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Spritam Generic Name & Formulations
Legal Class
Rx
General Description
Levetiracetam 250mg, 500mg, 750mg, 1000mg; tabs for oral susp; spearmint-flavored.
Pharmacological Class
Antiepileptic.
How Supplied
Tabs—60 (6x10 blister cards)
Manufacturer
Generic Availability
NO
Spritam Indications
Indications
Treatment of partial onset seizures in patients aged ≥4yrs weighing >20kg. Adjunct in myoclonic seizures in patients aged ≥12yrs with juvenile myoclonic epilepsy. Adjunct in primary generalized tonic-clonic seizures in patients aged ≥6yrs with idiopathic generalized epilepsy.
Spritam Dosage and Administration
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: not established; 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 established. ≥12yrs: Initially 1000mg daily; increase at 2-week intervals by 1000mg/day to target dose of 3000mg/day. Tonic-clonic: <6yrs: not established. ≥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.
Spritam Contraindications
Not Applicable
Spritam Boxed Warnings
Not Applicable
Spritam Warnings/Precautions
Warnings/Precautions
Monitor for behavioral abnormalities, psychotic symptoms, somnolence, fatigue, and coordination difficulties. Suicidal behavior and ideation; monitor. Hematologic abnormalities: do CBCs in those experiencing significant weakness, pyrexia, recurrent infections, or coagulation disorders. Discontinue if signs/symptoms of anaphylaxis or angioedema develops. Discontinue at the 1st sign of rash; do not resume if SJS/TEN is suspected. Avoid abrupt cessation. Renal impairment. Elderly: monitor renal function. Pregnancy: monitor closely (esp. during 3rd trimester). Nursing mothers.
Spritam Pharmacokinetics
See Literature
Spritam Interactions
Spritam Adverse Reactions
Adverse Reactions
Somnolence, asthenia, infection, dizziness; behavioral abnormalities (eg, anger, depression, anxiety, apathy), psychotic symptoms, coordination difficulties (eg, ataxia, abnormal gait), hematologic abnormalities, anaphylaxis, serious dermatological reactions; children: also fatigue, aggression, nasal congestion, decreased appetite, irritability; BP increases in children 1 month–<4yrs (monitor).
Spritam Clinical Trials
See Literature
Spritam Note
Notes
Enroll pregnant patients exposed to levetiracetam in the North American Antiepileptic Drug pregnancy registry at (888) 233-2334.
Spritam Patient Counseling
See Literature
