SABRIL for ORAL SOLUTION Rx
Generic Name and Formulations:
Vigabatrin 500mg/packet; pwd for oral soln.
Indications for SABRIL for ORAL SOLUTION:
Adjunctive therapy in patients ≥10yrs of age with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Not a first line agent for CPS. Monotherapy for infantile spasms (IS) in patients 1month–2yrs of age, when the potential benefits outweigh the risk of vision loss.
≥17yrs: initially 500mg twice daily; may be increased weekly by 500mg/day to maintenance 1.5g twice daily. CrCl >50–80mL/min: reduce dose by 25%; CrCl >30–50mL/min: reduce dose by 50%; CrCl >10–30mL/min: reduce dose by 75%. Reevaluate periodically. Withdraw gradually (reduce by 1g/day at weekly intervals).
CPS: <10yrs: not established. 10–16yrs: 25–60kg: initially 250mg twice daily; may be increased weekly by 500mg/day to maintenance 1g twice daily. >60kg: use adult dosing. CrCl >50–80mL/min: reduce dose by 25%; CrCl >30–50mL/min: reduce dose by 50%; CrCl >10–30mL/min: reduce dose by 75%. Reevaluate periodically. Withdraw gradually (reduce daily dose by ⅓ per week for 3 weeks). IS: <1month: not recommended. 1month–2yrs: use oral soln. Initially 50mg/kg/day (given in 2 divided doses); may titrate by 25–50mg/kg/day at 3-day intervals up to max 150mg/kg/day (75mg/kg twice daily). Withdraw gradually (reduce by 25–50mg/kg/day every 3–4 days).
Be fully familiar with drug’s toxicity before use. Monitor vision, including visual acuity and dilated indirect ophthalmoscopy, and visual fields, at baseline (within 4 weeks) and every 3 months, and for 3–6 months after discontinuing; risk of vision loss increases as dose and cumulative exposure increased. Avoid in patients with, or at high risk of other types of irreversible vision loss. Discontinue if no substantial benefit after treating for 3 months (in adults) or 2–4 weeks (in infants); sooner if obvious treatment failure. Increased risk of suicidal thoughts and behavior; monitor for depression, suicidal ideation, unusual changes in mood/behavior. MRI abnormalities in infants. Renal impairment. Use lowest effective dose for shortest duration. Avoid abrupt cessation. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
May antagonize phenytoin. May potentiate clonazepam. Avoid others that can cause visual or ophthalmic dysfunction. Suppresses ALT/AST activity. May cause false (+) amino acid test.
CPS: vision loss (may be severe and permanent), other visual changes (blurring, diplopia, asthenopia), fatigue, somnolence, nystagmus, tremor, memory impairment, weight gain, arthralgia, abnormal coordination, confusion, upper respiratory infection, aggression; headache, dizziness, anemia, peripheral neuropathy, edema. IS: bronchitis, ear infection, acute otitis media.
To register pregnant patients exposed to vigabatrin call (888) 233-2334. To report ADRs: (800) 455-1141.
Tabs—100; Pwd packets—50
Endocrinology Advisor Articles
- Single Blood Sample Highly Predictive for Subsequent Diabetes Diagnosis
- Adjunctive Metformin for Insulin Resistance in T1D: A Clinical Perspective
- Effect of Fructose, Allulose on Postprandial Glucose Regulation in Type 2 Diabetes
- Sex Hormone Levels May Affect Postmenopausal Heart Disease Risk
- Menopausal Hormone Therapy Slows Cognitive Decline in Postmenopausal Women
- Diabetes Treatments
- Metformin May Decrease Colorectal Cancer Risk Among Males With Diabetes
- SGLT2 Inhibitor, GLP-1 Receptor Agonist Combination Treatment for Type 2 Diabetes: Expert Insights
- Semaglutide May Induce Weight Loss in Type 2 Diabetes Despite BMI
- FDA Clears Omnipod DASH System for Diabetes Management
- Effect of Infant Feeding Practices and Gut Microbiota on Overweight in First Year
- Empagliflozin, Linagliptin Combination Therapy vs Linagliptin Monotherapy for Type 2 Diabetes
- Cleared Blood Glucose Monitor Systems Not Always Accurate
- CDC: Obesity Prevalence Higher in Non-Metropolitan Counties
- Vascular Mortality Declining in Adults With Diabetes in the United States