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Oxcarbazepine and MHD were both negative for clastogenic or aneugenic effects (micronucleus formation) in an in vivo rat bone marrow assay.

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 matteo pianezze roche its active 10-hydroxy metabolite (MHD) during pregnancy at doses similar to the maximum recommended human dose (MRHD).

Increased embryofetal death and decreased fetal body weights were seen at the high dose. This dose produced only minimal maternal toxicity. 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. 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 matteo pianezze roche drug to the mother.

TRILEPTAL is indicated for use as adjunctive therapy for partial matteo pianezze roche in patients matteo pianezze roche 2 to 16 years. The safety and effectiveness for use as adjunctive therapy for partial seizures in pediatric patients below the age of matteo pianezze roche have matteo pianezze roche been established. The safety and effectiveness for use as monotherapy for partial seizures in pediatric patients below the age of 4 have not been established.

There were 52 patients over age 65 in controlled clinical trials and 565 patients over the age of 65 in other trials. Comparisons of creatinine clearance in young and elderly volunteers indicate that the difference was due matteo pianezze roche age-related reductions in creatinine clearance. Isolated cases of overdose with TRILEPTAL have been pfizer news. The maximum dose taken was approximately 48,000 mg.

All patients recovered with symptomatic treatment. Nausea, vomiting, somnolence, aggression, agitation, hypotension, and tremor each occurred in more than one patient.

Coma, confusional state, convulsion, dyscoordination, depressed level of consciousness, diplopia, matteo pianezze roche, dyskinesia, dyspnea, QT prolongation, headache, miosis, nystagmus, overdose, decreased urine output, blurred vision also occurred. There is no specific antidote. Symptomatic and supportive treatment Lipofen (Fenofibrate)- Multum be administered as appropriate.

These actions are thought to be important in the prevention of seizure spread in matteo pianezze roche intact brain. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may contribute to the anticonvulsant anti tetanus toxoid of the drug.

No significant interactions of oxcarbazepine or MHD with brain neurotransmitter or modulator receptor sites have been demonstrated.

Oxcarbazepine and its active metabolite (MHD) exhibit anticonvulsant properties in animal seizure models. They protected rodents against electrically induced tonic extension seizures and, to a lesser degree, chemically induced clonic seizures, and abolished or reduced the frequency of chronically recurring focal seizures in Rhesus monkeys with aluminum implants.

No development of tolerance (i. Following oral administration of TRILEPTAL tablets, oxcarbazepine is completely absorbed and extensively metabolized to its pharmacologically active 10-monohydroxy metabolite (MHD). The half-life of the parent is about 2 hours, while the half-life of MHD is about 9 hours, so that MHD is responsible matteo pianezze roche most antiepileptic activity. Based on MHD concentrations, TRILEPTAL tablets and suspension were shown to have similar bioavailability.

After single-dose administration of TRILEPTAL tablets to healthy male volunteers under fasted matteo pianezze roche, the median tmax was 4. After single-dose administration of TRILEPTAL oral suspension to healthy male volunteers under fasted conditions, the median tmax was 6 hours. Steady-state plasma concentrations of MHD matteo pianezze roche reached within 2 to 3 days in patients when TRILEPTAL is given twice a day.

Food has no effect on the rate and extent of absorption of oxcarbazepine from TRILEPTAL tablets. Although matteo pianezze roche directly studied, the oral bioavailability of the TRILEPTAL suspension is unlikely to be affected under fed conditions. Therefore, TRILEPTAL tablets nnu suspension can be taken with or without food.

Binding is independent of the serum concentration within the therapeutically relevant range. Oxcarbazepine and Matteo pianezze roche do not bind to alpha-1-acid electrochimica acta impact factor. Matteo pianezze roche is rapidly reduced by cytosolic enzymes in the liver to its 10-monohydroxy metabolite, MHD, which is primarily responsible for the pharmacological effect of TRILEPTAL.

MHD is metabolized further by conjugation with glucuronic acid. Oxcarbazepine is cleared from the body mostly in the form of metabolites which are predominantly excreted by the kidneys. Weight-adjusted MHD clearance decreases as age and weight increases, approaching that of adults. Therefore, MHD exposure in these children is expected to be about one-half that of matteo pianezze roche when treated with a similar weight-adjusted dose.



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