Pronunciation:

(ox car BAZ e peen)

U.S. Brand Names:

Synonyms:

Generic Available:

Canadian Brand Names:

Use:

Use - Unlabeled/Investigational:

Pregnancy Risk Factor:

Pregnancy Implications:

Lactation:

Contraindications:

Warnings/Precautions:

Adverse Reactions:

>10%:

Central nervous system: Dizziness (22% to 49%), somnolence (20% to 36%), headache (13% to 32%, placebo 23%), ataxia (5% to 31%), fatigue (12% to 15%), vertigo (6% to 15%)

Gastrointestinal: Vomiting (7% to 36%), nausea (15% to 29%), abdominal pain (10% to 13%)

Neuromuscular & skeletal: Abnormal gait (5% to 17%), tremor (3% to 16%)

Ocular: Diplopia (14% to 40%), nystagmus (7% to 26%), abnormal vision (4% to 14%)

1% to 10%:

Cardiovascular: Hypotension (1% to 2%), leg edema (1% to 2%, placebo 1%)

Central nervous system: Nervousness (2% to 5%, placebo 1% to 2%), amnesia (4%), abnormal thinking (2% to 4%), insomnia (2% to 4%), speech disorder (1% to 3%), EEG abnormalities (2%), abnormal feelings (1% to 2%), agitation (1% to 2%, placebo 1%), confusion (1% to 2%, placebo 1%)

Dermatologic: Rash (4%), acne (1% to 2%)

Endocrine & metabolic: Hyponatremia (1% to 3%, placebo 1%)

Gastrointestinal: Diarrhea (5% to 7%), dyspepsia (5% to 6%), constipation (2% to 6%, placebo 0% to 4%), gastritis (1% to 2%, placebo 1%), weight gain (1% to 2%, placebo 1%)

Neuromuscular & skeletal: Weakness (3% to 6%, placebo 5%), back pain (4%), falling down (4%), abnormal coordination (1% to 4%, placebo 1% to 2%), dysmetria (1% to 3%), sprains/strains (2%), muscle weakness (1% to 2%)

Ocular: Abnormal accommodation (2%)

Respiratory: Upper respiratory tract infection (7%), rhinitis (2% to 5%, placebo 4%), chest infection (4%), epistaxis (4%), sinusitis (4%)

Postmarketing and/or case reports: Aggressive reaction, alopecia, amnesia, angioedema, anguish, anxiety, apathy, aphasia, appetite increased, asthma, arthralgia, aura, biliary pain, blood in stool, bradycardia, bruising, cardiac failure, cataract, cerebral hemorrhage, chest pain, cholelithiasis, colitis, conjunctival hemorrhage, consciousness decreased, contact dermatitis, convulsions aggravated, delirium, delusion, dry mouth, duodenal ulcer, dysphagia, dysphonia, dyspnea, dystonia, dysuria, eczema, emotional lability, enteritis, eructation, erythema multiforme, erythematosus rash, esophagitis, eosinophilia, euphoria, eye edema, extrapyramidal disorder, facial rash, feeling drunk, fever, flatulence, flushing, folliculitis, gastric ulcer, genital pruritus, GGT increased, gingival bleeding, gum hyperplasia, heat rash, hematuria, hemianopia, hemiplegia, hematemesis, hemorrhoids, hiccups, hot flushes, hyperglycemia, hyperkinesia, hyper-reflexia, hypersensitivity reaction, hypertonia, hypertension, hypocalcemia, hypochondrium pain, hypoesthesia, hypoglycemia, hypokalemia, hypokinesia, hyporeflexia, hypotonia, hysteria, intermenstrual bleeding, laryngismus, leukopenia, leukorrhea, libido decreased/increased, liver enzymes elevated, lymphadenopathy, maculopapular rash, malaise, manic reaction, migraine, menorrhagia, micturition frequency, muscle contractions (involuntary), mydriasis, neuralgia, oculogyric crisis, otitis externa, palpitation, panic disorder, paralysis, paroniria, personality disorder, photophobia, photosensitivity reaction, pleurisy, postural hypotension, priapism, psoriasis, purpura, psychosis, ptosis, rectal hemorrhage, renal calculus, renal pain, retching, rigors, scotoma, sialoadenitis, serum transaminases increased, Stevens-Johnson syndrome, stupor, syncope, systemic lupus erythematosus, tachycardia, taste perversion, tetany, thrombocytopenia, tinnitus, toxic epidermal necrolysis, ulcerative stomatitis, urinary tract pain, urticaria, vitiligo, weight loss, xerophthalmia

Overdosage/Toxicology:

Drug Interactions:

Carbamazepine: Oxcarbazepine serum concentrations may be reduced by a mean 40%

CYP3A4 substrates: Oxcarbazepine may decrease the levels/effects of CYP3A4 substrates. Example substrates include benzodiazepines, calcium channel blockers, clarithromycin, cyclosporine, erythromycin, estrogens, mirtazapine, nateglinide, nefazodone, nevirapine, protease inhibitors, tacrolimus, and venlafaxine.

