ETOPIRA

TOPIRAMATE

This drug is used to treat epilepsy in both children and adults. In children it is also indicated for treatment of Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delay). It is now most frequently prescribed for the prevention of migraines. It has been used by psychiatrists to treat bipolar disorder and alcoholism. The drug is also used to treat Post Traumatic Stress Disorder. Studies suggest that Topiramate is effective against infantile spasms. Monotherapy in Epilepsy: Topiramate is indicated as initial monotherapy in patients of 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Adjunctive Therapyin Epilepsy: Topiramate is indicated as adjunctive therapy for adults and pediatric patients ages 2-16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome. Migraine: Topiramate is indicated for adults for the prophylaxis of migraine headache.

Adjunct anti-epileptic drugs

Tolterodine is a competitive, specific muscarinic receptor antagonist which exhibits a selectivity for the urinary bladder over salivary glands, which have been demonstrated in non clinical pharmacological in vivo studies. Tolterodine has a high specificity for muscarinic receptors. A major active metabolite (5-hydroxymethyl derivative) of tolterodine exhibits a pharmacological profile which is similar to that of the parent compound. In extensive metabolisers this metabolite contributes significantly to the therapeutic effect of tolterodine. The effect of treatment can be expected within 4 weeks.

The initial dose normally is low and increased in slow steps.The usual initial dose is 25 to 50 mg daily in 2 single doses. Recommended increments are 25 to 50 mg every 1 or 2 weeks. Common doses for maintenance treatment are 100 to 200 mg daily. The highest dose possible is 1,000 mg daily in divided doses. Monotherapy Use: The recommended maximum dose for Topiramate monotherapy in adults and children 10 years of age and older is 400 mg/day in two divided doses. Adjunctive Therapy Use Adults (17 Years of Age and Over): The recommended total daily dose of Topiramate is 400 mg/day in Partial Seizures or Primary Generalized Tonic-Clonic Seizures. Daily doses above 1600 mg have not been studied. Pediatric Patients (Ages 2 to 16 Years): Partial Seizures or Primary Generalized Tonic-Clonic Seizures The recommended total daily dose of Topiramate tablets as adjunctive therapy for patients with partial seizures or primary generalized tonic-clonic seizures is approximately 5 to 9 mg/kg/day in two divided doses.Titration should begin at 25 mg (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1 or 2 week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Dose titration should be guided by clinical outcome.Topiramate tablets can be taken without regards to meals.

Potential interactions between Topiramate and standard AEDs like Phenytoin, Carbamazepine and Valproic acid were observed during the concomitant treatment with these drugs for antiepileptic patients. Beside these. Concomitant use of Topiramate, a carbonic anhydrase inhibitor, with other carbonic anhydrase inhibitors, e.g., acetazolamide or dichlorphenamide, may create a physiological environment that increases the risk of renal stone formation. Digoxin, CNS depressants, oral contraceptives. Hydrochlorothiazide (HCTZ) may also interact with Topiramate.

Topiramate tablets are contraindicated in patients with a history of hypersensitivity to any component of this product.

The most common side effects include a change in taste and feelings of pins and needles in the head and extremities. Less common side effects include cognitive deficiency (particularly word-finding difficulty); difficulty in understanding, grogginess, lethargy, renal (kidney) stones, vision abnormality, weight loss, breast pain, abdominal pain, intense sweating, menstrual disorder and dry mouth.

Topiramate is pregnancy category C. So it may be given only if clearly needed and after the assessment of risk benefit ratio. It is not known whether Topiramate is excreted through breast milk. So caution should be taken if it is prescribed to a breast feeding mother.

Overdoses of Topiramate includes convulsions, drowsiness, speech disturbance, blurred vision, diplopia, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression.The clinical consequences are not severe. Topiramate overdose results in severe metabolic acidosis. In acute Topiramate overdose, if the ingestion is recent, the stomach should be emptied immediately by lavage or by induction of ernes is. Activated charcoal has been shown to adsorb Topiramate in vitro. Hemodialysis is an effective means of removing Topiramate from the body.

Concomitant administration of Topiramate and valproic acid has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either drug alone. In patients who develop unexplained lethargy, vomiting, or changes in mental status, hyperammonemic encephalopathy should be considered and an ammonia level should be measured.

Store at a cool & dry place, protected from light and moisture. Keep out of reach of the children.