levetiracetam (Rx)

Brand and Other Names:Keppra, Keppra XR, more...Spritam
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet, immediate-release (Keppra, Generic)

  • 250mg
  • 500mg
  • 750mg
  • 1g

3-D tablet, immediate-release (Spritam)

  • 250mg
  • 500mg
  • 750mg
  • 1g

tablet, extended-release (Keppra XR)

  • 500mg
  • 750mg

oral solution (Keppra, Generic)

  • 100mg/mL

injectable solution

  • 5mg/mL
  • 10mg/mL
  • 15mg/mL
  • 100mg/mL
more...

Myoclonic Seizures

Immediate-release (Keppra, Spritam): 500 mg IV/PO q12hr; may increase q2week by 500 mg/dose to recommended dose of 1500 mg q12hr

Effectiveness of doses <3000 mg/day has not been adequately studied

Partial Onset Seizure

Used as adjunctive therapy

Immediate-release (Keppra, Spritam): 500 mg PO q12hr; may increase q2week by 500 mg/dose; not to exceed 3000 mg/day

Extended-release (Keppra XR): 1000 mg PO qDay; may increase q2week by 1000 mg/day; not to exceed 3000 mg/day

IV: 500 mg q12hr; may increase q2week by 500 mg/dose; not to exceed 3000 mg/day

Primary Generalized Tonic Clonic Seizures

Immediate-release (Keppra, Spritam): 500 mg IV/PO q12hr; may increase q2week by 500 mg/dose to recommended dose of 1500 mg q12hr

Effectiveness of doses <3000 mg/day has not been adequately studied

Renal Impairment

Immediate Release and IV Formulations

  • CrCl >80 mL/min/1.73 m²: Dose adjustment not required
  • CrCl 50-80 mL/min/1.73 m²: 500-1000 mg PO q12hr
  • CrCl 30-50 mL/min/1.73 m²: 250-750 mg PO q12hr
  • CrCl <30 mL/min/1.73 m²: 250-500 mg PO q12hr
  • Dialysis (conventional): 500-1000 mg PO qDay, THEN 250-500 mg supplemental dose after dialysis

Extended Release Tablets

  • CrCl >80 mL/min/1.73 m²: Dose adjustment not required
  • CrCl 50-80 mL/min/1.73 m²: 1000-2000 mg PO q24hr
  • CrCl 30-50 mL/min/1.73 m²: 500-1500 mg PO q24hr
  • CrCl <30 mL/min/1.73 m²: 500-1000 mg PO q24hr
  • End-stage renal disease requiring hemodialysis: Immediate release formulation recommended

Dosage Forms & Strengths

tablet, immediate-release (Keppra, Generic)

  • 250mg
  • 500mg
  • 750mg
  • 1g

3-D tablet, immediate-release (Spritam)

  • 250mg
  • 500mg
  • 750mg
  • 1g

tablet, extended-release (Keppra XR)

  • 500mg
  • 750mg

oral solution (Keppra, Generic)

  • 100mg/mL

injectable solution

  • 5mg/mL
  • 10mg/mL
  • 15mg/mL
  • 100mg/mL
more...

Partial Onset Seizures

Used as adjunctive therapy

Immediate-release tablets (Keppra)

  • <1 month: Safety and efficacy not established
  • 1-6 months: 7 mg/kg PO q12hr; increase by increments of 7 mg/kg q12hr q2weeks to recommended dose of 21 mg/kg q12hr  
  • 6 months-4 years: 10 mg/kg PO q12hr, increase in increments of 10 mg/kg q12hr q2weeks to recommended dose of 25 mg/kg q12hr
  • 4-16 years: 10 mg/kg PO q12hr; increase q2week by 10 mg/kg/dose to 30 mg/kg q12hr
  • >16 years: 500 mg PO q12hr, increase by 500 mg q12hr q2weeks to recommended dose of 1500 mg q12hr

Immediate-release 3-D tablets (Spritam)

