Revision Year: 2024
VIGAFYDE (vigabatrin) oral solution is an antiepileptic drug.
The chemical name of vigabatrin, is (±) 4-amino-5-hexenoic acid, a racemic mixture of R and S isomers. The molecular formula is C6H11NO2 and the molecular weight is 129.16.
It has the following structural formula:
Vigabatrin is a white to off-white powder which is freely soluble in water, slightly soluble in methyl alcohol, very slightly soluble in ethyl alcohol and chloroform, and insoluble in toluene and hexane. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin is about 0.011 (log P=-1.96) at physiologic pH. Vigabatrin melts with decomposition in a 3-degree range within the temperature interval of 171ºC to 176ºC. The dissociation constants (pKa) of vigabatrin are 4 and 9.7 at room temperature (25ºC).
Each mL of VIGAFYDE contains 100 mg of vigabatrin. The inactive ingredients are methylparaben; peppermint flavor; propylparaben; purified water; and sucralose.
| Dosage Forms and Strengths |
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Oral Solution: 100 mg/mL clear, colorless to light yellow solution with a peppermint odor. |
| How Supplied |
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VIGAFYDE (vigabatrin oral solution) contains 100 mg/mL vigabatrin. It is a clear, colorless to light yellow, peppermint-flavored solution supplied in a white opaque high-density polyethylene (HDPE) 150 mL bottle in a carton (NDC 80789-003-15). Manufactured for PYROS PHARMACEUTICALS, INC, Parsippany, NJ 07054, U.S.A. |
| Drug | Countries | |
|---|---|---|
| VIGAFYDE | United States |
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