vigabatrin for oral solution 50 mg/mL
vigabatrin · POWDER, FOR SOLUTION · Camber Pharmaceuticals, Inc.
vigabatrin for oral solution is a powder, for solution containing vigabatrin at 50 mg/mL, taken oral. Manufactured by Camber Pharmaceuticals, Inc..
Key Facts
- Brand Name
- vigabatrin for oral solution
- Generic Name
- vigabatrin
- NDC Code (Product)
31722-009- Manufacturer
- Camber Pharmaceuticals, Inc.
- Strength
- 50 mg/mL
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA213519
- Drug Class
- Anti-epileptic Agent [EPC]
- Marketing Start
- 01/26/2021
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 for oral solution is 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 for oral solution is 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 for oral solution is 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 for oral solution is not indicated as a first line agent for complex partial seizures. 1.2 Infantile Spasms (IS) Vigabatrin for oral solution 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 Warni…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Refractory Complex Partial Seizures • Adults (17 years of age and older): Initiate at 1000 mg/day (500 mg twice daily); increase total daily dose weekly in 500 mg/day increments, to the recommended dose of 3000 mg/day (1500 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 for oral solution consistent with clinical objectives [see Warnings and Precautions ( 5.1 )]. The vigabatrin for oral solution dosing regimen depends on the indication, age group, weight, and dosage form (tab…
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 med…
Frequently Asked Questions
What is vigabatrin for oral solution used for?
vigabatrin for oral solution contains vigabatrin. It is a powder, for solution taken oral. Consult your doctor for specific uses.
Is vigabatrin for oral solution a controlled substance?
vigabatrin for oral solution is not classified as a controlled substance by the DEA.
What is the generic name for vigabatrin for oral solution?
The generic name for vigabatrin for oral solution is vigabatrin. There are 11 other brand versions of vigabatrin.
What is the NDC code for vigabatrin for oral solution 50 mg/mL?
The NDC (National Drug Code) for vigabatrin for oral solution 50 mg/mL is 31722-009, listed by Camber Pharmaceuticals, Inc..