SPL Set ID: f07d81bc-5090-fbc5-2945-557cf002849c
1 drug(s) with this SPL Set ID
Topiramate, USP, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules are available as 25 mg, 50 mg, 100 mg and 200 mg capsules for oral administration. Topiramate, USP is a white to off-white powder. Topiramate is freely soluble in dichloromethane.Topiramate has the molecular formula C 12 H 21 NO 8 S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate extended-release capsules contains 25 mg, 50 mg, 100 mg and 200 mg of topiramate. Topiramate extended-release capsules contains the following inactive ingredients: Docusate sodium and sodium benzoate, ethylcellulose, hydroxy propyl methyl cellulose, iron oxide yellow, lecithin, mannitol, medium chain triglycerides, oleic acid, polyethylene glycol, polyvinyl alcohol, sugar spheres, talc, titanium dioxide, and xanthan gum. The capsule shells contain gelatin, titanium dioxide and colorants. The colorants are: FD&C Blue 1 and D & C Yellow 10 (all strength capsules) FD & C Yellow 6 (50 mg, 100 mg and 200 mg capsules) FD&C Red 40 (25 mg and 50 mg capsules) D &C Red 28 (25 mg and 50 mg capsules) FD & C Red 3 (100 mg capsules) Iron oxide yellow, iron oxide red, iron oxide black (200 mg capsules) All capsule shells are imprinted with black print that contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.