United States - English - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 100 mg in 1 ml - levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam injection is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam injection is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. levetiracetam injection is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.3) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam injection, during pregnancy. encourage women who are taking levetiracetam injection during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary prolonged experience with levetiracetam injection 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 decades [see human data ]. in animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see animal data ]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. clinical considerations levetiracetam blood levels may decrease during pregnancy [see warnings and precautions (5.9) ]. physiological changes during pregnancy may affect levetiracetam concentration. decrease in levetiracetam plasma concentrations has been observed during pregnancy. this decrease is more pronounced during the third trimester. dose adjustments may be necessary to maintain clinical response. data human data while available studies cannot definitively establish the absence of risk, data from the published literature and pregnancy registries have not established an association with levetiracetam use during pregnancy and major birth defects or miscarriage. animal data when levetiracetam (0, 400, 1200, or 3600 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, reduced fetal weights and increased incidence of fetal skeletal variations were observed at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on embryofetal developmental in rats (1200 mg/kg/day) is approximately 4 times the maximum recommended human dose (mrhd) of 3000 mg on a body surface area (mg/m2 ) basis. oral administration of levetiracetam (0, 200, 600, or 1800 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and incidence of fetal skeletal variations at the mid and high dose and decreased fetal weights and increased incidence of fetal malformations at the high dose, which was associated with maternal toxicity. the no-effect dose for adverse effects on embryofetal development in rabbits (200 mg/kg/day) is approximately equivalent to the mrhd on a mg/m2 basis. oral administration of levetiracetam (0, 70, 350, or 1800 mg/kg/day) to female rats throughout pregnancy and lactation led to an increased incidence of fetal skeletal variations, reduced fetal body weight, and decreased growth in offspring at the mid and high doses and increased pup mortality and neurobehavioral alterations in offspring at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on pre-and postnatal development in rats (70 mg/kg/day) is less than the mrhd on a mg/m2 basis. oral administration of levetiracetam to rats during the latter part of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the mrhd on a mg/m2 basis).   risk summary levetiracetam is excreted in human milk. there are no data on the effects of levetiracetam injection on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for levetiracetam injection and any potential adverse effects on the breastfed infant from levetiracetam injection or from the underlying maternal condition. the safety and effectiveness of levetiracetam injection for the treatment of partial onset seizures in patients 1 month to 16 years of age have been established [see clinical pharmacology (12.3) and clinical studies (14.1) ]. the dosing recommendation in these pediatric patients varies according to age group and is weight-based [see dosage and administration (2.6) ]. the safety and effectiveness of levetiracetam injection as adjunctive therapy for the treatment of myoclonic seizures in adolescents 12 years of age and older with juvenile myoclonic epilepsy have been established [see clinical studies (14.2) ]. the safety and effectiveness of levetiracetam injection as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in pediatric patients 6 years of age and older with idiopathic generalized epilepsy have been established [see clinical studies (14.3) ]. safety and effectiveness for the treatment of partial-onset seizures in pediatric patients below the age of 1 month; adjunctive therapy for the treatment of myoclonic seizures in pediatric patients below the age of 12 years; and adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in pediatric patients below the age of 6 years have not been established. a 3-month, randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of levetiracetam injection as adjunctive therapy in 98 (levetiracetam injection n=64, placebo n=34) pediatric patients, ages 4 years to 16 years, with partial seizures that were inadequately controlled. the target dose was 60 mg/kg/day. neurocognitive effects were measured by the leiter-r attention and memory (am) battery, which measures various aspects of a child's memory and attention. although no substantive differences were observed between the placebo and drug treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority of the drug and placebo. the achenbach child behavior checklist (cbcl/6-18), a standardized validated tool used to assess a child’s competencies and behavioral/emotional problems, was also assessed in this study. an analysis of the cbcl/6-18 indicated, on average, a worsening in levetiracetam injection-treated patients in aggressive behavior, one of the eight syndrome scores [see warnings and precautions (5.1) ]. juvenile animal toxicity data studies of levetiracetam in juvenile rats (dosed on postnatal days 4 through 52) and dogs (dosed from postnatal weeks 3 through 7) at doses of up to 1800 mg/kg/day (approximately 7 and 24 times, respectively, the maximum recommended pediatric dose of 60 mg/kg/day on a mg/m2 basis) did not demonstrate adverse effects on postnatal development.   there were 347 subjects in clinical studies of levetiracetam that were 65 years old and over. no overall differences in safety were observed between these subjects and younger subjects. there were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of levetiracetam injection in these patients. levetiracetam is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. 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) ]. clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance [see clinical pharmacology (12.3) ]. dosage adjustment is recommended for patients with impaired renal function and supplemental doses should be given to patients after dialysis [see dosage and administration (2.7) ].

