Topiramatedrug info
topiramate 15 MG Oral Capsule
What it is used for
Topiramate capsules are 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; 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 Preventive treatment of migraine in patients 12 years of age and older
1.1 Monotherapy
Epilepsy 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 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 capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective June 24, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Topiramate is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate is a white crystalline powder with a bitter taste. Topiramate 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 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 capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are black ink, cellulose acetate, gelatin, mannitol, povidone, sodium lauryl sulfate, sugar spheres (sucrose and starch) and titanium dioxide. FDA approved dissolution test specifications differ from USP. structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective June 24, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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