Oxcarbazepine
FULL PRESCRIBING INFORMATION: CONTENTS*
- OXCARBAZEPINE DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACODYNAMICS
- PHARMACOKINETICS
- CLINICAL STUDIES
- INDICATIONS & USAGE
- OXCARBAZEPINE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- DRUG & OR LABORATORY TEST INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- LABOR & DELIVERY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- OXCARBAZEPINE ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
OXCARBAZEPINE DESCRIPTION
PRECAUTIONS
CLINICAL PHARMACOLOGY
Mechanism of Action
Metabolism and Excretion
PHARMACODYNAMICS
PharmacodynamicsPHARMACOKINETICS
Effect of Food
Distribution
Metabolism and Excretion
Special Populations
Hepatic Impairment
Renal Impairment
PRECAUTIONSDOSAGE AND ADMINISTRATION
Pediatric Use
Geriatric Use
Gender
Race
CLINICAL STUDIES
Oxcarbazepine Monotherapy Trials
Figure 1
Figure 2
Figure 3
Figure 4
Oxcarbazepine Adjunctive Therapy Trials
ADVERSE REACTIONS
TrialTreatment GroupBaseline MedianMedian %NSeizure Rate*Reduction1Oxcarbazepine136 12.534.8(pediatrics)Placebo128 13.19.42 (adults)Oxcarbazepine174 10.049.92400 mg/dayOxcarbazepine177 9.840.21200 mg/dayOxcarbazepine168 9.626.4600 mg/dayPlacebo173 8.67.6*= # per 28 days
Subset analyses of the antiepileptic efficacy of Oxcarbazepine with regard to gender in these trials revealed no important differences in response between men and women. Because there were very few patients over the age of 65 in controlled trials, the effect of the drug in the elderly has not been adequately assessed.
The third adjunctive therapy trial enrolled 128 pediatric patients (1 month to <4 years of age) with inadequately-controlled partial seizures on 1-2 concomitant AEDs. Patients who experienced at least 2 study-specific seizures (i.e., electrographic partial seizures with a behavioral correlate) during the 72-hour baseline period were randomly assigned to either Oxcarbazepine 10 mg/kg/day or were titrated up to 60 mg/kg/day within 26 days. Patients were maintained on their randomized target dose for 9 days and seizures were recorded through continuous video-EEG monitoring during the last 72 hours of the maintenance period. The primary measure of effectiveness in this trial was a between-group comparison of the change in seizure frequency per 24 hours compared to the seizure frequency at baseline. For the entire group of patients enrolled, this comparison was statistically significant in favor of Oxcarbazepine 60 mg/kg/day. In this study, there was no evidence that Oxcarbazepine was effective in patients below the age of 2 years (N=75).
INDICATIONS & USAGE
INDICATIONS AND USAGEOXCARBAZEPINE CONTRAINDICATIONS
CONTRAINDICATIONSWARNINGS
HyponatremiaAnaphylactic Reactions and Angioedema
WARNINGS, Patients with a Past History of Hypersensitivity Reaction to Carbamazepine
Patients with a Past History of Hypersensitivity Reaction to Carbamazepine
WARNINGS, Anaphylactic Reactions and AngioedemaPRECAUTIONS, Multi-Organ Hypersensitivity
Serious Dermatological Reactions
Suicidal Behavior and Ideation
Ind-Placebo PatientsDrug PatientsRelative Risk: Incidence ofRisk Difference:icat-with Events Perwith Events PerEvents in Drug Patients/Additional Drug Patientsion1000 Patients1000 PatientsIncidence in Placebo Patientswith Events Per 1000 Patients
Withdrawal of AEDs
PRECAUTIONS
PRECAUTIONSFD&C Yellow No. 5 (Tartrazine)
Cognitive/Neuropsychiatric Adverse Events
Adult Patients
Pediatric Patients
Multi-Organ Hypersensitivity
WARNINGS, Patients with a Past History of Hypersensitivity Reaction to Carbamazepine
INFORMATION FOR PATIENTS
WARNINGS, Anaphylactic Reactions and AngioedemaWARNINGS, Patients with a Past History of Hypersensitivity Reaction to Carbamazepine
WARNINGS, Serious Dermatological Reactions
PRECAUTIONS, Multi-Organ Hypersensitivity
Drug Interactions
PRECAUTIONS, Pregnancy Category C
LABORATORY TESTS
