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: Pratik Bahekar, MBBS [2]

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Overview

Topiramate is a Mood Stabilizer that is FDA approved for the {{{indicationType}}} of Lennox-Gastaut syndrome (adjunct), migraine (prophylaxis), partial seizure (initial monotherapy), partial seizure(adjunct), tonic-clonic seizure, primary generalized (adjunct), tonic-clonic seizure, primary generalized (initial monotherapy). Common adverse reactions include flushing, serum bicarbonate level abnormal, loss of appetite, weight decreased, infectious disease, confusion, dizziness, impaired cognition, impaired, psychomotor performance, memory impairment, paresthesia, reduced concentration span, somnolence, feeling nervous, mood disorder, fatigue, fever.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Lennox-Gastaut syndrome

• Start 25 to 50 mg/day PO, increase dosage by 25 to 50 mg/day at 1-week intervals to maintenance dose of 200 to 400 mg/day in 2 divided doses.

• Migraine prophylaxis

• 100 mg/day PO administered in 2 divided doses; 25 mg in the evening for 1 week, 25 mg twice daily for 1 week, 25 mg in the morning and 50 mg in the evening for 1 week, and then 50 mg twice daily.

• Partial seizure, initial monotherapy

• 25 mg PO twice daily; second week 50 mg PO twice daily, third week 75 mg PO twice daily, fourth week 100 mg PO twice daily, fifth week 150 mg PO twice daily, sixth week (MAX dose) 200 mg PO

• Partial seizure; adjunct

• 25 to 50 mg/day PO; may increase dosage by 25 to 50 mg/day at 1-week intervals to the usual maintenance dose of 200 to 400 mg/day in 2 divided doses.

• Tonic-clonic seizure, primary generalized (adjunct)

• 25 to 50 mg/day ORALLY; may increase dosage by 25 to 50 mg/day at 1-week intervals to the usual maintenance dose of 400 mg/day in 2 divided doses.

• Tonic-clonic seizure, primary generalized (initial monotherapy).

• 25 mg PO twice daily (morning and evening); second week, 50 mg PO twice daily; third week, 75 mg PO twice daily; fourth week, 100 mg PO twice daily; fifth week, 150 mg PO twice daily; sixth week (MAX dose), 200 mg PO twice daily

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

• Alcoholism
• Diabetes mellitus type 2 in obese (adjunct)
• Eating disorder.
• Essential tremor
• Obesity

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Lennox-Gastaut syndrome

• 2 years or older for opamax(R) and Qudexy(TM) XR,
• 6 years or older for Trokendi XR(TM)

• Migraine prophylaxis

• 12 years or older for Topamax(R) only

• Partial seizure, initial monotherapy

• 2 years or older for Qudexy XR (TM)
• 10 years or older for Trokendi XR(TM),

• Partial seizure; adjunct

• 2 years or older for Topamax(R) and Qudexy(TM) XR,
• 6 years or older Trokendi XR(TM)

• Tonic-clonic seizure, primary generalized (adjunct)

• 2 years or older for Topamax(R) and Qudexy(TM) XR
• 6 years or older for Trokendi XR(TM)

• Tonic-clonic seizure, primary generalized (initial monotherapy)

• 2 years or older for Topamax(R)
• 10 years or older for Trokendi XR(TM) and Qudexy(TM) XR

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

There is limited information regarding Topiramate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Topiramate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Topiramate in women who are pregnant.
Pregnancy Category (AUS): 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 in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Topiramate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Topiramate in geriatric settings.

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

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

Monitoring

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

IV Compatibility

There is limited information regarding the compatibility of Topiramate and IV administrations.

Overdosage

There is limited information regarding Topiramate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

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Topiramate
Systematic (IUPAC) name
2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
Identifiers
CAS number	97240-79-4
ATC code	N03AX11
PubChem	5284627
DrugBank	DB00273
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	339.363 g/mol
SMILES	eMolecules & PubChem
Pharmacokinetic data
Bioavailability	80%
Protein binding	13-17%; 15-41%
Metabolism	Hepatic (20-30%)
Half life	19-25 hours
Excretion	Urine (70-80%)
Therapeutic considerations
Licence data	US
Pregnancy cat.	D(AU) D(US)
Legal status	Prescription Only (S4)(AU) ?(CA) POM(UK) [[Prescription drug|Template:Unicode-only]](US)
Routes	Oral

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Topiramate How Supplied in the drug label.

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 Topiramate Patient Counseling Information 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

There is limited information regarding Topiramate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Topiramate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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