Adult Dosing
Refractory complex partial seizures
- Initial: 500 mg PO bid; increase dose by 500 mg at weekly intervals depending on response
- Max: 1500 mg PO bid
Pediatric Dosing
Note: Safety and effectiveness in pediatric patients for refractory complex partial seizures have not been established
Infantile spasms
Child 1 month-2 yrs
- Initial: 50 mg/kg/day PO divided bid, increasing by 25-50 mg/kg/day PO increments q3 days
- Max: 150 mg/kg/day PO; dosage adjustments are necessary for renal impairment
[Outline]
Renal Dose Adjustment (Based on CrCl)
- >50–80 mL/minute: Decrease dose by 25%
- >30–50 mL/minute: Decrease dose by 50%
- >10-< 30 mL/minute: Decrease dose by 75%
Hepatic Dose Adjustment
- Hepatic impairment: Dose adjustments not defined
See Supplemental Patient Information
- In a high percentage of patients, therapy may cause progressive and permanent bilateral concentric visual field constriction. Risk increases with total dose and duration of use, but no exposure to therapy is known that is free of risk of vision loss [US Black Box Warning]
- Prolonged use may cause risk of new and worsening vision loss and possibly vision loss after discontinuing therapy. Vision testing should be performed periodically during therapy [US Black Box Warning]
- Therapy is available only through a special restricted distribution program because of the risk of permanent vision loss [US Black Box Warning]
- In some infants treated for infantile spasms, abnormal MRI signal changes characterized by increased T2 signal and restricted diffusion in a symmetric pattern involving the thalamus, basal ganglia, brain stem, and cerebellum have been reported
- Therapy is associated with neurotoxicity
- Vigabatrin may increase the risk of suicidal thoughts and behavior
- Abrupt withdrawal of therapy may cause withdrawal seizures. Therefore dose should be tapered gradually to avoid withdrawal seizures
- Monitor blood profile as therapy may cause anemia during the therapy
- Somnolence and fatigue have been reported with the use of therapy. Patients should be advised not to drive a car or operate other complex machinery until they are familiar with the effects on their ability to perform such activities
- Symptoms of peripheral neuropathy, weight gain and edema have also been reported with the use of therapy
Cautions: Use cautiously in
- Renal impairment
- Depression or history of depression
- Ophthalmologic disorders
- Concomitant CNS depressant use
- Alcohol use
Supplemental Patient Information
- Advice patients not drive a car or operate other complex machinery until they become familiar with the effects of therapy on ability to perform such activities
Pregnancy Category:C
Breastfeeding: Unsafe. Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.
Drug Name: Sabril 500 MG Oral Tablet
Ingredient(s): Vigabatrin
Imprint: OV;111
Color(s): White
Shape: Oval
Size (mm): 17.00
Score: 2
Inactive Ingredient(s): hypromellose / titanium dioxide / polyethylene glycol 8000 / magnesium stearate / cellulose, microcrystalline / povidone k30 / sodium starch glycolate type a potato
Drug Label Author:
Lundbeck Inc.
DEA Schedule:
Non-Scheduled