Laboratory TestsWARNINGS
DRUG INTERACTIONS
Drug InteractionsAntiepileptic Drugs
AEDDoseOxcarb-Influence of Oxcarbazepine on AEDInfluence of AED on MHDCoadm-ofazepineConcentration (Mean Change, 90%Concentratio of (Mean Change,inisteredAEDDoseConfidence Interval)90% Confidence Interval)(mg/(mg/day)day)****
Hormonal Contraceptives
Drug Interactions
Calcium Antagonists
Other Drug Interactions
DRUG & OR LABORATORY TEST INTERACTIONS
Drug/Laboratory Test InteractionsCARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Carcinogenesis/Mutagenesis/Impairment of FertilityPREGNANCY
Category CLABOR & DELIVERY
Labor and DeliveryNURSING MOTHERS
Nursing MothersPatients with Renal Impairment
CLINICAL PHARMACOLOGY, Pharmacokinetics
PEDIATRIC USE
Pediatric UseADVERSE REACTIONS
GERIATRIC USE
Geriatric UseOXCARBAZEPINE ADVERSE REACTIONS
Most Common Adverse Events in All Clinical StudiesAdjunctive Therapy/Monotherapy in Adults Previously Treated with other AEDs
Monotherapy in Adults Not Previously Treated with other AEDs
Adjunctive Therapy/Monotherapy in Pediatric Patients 4 Years Old and Above Previously Treated with other AEDs
Monotherapy in Pediatric Patients 4 Years Old and Above not Previously Treated with other AEDs
Adjunctive Therapy/Monotherapy in Pediatric Patients 1 month to < 4 Years Old Previously Treated or not Previously Treated with other AEDs
Incidence in Controlled Clinical Studies
Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Adults Previously Treated with other AEDs
Oxcarbazepine Dosage (mg/day)Body System/OXC 600OXC 1200OXC 2400PlaceboAdverse EventN = 163N = 171N = 126N = 166%%%%Body as a WholeCardiovascular SystemDigestive SystemMetabolic and Nutritional DisordersMusculoskeletal SystemNervous SystemRespiratory SystemSkin and AppendagesSpecial Senses
Oxcarbazepine Dosage (mg/day)Body System/2400300Adverse EventN = 86N = 86%%Body as a WholeDigestive SystemHemic and Lymphatic SystemInfections and InfestationsMetabolic and Nutritional DisordersNervous SystemRespiratory SystemSkin and AppendagesSpecial SensesUrogenital and Reproductive System
Controlled Clinical Study of Monotherapy in Adults not Previously Treated with other AEDs
Body System/OxcarbazepinePlaceboAdverse EventN = 55N = 49%%Body as a WholeDigestive SystemMusculoskeletal SystemNervous SystemRespiratory SystemSkin and AppendagesSpecial Senses
Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Pediatric Patients Previously Treated with other AEDs
Body System/ Adverse EventOxcarbazepinePlaceboAdverse EventN = 171N = 139%%Body as a WholeDigestive SystemNervous SystemRespiratory SystemSkin and AppendagesSpecial Senses
Other Events Observed in Association with the Administration of Oxcarbazepine
Post-Marketing and Other Experience
PRECAUTIONS, Multi-Organ Hypersensitivity
WARNINGS, Anaphylactic Reactions and Angioedema
WARNINGS, Serious Dermatological Reactions
DRUG ABUSE AND DEPENDENCE
AbuseDependence
OVERDOSAGE
Human Overdose ExperienceTreatment and Management
DOSAGE & ADMINISTRATION
CLINICAL PHARMACOLOGY, Pharmacokinetics
Adults
Adjunctive Therapy
PRECAUTIONS, Drug Interactions
Conversion to Monotherapy
Initiation of Monotherapy
Pediatric Patients
Adjunctive Therapy (Aged 2-16 years)
CLINICAL PHARMACOLOGY
Conversion to Monotherapy (Aged 4-16 years)
Initiation of Monotherapy (Aged 4-16 years)
FromToWeight in kgDose (mg/day)Dose (mg/day)
Patients with Hepatic Impairment
CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations
Patients with Renal Impairment
CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations
HOW SUPPLIED
INACTIVE INGREDIENT
INACTIVE INGREDIENTS:CROSPOVIDONE
SILICON DIOXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FD&C YELLOW NO. 5
FD&C BLUE NO. 2
POLYVINYL ALCOHOL
ALUMINUM OXIDE
LECITHIN, SOYBEAN
TALC
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
OxcarbazepineOxcarbazepine TABLET
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