  • <4 years: Safety and efficacy not established
  • ≥4 years weighing 20-40 kg: 250 mg PO BID initially; increase the daily dose q2wk by increments of 500 mg (250 mg BID) to a maximum recommended daily dose of 1500 mg (750 mg BID)
  • ≥4 years weighing >40 kg: 500 mg PO BID initially; increase the daily dose q2wk by increments of 1000 mg (500 mg BID) to a maximum recommended daily dose of 3000 mg (1500 mg BID)

Extended-release tablets (Keppra XR)

  • <12 years: Safety and efficacy not established
  • &12 years: 1000 mg PO qDay initially; may adjust dose by 1000 mg increments q2wk to a maximum of 3000 mg/day

Primary Generalized Tonic-Clonic Seizures

<6 years: Safety and efficacy not established

Keppra

  • 6-16 years: 10 mg/kg PO q12hr; increase q2week by 10 mg/kg/dose to recommended dose of 30 mg/kg q12hr; efficacy of doses <60 mg/kg/day not established  
  • >16 years: 500 mg PO q12hr, increase by 500 mg q12hr q2weeks to recommended dose of 1500 mg q12hr

Spritam

  • ≥6 years weighing 20-40 kg: 250 mg PO BID initially; increase the daily dose q2wk by increments of 500 mg (250 mg BID) to a maximum recommended daily dose of 1500 mg/day (750 mg BID) ≥6 years weighing
  • >40 kg: 500 mg PO BID initially; increase the daily dose q2wk by increments of 1000 mg (500 mg BID) to a maximum recommended daily dose of 3000 mg (1500 BID)
  • Effectiveness of doses <3000 mg/day has not been adequately studied

Myoclonic Seizures

Keppra, Spritam

<12 years: Safety and efficacy not established

≥12 years: 500 mg PO q12hr; increase by 500 mg q12hr q2week to recommended dose of 1500 mg q12hr

Effectiveness of doses <3000 mg/day has not been studied

Neonatal Seizures (Orphan)

Orphan indication sponsor

  • University of California; UCSD Medical Center 0935; La Jolla, CA 92093-0935
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Interactions

Interaction Checker

and levetiracetam

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Asthenia (11-15%)

            Headache (14-19%)

            Infection (11-15%)

            Increased blood pressure (17% in children < 4 years)

            Somnolence (11-15%)

            Drowsiness (2-23%)

            Fatigue (10-11%)

            Anorexia (3-13%)

            Weakness (9-15%)

            Nasopharyngitis (7-15%)

            Cough (2-11%)

            1-10%

            Viral infection (2%)

            Asthma (2%)

            Dizziness (5-9%)

            Nervousness (2-10%)

            Amnesia (2%)

            Anxiety (2-3%)

            Ataxia (3%)

            Depression (2-5%)

            Hostility (10%)

            Paresthesia (2%)

            Sinusitis (2%)

            Diplopia (2%)

            Amblyopia (2%)

            Conjunctivitis (2-3%)

            Albuminuria (4%)

            <1%

            Abnormal hepatic function tests

            Dyskinesia

            Eczema

            Neutropenia

            Decreased hematocrit

            Leukopenia

            Suicidal tendencies

            Hepatitis

            Pancreatitis

            Bone marrow suppression

            Epidermal necrolysis

            Postmarketing Reports

            Hepatic: Abnormal liver function tests, hepatic failure, hepatitis, pancreatitis

            Skin: Alopecia, erythema multiforme; drug rash with eosinophilia and systemic syndrome (DRESS)

            Neurologic: Choreoathetosis, dyskinesia

            Hematology: Leukopenia, neutropenia, pancytopenia, thrombocytopenia

            Skeletomuscular: Muscle weakness

            Psychological: Panic attack

            General: Weight loss

            Hyponatremia

            Acute kidney injury

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Somnolence and asthenia occurred most frequently within first 4 weeks of treatment; patients should be monitored for signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on levetiracetam to gauge whether it adversely affects ability to drive or operate machinery