United States - English - NLM (National Library of Medicine)

hospira, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 100 mg in 1 ml - levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam injection is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam injection is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. levetiracetam injection is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.3)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who a

United States - English - NLM (National Library of Medicine)

mylan institutional llc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 100 mg in 1 ml - levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam injection is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam injection is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. levetiracetam injection is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.3)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are

United States - English - NLM (National Library of Medicine)

sagent pharmaceuticals - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg in 5 ml - levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam injection is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam injection is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.3)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are taking le

United States - English - NLM (National Library of Medicine)

mylan institutional llc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 5 mg in 1 ml - levetiracetam in sodium chloride injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. levetiracetam in sodium chloride injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy. levetiracetam in sodium chloride injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy. levetiracetam in sodium chloride injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible. levetiracetam in sodium chloride injection is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.3)]. there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are taking levetiracetam injection during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. prolonged experience with levetiracetam 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 decades [see human data]. in animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see animal data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. levetiracetam blood levels may decrease during pregnancy [see warnings and precautions (5.8)]. physiological changes during pregnancy may affect levetiracetam concentration. decrease in levetiracetam plasma concentrations has been observed during pregnancy. this decrease is more pronounced during the third trimester. dose adjustments may be necessary to maintain clinical response. while available studies cannot definitively establish the absence of risk, data from the published literature and pregnancy registries have not established an association with levetiracetam use during pregnancy and major birth defects or miscarriage. when levetiracetam (0, 400, 1200, or 3600 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, reduced fetal weights and increased incidence of fetal skeletal variations were observed at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on embryofetal development in rats (1200 mg/kg/day) is approximately 4 times the maximum recommended human dose (mrhd) of 3000 mg on a body surface area (mg/m2 ) basis. oral administration of levetiracetam (0, 200, 600, or 1800 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and incidence of fetal skeletal variations at the mid and high dose and decreased fetal weights and increased incidence of fetal malformations at the high dose, which was associated with maternal toxicity. the no-effect dose for adverse effects on embryofetal development in rabbits (200 mg/kg/day) is approximately equivalent to the mrhd on a mg/m2 basis. oral administration of levetiracetam (0, 70, 350, or 1800 mg/kg/day) to female rats throughout pregnancy and lactation led to an increased incidence of fetal skeletal variations, reduced fetal body weight, and decreased growth in offspring at the mid and high doses and increased pup mortality and neurobehavioral alterations in offspring at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on pre- and postnatal development in rats (70 mg/kg/day) is less than the mrhd on a mg/m2 basis oral administration of levetiracetam to rats during the latter part of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the mrhd on a mg/m2 basis). levetiracetam is excreted in human milk. there are no data on the effects of levetiracetam on the breastfed infant, or the effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for levetiracetam and any potential adverse effects on the breastfed infant from levetiracetam or from the underlying maternal condition. safety and effectiveness of levetiracetam injection in patients below the age of 16 years have not been established. there were 347 subjects in clinical studies of levetiracetam that were 65 years old and over. no overall differences in safety were observed between these subjects and younger subjects. there were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of levetiracetam in these patients. levetiracetam is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. 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)] . clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance [see clinical pharmacology (12.3)] . dosage 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)] .

United States - English - NLM (National Library of Medicine)

nexus pharmaceuticals inc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 100 mg in 1 ml - levetiracetam injection is an alternative for adult patients (16 years and older) when oral administration is temporarily not feasible. levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy. none pregnancy category c  - there are no adequate and well-controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human the

United States - English - NLM (National Library of Medicine)

jubilant cadista pharmaceuticals inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 100 mg in 1 ml - levetiracetam injection, usp is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. levetiracetam injection, usp is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. levetiracetam injection, usp is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam injection, usp is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. levetiracetam injection, usp is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. levetiracetam injection, usp is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. levetiracetam injection is

United States - English - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg in 5 ml - levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetirecetam is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. levetiracetam injection is contraindicted in patients with a hypersensitivity to levetiracetam.  reactions have included anaphylaxis and angioedema. [see warnings and precautions (5.3) ]. there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam injection, during pregnancy. encourage women who are taking levetiraceta

United States - English - NLM (National Library of Medicine)

gland pharma limited - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 5 mg in 1 ml - levetiracetam in sodium chloride injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. levetiracetam in sodium chloride injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy. levetiracetam in sodium chloride injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy. levetiracetam in sodium chloride injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible. levetiracetam in sodium chloride injection is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.3)]. pregnancy exposure registry   there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds),

Australia - English - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - levetiracetam, quantity: 10 % w/v - injection, concentrated - excipient ingredients: glacial acetic acid; sodium chloride; water for injections; sodium acetate trihydrate - levetiracetam-aft oral solution is indicated for:,use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation,,monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.,add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme),and,add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (ige).,levetiracetam-aft concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.