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
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
OXCARBAZEPINE DESCRIPTION
CLINICAL PHARMACOLOGY
Mechanism of ActionMetabolism and Excretion subsection
PHARMACODYNAMICS
PHARMACOKINETICS
Distribution
Metabolism and Excretion
Special Populations
Hepatic Impairment
Renal Impairment
PRECAUTIONSDOSAGE AND ADMINISTRATION
Pediatric Use
Geriatric Use
Gender
Race
CLINICAL STUDIES
Oxcarbazepine Monotherapy Trials
Oxcarbazepine Adjunctive Therapy Trials
Table 1ADVERSE REACTIONS
Table 1: Summary of Percentage Change in Partial Seizure Frequency from Baseline for Placebo-Controlled Adjunctive Therapy Trials
INDICATIONS & USAGE
OXCARBAZEPINE CONTRAINDICATIONS
WARNINGS
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
Table 2
Withdrawal of AEDs
PRECAUTIONS
Cognitive/Neuropsychiatric Adverse EventsAdult Patients
Pediatric Patients
Multi-Organ Hypersensitivity
WARNINGS, Patients with a Past History of Hypersensitivity Reaction to Carbamazepinesubsection).
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
WARNINGSDRUG INTERACTIONS
Antiepileptic Drugs
Table 3
Influence ofInfluence of AED onOxcarbazepine on AEDMHD ConcentrationOxcarbazepineConcentration (Mean(Mean Change, 90%AEDDose of AEDDoseChange, 90%Confidence Interval)Coadministered(mg/day)(mg/day)Confidence Interval)
Hormonal Contraceptives
Drug Interactions
Calcium Antagonists
Other Drug Interactions
DRUG & OR LABORATORY TEST INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Carcinogenesis/Mutagenesis/Impairment of FertilityPREGNANCY
Pregnancy Category CLABOR & DELIVERY
NURSING MOTHERS
CLINICAL PHARMACOLOGY, Pharmacokinetics
PEDIATRIC USE
ADVERSE REACTIONSGeriatric Use
Most Common Adverse Events in All Clinical Studies
Table 4Table 5
Table 4: Treatment-Emergent Adverse Event Incidence in a Controlled Clinical Study of Adjunctive Therapy in Adults (Events in at Least 2% of Patients Treated with 2400 mg/day of Oxcarbazepine and Numerically More Frequent Than in the Placebo Group)
Oxcarbazepine Dosage (mg/day)Body System/ Adverse EventOXC 600OXC 1200OXC 2400PlaceboN=163N=171N=126N=166Body as a Whole%%%%Cardiovascular SystemDigestive SystemMetabolic and Nutritional DisordersMusculoskeletal SystemNervous SystemRespiratory SystemSkin and AppendagesSpecial Senses
Table 5: Treatment-Emergent Adverse Event Incidence in Controlled Clinical Studies of Monotherapy in Adults Previously Treated with Other AEDs (Events in at Least 2% of Patients Treated with 2400 mg/day of Oxcarbazepine and Numerically More Frequent Than in the Low Dose Control Group)
Oxcarbazepine Dosage (mg/day)2400300Body System/N=86N=86Adverse Event%%Body as a WholeDigestive SystemHemic and Lymphatic SystemInfections and InfestationsMetabolic and Nutritional DisordersNervous SystemRespiratory SystemSkin and AppendagesSpecial SensesUrogenital and Reproductive SystemTable 6
Table 6: Treatment-Emergent Adverse Event Incidence in a Controlled Clinical Study of Monotherapy in Adults Not Previously Treated with Other AEDs (Events in at Least 2% of Patients Treated with Oxcarbazepine and Numerically More Frequent Than in the Placebo Group)
OxcarbazepinePlaceboBody System/N=55N=49Adverse Event%%Body as a WholeDigestive SystemMusculoskeletal SystemNervous SystemRespiratory SystemSkin and AppendagesTable 7
Table 7: Treatment-Emergent Adverse Event Incidence in Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Pediatric Patients Previously Treated with Other AEDs (Events in at Least 2% of Patients Treated with Oxcarbazepine and Numerically More Frequent Than in the Placebo Group)
OxcarbazepinePlaceboBody System /N=171N=139Adverse Event%%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 Interactionssubsection).
Conversion to Monotherapy
Initiation of Monotherapy
Pediatric Patients
Adjunctive Therapy (Aged 2 to 16 Years)
CLINICAL PHARMACOLOGY
Conversion to Monotherapy (Aged 4 to 16 Years)
Initiation of Monotherapy (Aged 4 to 16 Years)
Table 8: Range of Maintenance Doses of Oxcarbazepine for Children by Weight During Monotherapy
FromToWeight in kgDose (mg/day)Dose (mg/day)
Patients with Hepatic Impairment
CLINICAL PHARMACOLOGYPharmacokineticsSpecial Populations
Patients with Renal Impairment
CLINICAL PHARMACOLOGYPharmacokineticsSpecial Populations
HOW SUPPLIED
INACTIVE INGREDIENT
SILICON DIOXIDEPOVIDONE K30
POLYETHYLENE GLYCOL
CROSCARMELLOSE SODIUM
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
SODIUM STEARYL FUMARATE
HYPROMELLOSE
POLYSORBATE 80
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
OxcarbazepineOxcarbazepine TABLET, FILM COATED
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
