Oxcarbazepine Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
Oxcarbazepine is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.
What should I know before taking it?
Oxcarbazepine tablets are contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [ see Warnings and Precautions ( 5.2, 5.3) ].
What important warnings are listed?
5 WARNINGS AND PRECAUTIONS • Hyponatremia: Monitor serum sodium levels ( 5.1 ) • Cross Hypersensitivity Reaction to Carbamazepine: Discontinue immediately if hypersensitivity occurs ( 5.3 ) • Serious Dermatological Reactions: If occurs, consider discontinuation ( 5.4 ) • Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior ( 5.5 ) • Withdrawal of AEDs: Withdraw oxcarbazepine gradually ( 5.6 ) • Cognitive/Neuropsychiatric Adverse Reactions: May cause cognitive dysfunction, somnolence, and coordination abnormalities. Use caution when operating machinery ( 5.7 ) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Monitor and.
How is this medication usually taken?
Film-coated Tablets: • 300 mg: Brown colored, oval shaped, biconvex, film coated tablets debossed with 'V' on one side and '7' and '7' on another side separated by a score line (functional scoring) on both sides.
What side effects are listed?
The following serious adverse reactions are described below and elsewhere in the labeling: • Hyponatremia [see Warnings and Precautions ( 5.1)] • Anaphylactic Reactions and Angioedema [see Warnings and Precautions ( 5.2)] • Cross Hypersensitivity Reaction to Carbamazepine [see Warnings and Precautions ( 5.3)] • Serious Dermatological Reactions [see Warnings and Precautions ( 5.4)] • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.5)] • Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions ( 5.7)] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see Warnings and Precautions ( 5.8)] • Hematologic Events [see.
What interactions are listed?
7 DRUG INTERACTIONS • Phenytoin: Increased phenytoin levels. Reduced dose of phenytoin may be required ( 7.1 ) • Carbamazepine, Phenytoin, and Phenobarbital: Decreased plasma levels of MHD (the active metabolite). Dose adjustments may be necessary ( 7.1 ) • Oral Contraceptive: Oxcarbazepine may decrease the effectiveness of hormonal contraceptives ( 7.3 ) 7.1 Effect of Oxcarbazepine on Other Drugs Phenytoin levels have been shown to increase with concomitant use of oxcarbazepine at doses greater than 1200 mg/day [see Clinical Pharmacology ( 12.3 )]. Therefore, it is recommended that the plasma levels of phenytoin be monitored during the period of oxcarbazepine titration and dosage.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0abe9478-4084-286d-e063-6294a90a9ba7
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.