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



PHARMACOKINETICS






Effect of Food



Distribution



Metabolism and Excretion



USE IN SPECIFIC 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 GroupNBaseline Median Seizure Rate*Median % Reduction*1 (pediatrics)Oxcarbazepine13612.534.8Placebo12813.19.42 (adults)Oxcarbazepine 2400 mg/day17410.049.9Oxcarbazepine 1200 mg/day1779.840.2Oxcarbazepine 600 mg/day1689.626.4Placebo1738.67.6Subset 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



OXCARBAZEPINE 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 Hypersensitivitysubsection).

Serious Dermatological Reactions
Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults in association with Oxcarbazepine use. The median time of onset for reported cases was 19 days. Such serious skin reactions may be life threatening, and some patients have required hospitalization with very rare reports of fatal outcome. Recurrence of the serious skin reactions following rechallenge with Oxcarbazepine has also been reported.
The reporting rate of TEN and SJS associated with Oxcarbazepine use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate estimates by a factor of 3-to 10-fold. Estimates of the background incidence rate for these serious skin reactions in the general population range between 0.5 to 6 cases per million-person years. Therefore, if a patient develops a skin reaction while taking Oxcarbazepine, consideration should be given to discontinuing Oxcarbazepine use and prescribing another antiepileptic medication.

Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including Oxcarbazepine, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.
The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed. Table 2 shows absolute and relative risk by indication for all evaluated AEDs.
Table 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis
IndicationPlacebo Patients with Events Per 1,000 PatientsDrug Patients with Events Per 1,000 PatientsRelative Risk: Incidence of Events in Drug Patients/Incidence in Placebo PatientsRisk Difference: Additional Drug Patients with Events Per 1,000 PatientsEpilepsy1.03.43.52.4Psychiatric5.78.51.52.9Other1.01.81.90.9Total2.44.31.81.9The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.
Anyone considering prescribing Oxcarbazepine or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Withdrawal of AEDs
As with all antiepileptic drugs, Oxcarbazepine should be withdrawn gradually to minimize the potential of increased seizure frequency.

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

WARNINGS


DRUG INTERACTIONS







Antiepileptic Drugs


AED CoadministeredDose of AED (mg/day)Oxcarbazepine Dose (mg/day)Influence of Oxcarbazepine on AED Concentration (Mean Change, 90% Confidence Interval)Influence of AED on MHD Concentration (Mean Change, 90% Confidence Interval)****



Hormonal Contraceptives
Drug Interactions

Calcium Antagonists



Other Drug Interactions


DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Category C







LABOR & DELIVERY



NURSING MOTHERS



Patients with Renal Impairment
CLINICAL PHARMACOLOGY, Pharmacokinetics

PEDIATRIC USE

ADVERSE REACTIONS

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/ Adverse EventOXC 600 N=163 %OXC 1200 N=171 %OXC 2400 N=126 %Placebo N=166 %

Oxcarbazepine Dosage (mg/day)Body System/ Adverse Event2400 N=86 %300 N=86 %
Controlled Clinical Study of Monotherapy in Adults not Previously Treated with other AEDs


Body System/ Adverse EventOxcarbazepine N=55 %Placebo N=49 %
Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Pediatric Patients Previously Treated with other AEDs


Body System/ Adverse EventOxcarbazepine N=171 %Placebo N=139 %
Other Events Observed in Association with the Administration of Oxcarbazepine

Body as a Whole:
Cardiovascular System:
Digestive System:
Hemic and Lymphatic System:
Laboratory Abnormality:
Musculoskeletal System:
Nervous System:
Respiratory System:
Skin and Appendages:
Special Senses:
Surgical and Medical Procedures:
Urogenital and Reproductive System:
Other:

Post-Marketing and Other Experience

Body as a Whole:PRECAUTIONS, Multi-Organ Hypersensitivity
WARNINGS, Anaphylactic Reactions and Angioedema
Digestive System
Skin and Appendages: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






STORAGE AND HANDLING




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Oxcarbazepine

Oxcarbazepine

Oxcarbazepine

Oxcarbazepine TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-785(NDC:51991-292)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OXCARBAZEPINE OXCARBAZEPINE 150 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 11 mm B292 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-785-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078069 2011-09-27


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