Names and pronunciation
(lev-eh-teer-ass′eh-tam) Keppra, Keppra XR, Spritam
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Individual generic drug information
Extracted information for levETIRAcetam only.
(lev-eh-teer-ass′eh-tam) Keppra, Keppra XR, Spritam
Source page 771
Func. class.: Anticonvulsant
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Chem. class.: Pyrrolidine derivative
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Do not confuse: Keppra/Kaletra/Keflexlevetiracetam/ lamotrigine/levocarnitine/levofloxacin levETIRAcetam/lamotrigine/levocarnitine/ levofloxacin
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ACTION: Unknown; may inhibit nerve impulses by limiting influx of sodium ions across cell membrane in motor cortex
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USES: Adjunctive therapy for partial- onset seizures, primary generalized tonic-clonic seizures, myoclonic seizures in juvenile patients
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Extracted information for levETIRAcetam only.
CONTRAINDICATIONS: Hyper- sensitivity, breastfeeding Precautions: Pregnancy, children, geriatric patients, renal/cardiac disease, psychosis
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SIDE EFFECTS CNS: Dizziness, somnolence, asthenia, psychosis, ideation, suicidal nonpsychotic behavioral symptoms, headache, ataxia EENT: Diplopia, conjunctivitis GI: Nausea, vomiting, anorexia, diarrhea, constipation, hepatitis HEMA: Infection, leukopenia INTEG: Pruritus, rash MISC: Infection, abdominal pain, pharyngitis SYST: Stevens-Johnson syndrome, toxic epidermal necrolysis; dehydration (child <4 yr)
Source page 772
INTERACTIONS Increase: sedation—TCAs, antihista- mines, benzodiazepines, other CNS depressants, alcohol • Possible increased carBAMazepine toxicity: carBAMazepine Decrease: levETIRAcetam absorption— sevelamer; separate by 1 hr before, 3 hr after sevelamer Drug/Lab Test Decrease: Hct/HB, WBC, RBC
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Extracted information for levETIRAcetam only.
DOSAGE AND ROUTES Adjunctive treatment of partial- onset seizures • Adult/adolescent ≥16 yr: IV 500 mg bid, may be titrated by 1000 mg/day q2wk, max 3000 mg/day in divided doses; EXT REL 1000 mg/day, may in- crease q2wk, max 3000 mg/day • Adolescent <16 yr/child: 1 mo to <6 mo (immediate-release tablet, in- jection or oral solution): Initially, 7 mg/kg IV/PO bid; increase by 14 mg/ kg/day in 2 divided doses q2wk to tar- get dose of 42 mg/kg/day in 2 divided doses. For PO, use oral sol with weight of ≤20 kg 6 mo to <4 yr (immediate-release tablet, injection, or oral sol): Initially, 10 mg/kg IV/PO bid; increase by 20 mg/kg/day in 2 divided doses q2wk to L target dose of 50 mg/kg/day in 2 divided doses as tolerated. For oral administra- tion, use oral sol with weight of ≤20 kg 4 yr to <16 yr and 20-40 kg (imme- diate-release tablet): Initially, 250 mg PO bid; titration, increase by 500 mg/day in 2 divided doses q2wk to max 1500 mg/ day in 2 divided doses 4 yr to <16 yr and >40 kg (immedi- ate-release tablet): Initially, 500 mg PO bid; increase by 1000 mg/day q2wk in 2 divided doses to max 3000 mg/day in 2 divided doses 4 yr to <16 yr (oral sol): Initially, 10 mg/kg orally bid; increase by 20 mg/kg/ day in 2 divided doses q2wk to target dose of 60 mg/kg/day in 2 divided doses as tolerated Myoclonic seizures/tonic-clonic seizures/partial seizures • Adult/adolescent ≥16 yr: PO/IV 500 mg bid, may increase by 1000 mg/day q2wk, max 3000 mg/day in 2 divided doses Adjunctive treatment of partial on- set seizures in those with epilepsy (Spritam) • Adult/child ≥4 yr and >40 kg: PO 500 mg bid, may increase q2wk by 500 mg bid, max 1500 mg bid Renal dose • Adult: PO CCr 50-80 mL/min, 500-1000 mg q12hr or EXT REL 1000-2000 mg q24hr, max 2000 mg/day; CCr 30-49 mL/min, 250- 750 mg q12hr or EXT REL 500-1500 mg q24hr, max 1500 mg/day; CCr <30 mL/min, 250-500 mg q12hr or EXT REL 500-1000 mg q24hr, max 1000 mg/day
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Available forms: Tabs 250, 500, 750, 1000 mg; oral sol 100 mg/mL; sol for inj 100 mg/mL; ext rel tab 500, 750 mg; pre- mixed solution 1000 mg/100 mL 0.75% NaCl, 1500 mg/100 mL, 500 mg/100 mL 0.82% NaCl; tabs for oral suspension (Spirtam) 250, 500, 750, 1000 mg
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Administer: PO route • Extended-release product should not be used in dialysis patients • Swallow tab whole; do not break, crush, or chew • With food, milk to decrease GI symp- toms (rare) if needed • Store at room temperature (PO) Child: • <20 kg should be given oral solution; use calibrated device Tabs for oral suspension (Spirtam) • Give only whole tabs • Peel foil from blister; do not push through foil • Place on tongue and swallow with a sip of liquid; do not swallow whole • Tab can be added to a tablespoon of liquid in a cup; swirl gently, consume Intermittent IV INFUSION route • Single-use vials: dilute in 100 mL of 0.9% NaCl, D5W, LR; give over 15 min, discard unused vial contents, do not use product with particulates or discoloration • Child: max concentration of product 15 mg/mL (diluted solution); infuse over 15 min • Diluted preparation stable for 24 hr at room temperature in polyvinyl bags • Store vials at room temperature
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Extracted information for levETIRAcetam only.
