eslikarbazepīna acetāts - search results

Sweden - English - Läkemedelsverket (Medical Products Agency)

arupsan 200 mg tablett

Sweden - English - Läkemedelsverket (Medical Products Agency)

arupsan 800 mg tablett

Ireland - English - HPRA (Health Products Regulatory Authority)

eslicarbazepine acetate mylan 800 mg tablets

mcdermott laboratories ltd., t/a gerard laboratories - eslicarbazepine acetate - tablet - 800 milligram(s) - carboxamide derivatives; eslicarbazepine

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

eslicarbazepine acetate- eslicarbazepine acetate tablet

camber pharmaceuticals, inc. - eslicarbazepine acetate (unii: bea68zvb2k) (eslicarbazepine - unii:s5vxa428r4) - eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. eslicarbazepine acetate tablets are contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see warnings and precautions ( 5.2, 5.3, and 5.4)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as eslicarbazepine acetate, during pregnancy. encourage women who are taking eslicarbazepine acetate 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 limited available data with eslicarbazepine acetate use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. in oral studies conducted in pregnant mice, rats, and rabbits, eslicarbazepine acetate demons

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

aptiom- eslicarbazepine acetate tablet aptiom- eslicarbazepine acetate kit

sumitomo pharma america, inc. - eslicarbazepine acetate (unii: bea68zvb2k) (eslicarbazepine - unii:s5vxa428r4) - eslicarbazepine acetate 200 mg - aptiom is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. aptiom is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see warnings and precautions (5.2, 5.3, and 5.4)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as aptiom, during pregnancy. encourage women who are taking aptiom 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 limited available data with aptiom use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. in oral studies conducted in pregnant mice, rats, and rabbits, eslicarbazepine acetate demonstrated developmental toxicity, including increased incidence of malformations (mice), embryolethality (rats), and fetal growth retardation (all species), at clinically relevant doses (see data). advise a pregnant woman of the potential risk to a fetus. 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. data animal data when eslicarbazepine acetate was orally administered (150, 350, 650 mg/kg/day) to pregnant mice throughout organogenesis, increased incidences of fetal malformations was observed at all doses and fetal growth retardation was observed at the mid and high doses. a no-effect dose for adverse developmental effects was not identified. at the lowest dose tested, plasma eslicarbazepine exposure (cmax , auc) is less than that in humans at the maximum recommended human dose (mrhd, 1600 mg/day). oral administration of eslicarbazepine acetate (40, 160, 320 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in fetal growth retardation and increased incidences of skeletal variations at the mid and high doses. the no-effect dose (40 mg/kg/day) is less than the mrhd on a mg/m2 basis. oral administration to pregnant rats (65, 125, 250 mg/kg/day) throughout organogenesis resulted in embryolethality at all doses, increased incidences of skeletal variations at the mid and high doses, and fetal growth retardation at the high dose. the lowest dose tested (65 mg/kg/day) is less than the mrhd on a mg/m2 basis. when eslicarbazepine acetate was orally administered to female mice during pregnancy and lactation (150, 350, 650 mg/kg/day), the gestation period was prolonged at the highest dose tested. in offspring, a persistent reduction in offspring body weight and delayed physical development and sexual maturation were observed at the mid and high doses. the lowest dose tested (150 mg/kg/day) is less than the mrhd on a mg/m2 basis. when eslicarbazepine acetate was orally administered (65, 125, 250 mg/kg/day) to rats during pregnancy and lactation, reduced offspring body weight was seen at the mid and high doses. delayed sexual maturation and a neurological deficit (decreased motor coordination) were observed at the highest dose tested. the no-effect dose for adverse developmental effects (65 mg/kg/day) is less than the mrhd on a mg/m2 basis. the rat data are of uncertain relevance to humans because of differences in metabolic profile between species. eslicarbazepine is present in human milk. the effects of aptiom on the breastfed infant or on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for aptiom and any potential adverse effects on the breastfed infant from aptiom or from the underlying