Levetiracetam

DRUG INFORMATION

  ADULT
    - Levetiracetam tablets should not be chewed or crushed. 2.2 Partial Onset Seizures
      Adults 16 Years and Older In clinical trials, daily doses of 1000 mg, 2000 mg, and
      3000 mg, given as twice-daily dosing were shown to be effective.
      Source: US FDA label for levetiracetam (Levetiracetam), section 'dosage and
      administration', retrieved 2026-08-29
    - Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-
      daily dosing (500 mg twice daily).
      Source: US FDA label for levetiracetam (Levetiracetam), section 'dosage and
      administration', retrieved 2026-08-29
    - Additional dosing increments may be given (1000 mg/day additional every 2 weeks)
      to a maximum recommended daily dose of 3000 mg.
      Source: US FDA label for levetiracetam (Levetiracetam), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of levetiracetam in the adjunctive treatment of
      partial onset seizures in pediatric patients age 1 month to 16 years old with
      epilepsy have been established [see Clinical Studies (14.1) ]. The dosing
      recommendation in these pediatric patients varies according to age group and is
      weight-based [see Dosage and Administration (2.2) ].
      Source: US FDA label for levetiracetam (Levetiracetam), section 'pediatric use',
      retrieved 2026-08-29
    - Pediatric Patients 1 Month to < 6 Months Treatment should be initiated with a
      daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily).
      Source: US FDA label for levetiracetam (Levetiracetam), section 'dosage and
      administration', retrieved 2026-08-29
    - The daily dose should be increased every 2 weeks by increments of 14 mg/kg to the
      recommended daily dose of 42 mg/kg (21 mg/kg twice daily).
      Source: US FDA label for levetiracetam (Levetiracetam), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - In order to calculate the dose recommended for patients with renal impairment,
      creatinine clearance adjusted for body surface area must be calculated.
      Source: US FDA label for levetiracetam (Levetiracetam), section 'dosage and
      administration', retrieved 2026-08-29
    - Because elderly patients are more likely to have decreased renal function, care
      should be taken in dose selection, and it may be useful to monitor renal function
      [see Clinical Pharmacology (12.3) ]. 8.6 Use in Patients with Impaired Renal
      Function Clearance of levetiracetam is decreased in patients with renal impairment
      and is correlated with creatinine clearance [see Clinical Pharmacology (12.3) ].
      Source: US FDA label for levetiracetam (Levetiracetam), section 'use in specific
      populations', retrieved 2026-08-29
    - Dose adjustment is recommended for patients with impaired renal function and
      supplemental doses should be given to patients after dialysis [see Dosage and
      Administration (2.5) ].
      Source: US FDA label for levetiracetam (Levetiracetam), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for levetiracetam (Levetiracetam),
      retrieved 2026-08-29

  PREGNANCY   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Levetiracetam levels may decrease during pregnancy [see Warnings and Precautions
      (5.9) ].
      Source: US FDA label for levetiracetam (Levetiracetam), section 'pregnancy',
      retrieved 2026-08-29
    - Pregnancy Category C There are no adequate and well-controlled studies in pregnant
      women.
      Source: US FDA label for levetiracetam (Levetiracetam), section 'pregnancy',
      retrieved 2026-08-29
    - In animal studies, levetiracetam produced evidence of developmental toxicity,
      including teratogenic effects, at doses similar to or greater than human
      therapeutic doses. levetiracetam should be used during pregnancy only if the
      potential benefit justifies the potential risk to the fetus.
      Source: US FDA label for levetiracetam (Levetiracetam), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Levetiracetam is excreted in human milk.
      Source: US FDA label for levetiracetam (Levetiracetam), section 'nursing mothers',
      retrieved 2026-08-29
    - Because of the potential for serious adverse reactions in nursing infants from
      levetiracetam, a decision should be made whether to discontinue nursing or
      discontinue the drug, taking into account the importance of the drug to the
      mother.
      Source: US FDA label for levetiracetam (Levetiracetam), section 'nursing mothers',
      retrieved 2026-08-29
    - Oral administration of levetiracetam to female rats throughout pregnancy and
      lactation led to increased incidences of minor fetal skeletal abnormalities and
      retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day
      (equivalent to the maximum recommended human dose of 3000 mg [MRHD] on a mg/m 2
      basis) and with increased pup mortality and offspring behavioral alterations at a
      dose of 1800 mg/kg/day (6 times the MRHD on a mg/m 2 basis).
      Source: US FDA label for levetiracetam (Levetiracetam), section 'use in specific
      populations', retrieved 2026-08-29