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Drug Information for Topiramate Tablets (Sun Pharmaceutical Industries Limited): DESCRIPTION
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- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Label - 25 mg
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Label - 50 mg
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Label - 100 mg
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Label - 200 mg
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Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration.
Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-ß-D-fructopyranose sulfamate and has the following structural formula:
Topiramate tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc.
In addition, individual tablets contain:
50 mg tablets: iron oxide yellow100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black
- Drug Information Provided by National Library of Medicine (NLM).