Topiramate
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
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
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| Systematic (IUPAC) name | |
| 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate | |
| Identifiers | |
| CAS number | |
| ATC code | N03 |
| PubChem | |
| DrugBank | |
| 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 | & |
| 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 |
|
| Pregnancy cat. | |
| 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.