SPRITAM Rx

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SPRITAM

Seizure disorders
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Generic Name and Formulations:

Levetiracetam 250mg, 500mg, 750mg, 1000mg; tabs for oral susp; spearmint-flavored.

Select therapeutic use:

Indications for SPRITAM:

Adjunct in partial onset seizures in patients ≥4yrs old. Adjunct in myoclonic seizures in patients ≥12yrs old with juvenile myoclonic epilepsy. Adjunct in primary generalized tonic-clonic seizures in patients ≥6yrs old with idiopathic generalized epilepsy.

Adults and Children:

Do not swallow tab(s) intact. Allow tab(s) to disintegrate in the mouth when taken with a sip of liquid; then swallow. Or, may add tab(s) to small volume of liquid (~1tbsp); consume entire contents after dispersion. All: give in 2 divided doses. Partial onset: <4yrs or <20kg: not recommended. ≥4yrs (20–40kg): initially 500mg daily; increase at 2-week intervals by increments of 500mg/day to max 1500mg/day; (>40kg): initially 1000mg daily; increase at 2-week intervals by increments of 1000mg/day to max 3000mg/day. Myoclonic: <12yrs: not recommended. ≥12yrs: Initially 1000mg daily; increase at 2-week intervals by 1000mg/day to target dose of 3000mg/day. Tonic-clonic: <6yrs: not recommended. ≥6yrs (20–40kg): initially 500mg daily; increase at 2-week intervals by 500mg/day to max 1500mg/day; (>40kg): initially 1000mg daily; increase at 2-week intervals by 1000mg/day to max 3000mg/day. Renal impairment: CrCl 50–80mL/min: 500mg–1000mg every 12hrs; CrCl 30–50mL/min: 250mg–750mg every 12hrs; CrCl <30mL/min: 250mg–500mg every 12hrs; ESRD patients on dialysis: 500mg–1000mg every 24hrs and a supplement of 250mg–500mg post-dialysis.

Warnings/Precautions:

Monitor for behavioral abnormalities, psychotic symptoms, somnolence, fatigue, coordination difficulties. Suicidal behavior and ideation; monitor. Discontinue at the first sign of rash; do not resume if Stevens-Johnson syndrome or toxic epidermal necrolysis is suspected. Avoid abrupt cessation. Renal impairment. Elderly (consider monitoring renal function). Pregnancy (Cat.C); monitor carefully esp. during 3rd trimester. Nursing mothers: not recommended.

Pharmacological Class:

Antiepileptic.

Adverse Reactions:

Somnolence, asthenia, infection, dizziness; behavioral abnormalities (eg, anger, depression, anxiety, apathy), psychotic symptoms, coordination difficulties (eg, ataxia, abnormal gait), hematologic abnormalities, anaphylaxis (discontinue if occurs). Children: also fatigue, aggression, nasal congestion, decreased appetite, irritability; BP increases in children 1 month–<4yrs (monitor).

Note:

Enroll pregnant patients exposed to levetiracetam in the North American Antiepileptic Drug pregnancy registry at (888) 233-2334.

Generic Availability:

NO

How Supplied:

Tabs—60 (6 x 10 blister cards)

SPRITAM 60 tablets for oral suspension of 500mg cartons (Qty:1)

appx. price $495.00