Vigabatrin 50 mg/mL
vigabatrin · FOR SOLUTION · Novadoz Pharmaceuticals LLC
Vigabatrin is a for solution containing vigabatrin at 50 mg/mL, taken oral. Manufactured by Novadoz Pharmaceuticals LLC.
Key Facts
- Brand Name
- Vigabatrin
- Generic Name
- vigabatrin
- NDC Code (Product)
72205-093- Manufacturer
- Novadoz Pharmaceuticals LLC
- Strength
- 50 mg/mL
- Dosage Form
- FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA215363
- Drug Class
- Anti-epileptic Agent [EPC]
- Marketing Start
- 09/07/2022
Recall History
InvaGen Pharmaceuticals, Inc.
Defective Container: powder may leak out of the pouch
Lundbeck LLC
Cross contamination with other products
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
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 Vigabatrin tablets are indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; vigabatrin tablets are not indicated as a first line agent (1.1) Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss (1.2) 1.1 Refractory Complex Partial Seizures (CPS) Vigabatrin tablets are indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see Warnings and Precautions (5.1) ] . Vigabatrin tablets are not indicated as a first line agent for complex partial seizures. 1.2 Infantile Spasms (IS) Vigabatrin is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see Warnings and Precautions (5.1) ] .
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Refractory Complex Partial Seizures Adults (17 years of age and older): Initiate at 1,000 mg/day (500 mg twice daily); increase total daily dose weekly in 500 mg/day increments, to the recommended dose of 3,000 mg/day (1,500 mg twice daily) (2.2) Pediatric (2 to 16 years of age): The recommended dosage is based on body weight and administered as two divided doses (2.2) The dosage may be increased in weekly intervals, depending on response (2.2) Dose patients weighing more than 60 kg according to adult recommendations (2.2) Infantile Spasms Initiate at a daily dose of 50 mg/kg (25 mg/kg twice daily); increase total daily dose every 3 days, in increments of 25 mg/kg/day to 50 mg/kg/day, up to a maximum daily dose of 150 mg/kg (75 mg/kg twice daily) (2.3) Renal Impairment: Dose adjustment recommended (2.4, 8.5, 8.6) 2.1 Important Dosing and Administration Instructions Dosing Use the lowest dosage and shortest exposure to vigabatrin tablets consistent with clinical objectives [see Warnings and Precautions (5.1) ] . The vigabatrin tablets dosing regimen depends on the indication, age group, weight, and dosage form (tablets or for oral solution) [see Dosage an…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Decreased phenytoin plasma levels: dosage adjustment may be needed ( 7.1 ) 7.1 Antiepileptic Drugs Phenytoin Although phenytoin dose adjustments are not routinely required, dose adjustment of phenytoin should be considered if clinically indicated, since vigabatrin may cause a moderate reduction in total phenytoin plasma levels [see Clinical Pharmacology (12.3) ] . Clonazepam Vigabatrin may moderately increase the C max of clonazepam resulting in an increase of clonazepam-associated adverse reactions [see Clinical Pharmacology (12.3) ] . Other AEDs There are no clinically significant pharmacokinetic interactions between vigabatrin and either phenobarbital or sodium valproate. Based on population pharmacokinetics, carbamazepine, clorazepate, primidone, and sodium valproate appear to have no effect on plasma concentrations of vigabatrin [see Clinical Pharmacology (12.3) ] . 7.2 Oral Contraceptives Vigabatrin is unlikely to affect the efficacy of steroid oral contraceptives [see Clinical Pharmacology (12.3) ] . 7.3 Drug-Laboratory Test Interactions Vigabatrin decreases alanine transaminase (ALT) and aspartate transaminase (AST) plasma activity in up to 90% of patien…
Adverse Reactions
6 ADVERSE REACTIONS The following serious and otherwise important adverse reactions are described elsewhere in labeling: Permanent Vision Loss [see BOXED WARNING and Warnings and Precautions (5.1) ] Magnetic Resonance Imaging (MRI) Abnormalities in Infants [see Warnings and Precautions (5.3) ] Neurotoxicity [see Warnings and Precautions (5.4) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.5) ] Withdrawal of Antiepileptic Drugs (AEDs) [see Warnings and Precautions (5.6) ] Anemia [see Warnings and Precautions (5.7) ] Somnolence and Fatigue [see Warnings and Precautions (5.8) ] Peripheral Neuropathy [see Warnings and Precautions (5.9) ] Weight Gain [see Warnings and Precautions (5.10) ] Edema [see Warnings and Precautions (5.11) ] Refractory Complex Partial Seizures Most common adverse reactions in controlled studies include (incidence ≥5% over placebo): Adults: blurred vision, somnolence, dizziness, abnormal coordination, tremor, and fatigue (6.1) Pediatric patients (3 to 16 years of age): weight gain (6.1) Infantile Spasms (incidence >5% and greater than on placebo) Somnolence, bronchitis, ear infection, and acute otitis media (6.1) To report SUSPECTED ADVERSE REA…
Frequently Asked Questions
What is Vigabatrin used for?
Vigabatrin contains vigabatrin. It is a for solution taken oral. Consult your doctor for specific uses.
Is Vigabatrin a controlled substance?
Vigabatrin is not classified as a controlled substance by the DEA.
What is the generic name for Vigabatrin?
The generic name for Vigabatrin is vigabatrin. There are 6 other brand versions of vigabatrin.
What is the NDC code for Vigabatrin 50 mg/mL?
The NDC (National Drug Code) for Vigabatrin 50 mg/mL is 72205-093, listed by Novadoz Pharmaceuticals LLC.