The adverse reaction profile of levetiracetam is generally similar across age groups and across the approved epilepsy indications.
Initially 250 mg once daily for 1 week, then increased to 250 mg twice daily, then increased in steps of 250 mg twice daily (max. The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only. There is no evidence for any relevant gender, race or circadian variability. The mean total body clearance was 0.96 ml/min/kg.The major route of excretion was via urine, accounting for a mean 95 % of the dose (approximately 93 % of the dose was excreted within 48 hours). In patients aged 4-16 years, a total of 645 patients have been treated with levetiracetam in placebo-controlled and open label extension studies.
These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience. By continuing to browse the site you are agreeing to our policy on the use of cookies. Immediate-release (Keppra, Spritam): 500 mg IV/PO q12hr; may increase q2week by 500 mg/dose to recommended dose of 1500 mg q12hrEffectiveness of doses >3000 mg/day has not been adequately studiedImmediate-release (Keppra, Spritam): 500 mg PO q12hr; may increase q2week by 500 mg/dose; not to exceed 3000 mg/dayExtended-release (Keppra XR or Elepsia XR): 1000 mg PO qDay; may increase q2week by 1000 mg/day; not to exceed 3000 mg/dayIV: 500 mg q12hr; may increase q2week by 500 mg/dose; not to exceed 3000 mg/dayImmediate-release (Keppra, Spritam): 500 mg IV/PO q12hr; may increase q2week by 500 mg/dose to recommended dose of 1500 mg q12hrEffectiveness of doses >3000 mg/day has not been adequately studiedDiscontinuing levetiracetam: Gradually reduce dose and avoid abrupt discontinuation because of risk of increased seizure frequency and status epilepticus≥12 years: 500 mg PO q12hr; increase by 500 mg q12hr q2week to recommended dose of 1500 mg q12hrEffectiveness of doses >3000 mg/day has not been studiedIncreased blood pressure (17% in children < 4 years)Hepatic: Abnormal liver function tests, hepatic failure, hepatitis, pancreatitisSkin: Alopecia, erythema multiforme; drug rash with eosinophilia and systemic syndrome (DRESS)Hematology: Leukopenia, neutropenia, pancytopenia, thrombocytopenia, agranulocytosisSomnolence 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 machineryAs with most antiepileptic drugs, drug should generally be withdrawn gradually because of risk of increased seizure frequency and status epilepticus; if withdrawal needed because of serious adverse reaction, rapid discontinuation can be consideredPsychiatric 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 requiredMonitor 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 behaviorSerious 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 consideredDrug rash with eosinophilia and systemic syndrome (DRESS) reportedTherapy can cause hematologic abnormalities, including decreases in white blood cell (WBC), neutrophil, and red blood cell (RBC) counts; decreases in hemoglobin and hematocrit; and increases in eosinophil counts; cases of agranulocytosis, pancytopenia, and thrombocytopenia reported in postmarketing setting; a complete blood count is recommended in patients experiencing significant weakness, pyrexia, recurrent infections, or coagulation disordersMonitor patients 1 month to <4 years of age for increases in diastolic blood pressureSeizure 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 periodAgranulocytosis 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 countsOne 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 hemodialysisCan cause anaphylaxis or angioedema after the first dose or at any time during treatment; if patient develops signs or symptoms of anaphylaxis or angioedema, therapy should be discontinued and patient should seek immediate medical attention; therapy should be discontinued permanently if clear alternative etiology for reaction cannot be establishedThere are no adequate and well-controlled studies in pregnant women; prolonged experience in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries, and reflects experience over two decadesIn animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic dosesUse during pregnancy only if the potential benefit justifies the potential risk to the fetusDrug blood levels may decrease during pregnancy; physiological changes during pregnancy may affect drug concentration; decrease in drug plasma concentrations has been observed during pregnancy; this decrease is more pronounced during third trimester; dose adjustments may be necessary to maintain clinical responseEnroll patients in the North American Antiepileptic Drug pregnancy registry; 1-888-233-2334 or visit http://www.aedpregnancyregistry.orgDrug is excreted in human milk; there are no data on effects of drug on breastfed infant, or on milk productionConsider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal conditioA: Generally acceptable.