            Withdraw gradually

            Psychiatric reactions: 13.3% of adults and 37.6% of children treated with levetiracetam reported nonpsychotic behavioral symptoms (eg, aggression, agitation, anger, anxiety, apathy, depersonalization, lability, hostility, hyperkinesis, irritability, nervousness, neurosis, and personality disorder) compared to 6.2% and 18.6% of adult and pediatric placebo patients respectively; dose reduction or discontinuation may be required

            Monitor patients for behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, aggressive behavior, and for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior

            Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) reported; median time of onset is reported to be 14-17 days; if signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered

            Drug rash with eosinophilia and systemic syndrome (DRESS) reported

            May impair ability to operate heavy machinery

            Decreases in red blood cell count, hematocrit, hemoglobin, neutrophils, and white blood cell counts reported

            Increases in eosinophil counts observed

            Monitor patients 1 month to <4 years of age for increases in diastolic blood pressure

            Seizure control during pregnancy: Physiological changes during pregnancy may gradually decrease therapeutic plasma concentrations, this is particularly pronounced during the 3rd trimester; closely monitor serum levels during pregnancy and through the postpartum period

            Agranulocytosis reported; in pediatric patients (4 to <16 years of age), statistically significant decreases in WBC and neutrophil counts were seen in patients treated with immediate-release levetiracetam; no patient was discontinued secondary to low WBC or neutrophil counts

            One percent of adult patients and 2% of pediatric patients (4 to 16 years of age) treated with immediate-release levetiracetam experienced psychotic symptoms (paranoia)

            Use caution in renal impairment; adjust dose; use immediate release formulation, instead of the extended release formulation, in patients with ESRD requiring hemodialysis

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            Pregnancy & Lactation

            Pregnancy Category: C; As with all antiepileptic drugs, physiological changes (ie, intravascular volume expansion) during pregnancy may affect therapeutic levels and result in decreased serum concentrations

            Lactation: Excreted in breast milk; not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Antiepileptic mechanism unknown; may inhibit voltage-depedent N-type calcium channels; may bind to synaptic proteins that modulate neurotransmitter release; through displacement of negative modulators may facilitate GABA-ergic inhibitory transmission

            Pyrrolidone derivative

            Absorption

            Bioavailability: 100%

            Peak plasma time: 1 hr (immediate release); 4 hr (extended release)

            Distribution

            Protein bound: <10%

            Metabolism

            Metabolism: Hepatic enzymatic hydrolysis

            Metabolites: Inactive

            Elimination

            Half-life: 6-8 hr (increased in elderly or renal disease)

            Total body clearance: 0.96 mL/min/kg

            Renal clearance: 0.6 mL/min/kg; 4 mL/min/kg (metabolite)

            Clearance ~40% higher in children

            Dialyzable: Yes

            Excretion: Urine (66%)

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            Administration

            IV Use

            IV preparation: Dilute IV solution in 100 mL compatible solution

            IV administration: Infuse IV over 15 minutes

            Compatabilities

            • Solutions: NS, LR, D5W
            • Additive/syringe: lorazepam, diazepam, valproate sodium

            Oral Administration

            May take with or without food

            Use oral solution for children who weigh ≤20 kg

            Elepsia XR, Keppra XR: Swallow tablet whole; do not chew, split, crush, or cut tablets

            Spritam

            • Developed with ZipDose technology, which uses 3-dimensional printing to create a porous formulation of the antiepileptic that disintegrates rapidly with a sip of liquid, even at a high dose of up to 1000 mg
            • May take with or without food
            • Place the whole tablet on the tongue with a dry hand and follow with a sip of liquid
            • Swallow only after tablet disintegrates in mouth (mean disintegration time 11 seconds [range 2-27 seconds])
            • Tablet should not be swallowed intact
            • Instruct patients not to push the tablet through the foil; the foil should be peeled from the blister by bending and lifting the peel tab around the blister seal so the table does not break

            Storage

            May store diluted IV solution in PVC bags at 15-30°C (59-86°F) for up to 24 hr

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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