Ireland - English - HPRA (Health Products Regulatory Authority)

novartis ireland limited - oxcarbazepine - film-coated tablet - 150 milligram(s) - carboxamide derivatives; oxcarbazepine

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis pharmaceuticals uk ltd - oxcarbazepine - film coated tablet - 150 milligram - antiepileptics

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis pharmaceuticals uk ltd - oxcarbazepine - film coated tablet - 300 milligram - antiepileptics

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis pharmaceuticals uk ltd - oxcarbazepine - oral suspension - 60 mg/ml - antiepileptics

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis pharmaceuticals uk ltd - oxcarbazepine - film coated tablet - 600 milligram - antiepileptics

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis ireland limited - oxcarbazepine - film-coated tablet - 300 milligram(s) - carboxamide derivatives; oxcarbazepine

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis ireland limited - oxcarbazepine - film-coated tablet - 600 milligram(s) - carboxamide derivatives; oxcarbazepine

Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - oxcarbazepine - film-coated tablet - 300 milligram(s) - carboxamide derivatives; oxcarbazepine

Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - oxcarbazepine - film-coated tablet - 600 milligram(s) - carboxamide derivatives; oxcarbazepine

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

novartis pharmaceuticals corporation - oxcarbazepine (unii: vzi5b1w380) (oxcarbazepine - unii:vzi5b1w380) - oxcarbazepine 150 mg - trileptal is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. trileptal is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [see warnings and precautions (5.2, 5.3) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as trileptal, during pregnancy. encourage women who are taking trileptal 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 trileptal in pregnant women; however, trileptal is closely related structurally to carbamazepine, which is considered to be teratogenic in humans. data on a limited number of pregnancies from pregnancy registries suggest that trileptal monotherapy use is associated with congenital malformations (e.g., craniofacial defects, such as oral clefts, and cardiac malformations, such as ventricular septal defects). increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity (embryolethality, growth retardation) were observed in the offspring of animals treated with either oxcarbazepine or its active 10-hydroxy metabolite (mhd) during pregnancy at doses similar to the maximum recommended human dose (mrhd). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. clinical considerations an increase in seizure frequency may occur during pregnancy because of altered levels of the active metabolite of oxcarbazepine. monitor patients carefully during pregnancy and through the postpartum period [see warnings and precautions (5.10)] . data human data data from published registries have reported craniofacial defects, such as oral clefts and cardiac malformations, such as ventricular septal defects in children with prenatal oxcarbazepine exposure. animal data when pregnant rats were given oxcarbazepine (0, 30, 300, or 1000 mg/kg/day) orally throughout the period of organogenesis, increased incidences of fetal malformations (craniofacial, cardiovascular, and skeletal) and variations were observed at the intermediate and high doses (approximately 1.2 and 4 times, respectively, the mrhd on a mg/m2 basis). increased embryofetal death and decreased fetal body weights were seen at the high dose. doses ≥300 mg/kg/day were also maternally toxic (decreased body weight gain, clinical signs), but there is no evidence to suggest that teratogenicity was secondary to the maternal effects. in a study in which pregnant rabbits were orally administered mhd (0, 20, 100, or 200 mg/kg/day) during organogenesis, embryofetal mortality was increased at the highest dose (1.5 times the mrhd on a mg/m2 basis). this dose produced only minimal maternal toxicity. in a study in which female rats were dosed orally with oxcarbazepine (0, 25, 50, or 150 mg/kg/day) during the latter part of gestation and throughout the lactation period, a persistent reduction in body weights and altered behavior (decreased activity) were observed in offspring exposed to the highest dose (less than the mrhd on a mg/m2 basis). oral administration of mhd (0, 25, 75, or 250 mg/kg/day) to rats during gestation and lactation resulted in a persistent reduction in offspring weights at the highest dose (equivalent to the mrhd on a mg/m2 basis). risk summary oxcarbazepine and its active metabolite (mhd) are present in human milk after trileptal administration. the effects of oxcarbazepine and its active metabolite (mhd) 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 trileptal and any potential adverse effects on the breastfed infant from trileptal or from the underlying maternal condition. contraception use of trileptal with hormonal contraceptives containing ethinylestradiol or levonorgestrel is associated with decreased plasma concentrations of these hormones and may result in a failure of the therapeutic effect of the oral contraceptive drug. advise women of reproductive potential taking trileptal who are using a contraceptive containing ethinylestradiol or levonorgestrel to use additional or alternative non-hormonal birth control [see drug interactions (7.3) and clinical pharmacology (12.3)] . trileptal is indicated for use as adjunctive therapy for partial-onset seizures in patients aged 2 to 16 years. the safety and effectiveness for use as adjunctive therapy for partial-onset seizures in pediatric patients below the age of 2 have not been established. trileptal is also indicated as monotherapy for partial-onset seizures in patients aged 4 to 16 years. the safety and effectiveness for use as monotherapy for partial-onset seizures in pediatric patients below the age of 4 have not been established. trileptal has been given to 898 patients between the ages of 1 month to 17 years in controlled clinical trials (332 treated as monotherapy) and about 677 patients between the ages of 1 month to 17 years in other trials [s ee warnings and precautions (5.11), adverse reactions (6.1) , clinical pharmacology (12.3), and clinical studies (14 ) ]. there were 52 patients over age 65 in controlled clinical trials and 565 patients over the age of 65 in other trials. following administration of single (300 mg) and multiple (600 mg/day) doses of trileptal in elderly volunteers (60 to 82 years of age), the maximum plasma concentrations and area under the curve (auc) values of mhd were 30% to 60% higher than in younger volunteers (18 to 32 years of age). comparisons of creatinine clearance in young and elderly volunteers indicate that the difference was due to age-related reductions in creatinine clearance. close monitoring of sodium levels is required in elderly patients at risk for hyponatremia [see warnings and precautions (5.1) ]. dose adjustment is recommended for renally impaired patients (creatinine clearance < 30 ml/min) [see dosage and administration (2. 7 ) and clinical pharmacology (12.3) ]. the abuse potential of trileptal has not been evaluated in human studies. intragastric injections of oxcarbazepine to 4 cynomolgus monkeys demonstrated no signs of physical dependence as measured by the desire to self-administer oxcarbazepine by lever pressing activity. trileptal® (oxcarbazepine) oral suspension           300 mg/5 ml each 5 ml contains 300 mg oxcarbazepine instructions for use read these instructions carefully to learn how to use the medicine dispensing system correctly. distributed by: novartis pharmaceuticals corporation east hanover, new jersey 07936 march 2018 t2018-33 © novartis