These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience. By continuing to browse the site you are agreeing to our policy on the use of cookies. Immediate-release (Keppra, Spritam): 500 mg IV/PO q12hr; may increase q2week by 500 mg/dose to recommended dose of 1500 mg q12hrEffectiveness of doses >3000 mg/day has not been adequately studiedImmediate-release (Keppra, Spritam): 500 mg PO q12hr; may increase q2week by 500 mg/dose; not to exceed 3000 mg/dayExtended-release (Keppra XR or Elepsia XR): 1000 mg PO qDay; may increase q2week by 1000 mg/day; not to exceed 3000 mg/dayIV: 500 mg q12hr; may increase q2week by 500 mg/dose; not to exceed 3000 mg/dayImmediate-release (Keppra, Spritam): 500 mg IV/PO q12hr; may increase q2week by 500 mg/dose to recommended dose of 1500 mg q12hrEffectiveness of doses >3000 mg/day has not been adequately studiedDiscontinuing levetiracetam: Gradually reduce dose and avoid abrupt discontinuation because of risk of increased seizure frequency and status epilepticus≥12 years: 500 mg PO q12hr; increase by 500 mg q12hr q2week to recommended dose of 1500 mg q12hrEffectiveness of doses >3000 mg/day has not been studiedIncreased blood pressure (17% in children < 4 years)Hepatic: Abnormal liver function tests, hepatic failure, hepatitis, pancreatitisSkin: Alopecia, erythema multiforme; drug rash with eosinophilia and systemic syndrome (DRESS)Hematology: Leukopenia, neutropenia, pancytopenia, thrombocytopenia, agranulocytosisSomnolence 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 machineryAs with most antiepileptic drugs, drug should generally be withdrawn gradually because of risk of increased seizure frequency and status epilepticus; if withdrawal needed because of serious adverse reaction, rapid discontinuation can be consideredPsychiatric 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 requiredMonitor 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 behaviorSerious 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 consideredDrug rash with eosinophilia and systemic syndrome (DRESS) reportedTherapy can cause hematologic abnormalities, including decreases in white blood cell (WBC), neutrophil, and red blood cell (RBC) counts; decreases in hemoglobin and hematocrit; and increases in eosinophil counts; cases of agranulocytosis, pancytopenia, and thrombocytopenia reported in postmarketing setting; a complete blood count is recommended in patients experiencing significant weakness, pyrexia, recurrent infections, or coagulation disordersMonitor patients 1 month to <4 years of age for increases in diastolic blood pressureSeizure 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 periodAgranulocytosis 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 countsOne 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 hemodialysisCan cause anaphylaxis or angioedema after the first dose or at any time during treatment; if patient develops signs or symptoms of anaphylaxis or angioedema, therapy should be discontinued and patient should seek immediate medical attention; therapy should be discontinued permanently if clear alternative etiology for reaction cannot be establishedThere are no adequate and well-controlled studies in pregnant women; prolonged experience in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries, and reflects experience over two decadesIn animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic dosesUse during pregnancy only if the potential benefit justifies the potential risk to the fetusDrug blood levels may decrease during pregnancy; physiological changes during pregnancy may affect drug concentration; decrease in drug plasma concentrations has been observed during pregnancy; this decrease is more pronounced during third trimester; dose adjustments may be necessary to maintain clinical responseEnroll patients in the North American Antiepileptic Drug pregnancy registry; 1-888-233-2334 or visit http://www.aedpregnancyregistry.orgDrug is excreted in human milk; there are no data on effects of drug on breastfed infant, or on milk productionConsider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal conditioA: Generally acceptable.