Oxcarbazepine

OXCARBAZEPINE

Manufacturer: Precision Dose, Inc.

Score: 141.0

Quick Summary

Oxcarbazepine is an antiepileptic drug used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and pediatric patients aged 4 years and above. The recommended daily dose is dependent on patient weight and age. Key clinical findings indicate that oxcarbazepine is effective in reducing seizure frequency. Important safety information includes warnings about hyponatremia, anaphylactic reactions, and cross hypersensitivity reaction to carbamazepine. The main dosing recommendations involve initiating treatment with a dose of 600 mg/day, given twice-a-day, with a maximum recommended daily dose of 1200 mg/day for adjunctive therapy in adults. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, with specific recommendations for each group.

Key Clinical Findings and Indications

Oxcarbazepine is used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and pediatric patients aged 4 years and above.
The drug is effective in reducing seizure frequency.
Oxcarbazepine is indicated for use as adjunctive therapy for partial-onset seizures in patients aged 2 to 16 years.

Important Safety Information

Warning

Hyponatremia has been reported, with serum sodium levels below 125 mmol/L.

Contraindications

Known hypersensitivity to oxcarbazepine or to any of its components.
Known hypersensitivity to eslicarbazepine acetate.

Adverse Reactions

Dizziness
Somnolence
Diplopia
Fatigue
Nausea
Vomiting
Ataxia
Abnormal vision
Headache
Nystagmus
Tremor
Abnormal gait

Dosing Recommendations

General Guidance

Dosage adjustment is recommended with concomitant use of strong CYP3A4 enzyme inducers or UGT inducers.

Partial-onset seizures

Adult Dose

Initiate with a dose of 600 mg/day, given twice-a-day, with a maximum recommended daily dose of 1200 mg/day for adjunctive therapy.

Pediatric Dose

Initiate with a dose of 8 to 10 mg/kg/day, given twice-a-day, with a maximum recommended daily dose dependent on patient weight.

Special Population Considerations

Pregnancy

Oxcarbazepine is closely related structurally to carbamazepine, which is considered to be teratogenic in humans.
Data on a limited number of pregnancies from pregnancy registries suggest that oxcarbazepine monotherapy use is associated with congenital malformations.

Nursing Mothers

Use of oxcarbazepine with hormonal contraceptives containing ethinylestradiol or levonorgestrel is associated with decreased plasma concentrations of these hormones and may result in a failure of the therapeutic effect of the oral contraceptive drug.
Advise women of reproductive potential taking oxcarbazepine who are using a contraceptive containing ethinylestradiol or levonorgestrel to use additional or alternative non-hormonal birth control.

Pediatric Use

Oxcarbazepine is indicated for use as adjunctive therapy for partial-onset seizures in patients aged 2 to 16 years.
The safety and effectiveness for use as adjunctive therapy for partial-onset seizures in pediatric patients below the age of 2 have not been established.

Geriatric Use

There were 52 patients over age 65 in controlled clinical trials and 565 patients over the age of 65 in other trials.
Following administration of single (300 mg) and multiple (600 mg/day) doses of Oxcarbazepine in elderly volunteers (60 to 82 years of age), the maximum plasma concentrations and AUC values of MHD were 30% to 60% higher than in younger volunteers (18 to 32 years of age).

Similar Drugs

Aptiom

ESLICARBAZEPINE ACETATE

Sumitomo Pharma America, Inc.

Similarity: 63.6%