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Topiramate ER

Strength: 100mg Count: 30

NDC

42291-957-30

Class

Rx

Brand Name

Trokendi XR Extended-Release Capsules

Imprint Code

WPI;2358

Color(s)

Blue (light blue)

Shape

Capsule

Score

No Score

Case Count

NA

Inactive Ingredients

ammonium hydroxide, ethylcellulose, hypromellose 2910, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol 400, polyethylene glycol 8000, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), and talc. The capsule shells contain gelatin and titanium dioxide. The 50 mg capsules also contain FD&C Yellow #6 and D&C Yellow #10. The 100 mg capsules also contain D&C Red # 28 and FD&C Blue #1. The 200 mg capsules also contain FD&C Red #40. All capsule shells are imprinted with black ink that contains shellac glaze, iron oxide black, propylene glycol, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake and D&C Yellow #10 Aluminum Lake.

Indications and Usage

1.1 Monotherapy Epilepsy Topiramate extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older. 1.2 Adjunctive Therapy Epilepsy Topiramate extended-release 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 6 years of age and older. 1.3 Migraine Topiramate extended-release capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older.