Etopira
Generic Name
Topiramate 25 mg tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| etopira 25 mg tablet | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Topiramate is an anticonvulsant medication used to treat epilepsy and prevent migraine headaches. It can also be used off-label for other conditions under medical supervision.
Uses & Indications
Dosage
Adults
Epilepsy (Monotherapy): Initially 25 mg twice daily for 1 week, then gradually increase by 50 mg/week in 2 divided doses up to 100-200 mg/day. Max 500 mg/day. Migraine Prophylaxis: Initially 25 mg once daily at night for 1 week, then gradually increase by 25 mg/week up to 50 mg twice daily (100 mg/day).
Elderly
Dose adjustment may be necessary based on renal function. Initiate with lower doses and titrate slowly.
Renal_impairment
For creatinine clearance <70 mL/min, the usual adult dose should be reduced by 50%. Administer half the usual starting and maintenance dose, and titrate at a slower rate.
How to Take
Etopira tablets should be swallowed whole with plenty of fluids, with or without food. Do not chew or crush the tablets.
Mechanism of Action
Topiramate's anticonvulsant and migraine prophylactic actions are attributed to multiple mechanisms: potentiation of GABAergic activity, modulation of voltage-dependent sodium channels, antagonism of AMPA/kainate glutamate receptors, and weak carbonic anhydrase inhibition.
Pharmacokinetics
Onset
Variable, depending on the indication and titration schedule. Therapeutic effects are generally observed after several weeks of titration.
Excretion
Primarily renal; approximately 70% of the dose is excreted unchanged in the urine. Renal clearance is dose-dependent.
Half life
Approximately 21 hours in healthy adults. Longer half-life in renally impaired patients.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations occurring within 2 hours. Bioavailability is approximately 80%.
Metabolism
Minimally metabolized; less than 30% of an oral dose is metabolized, primarily by hydroxylation and hydrolysis. Minimal hepatic enzyme induction/inhibition.
Side Effects
Contraindications
- Hypersensitivity to topiramate or any component of the formulation
- Acute angle-closure glaucoma (due to carbonic anhydrase inhibition)
Drug Interactions
Valproic Acid
Concurrent use may increase the risk of hyperammonemia with or without encephalopathy.
CNS Depressants
Concomitant use with other CNS depressants (e.g., alcohol, benzodiazepines) may result in additive CNS depression.
Oral Contraceptives
Topiramate may decrease the efficacy of oral contraceptives containing estrogen. Patients should be advised to use alternative or additional birth control methods.
Carbonic Anhydrase Inhibitors
Concurrent use of other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide) may increase the risk of metabolic acidosis and kidney stone formation.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include convulsions, drowsiness, speech disturbance, blurred vision, diplopia, lethargy, ataxia, hypotension, abdominal pain. In acute overdose, hemodialysis is an effective method for removing topiramate from the body. Supportive measures should be instituted.
Pregnancy & Lactation
Pregnancy Category D. Topiramate can cause fetal harm when administered to a pregnant woman. Use only if the potential benefit outweighs the potential risk to the fetus. Topiramate is excreted in human milk; caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to topiramate or any component of the formulation
- Acute angle-closure glaucoma (due to carbonic anhydrase inhibition)
Drug Interactions
Valproic Acid
Concurrent use may increase the risk of hyperammonemia with or without encephalopathy.
CNS Depressants
Concomitant use with other CNS depressants (e.g., alcohol, benzodiazepines) may result in additive CNS depression.
Oral Contraceptives
Topiramate may decrease the efficacy of oral contraceptives containing estrogen. Patients should be advised to use alternative or additional birth control methods.
Carbonic Anhydrase Inhibitors
Concurrent use of other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide) may increase the risk of metabolic acidosis and kidney stone formation.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include convulsions, drowsiness, speech disturbance, blurred vision, diplopia, lethargy, ataxia, hypotension, abdominal pain. In acute overdose, hemodialysis is an effective method for removing topiramate from the body. Supportive measures should be instituted.
Pregnancy & Lactation
Pregnancy Category D. Topiramate can cause fetal harm when administered to a pregnant woman. Use only if the potential benefit outweighs the potential risk to the fetus. Topiramate is excreted in human milk; caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture, specific expiry date printed on the package.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Topiramate has been extensively evaluated in numerous randomized, placebo-controlled clinical trials across its approved indications, demonstrating significant efficacy in seizure control and migraine prophylaxis.
Lab Monitoring
- Serum bicarbonate levels (especially at baseline and periodically thereafter) for metabolic acidosis
- Renal function tests (creatinine, BUN) prior to and during treatment
- Electrolyte levels
- Intraocular pressure (if visual symptoms occur)
Doctor Notes
- Counsel patients regarding the risk of suicidal ideation and behavioral changes, emphasizing prompt reporting.
- Emphasize the importance of adequate hydration to mitigate the risk of nephrolithiasis.
- Monitor serum bicarbonate and renal function regularly, especially in patients at risk for metabolic acidosis or renal impairment.
- Advise women of childbearing potential about the decreased efficacy of oral contraceptives and the need for alternative birth control.
Patient Guidelines
- Take Etopira exactly as prescribed by your doctor.
- Drink plenty of fluids throughout the day to help prevent kidney stones.
- Report any changes in mood, behavior, or thoughts (especially suicidal thoughts) to your doctor immediately.
- Do not stop taking this medicine abruptly without consulting your doctor, as it can worsen your condition.
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 take a double dose to make up for a missed one.
Driving Precautions
Etopira may cause dizziness, somnolence, and impaired concentration. Patients should be cautioned about operating hazardous machinery, including automobiles, until they know how the drug affects them.
Lifestyle Advice
- Avoid alcohol consumption while taking Etopira, as it can increase CNS depressant effects.
- Stay adequately hydrated to minimize the risk of kidney stones.
- Monitor your weight regularly and report any significant changes to your doctor.
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