Spritam

— THERAPEUTIC CATEGORIES —
  • Seizure disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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

    Aprecia Pharmaceuticals

    Generic Availability

    NO

    Mechanism of Action

    The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown.

    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. Evaluate immediately if signs or symptoms of drug reaction with eosinophilia and systemic symptoms (DRESS)/multiorgan hypersensitivity develop; discontinue if alternative etiology cannot be established. Avoid abrupt cessation. Renal impairment. Elderly: monitor renal function. Pregnancy: monitor closely (esp. during 3rd trimester). Nursing mothers.

    Spritam Pharmacokinetics

    Absorption

    Peak plasma concentrations occurred in about an hour. Oral bioavailability: 100%.

    Distribution

    <10% plasma protein bound.

    Metabolism

    Not extensively metabolized. Major metabolic pathway: enzymatic hydrolysis.

    Elimination

    Renal (66%). Half-life: 7±1 hour. Total body clearance: 0.96 mL/min/kg. Renal clearance: 0.6 mL/min/kg.

    Spritam Interactions

    Not Applicable

    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

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