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SABRIL TABLETS
Seizure disorders
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Drug Name:

SABRIL TABLETS Rx

Generic Name and Formulations:
Vigabatrin 500mg; tabs.

Company:
Lundbeck Inc.

Therapeutic Use:

Indications for SABRIL TABLETS:

Adjunctive therapy in adult patients 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.

Adult:

>16yrs: Use tabs. 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).

Children:

<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. Withdraw gradually (reduce daily dose by ⅓ per week for 3 weeks).

Warnings/Precautions:

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. Discontinue if no substantial benefit after treating for 3 months (in adults) or 2–4 weeks (in infants); sooner if obvious treatment failure. Monitor for depression, suicidal ideation, changes in mood/behavior. Renal impairment. Avoid abrupt cessation. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

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.

See Also:

SABRIL for ORAL SOLUTION

Pharmacological Class:

Antiepileptic.

Adverse Reactions:

RCPS: 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; abnormal MRI signal changes.

Note:

Available only through restricted distribution program. To register call (888) 45-SHARE. Encourage pregnant patients exposed to vigabatrin to call (888) 233-2334. To report ADRs: (800) 455-1141.

REMS:

YES

How Supplied:

Tabs—100; Pwd packets—50

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