Classes
DEA Class; Rx
Common Brand Names; Sabril, Vigadrone
- Anticonvulsants, Other
Description
Oral anticonvulsant designed to inhibit GABA metabolism
Used for complex partial seizures and infantile spasms
Risk of permanent vision loss; only available through restricted distribution
Indications
Indicated for the treatment of infantile spasms.
Adverse Effects
- Weight gain, children (47%)
- Permanent bilateral concentric visual field constriction (>30%)
- Fatigue (28%)
- Somnolence (24%)
- Headache (18%)
- Weight gain, adults (17%)
- Dizziness (15%)
- Convulsion (11%)
- Hyperactivity, in children (11%)
- Nasopharyngitis (10%)
- Weight increased (10%)
- Upper respiratory tract infection (10%)
- Visual field defect (9%)
- Depression (8%)
- Tremor (7%)
- Nystagmus (7%)
- Nausea (7%)
- Diarrhea (7%)
- Memory impairment (7%)
- Insomnia (7%)
- Irritability (7%)
- Coordination abnormal (7%)
- Vision blurred (6%)
- Diplopia (6%)
- Vomiting (6%)
- Influenza (6%)
- Pyrexia (6%)
- Rash (6%)
Warnings
Can cause permanent vision loss; because of this risk and because, when it is effective, vigabatrin provides an observable symptomatic benefit; patient response and continued need for treatment should be periodically assessed (see Black Box Warnings)
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 observed in some infants
Intramyelinic edema (IME) has been reported in postmortem examination of infants being treated for infantile seizures with vigabatrin
Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication; patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
Withdraw drug gradually; however, if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered; patients and caregivers should be told not to suddenly discontinue vigabatrin
Anemia reported
May cause somnolence and fatigue; advise patients not to drive or operate complex machinery until they are familiar with how the drug affects them
Peripheral neuropathy reported in adults
Causes weight gain in adults and children
Edema reported in adults
Pregnancy and Lactation
No adequate and well-controlled studies in pregnant women
Excreted in human milk
Because of the potential for serious adverse reactions from vigabatrin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
Maximum Dosage
3,000 mg/day PO.
3,000 mg/day PO.
17 years: 3,000 mg/day PO.
13 to 16 years weighing more than 60 kg: 3,000 mg/day PO.
13 to 16 years weighing 26 to 60 kg: 2,000 mg/day PO.
13 to 16 years weighing 21 to 25 kg: 1,500 mg/day PO.
2 to 12 years weighing more than 60 kg: 3,000 mg/day PO.
2 to 12 years weighing 26 to 60 kg: 2,000 mg/day PO.
2 to 12 years weighing 21 to 25 kg: 1,500 mg/day PO.
2 to 12 years weighing 16 to 20 kg: 1,300 mg/day PO.
2 to 12 years weighing 10 to 15 kg: 1,050 mg/day PO.
1 year: 150 mg/kg/day PO for infantile spasms. Safety and efficacy have not been established for other seizure types.
150 mg/kg/day PO for infantile spasms. Safety and efficacy have not been established for other seizure types.
Safety and efficacy have not been established.
How supplied
Vigabatrin
tablet
- 500mg (Sabril, generic)
powder for oral solution
- 500mg/packet (Sabril, Vigadrone, generic)
