topiramate tablet film coated
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.
Zydus Pharmaceuticals (USA) Inc.
ROUND WHITE ZD 15
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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: NDC 68382-138-14 in bottle of 60 tablets with child-resistant closure NDC 68382-138-16 in bottle of 90 tablets with child-resistant closure NDC 68382-138-01 in bottle of 100 tablets NDC 68382-138-05 in bottle of 500 tablets
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: NDC 68382-139-14 in bottle of 60 tablets with child-resistant closure NDC 68382-139-16 in bottle of 90 tablets with child-resistant closure NDC 68382-139-01 in bottle of 100 tablets NDC 68382-139-05 in bottle of 500 tablets
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: NDC 68382-140-14 in bottle of 60 tablets with child-resistant closure NDC 68382-140-16 in bottle of 90 tablets with child-resistant closure NDC 68382-140-01 in bottle of 100 tablets NDC 68382-140-05 in bottle of 500 tablets
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: NDC 68382-141-14 in bottle of 60 tablets with child-resistant closure NDC 68382-141-16 in bottle of 90 tablets with child-resistant closure NDC 68382-141-01 in bottle of 100 tablets NDC 68382-141-05 in bottle of 500 tablets
TOPIRAMATE capsules, USP
TOPIRAMATE capsules USP, 15 mg are white to off-white pellets filled in size '2' empty hard gelatin capsules with white opaque cap imprinted with "ZA63" and white opaque body imprinted with "15 mg" in black ink and are supplied as follows: NDC 68382-004-14 in bottle of 60 capsules with child-resistant closure NDC 68382-004-16 in bottle of 90 capsules with child-resistant closure NDC 68382-004-01 in bottle of 100 capsules with child-resistant closure NDC 68382-004-05 in bottle of 500 capsules NDC 68382-004-10 in bottle of 1,000 capsules
TOPIRAMATE capsules USP, 25 mg are white to off-white pellets filled in size '1' empty hard gelatin capsules with white opaque cap imprinted with "ZA64" and white opaque body imprinted with "25 mg" in black ink and are supplied as follows: NDC 68382-005-17 in bottle of 28 capsules with child-resistant closure NDC 68382-005-14 in bottle of 60 capsules with child-resistant closure NDC 68382-005-16 in bottle of 90 capsules with child-resistant closure NDC 68382-005-01 in bottle of 100 capsules with child-resistant closure NDC 68382-005-05 in bottle of 500 capsules NDC 68382-005-10 in bottle of 1,000 capsules 16.2 Storage and Handling Store at 20 o C to 25 o C (68 o F to 77 o F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.
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