Oxcarbazepine description, usages, side effects, indications, overdosage, supplying and lots more!

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Oxcarbazepine

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

OXCARBAZEPINE DESCRIPTION


Oxcarbazepine




PRECAUTIONS

CLINICAL PHARMACOLOGY


Mechanism of Action
Metabolism and Excretion

PHARMACODYNAMICS

Pharmacodynamics


PHARMACOKINETICS






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


Oxcarbazepine

Figure 2
Oxcarbazepine


Figure 3


Oxcarbazepine

Figure 4

Oxcarbazepine






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 USAGE


OXCARBAZEPINE CONTRAINDICATIONS

CONTRAINDICATIONS


WARNINGS

Hyponatremia



Anaphylactic 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

PRECAUTIONS

FD&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 Angioedema
WARNINGS, 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 Tests
WARNINGS


DRUG INTERACTIONS

Drug Interactions






Antiepileptic 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 Interactions


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis/Mutagenesis/Impairment of Fertility




PREGNANCY

Category C






LABOR & DELIVERY

Labor and Delivery


NURSING MOTHERS

Nursing Mothers

Patients with Renal Impairment
CLINICAL PHARMACOLOGY, Pharmacokinetics

PEDIATRIC USE

Pediatric Use
ADVERSE REACTIONS

GERIATRIC USE

Geriatric Use


OXCARBAZEPINE ADVERSE REACTIONS

Most Common Adverse Events in All Clinical Studies

Adjunctive 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

Abuse


Dependence


OVERDOSAGE

Human Overdose Experience


Treatment 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



















Oxcarbazepine




Oxcarbazepine

Oxcarbazepine

Oxcarbazepine TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-261(NDC:51991-293)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OXCARBAZEPINE OXCARBAZEPINE 300 mg

Inactive Ingredients

Ingredient Name Strength
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

Product Characteristics

Color Size Imprint Code Shape
brown 15 mm B293 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-261-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078069 2011-05-06


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