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Use In Specific Populations. TRILEPTAL levels may decrease during pregnancy [see WARNINGS AND PRECAUTIONS ]. There are no adequate and well-controlled clinical studies 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 congenital malformations associated with TRILEPTAL monotherapy use (e. TRILEPTAL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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). When pregnant rats were given oxcarbazepine (30, 300, or 1000 mg/kg) 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, buy drostan-e 200 mg injectable steroids masteron. Increased embryofetal death and decreased fetal body weights were seen at the high dose. Doses ?300 mg/kg 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 (20, 100, or 200 mg/kg) during organogenesis, embryofetal mortality was increased at the highest dose (1. This dose produced only minimal maternal toxicity. In a study in which female rats were dosed orally with oxcarbazepine (25, 50, or 150 mg/kg) 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 (0. Oral administration of MHD (25, 75, or 250 mg/kg) 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/m? basis). To provide information regarding the effects of in utero exposure to TRILEPTAL, physicians are advised to recommend that pregnant patients taking TRILEPTAL enroll in the NAAED Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website: http://www. Oxcarbazepine and its active metabolite (MHD) are excreted in human milk. A milk-to-plasma concentration ratio of 0. Because of the potential for serious adverse reactions to TRILEPTAL in nursing infants, a decision should be made about whether to discontinue nursing or to discontinue the drug in nursing women, taking into account the importance of the drug to the mother. TRILEPTAL is indicated for use as adjunctive therapy for partial seizures in patients aged 2 to 16 years. The safety and effectiveness for use as adjunctive therapy for partial seizures in pediatric patients below the age of 2 have not been established. TRILEPTAL is also indicated as monotherapy for partial seizures in patients aged 4 to 16 years. The safety and effectiveness for use as monotherapy for partial 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 [see WARNINGS AND PRECAUTIONS , ADVERSE REACTIONS , CLINICAL PHARMACOLOGY , and Clinical Studies ]. There were 52 patients over age 65 in controlled clinical trials and 565 patients over the age of 65 in other trials.
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