maternal condition. contraception use of aptiom with hormonal contraceptives containing ethinylestradiol or levonorgestrel is associated with lower plasma levels of these hormones. advise women of reproductive potential taking aptiom who are using a contraceptive containing ethinylestradiol or levonorgestrel to use additional or alternative non-hormonal birth control [see drug interactions (7.4)] . infertility eslicarbazepine acetate was evaluated in rats and mice for potential adverse impact on fertility of the parental and first generation [see nonclinical toxicology (13.1)] . in a fertility study in male and female mice, adverse developmental outcomes were observed in embryos. in a fertility study in male and female rats, impairment of female fertility by eslicarbazepine acetate was shown. safety and effectiveness of aptiom have been established in the age groups 4 to 17 years. use of aptiom in these age groups is supported by evidence from adequate and well-controlled studies of aptiom in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data from clinical studies in 393 pediatric patients 4 to 17 years of age [see adverse reactions (6.1) and clinical pharmacology (12.3)] . safety and effectiveness in pediatric patients below the age of 4 years have not been established. animal data in a juvenile animal study in which eslicarbazepine acetate (40, 80, 160 mg/kg/day) was orally administered to young dogs for 10 months starting on postnatal day 21, adverse effects on bone growth (decreased bone mineral content and density) were seen in females at all doses at the end of the dosing period, but not at the end of a 2-month recovery period. convulsions were seen at the highest dose tested. a no-effect dose for adverse effects in juvenile dogs was not identified. the lowest dose tested is less than the maximum recommended pediatric dose (1200 mg/day) on a body surface area (mg/m2 ) basis. a separate juvenile animal study was conducted to assess possible adverse effects on the immune system. eslicarbazepine acetate (10, 40, 80 mg/kg/day) was orally administered to young dogs for 17 weeks starting on postnatal day 21. no effects on the immune system were observed. there were insufficient numbers of patients ≥65 years old enrolled in the controlled adjunctive epilepsy trials (n=15) to determine the efficacy of aptiom in this patient population. the pharmacokinetics of aptiom were evaluated in elderly healthy subjects (n=12) (figure 1). although the pharmacokinetics of eslicarbazepine are not affected by age independently, dose selection should take in consideration the greater frequency of renal impairment and other concomitant medical conditions and drug therapies in the elderly patient. dose adjustment is necessary if crcl is <50 ml/min [see clinical pharmacology (12.3)]. clearance of eslicarbazepine is decreased in patients with impaired renal function and is correlated with creatinine clearance. dosage adjustment is necessary in patients with crcl<50 ml/min (figure 1) [see dosage and administration (2.4) and clinical pharmacology (12.3)]. dose adjustments are not required in patients with mild to moderate hepatic impairment (figure 1). use of aptiom in patients with severe hepatic impairment has not been evaluated, and use in these patients is not recommended [see clinical pharmacology (12.3)]. aptiom is not a controlled substance. prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. drug abuse and drug addiction are separate and distinct from physical dependence (for example, abuse may not be accompanied by physical dependence) [see drug abuse and dependence (9.3)]. in a human abuse study in recreational sedative abusers aptiom showed no evidence of abuse. in phase 1, 1.5% of the healthy volunteers taking aptiom reported euphoria compared to 0.4% taking placebo. physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. there was some evidence of physical dependence or a withdrawal syndrome with aptiom in a physical dependence study conducted in healthy volunteers who were maintained at a daily dose of 800 mg aptiom for 4 weeks prior to discontinuation. the primary endpoint was the maximum change from steady-state baseline in the total score of the physician's withdrawal checklist (pwc-34) during the 21-day discontinuation period. aptiom and placebo were shown to be equivalent on the primary endpoint. two out of 8 secondary endpoints (visual analog scales for anxiety and nausea) showed some increase in these symptoms for subjects who were maintained on aptiom and discontinued, versus subjects who were maintained on placebo. in general, aeds should not be abruptly discontinued in patients with epilepsy because of the risk of increased seizure frequency and status epilepticus.