OXTELLAR XR

Following oral administration, oxcarbazepine is absorbed and extensively metabolized to its pharmacologically active 10-monohydroxy metabolite (MHD), which is responsible for most antiepileptic activity. In clinical studies of Oxtellar XR, the elimination half-life of oxcarbazepine was between 7 and 11 hours; the elimination half-life of MHD is between 9 and 11 hours. In a mass balance study in humans, only 2% of total radioactivity in plasma after administration of immediate-release oxcarbazepi...

Oxtellar XR has been evaluated as adjunctive therapy for partial-onset seizures in adults. The use of Oxtellar XR for the treatment of partial-onset seizures in pediatric patients 6 years of age and older is based on adequate and well-controlled studies of Oxtellar XR in adults, along with clinical trials of immediate-release oxcarbazepine in pediatric patients, and on pharmacokinetic evaluations of the use of Oxtellar XR in pediatric patients. 14.1 Oxtellar XR Primary Trial A multicenter, randomized, double-blind, placebo-controlled, three-arm, parallel-group study (Study 1) in male and femal...

The following serious adverse reactions are described in other sections of the labeling: Hyponatremia [see Warnings and Precautions (5.1) ] Anaphylactic Reactions and Angioedema [see Warnings and Precautions (5.2) ] Cross Hypersensitivity Reaction to Carbamazepine [see Warnings and Precautions (5.3) ] Serious Dermatological Reactions [see Warnings and Precautions (5.4) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.5) ] Withdrawal of AEDs [see Warnings and Precautions (5.6) ] ...

Oxtellar XR is contraindicated in patients with a known hypersensitivity to oxcarbazepine, to any of the components of Oxtellar XR, or to eslicarbazepine acetate. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.2 , 5.3) ]. Known hypersensitivity to oxcarbazepine, any of the components of Oxtellar XR, or to eslicarbazepine acetate. ( 4 )

Hyponatremia: Monitor sodium as recommended. ( 5.1 ) Cross Hypersensitivity Reaction to Carbamazepine: Discontinue immediately if hypersensitivity occurs. ( 5.3 ) Serious Dermatological Reactions: Discontinue if observed. ( 5.4 ) Suicidal Behavior and Ideation: Monitor for symptoms. ( 5.5 ) Withdrawal of Oxtellar XR ® : Withdrawal gradually. ( 5.6 ) Drug Reaction with Eosinophilia and Systemic symptoms (DRESS)/Multi-Organ Hypersensitivity: Discontinue if suspected. ( 5.7 ) Hematologic Reactions:...

7 DRUG INTERACTIONS Phenytoin, Carbamazepine, and Phenobarbital: Coadministration decreased blood levels of an active metabolite of Oxtellar XR: Greater dosage of Oxtellar XR may be required. ( 2.5 , 7.2 ) Oral Contraceptives : Advise patients that Oxtellar XR may decrease the effectiveness of hormonal contraceptives. Additional non-hormonal forms of contraception are recommended. ( 7.3 ) 7.1 Effe...