Label: TOPIRAMATE tablet, film coated

  • NDC Code(s): 71335-1064-0, 71335-1064-1, 71335-1064-2, 71335-1064-3, view more
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 29300-116
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 16, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Monotherapy Epilepsy - Topiramate tablets 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 tablets monotherapy in adults and pediatric patients 10 years ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Topiramate tablets, USP are available as round, biconvex, film-coated tablets in the following strengths and colors: 25 mg:Light yellow with 'U' debossed on one side and '115' debossed on ...
  • 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 Precautions ...
  • 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 - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. Patients should be ...
  • 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 tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP ...
  • 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 topiramate tablets. 14.1 Monotherapy Epilepsy - Patients with Partial-Onset or Primary Generalized Tonic-Clonic ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    50 mg Tablet: White to off-white, round, bevel edged, biconvex, film-coated tablets with 'U' debossed on one side and '116' debossed on other side. NDC 71335-1064-1: 30 Tablets in a BOTTLE - NDC ...
  • 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 Tablets, USP - (toe pir' a mate), for oral use - What is the most important information I should know abouttopiramate tablets? Topiramate tablets may cause ...
  • PRINCIPAL DISPLAY PANEL
    Topiramate 50mg Tablet
  • INGREDIENTS AND APPEARANCE
    Product Information