Label: TOPIRAMATE capsule

  • NDC Code(s): 72888-228-05, 72888-228-12, 72888-228-30, 72888-228-60, view more
  • Packager: Advagen Pharma Ltd
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 2, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use TOPIRAMATE CAPSULES safely and effectively. See full prescribing information for TOPIRAMATE CAPSULES - TOPIRAMATE capsules, for ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    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 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosing in Monotherapy Epilepsy - Adults and Pediatric Patients 10 Years of Age and Older - The recommended dose for topiramate capsules monotherapy in adults and pediatric patients 10 years ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Topiramate Capsules, USP 15 mg are size ‘2’ clear transparent cap and white opaque body, hard gelatin capsule shells, imprinted with “˄” on cap and “A66” on body with black ink filled with off ...
  • 4 CONTRAINDICATIONS
    None.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Acute Myopia and Secondary Angle Closure Glaucoma Syndrome - A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are discussed in more detail in other sections of the labeling: Acute Myopia and Secondary Angle Closure Glaucoma - [see - Warnings and ...
  • 7 DRUG INTERACTIONS
    7.1 Antiepileptic Drugs - Concomitant administration of phenytoin or carbamazepine with topiramate resulted in a clinically significant decrease in plasma concentrations of topiramate when ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate - in uterohave ...
  • 10 OVERDOSAGE
    Overdoses of topiramate have been reported. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination ...
  • 11 DESCRIPTION
    Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg capsules for oral administration as whole capsules or opened and ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The precise mechanisms by which topiramate exerts its anticonvulsant and preventive migraine effects are unknown; however, preclinical studies have revealed four ...
  • 13 NON-CLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - An increase in urinary bladder tumors was observed in mice given topiramate (0, 20, 75, and 300 mg/kg/day) in the diet ...
  • 14 CLINICAL STUDIES
    The studies described in the following sections were conducted using TOPAMAX Tablets. 14.1 Monotherapy Epilepsy - Patients with Partial-Onset or Primary Generalized Tonic-Clonic ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Topiramate Capsules, USP are available as follows: Topiramate Capsules, USP 15 mg are size ‘2’ clear transparent cap and white opaque body, hard gelatin capsule shells ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Eye Disorders - Instruct patients taking topiramate to seek immediate medical attention if they experience blurred ...
  • MEDICATION GUIDE
    MEDICATION GUIDE - Topiramate (toe pir’ a mate) capsules USP, for oral use - What is the most important information I should know about topiramate ...
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL
    Topiramate Capsules, USP 15 mg - NDC 72888-228-30 - 30s Bottle Label - Topiramate Capsules, USP 15 mg - NDC 72888-228-60 - 60s Bottle Label - Topiramate Capsules, USP 15 mg ...
  • INGREDIENTS AND APPEARANCE
    Product Information