Felodipine: Metabolism is increased due to enzyme induction; similar effects may be anticipated with other dihydropyridine calcium channel blockers

Oral contraceptives: Metabolism may be increased due to enzyme induction; use alternative contraceptive measures; oxcarbazepine with oral contraceptives has been shown to decrease plasma concentrations of the two hormonal components, ethinyl estradiol (48% and 52%) and levonorgestrel (32% and 52%).

Phenobarbital: Phenobarbital levels are increased (average of 14%); oxcarbazepine levels are decreased (average of 25%)

Phenytoin: Phenytoin levels may be increased (high dosages) by an average of 40%; oxcarbazepine levels may be decreased (by an average of 30%) during concurrent therapy; monitor phenytoin levels

Valproic acid decreases oxcarbazepine levels by an average of 18%

Verapamil's metabolism may be increased due to enzyme induction; verapamil may reduce blood levels of oxcarbazepine's active metabolite (MHD)

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Herb/Nutraceutical: St John's wort may decrease oxcarbazepine levels. Avoid evening primrose (seizure threshold decreased). Avoid valerian, St John's wort, kava kava, gotu kola.

Stability:

Mechanism of Action:

Pharmacodynamics/Kinetics:

Absorption: Complete; food has no affect on rate or extent

Distribution: MHD: Vd: 49 L

Protein binding, serum: MHD: 40%

Metabolism: Hepatic to 10-monohydroxy metabolite (MHD; active); MHD is further conjugated to DHD (inactive)

Bioavailability: Decreased in children <8 years; increased in elderly >60 years

Half-life elimination: Parent drug: 2 hours; MHD: 9 hours; renal impairment (Clcr 30 mL/minute): 19 hours

Time to peak, serum: 4.5 hours (3-13 hours)

Excretion: Urine (95%, <1% as unchanged oxcarbazepine, 27% as unchanged MHD, 49% as MHD glucuronides); feces (<4%)

Dosage:

Children 4-16 years:

Adjunctive therapy: 8-10 mg/kg/day, not to exceed 600 mg/day, given in 2 divided daily doses. Maintenance dose should be achieved over 2 weeks, and is dependent upon patient weight, according to the following:

20-29 kg: 900 mg/day in 2 divided doses

29.1-39 kg: 1200 mg/day in 2 divided doses

>39 kg: 1800 mg/day in 2 divided doses

Conversion to monotherapy: Oxcarbazepine 8-10 mg/kg/day in twice daily divided doses, while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drug; the concomitant drug should be withdrawn over 3-6 weeks. Oxcarbazepine dose may be increased by a maximum of 10 mg/kg/day at weekly intervals. See below for recommended total daily dose by weight.

Initiation of monotherapy: Oxcarbazepine should be initiated at 8-10 mg/kg/day in twice daily divided doses; doses may be titrated by 5 mg/kg/day every third day. See below for recommended total daily dose by weight.

Range of maintenance doses by weight during monotherapy:

20 kg: 600-900 mg/day

25-30 kg: 900-1200 mg/day

35-40 kg: 900-1500 mg/day

45 kg: 1200-1500 mg/day

50-55 kg: 1200-1800 mg/day

60-65 kg: 1200-2100 mg/day

70 kg: 1500-2100 mg/day

Adults:

Adjunctive therapy: Initial: 300 mg twice daily; dose may be increased by as much as 600 mg/day at weekly intervals; recommended daily dose: 1200 mg/day in 2 divided doses. Although daily doses >1200 mg/day demonstrated greater efficacy, most patients were unable to tolerate 2400 mg/day (due to CNS effects).

Conversion to monotherapy: Oxcarbazepine 600 mg/day in twice daily divided doses while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drug. The concomitant dosage should be withdrawn over 3-6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2-4 weeks. Recommended daily dose: 2400 mg/day.

Initiation of monotherapy: Oxcarbazepine should be initiated at a dose of 600 mg/day in twice daily divided doses; doses may be titrated upward by 300 mg/day every third day to a final dose of 1200 mg/day given in 2 daily divided doses

Dosing adjustment in renal impairment: Clcr<30 mL/minute: Therapy should be initiated at one-half the usual starting dose (300 mg/day) and increased slowly to achieve the desired clinical response

Dosing adjustment in hepatic impairment: Adjustment not needed for mild-to-moderate impairment

Administration:

Monitoring Parameters:

Dietary Considerations:

Patient Education:

Nursing Implications:

Dental Health: Effects on Dental Treatment:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Dosage Forms:

Suspension, oral: 300 mg/5 mL (250 mL) [contains ethanol]

Tablet [film coated]: 150 mg, 300 mg, 600 mg

International Brand Names: