Etopira
Generic Name
Topiramate
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
etopira 50 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Topiramate is an antiepileptic drug used to treat various types of seizures and to prevent migraine headaches in adults and adolescents.
Uses & Indications
Dosage
Adults
Epilepsy (adjunctive): Initial 25-50 mg/day, titrated up to 100-400 mg/day in 2 divided doses. Migraine Prophylaxis: Initial 25 mg at night for 1 week, then titrate up by 25-50 mg/week to a recommended dose of 50-100 mg/day in 2 divided doses.
Elderly
Initiate with lower doses and titrate gradually, with careful monitoring for adverse effects due to potential decreased renal clearance.
Renal_impairment
Dosage reduction (e.g., half the usual dose) may be necessary in patients with moderate to severe renal impairment (CrCl <70 mL/min). Careful monitoring is required.
How to Take
Etopira tablets should be swallowed whole, with or without food. Do not chew or crush the tablets. Maintain adequate hydration while on therapy.
Mechanism of Action
Topiramate's exact mechanism is not fully understood but involves multiple actions: blockade of voltage-dependent sodium channels, enhancement of gamma-aminobutyrate (GABA) activity, antagonism of AMPA/kainate glutamate receptors, and inhibition of carbonic anhydrase.
Pharmacokinetics
Onset
Therapeutic effects for epilepsy may be observed over several days to weeks with titration. For migraine prophylaxis, benefits are usually seen within weeks.
Excretion
Primarily renal, with approximately 70% of an administered dose excreted unchanged in the urine.
Half life
Approximately 21 hours in adults, allowing for twice-daily dosing.
Absorption
Rapidly and well absorbed from the gastrointestinal tract. Bioavailability is approximately 80%. Peak plasma concentrations are achieved within 2-4 hours.
Metabolism
Minimally metabolized by the liver (about 20-30% in patients not taking other enzyme-inducing antiepileptic drugs), primarily excreted unchanged.
Side Effects
Contraindications
- Hypersensitivity to topiramate or any component of the formulation.
- Patients with metabolic acidosis taking metformin (due to increased risk of metabolic acidosis).
Drug Interactions
Metformin
Concomitant use with topiramate is contraindicated in patients with metabolic acidosis.
Valproic Acid
Concomitant use may increase the risk of hyperammonemia with or without encephalopathy.
Oral Contraceptives
May decrease the efficacy of oral contraceptives, requiring higher estrogen doses or alternative birth control methods.
CNS Depressants (e.g., alcohol, benzodiazepines)
May enhance CNS depression, leading to increased sedation, dizziness, and cognitive impairment.
Carbonic Anhydrase Inhibitors (e.g., acetazolamide)
Increased risk of metabolic acidosis and kidney stone formation.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, blurred vision, dizziness, diplopia, impaired thinking, lethargy, speech disturbance, uncoordinated body movement, stomach pain, hypotension, and seizures. Management involves gastric lavage, emesis, and supportive therapy. Hemodialysis is effective for removing topiramate.
Pregnancy & Lactation
Pregnancy Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable in certain situations. Not recommended during breastfeeding due to excretion into breast milk and potential for serious adverse reactions in the infant.
Side Effects
Contraindications
- Hypersensitivity to topiramate or any component of the formulation.
- Patients with metabolic acidosis taking metformin (due to increased risk of metabolic acidosis).
Drug Interactions
Metformin
Concomitant use with topiramate is contraindicated in patients with metabolic acidosis.
Valproic Acid
Concomitant use may increase the risk of hyperammonemia with or without encephalopathy.
Oral Contraceptives
May decrease the efficacy of oral contraceptives, requiring higher estrogen doses or alternative birth control methods.
CNS Depressants (e.g., alcohol, benzodiazepines)
May enhance CNS depression, leading to increased sedation, dizziness, and cognitive impairment.
Carbonic Anhydrase Inhibitors (e.g., acetazolamide)
Increased risk of metabolic acidosis and kidney stone formation.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, blurred vision, dizziness, diplopia, impaired thinking, lethargy, speech disturbance, uncoordinated body movement, stomach pain, hypotension, and seizures. Management involves gastric lavage, emesis, and supportive therapy. Hemodialysis is effective for removing topiramate.
Pregnancy & Lactation
Pregnancy Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable in certain situations. Not recommended during breastfeeding due to excretion into breast milk and potential for serious adverse reactions in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, specific expiry date is printed on the packaging.
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generically available
WHO Essential Medicine
YesClinical Trials
Topiramate has been extensively studied in numerous clinical trials demonstrating its efficacy and safety for various seizure types and migraine prophylaxis in both adult and pediatric populations.
Lab Monitoring
- Monitor serum bicarbonate levels before and periodically during treatment due to risk of metabolic acidosis.
- Monitor renal function (creatinine clearance) at baseline and periodically.
- Monitor for signs and symptoms of kidney stones.
- Monitor intraocular pressure if visual symptoms occur.
Doctor Notes
- Emphasize gradual titration to minimize side effects.
- Counsel patients on the importance of hydration to prevent nephrolithiasis.
- Monitor for signs of metabolic acidosis, cognitive changes, and mood disturbances.
- Advise patients to report any visual disturbances immediately due to the risk of acute glaucoma.
Patient Guidelines
- Take Etopira exactly as prescribed by your doctor.
- Do not stop taking Etopira suddenly, as it can worsen seizures. Taper off gradually under medical supervision.
- Stay well-hydrated throughout the day to reduce the risk of kidney stones.
- Report any unusual changes in mood, behavior, or vision 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 your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Etopira may cause dizziness, somnolence, blurred vision, and other central nervous system effects. Patients should not drive or operate complex machinery until they are reasonably certain that Etopira does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- Maintain adequate fluid intake to prevent kidney stone formation.
- Avoid alcohol and other CNS depressants as they can increase drowsiness and dizziness.
- Regular exercise and a balanced diet can help manage weight, as topiramate can cause weight loss.
- Be aware of potential heat intolerance, especially during physical activity or in warm environments.
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