Discontinuation of the drug should be considered if any evidence of these hematologic events develops.Due to physiological changes during pregnancy, plasma levels of the active metabolite of Oxcarbazepine, the 10-monohydroxy derivative (MHD), may gradually decrease throughout pregnancy. Close monitoring of sodium levels is required in elderly patients at risk for hyponatremia Dose adjustment is recommended for renally impaired patients (CLcr <30 mL/min) The abuse potential of Oxcarbazepine tablets 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.Isolated cases of overdose with Oxcarbazepine tablets have been reported. Finally, 28.7% of Oxcarbazepine-treated patients and 6.4% of placebo-treated patients experienced ataxia or gait disturbances. If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals; the recommended daily dose is 1200 mg/day. Comparisons of creatinine clearance in young and elderly volunteers indicate that the difference was due to age-related reductions in creatinine clearance. This comparison was statistically significant in favor of Oxcarbazepine tablets at all doses tested in both trials (p=0.0001 for all doses for both trials). Error bars represent standard deviation.During the up-titration phase (Days 1–42), adverse events were comparable in the lamotrigine and placebo cohorts (During the polytherapy phase (Days 43–53), 44 adverse events occurred in the 15 subjects receiving lamotrigine and placebo; all adverse events were of mild intensity, except for one episode each of moderate intensity dry skin and headache. Clinical pharmacology and pharmacokinetics of oxcarbazepine. In both of the trials, patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. Such serious skin reactions may be life threatening, and some patients have required hospitalization, with very rare reports of fatal outcome.

1994;35 Suppl 3:S10-3. The most significant of these can be classified into 3 general categories: 1) cognitive symptoms including psychomotor slowing, difficulty with concentration, and speech or language problems, 2) somnolence or fatigue, and 3) coordination abnormalities, including ataxia and gait disturbances.Patients should be monitored for these signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on Oxcarbazepine tablets to gauge whether it adversely affects their ability to drive or operate machinery.In this trial, 7.1% of Oxcarbazepine-treated patients and 4% of placebo-treated patients experienced a cognitive adverse reaction.

The majority of patients from both dose groups completed the 5-day study without exiting.Although this study failed to demonstrate an effect of Oxcarbazepine as monotherapy in pediatric patients, several design elements, including the short treatment and assessment period, the absence of a true placebo, and the likely persistence of plasma levels of previously administered AEDs during the treatment period, make the results uninterpretable. In these trials, no patients discontinued because of ataxia or gait disturbances in either treatment group.Cognitive adverse events occurred in 5.8% of Oxcarbazepine-treated patients (the single most common event being concentration impairment, 4 of 138 patients) and in 3.1% of patients treated with placebo. You should tell your healthcare provider if you have any of these side effects and if they bother you or they do not go away.Some other medicines can also cause low sodium in your blood. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Therefore, if a patient develops a skin reaction while taking Oxcarbazepine tablets, consideration should be given to discontinuing Oxcarbazepine tablets use and prescribing another antiepileptic medication.Human Leukocyte Antigen (HLA) allele B*1502 increases the risk for developing SJS/TEN in patients treated with carbamazepine. Fecal excretion accounts for less than 4% of the administered dose. Drug interactions are reported among people who take Percocet and Oxcarbazepine together. Trileptal ® (oxcarbazepine) is an antiepileptic drug available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. The LLQ for each were 0.1 μg/ml. 1.

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