Rufinamide
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
Rufinamide is an anti-epileptic drug that is FDA approved for the {{{indicationType}}} of lennox-gastaut syndrome (LGS). Common adverse reactions include headache, dizziness, fatigue, somnolence, and nausea.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Lennox-Gastaut Syndrome
- Treatment should be initiated at a daily dose of 400-800 mg/day administered in two equally divided doses. The dose should be increased by 400-800 mg every other day until a maximum daily dose of 3200 mg/day, administered in two equally divided doses is reached. It is not known whether doses lower than 3200 mg are effective.
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 Rufinamide in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Rufinamide in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Lennox-Gastaut Syndrome
- Treatment should be initiated at a daily dose of approximately 10 mg/kg/day administered in two equally divided doses. The dose should be increased by approximately 10 mg/kg increments every other day to a target dose of 45 mg/kg/day or 3200 mg/day, whichever is less, administered in two equally divided doses. It is not known whether doses lower than the target doses are effective.
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 Rufinamide in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Rufinamide in pediatric patients.
Contraindications
- BANZEL is contraindicated in patients with Familial Short QT syndrome.
Warnings
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Rufinamide 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 Rufinamide 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
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Rufinamide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Rufinamide during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Rufinamide with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Rufinamide with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Rufinamide with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Rufinamide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Rufinamide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Rufinamide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Rufinamide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Rufinamide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Rufinamide in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Rufinamide in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Rufinamide in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Rufinamide in the drug label.
Pharmacology
There is limited information regarding Rufinamide Pharmacology in the drug label.
Mechanism of Action
Structure
This image is provided by the National Library of Medicine.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Rufinamide in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Rufinamide in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Rufinamide in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Rufinamide in the drug label.
How Supplied
Storage
There is limited information regarding Rufinamide 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 Rufinamide in the drug label.
Precautions with Alcohol
- Alcohol-Rufinamide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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- ↑ "http://www.ismp.org". External link in
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