topiramate 100 MG Oral Tablet
1 INDICATIONS AND USAGE Topiramate 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 ( 1.1 ); 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 ( 1.2 ) Preventive treatment of migraine in patients 12 years of age and older ( 1.3 ) 1.1 Monotherapy Epilepsy Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjunctive Therapy Epilepsy Topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older. 1.3 Migraine Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older.
Apotex Corp
ROUND YELLOW APO TP 100
APO TP 100 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Topiramate tablets, USP are supplied as round, unscored, film-coated tablets as follows: 25 mg white to off-white tablets imprinted “APO” on one side and “TP” over “25” on the other side; Bottles of 30 (NDC 60505-2760-3) Bottles of 60 (NDC 60505-2760-6) Bottles of 500 (NDC 60505-2760-5) Bottles of 1,000 (NDC 60505-2760-8) 50 mg light yellow tablets “APO” on one side and “TP” over “50” on the other side; Bottles of 30 (NDC 60505-2761-3) Bottles of 60 (NDC 60505-2761-6) Bottles of 500 (NDC 60505-2761-5) Bottles of 1,000 (NDC 60505-2761-8) 100 mg mustard yellow tablets imprinted “APO” on one side and “TP” over “100” on the other side; Bottles of 30 (NDC 60505-2762-3) Bottles of 60 (NDC 60505-2762-6) Bottles of 500 (NDC 60505-2762-5) Bottles of 1,000 (NDC 60505-2762-8) 200 mg reddish-brown tablets imprinted “APO” on one side and “TP” over “200” on the other side; Bottles of 30 (NDC 60505-2763-3) Bottles of 60 (NDC 60505-2763-6) Bottles of 500 (NDC 60505-2763-5) Bottles of 1,000 (NDC 60505-2763-8) 16.2 Storage and Handling Topiramate tablets, USP should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.
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