Topiramate is a prescription medicine indicated for epilepsy, among other approved uses. It is available as tablets, extended-release capsules and capsules for oral use. MedsAcross supplies Topiramate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
TOPAMAX is 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
Source: US FDA prescribing information
The precise mechanisms by which topiramate exerts its anticonvulsant and preventive migraine effects are unknown, however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy and the preventive treatment of migraine. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.
Source: US FDA prescribing information
TOPAMAX initial dose, titration, and recommended maintenance dose varies by indication and age group. See Full Prescribing Information for recommended dosage, and dosing considerations in patients with renal impairment, geriatric patients, and patients undergoing hemodialysis
Source: US FDA prescribing information
TOPAMAX is contraindicated in patients with a history of hypersensitivity reaction to topiramate, TOPAMAX, or any of the inactive ingredients of TOPAMAX. Anaphylaxis and angioedema have occurred. History of hypersensitivity reaction to topiramate, TOPAMAX, or any of the inactive ingredients of TOPAMAX
Source: US FDA prescribing information
Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss, discontinue TOPAMAX as soon as possible. Visual field defects: consider discontinuation of TOPAMAX. Oligohidrosis and hyperthermia: monitor decreased sweating and increased body temperature, especially in pediatric patients. Metabolic acidosis: baseline and periodic measurement of serum bicarbonate is recommended, consider dose reduction or discontinuation of TOPAMAX if clinically appropriate. Suicidal behavior and ideation: antiepileptic drugs increase the risk of suicidal behavior or ideation. Cognitive/neuropsychiatric adverse reactions: use caution when operating machinery including cars, depression and mood problems may occur. Fetal Toxicity: use during pregnancy can cause major congenital malformations, including but not limited to cleft lip and/or palate, and being small for gestational age.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in more detail in other sections of the labeling: Acute Myopia and Secondary Angle Closure Glaucoma Visual Field Defects Oligohidrosis and Hyperthermia Metabolic Acidosis Suicidal Behavior and Ideation Cognitive/Neuropsychiatric Adverse Reactions Decrease of Bone Mineral Density Negative Effects on Growth (Height and Weight) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions Serious Skin Reactions Anaphylaxis and Angioedema Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid [VPA] Use) Kidney Stones Hypothermia with Concomitant Valproic Acid (VPA) Use The data described in the following sections were obtained using TOPAMAX Tablets.
Source: US FDA prescribing information
Contraceptives: decreased contraceptive efficacy and increased breakthrough bleeding, especially at doses greater than 200 mg/day. Monitor lithium levels if lithium is used with high-dose TOPAMAX
Source: US FDA prescribing information
TOPAMAX Tablets TOPAMAX Tablets should be stored in tightly-closed containers at controlled room temperature (59 ° to 86 °F, 15 ° to 30 °C). TOPAMAX Sprinkle Capsules TOPAMAX Sprinkle Capsules should be stored in tightly-closed containers at or below 25 °C (77 °F). Protect from moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
29 presentations of Topiramate, sorted by availability.
4 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 24 December 1996 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Topiramate in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 29 presentations of Topiramate and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 4 brand names for Topiramate, including Eprontia, Qudexy XR, Topamax, Trokendi XR.
Yes. The US FDA first approved Topiramate on 24 December 1996, according to Drugs@FDA.
No listed presentation of Topiramate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Topiramate is classified under ATC code N03AX11 (Topiramate).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.