management is primarily supportive; maintain airway, monitor cardiac and vital signs. Activated charcoal may be considered. No specific antidote.
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 breast milk; caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- 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
Concurrent use may lead to serious, sometimes fatal, reactions including serotonin syndrome.
Pimozide
Increased pimozide levels and potential for cardiac effects.
Warfarin
May prolong prothrombin time (INR); monitor closely.
Serotonergic drugs
Increased risk of serotonin syndrome (e.g., triptans, fentanyl, tramadol, lithium, St. John's Wort).
Other CNS depressants
Additive effects with alcohol and other CNS depressants.
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 rarely, coma. Management is primarily supportive; maintain airway, monitor cardiac and vital signs. Activated charcoal may be considered. No specific antidote.
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 breast milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
3 years from manufacturing date
Availability
Pharmacies nationwide
Approval Status
Approved by FDA/DGDA
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Sertraline has undergone extensive clinical trials demonstrating its efficacy and safety for approved indications, with studies ranging from short-term to long-term (up to 1 year) in various patient populations.
Lab Monitoring
- Monitor serum sodium levels periodically, especially in elderly patients, those taking diuretics, or patients who are otherwise volume depleted, due to risk of hyponatremia.
- Liver function tests in patients with hepatic impairment.
Doctor Notes
- Initiate at a low dose and gradually increase to achieve therapeutic effect while monitoring for adverse reactions.
- Educate patients about the delayed onset of action and the importance of continued treatment even if symptoms improve.
- Closely monitor for suicidal ideation, particularly at the beginning of treatment or after dosage changes, especially in young patients.
- Advise patients against abrupt discontinuation to prevent withdrawal symptoms.
Patient Guidelines
- Do not stop taking this medicine abruptly without consulting your doctor, as withdrawal symptoms may occur.
- It may take several weeks to notice the full benefits of this medication.
- Report any worsening of depression, suicidal thoughts, or unusual changes in behavior to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not double the dose.
Driving Precautions
Sertraline may cause dizziness, drowsiness, or visual disturbances. Avoid driving or operating heavy machinery until you know how this medicine affects you.
Lifestyle Advice
- Avoid alcohol consumption while taking sertraline.
- Maintain a healthy lifestyle, including regular exercise and a balanced diet.
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