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(topiramate) Extended-release Capsules
Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR® (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg and 200 mg capsules for oral administration.
Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:
TROKENDI XR® (topiramate) is an extended-release capsule. TROKENDI XR® capsules contain the following inactive ingredients:
Sugar Spheres, NF
Hypromellose (Type 2910), USP
Docusate Sodium, USP
Sodium Benzoate, NF
Oleic Acid, NF
Medium Chain Triglycerides, NF
Polyethylene Glycol, NF
Polyvinyl Alcohol, USP
Titanium Dioxide, USP
Xanthan Gum, NF
The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants.
The colorants are:
FD&C Blue #1 (all strength capsules)
Yellow Iron Oxide, USP (25 mg and 50 mg capsules)
FD&C Red #3 (50 mg, 100 mg and 200 mg capsules)
FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules)
Riboflavin, USP (25 mg capsules)
All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.
Last reviewed on RxList: 9/2/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Trokendi XR Information
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