VIGADRONE 50 mg/mL
vigabatrin · POWDER, FOR SOLUTION · Upsher-Smith Laboratories, LLC
Vigabatrin is an anti-epileptic medication used to treat certain types of seizures, available as an oral powder that you mix into a solution. This prescription drug is typically prescribed by a neurologist or epilepsy specialist to help control seizures in patients who have not responded adequately to other anti-epileptic treatments.
Key Facts
- Brand Name
- VIGADRONE
- Generic Name
- vigabatrin
- NDC Code (Product)
0245-0556- Manufacturer
- Upsher-Smith Laboratories, LLC
- Strength
- 50 mg/mL
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210196
- Drug Class
- Anti-epileptic Agent [EPC]
- Marketing Start
- 06/21/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE VIGADRONE 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; VIGADRONE 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) VIGADRONE 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) ]. VIGADRONE is not indicated as a first line agent for complex partial seizures. 1.2 Infantile Spasms (IS) VIGADRONE 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 VIGADRONE consistent with clinical objectives [see Warnings and Precautions (5.1) ]. The VIGADRONE dosing regimen depends on the indication, age group, weight, and dosage form (tablets or powder for oral solution) [see Dosage…
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 VIGADRONE may cause a moderate reduction in total phenytoin plasma levels [see Clinical Pharmacology (12.3) ]. Clonazepam VIGADRONE 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 VIGADRONE is unlikely to affect the efficacy of steroid oral contraceptives [see Clinical Pharmacology (12.3) ]. 7.3 Drug-Laboratory Test Interactions VIGADRONE decreases alanine transaminase (ALT) and aspartate transaminase (AST) plasma activity in up to 90% of patients. In s…
Adverse Reactions
6 ADVERSE REACTIONS The following serious and otherwise important adverse reactions are described elsewhere in labeling: Permanent Vision Loss [see BOXED WARNING , 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…
Frequently Asked Questions
What is VIGADRONE used for?
Vigabatrin is an anti-epileptic medication used to treat certain types of seizures, available as an oral powder that you mix into a solution. This prescription drug is typically prescribed by a neurologist or epilepsy specialist to help control seizures in patients who have not responded adequately to other anti-epileptic treatments.
Is VIGADRONE a controlled substance?
VIGADRONE is not classified as a controlled substance by the DEA.
What is the generic name for VIGADRONE?
The generic name for VIGADRONE is vigabatrin. There are 12 other brand versions of vigabatrin.
What is the NDC code for VIGADRONE 50 mg/mL?
The NDC (National Drug Code) for VIGADRONE 50 mg/mL is 0245-0556, listed by Upsher-Smith Laboratories, LLC.