Topiramate

Topiramate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

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Overview

Topiramate is an antiepileptic drug that is FDA approved for the {{{indicationType}}} of partial seizures, primary generalized tonic-clonic seizures and lennox-gastaut syndrome. Common adverse reactions include paresthesia, anorexia, weight decrease, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, difficulty with memory, difficulty with concentration/attention, cognitive problem, confusion, mood problems, fever, infection, and flushing.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Partial Onset Seizures

• Monotherapy Use

• The recommended dose for topiramate monotherapy in adults is 400 mg orally once daily. Titrate QUDEXY XR according to the following schedule:

T

• Adjunctive Therapy Use

• The recommended total daily dose of QUDEXY XR as adjunctive therapy in adults with partial onset seizures is 200 mg to 400 mg orally once daily.

Primary Generalized Tonic-Clonic Seizures

• Monotherapy Use

• The recommended dose for topiramate monotherapy in adults is 400 mg orally once daily. Titrate QUDEXY XR according to the following schedule:

T

• Adjunctive Therapy Use

• The recommended total dose for adults with primary generalized tonic-clonic seizures is 400 mg orally once daily.

Lennox-Gastaut Syndrome

• Adjunctive Therapy Use

• The recommended total daily dose of QUDEXY XR as adjunctive therapy in adults with Lennox-Gastaut Syndrome is 200 mg to 400 mg orally once daily.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Topiramate in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Topiramate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Topiramate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Topiramate in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Topiramate in pediatric patients.

Contraindications

• QUDEXY XR is contraindicated in patients with metabolic acidosis who are taking concomitant metformin.

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Topiramate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Topiramate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Topiramate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Topiramate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Topiramate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Topiramate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Topiramate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Topiramate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Topiramate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Topiramate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Topiramate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Topiramate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Topiramate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Topiramate in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Topiramate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Topiramate in the drug label.

Pharmacology

There is limited information regarding Topiramate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Topiramate01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Topiramate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Topiramate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Topiramate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Topiramate in the drug label.

How Supplied

Storage

There is limited information regarding Topiramate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Topiramate in the drug label.

Precautions with Alcohol

• Alcohol-Topiramate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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