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

state of florida doh central pharmacy - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam tablets usp are indicated  as   adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for ucb, inc.’s levetiracetam tablets. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information . levetiracetam tablets usp are 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 tablets usp are 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. none. levetiracetam levels may decrease during pregnancy [see warnings and precautions (5.9)] . pregnancy category

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

atlantic biologicals corp. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam oral solution usp is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for ucb, inc.'s levetiracetam oral solution. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. levetiracetam oral solution 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 oral solution 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.    none. levetiracetam blood levels may decrease during pregnancy [see warnings and precautions (5.9)

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

tris pharma inc - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide tablets is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.’s vimpat®  (lacosamide) tablets. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy exposure registry  there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide 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 available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage

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

camber pharmaceuticals, inc. - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide tablet is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.'s vimpat ® (lacosamide) tablets. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide 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    available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug-associated

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

sciegen pharmaceuticals inc - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. additional pediatric use information is approved for ucb, inc.’s vimpat ® (lacosamide) tablets. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide 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 available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug-associated risk of major

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

indoco remedies limited - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older. pediatric use information is approved for ucb, inc.’s vimpat® (lacosamide) injection. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none.   pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide 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   there are no adequate data on the developmental risks associated with the use of lacosamide in pregnant women. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. devel

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

major pharmaceuticals - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.'s vimpat® (lacosamide) tablet. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide 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 there are no adequate data on the developmental risks associated with the use of lacosamide in pregnant women. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. de

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

fresenius kabi usa, llc - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older. pediatric use information is approved for ucb, inc.'s vimpat ® (lacosamide) injection. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide 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 there are no adequate data on the developmental risks associated with the use of lacosamide in pregnant women. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. develo

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

virtus pharmaceuticals, llc - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older. pediatric use information is approved for ucb, inc.’s vimpat® (lacosamide) injection. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide 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 available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or oth

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

amneal pharmaceuticals of new york llc - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.’s vimpat® (lacosamide) tablets. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none.  pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide 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 available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriag