topiramate 25 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 and topiramate capsules 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 and topiramate capsules 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 and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older.
American Health Packaging
ROUND WHITE ZD 16
ZD 16 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TOPIRAMATE Tablets, USP
TOPIRAMATE Tablets USP, 25 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 16" on one side and plain on the other side and are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-342-01
TOPIRAMATE Tablets USP, 50 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with “ZD 15” on one side and plain on the other side and are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-343-01
TOPIRAMATE Tablets USP, 100 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 14" on one side and plain on the other side and are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-344-01
TOPIRAMATE Tablets USP, 200 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 13" on one side and plain on the other side and are supplied as follows: Unit dose packages of 30 (3 x 10) NDC 68084-345-21 16.2 Storage and Handling Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
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