Topiramatedrug info
24 HR topiramate 50 MG Extended Release Oral Capsule
What it is used for
Topiramate extended-release capsules are indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older; adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older Preventive treatment of migraine in patients 12 years of age and older
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.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 4, 2023. 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, 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 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 C 12 H 21 NO 8 S 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: Topiramate extended-release capsules are an extended-release capsule. Topiramate extended-release capsules contain the following inactive ingredients: Sugar Spheres (contains sucrose and corn starch) Hypromellose Povidone Ethylcellulose Titanium Dioxide Talc The capsule shells contain gelatin, titanium dioxide and colorants.
The colorants are: Red Iron Oxide (50 mg and 100 mg capsules) FD&C Red #40 (200 mg capsules) FD&C Yellow #6 (25 mg, 100 mg and 200 mg capsules) All capsule shells are imprinted with black print that contains shellac, black iron oxide, propylene glycol, FD&C red #40, FD&C blue #2, FD&C blue #1 and D&C yellow #10 structure.jpg
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 4, 2023. 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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