Tumpa
Generic Name
Sertarol Hydrochloride
Manufacturer
MediCare Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tumpa 50 mg tablet | ৳ 6.00 | ৳ 60.00 |
Description
Overview of the medicine
Tumpa 50 mg Tablet is an antidepressant medicine containing Sertarol Hydrochloride as its active ingredient. It is primarily used to treat major depressive disorder, panic disorder, obsessive-compulsive disorder (OCD), and post-traumatic stress disorder (PTSD). It helps restore the balance of serotonin, a natural substance in the brain, improving mood and well-being.
Uses & Indications
Dosage
Adults
Initial dose 50 mg once daily. May be increased up to a maximum of 200 mg daily, typically in increments of 50 mg at weekly intervals. Administered once daily, morning or evening, with or without food.
Elderly
Lower initial doses (e.g., 25 mg) and slower titration may be recommended due to increased sensitivity and potential for adverse effects. Max dose may also be lower.
Renal_impairment
No dosage adjustment typically required for mild to moderate renal impairment. Use with caution in severe impairment as data are limited.
How to Take
Take orally, with or without food, at the same time each day to maintain consistent drug levels. Tablets should be swallowed whole, not crushed or chewed.
Mechanism of Action
Sertarol Hydrochloride selectively inhibits the reuptake of serotonin (5-HT) by presynaptic neurons in the central nervous system, leading to an increased concentration of serotonin in the synaptic cleft. This potentiation of serotonergic neurotransmission is believed to be responsible for its antidepressant and anxiolytic effects.
Pharmacokinetics
Onset
Clinical effects typically observed within 2-4 weeks, with full effect potentially taking longer.
Excretion
Excreted in urine and feces as metabolites. Less than 2% is excreted unchanged in urine.
Half life
Approximately 26-32 hours (for Sertarol and its active metabolite, N-desmethylsertarol).
Absorption
Well absorbed orally, peak plasma concentrations reached in 4-8 hours. Bioavailability is approximately 45%.
Metabolism
Extensively metabolized in the liver, primarily by CYP2C19 and CYP3A4, to an active metabolite (N-desmethylsertarol) and inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Sertarol Hydrochloride 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 due to potential for QTc prolongation
- Known history of serotonin syndrome
Drug Interactions
MAOIs
Concomitant use is contraindicated due to a high risk of developing serotonin syndrome (symptoms include hyperthermia, rigidity, mental status changes, autonomic instability).
Pimozide
Concomitant use is contraindicated due to potential for QTc prolongation and cardiac arrhythmias.
Triptans
Increased risk of serotonin syndrome when co-administered. Use with caution and monitor for symptoms.
Warfarin
Increased risk of bleeding due to effects on platelet aggregation and inhibition of CYP2C9, which metabolizes warfarin. Close monitoring of INR is recommended.
CYP2D6 Substrates
Sertarol is a moderate inhibitor of CYP2D6, potentially increasing plasma concentrations of drugs metabolized by this enzyme (e.g., flecainide, propafenone, metoprolol, some tricyclic antidepressants).
Other Serotonergic Drugs
Concomitant use with other SSRIs, SNRIs, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, or St. John's Wort may increase the risk of serotonin syndrome.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach and sight of children. Do not freeze.
Overdose
Symptoms of overdose include somnolence, vomiting, tachycardia, tremor, agitation, dizziness, and rarely, convulsions and coma. Management involves supportive and symptomatic treatment, maintaining airway, and monitoring cardiac and vital signs. Induction of emesis is not recommended. Gastric lavage and activated charcoal may be considered if performed soon after ingestion. No specific antidote is known.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Sertarol is excreted in small amounts in breast milk; consult a doctor before breastfeeding as potential risks to the infant cannot be ruled out.
Side Effects
Contraindications
- Hypersensitivity to Sertarol Hydrochloride 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 due to potential for QTc prolongation
- Known history of serotonin syndrome
Drug Interactions
MAOIs
Concomitant use is contraindicated due to a high risk of developing serotonin syndrome (symptoms include hyperthermia, rigidity, mental status changes, autonomic instability).
Pimozide
Concomitant use is contraindicated due to potential for QTc prolongation and cardiac arrhythmias.
Triptans
Increased risk of serotonin syndrome when co-administered. Use with caution and monitor for symptoms.
Warfarin
Increased risk of bleeding due to effects on platelet aggregation and inhibition of CYP2C9, which metabolizes warfarin. Close monitoring of INR is recommended.
CYP2D6 Substrates
Sertarol is a moderate inhibitor of CYP2D6, potentially increasing plasma concentrations of drugs metabolized by this enzyme (e.g., flecainide, propafenone, metoprolol, some tricyclic antidepressants).
Other Serotonergic Drugs
Concomitant use with other SSRIs, SNRIs, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, or St. John's Wort may increase the risk of serotonin syndrome.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach and sight of children. Do not freeze.
Overdose
Symptoms of overdose include somnolence, vomiting, tachycardia, tremor, agitation, dizziness, and rarely, convulsions and coma. Management involves supportive and symptomatic treatment, maintaining airway, and monitoring cardiac and vital signs. Induction of emesis is not recommended. Gastric lavage and activated charcoal may be considered if performed soon after ingestion. No specific antidote is known.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Sertarol is excreted in small amounts in breast milk; consult a doctor before breastfeeding as potential risks to the infant cannot be ruled out.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture when stored under recommended conditions.
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Patent expired
Clinical Trials
Extensive randomized, placebo-controlled clinical trials have demonstrated the efficacy and safety of Sertarol Hydrochloride across various depressive and anxiety disorders. Studies have shown significant improvement in Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) scores compared to placebo.
Lab Monitoring
- Liver function tests (periodically, especially in patients with pre-existing hepatic impairment)
- Renal function tests (periodically, in patients with severe renal impairment)
- Electrolytes (especially sodium, in patients at risk for hyponatremia)
- Thyroid function tests (if clinically indicated)
Doctor Notes
- Counsel patients on potential delayed onset of therapeutic effects (2-4 weeks) and the importance of continuous adherence to treatment to achieve optimal outcomes.
- Monitor for signs of clinical worsening, suicidality, or unusual behavioral changes, particularly during initial therapy or dose adjustments, especially in young adults.
- Emphasize the importance of gradual dose reduction under medical supervision to avoid discontinuation symptoms if treatment needs to be stopped.
- Advise patients about potential drug interactions, especially with MAOIs, other serotonergic drugs, and drugs affecting platelet function.
Patient Guidelines
- Do not stop taking Tumpa suddenly, even if you feel better, without consulting your doctor, as abrupt discontinuation can lead to withdrawal symptoms.
- It may take several weeks (typically 2-4 weeks) to feel the full antidepressant effects. Continue taking the medicine as prescribed.
- Report any suicidal thoughts, worsening depression, or unusual changes in mood or behavior to your doctor immediately.
- Avoid consuming alcohol while taking this medicine as it may worsen central nervous system side effects.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose (within 8-12 hours). Do not double the dose to catch up, as this may increase the risk of side effects.
Driving Precautions
Tumpa may cause dizziness, drowsiness, or impaired judgment. Patients should be advised to exercise caution when driving or operating heavy machinery until they are reasonably certain that the medicine does not adversely affect their ability to perform such activities.
Lifestyle Advice
- Engage in regular physical activity, which can help improve mood and reduce anxiety.
- Maintain a balanced diet and ensure adequate sleep for overall well-being.
- Consider psychotherapy, counseling, or support groups as complementary treatments alongside medication.
- Practice stress-reduction techniques such as meditation or mindfulness.
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