Label: OXCARBAZEPINE tablet

  • NDC Code(s): 72888-460-01, 72888-460-02, 72888-461-01, 72888-461-02, view more
  • Packager: Advagen Pharma Ltd.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 2, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Oxcarbazepine tablets is 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 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Adjunctive Therapy for Adults - Initiate Oxcarbazepine tablets USP with a dose of 600 mg/day, given twice-a-day. If clinically indicated, the dose may be increased by a maximum of 600 mg/day ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Film-coated Tablets:  150 mg: Yellow colored, Ovaloid, slightly biconvex film-coated tablet, scored on both the sides, debossed on only one side with 13/13. 300 mg: Yellow colored, Ovaloid ...
  • 4 CONTRAINDICATIONS
    Oxcarbazepine tablets is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [ see Warnings and Precautions ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hyponatremia - Clinically significant hyponatremia (sodium <125 mmol/L) can develop during oxcarbazepine tablets use. In the 14 controlled epilepsy studies 2.5% of oxcarbazepine ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described below and elsewhere in the labeling: Hyponatremia [ see Warnings and Precautions (5.1)] Anaphylactic Reactions and Angioedema ...
  • 7 DRUG INTERACTIONS
    7.1 Effect of Oxcarbazepine Tablets on Other Drugs - Phenytoin levels have been shown to increase with concomitant use of Oxcarbazepine Tablets at doses greater than 1200 mg/day - [ see ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as Oxcarbazepine tablets, during pregnancy ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.2 Abuse - The abuse potential of oxcarbazepine tablets has not been evaluated in human studies. 9.3 Dependence - Intragastric injections of oxcarbazepine to 4 cynomolgus monkeys ...
  • 10 OVERDOSAGE
    10.1 Human Overdose Experience - Isolated cases of overdose with oxcarbazepine tablets have been reported. The maximum dose taken was approximately 48,000 mg. All patients recovered with ...
  • 11 DESCRIPTION
    Oxcarbazepine tablets USP is an antiepileptic drug available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 - H-dibenz[b ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The pharmacological activity of Oxcarbazepine is primarily exerted through the 10-monohydroxy metabolite (MHD) of Oxcarbazepine [see - Clinical Pharmacology (12.3)] ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - In 2-year carcinogenicity studies, oxcarbazepine was administered in the diet at doses of up to 100 mg/kg/day to mice ...
  • 14 CLINICAL STUDIES
    The effectiveness of oxcarbazepine tablets as adjunctive and monotherapy for partial-onset seizures in adults, and as adjunctive therapy in children aged 2 to 16 years was established in seven ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Tablets - 150 mg Film-Coated Tablets:Yellow colored, Ovaloid, slightly biconvex film coated tablet, scored on both sides, debossed on only one side with 13/13. Bottle of ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Administration Information - Counsel patients that oxcarbazepine tablets may be taken with or without ...
  • MEDICATION GUIDE
    MEDICATION ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    oxcarbazepine 150mg
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    oxcarbazepine-tablets-usp-300mg
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    oxcarbazepine-tablets-usp-600mg
  • INGREDIENTS AND APPEARANCE
    Product Information