Assess: • Seizures: type, location, duration, character, intensity, precipitating factors; provide seizure precautions • Renal studies: urinalysis, BUN, urine creatinine q3mo • Blood studies: CBC, LFTs • Mental status: mood, sensorium, af suicidal fect, behavioral changes, thoughts/behaviors; if mental status changes, notify prescriber • Assistance with ambulation during early part of treatment; dizziness oc- curs • Beers: avoid in older adults unless safer alternative is unavailable; may cause ataxia, impaired psychomotor function • Pregnancy: if used during pregnancy, patient should enroll in the Antiepileptic Drug Pregnancy Registry at 888-233- 2334; do not breastfeed
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Evaluate: • Therapeutic response: decreased sei- zure activity; document on patient’s chart
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To take with or without food • Not to crush, break, chew tablets • To carry emergency ID stating patient’s name, products taken, condition, pre- scriber’s name, phone number • How to use oral sol; if trouble swallow- ing, measure oral sol in medicine cup or dropper, do not use teaspoon • To avoid driving, other activities that require alertness until response is known; drowsiness occurs during first month • Not to discontinue medication quickly after long-term use because withdrawal seizure may occur • To immediately report suicidal thoughts or behaviors, mood changes, hostility; thoughts of death, dying • Pregnancy/breastfeeding: to notify prescriber if pregnant, intending to be come pregnant; not to breastfeed, excre ted in breast milk See Appendix B
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Extracted information for levETIRAcetam only.
PHARMACOKINETICS Rapidly absorbed; not protein bound; excreted via kidneys 66% unchanged; half-life 6-8 hr, longer in geriatric patients or with renal disease
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Filter the extracted dose blocks for this individual drug.
Adjunctive treatment of partial- onset seizures
• Adult/adolescent ≥16 yr: IV 500 mg bid, may be titrated by 1000 mg/day q2wk, max 3000 mg/day in divided doses; EXT REL 1000 mg/day, may in- crease q2wk, max 3000 mg/day
Candidate age grouping · source pages 771, 772
Adjunctive treatment of partial- onset seizures
• Adolescent <16 yr/child: 1 mo to <6 mo (immediate-release tablet, in- jection or oral solution): Initially, 7 mg/kg IV/PO bid; increase by 14 mg/ kg/day in 2 divided doses q2wk to tar- get dose of 42 mg/kg/day in 2 divided doses. For PO, use oral sol with weight of ≤20 kg 6 mo to <4 yr (immediate-release tablet, injection, or oral sol): Initially, 10 mg/kg IV/PO bid; increase by 20 mg/kg/day in 2 divided doses q2wk to L target dose of 50 mg/kg/day in 2 divided doses as tolerated. For oral administra- tion, use oral sol with weight of ≤20 kg 4 yr to <16 yr and 20-40 kg (imme- diate-release tablet): Initially, 250 mg PO bid; titration, increase by 500 mg/day in 2 divided doses q2wk to max 1500 mg/ day in 2 divided doses 4 yr to <16 yr and >40 kg (immedi- ate-release tablet): Initially, 500 mg PO bid; increase by 1000 mg/day q2wk in 2 divided doses to max 3000 mg/day in 2 divided doses 4 yr to <16 yr (oral sol): Initially, 10 mg/kg orally bid; increase by 20 mg/kg/ day in 2 divided doses q2wk to target dose of 60 mg/kg/day in 2 divided doses as tolerated Myoclonic seizures/tonic-clonic seizures/partial seizures
Candidate age grouping · source pages 771, 772
Adjunctive treatment of partial- onset seizures
• Adult/adolescent ≥16 yr: PO/IV 500 mg bid, may increase by 1000 mg/day q2wk, max 3000 mg/day in 2 divided doses Adjunctive treatment of partial on- set seizures in those with epilepsy (Spritam)
Candidate age grouping · source pages 771, 772
Adjunctive treatment of partial- onset seizures
• Adult/child ≥4 yr and >40 kg: PO 500 mg bid, may increase q2wk by 500 mg bid, max 1500 mg bid Renal dose
Candidate age grouping · source pages 771, 772
Adjunctive treatment of partial- onset seizures
• Adult: PO CCr 50-80 mL/min, 500-1000 mg q12hr or EXT REL 1000-2000 mg q24hr, max 2000 mg/day; CCr 30-49 mL/min, 250- 750 mg q12hr or EXT REL 500-1500 mg q24hr, max 1500 mg/day; CCr <30 mL/min, 250-500 mg q12hr or EXT REL 500-1000 mg q24hr, max 1000 mg/day
Candidate age grouping · source pages 771, 772