Rufinamide 40 mg/mL
Rufinamide · SUSPENSION · NorthStar RxLLC
Rufinamide is a suspension containing rufinamide at 40 mg/mL, taken oral. Manufactured by NorthStar RxLLC.
Key Facts
- Brand Name
- Rufinamide
- Generic Name
- Rufinamide
- NDC Code (Product)
72603-261- Manufacturer
- NorthStar RxLLC
- Strength
- 40 mg/mL
- Dosage Form
- SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA216841
- Marketing Start
- 08/01/2024
Recall History
Aurobindo Pharma USA Inc.
cGMP deviations: Batch was released prior to approval.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Aurobindo Pharma USA Inc.
cGMP deviations: Batch was released prior to approval.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Rufinamide tablet is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide tablet is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Rufinamide tablets should be given with food. Tablets can be administered whole, as half tablets, or crushed ( 2.2 ) Pediatric patients 1 year and older: Starting daily dose: 10 mg/kg per day in two equally divided doses ( 2.1 ) Increase by 10 mg/kg increments every other day to maximum dose of 45 mg/kg per day, not to exceed 3200 mg per day, in two divided doses ( 2.1 ) Adults: Starting daily dose: 400 to 800 mg per day in two equally divided doses ( 2.1 ) Increase by 400 to 800 mg every other day until a maximum dose of 3200 mg per day, in two divided doses, is reached ( 2.1 ) 2.1 Dosage Information Pediatric patients (1 year to less than 17 years) The recommended starting daily dose of rufinamide tablets in pediatric patients with Lennox-Gastaut Syndrome is approximately 10 mg/kg administered in two equally divided doses. The dose should be increased by approximately 10 mg/kg increments every other day until a maximum daily dose of 45 mg/kg, not to exceed 3200 mg, administered in two equally divided doses, is reached. It is not known whether doses lower than the target doses are effective. Adults (17 years and older) The recommended starting daily dos…
Contraindications
4 CONTRAINDICATIONS Rufinamide tablets are contraindicated in patients with Familial Short QT syndrome [see Warnings and Precautions (5.3) ] . Rufinamide tablet is contraindicated in patients with Familial Short QT syndrome ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Patients on valproate should begin at a rufinamide tablets dose lower than 10 mg/kg per day (pediatric patients) or 400 mg per day (adults) ( 7.2 ) Hormonal contraceptives may be less effective with Rufinamide tablet; use additional non-hormonal forms of contraception ( 7.3 ) 7.1 Effects of Rufinamide Tablet on other AEDs Population pharmacokinetic analysis of average concentration at steady state of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, and valproate showed that typical rufinamide C avss levels had little effect on the pharmacokinetics of other AEDs. Any effects, when they occur, have been more marked in the pediatric population. Table 6 summarizes the drug-drug interactions of rufinamide tablets with other AEDs. Table 6: Summary of drug-drug interactions of rufinamide Tablets with other antiepileptic drugs AED Co-administered Influence of Rufinamide on AED concentration a) Influence of AED on Rufinamide concentration Carbamazepine Decrease by 7 to 13% b) Decrease by 19 to 26% Dependent on dose of carbamazepine Lamotrigine Decrease by 7 to 13% b) No Effect Phenobarbital Increase by 8 to 13% b) Decrease by 25 to 46% c),d) Independent …
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Behavior and Ideation [see Warnings and Precautions (5.1) ] Central Nervous System Reactions [see Warnings and Precautions (5.2) ] QT Shortening [see Warnings and Precautions (5.3) ] Multi-Organ Hypersensitivity/Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.4) ] Leukopenia [see Warnings and Precautions (5.7) ] Most common adverse reactions (≥10% and greater than placebo) were headache, dizziness, fatigue, somnolence, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult and Pediatric Patients ages 3 to 17 years of age In the pooled, double-blind, adjunctive therapy studies in adult and pediatric pati…
Frequently Asked Questions
What is Rufinamide used for?
Rufinamide contains Rufinamide. It is a suspension taken oral. Consult your doctor for specific uses.
Is Rufinamide a controlled substance?
Rufinamide is not classified as a controlled substance by the DEA.
What is the generic name for Rufinamide?
The generic name for Rufinamide is Rufinamide. There are 2 other brand versions of Rufinamide.
What is the NDC code for Rufinamide 40 mg/mL?
The NDC (National Drug Code) for Rufinamide 40 mg/mL is 72603-261, listed by NorthStar RxLLC.