Pharm

Vigabatrin

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Vigabatrin, Sabril

  • See Also
  1. Seizure Disorder
  2. Anticonvulsant
  • Indications
  1. Complex Partial Seizures (adjunct in refractory cases)
  • Precautions
  1. Risk of Vision Loss (see Adverse Effects below)
    1. Restricted distribution of Vigabatrin in U.S.
    2. Must be part of monitoring program in U.S. to receive
    3. Not recommended in age <9 years due to greater difficulty in detecting Vision Loss
  • Mechanism
  1. Anticonvulsant
  2. GABA analog
  3. Irreversibly inhibits 4-Aminobutyrate transaminase (which catalyzes GABA)
  • Safety
  1. Pregnancy Category C
    1. Teratogenic in animals (Cleft Lip)
  2. Avoid in Lactation
  • Dosing
  1. Adults (and children age >16 years, weight > 60 kg)
    1. Initial: 500 mg orally twice daily orally
    2. Titrate weekly at 500 mg/day/week
    3. Target: 1500 mg orally twice daily
  2. Children (age 10 to 16 years, weight 25 to 60 kg)
    1. Initial: 250 mg orally twice daily orally
    2. Titrate weekly at 500 mg/day/week
    3. Target: 1000 mg orally twice daily
  3. Infants with Infantile Spasms (age 1 month to 2 years)
    1. Initial: 50 mg/kg/day divided twice daily orally
    2. Titrate every 3 days by 25 to 50 mg/kg/day
    3. Maximum: 150 mg/kg/day divided twice daily orally
  4. Renal Dosing
    1. Creatinine Clearance 50 to 80 ml/min: Decrease dose by 25%
    2. Creatinine Clearance 30 to 50 ml/min: Decrease dose by 50%
    3. Creatinine Clearance 10 to 30 ml/min: Decrease dose by 75%
  • Adverse Effects
  1. Common
    1. Sedation
    2. Fatigue
    3. Weight gain
    4. Headache
    5. Dizziness, Ataxia or Vertigo
    6. Nervousness
    7. Abdominal Pain
    8. Constipation
  2. Serious
    1. Vision Loss (Retinal nerve atrophy)
      1. Onset may be at any time while taking medication, and irreversible once it occurs
      2. Obtain Visual Field testing at baseline, then every 3 months, and for 3 to 6 months after stopping medication
    2. Psychosis
  • Pharmacokinetics
  1. Most (95%) is excreted unchanged in the urine
  • References
  1. Hamilton (2020) Tarascon Pocket Pharmacopoeia