Topiramate is a sulfamate-substituted monosaccharide. TOPAMAX ® (topiramate) Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. TOPAMAX ® (topiramate capsules) Sprinkle Capsules are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodi...

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TOPAMAX ® is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older Preventive treatment of migraine in patients 12 years of age and older 1.1 Monotherapy Epilepsy TOPAMAX ® is indicated as initia...

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TOPAMAX ® Tablets are available as debossed, coated, round tablets in the following strengths and colors: 25 mg cream (debossed "OMN" on one side; "25" on the other) 50 mg light-yellow (debossed "OMN" on one side; "50" on the other) 100 mg yellow (debossed "OMN" on one side; "100" on the other) 200 mg salmon (debossed "OMN" on one side; "200" on the other) TOPAMAX ® Sprinkle Capsules contain small, white to off-white spheres. The gelatin capsules are white and clear. They are marked as follows: 15...

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TOPAMAX ® initial dose, titration, and recommended maintenance dose varies by indication and age group. See Full Prescribing Information for recommended dosage, and dosing considerations in patients with renal impairment, geriatric patients, and patients undergoing hemodialysis ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) 2.1 Dosing in Monotherapy Epilepsy Adults and Pediatric Patients 10 Years of Age and Older The recommended dose for TOPAMAX ® monotherapy in adults and pediatric patients 10 years of a...

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Overdoses of TOPAMAX ® have been reported. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving TOPAMAX ® . TOPAMAX ® overdose has resulted in severe metabolic acidosis . A patient who ingested a dose of TOPAMAX ® be...

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Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss; discontinue TOPAMAX ® as soon as possible Visual field defects: consider discontinuation of TOPAMAX ® Oligohidrosis and hyperthermia: monitor decreased sweating and increased body temperature, especially in pediatric patients Metabolic acidosis: baseline and periodic measurement of serum bicarbonate is recommended; consider dose reduction or discontinuation of TOPAMAX ® if clinically appropriate Suicidal behavi...

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Contraceptives: decreased contraceptive efficacy and increased breakthrough bleeding, especially at doses greater than 200 mg/day Monitor lithium levels if lithium is used with high-dose TOPAMAX ® 7.1 Antiepileptic Drugs Concomitant administration of phenytoin or carbamazepine with TOPAMAX ® resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to TOPAMAX ® given alone. A dosage adjustment may be needed . Concomitant administration of valproic acid and ...

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8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TOPAMAX ® during pregnancy. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334. Information about the North American Drug Pre...

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