OXCARBAZEPINE 300 mg/1
OXCARBAZEPINE · TABLET, FILM COATED · REMEDYREPACK INC.
OXCARBAZEPINE is a tablet, film coated containing oxcarbazepine at 300 mg/1, taken oral. Manufactured by REMEDYREPACK INC..
Key Facts
- Brand Name
- OXCARBAZEPINE
- Generic Name
- OXCARBAZEPINE
- NDC Code (Product)
70518-2370- Manufacturer
- REMEDYREPACK INC.
- Strength
- 300 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA078069
- Drug Class
- Anti-epileptic Agent [EPC]
- Marketing Start
- 10/19/2019
Recall History
West-Ward Columbus Inc
Failed Impurities/Degradation Specificattion
Caraco Pharmaceutical Laboratories Ltd.
Failed Tablet Specifications: Broken Tablets Present.
Aidapak Services, LLC
Labeling:Label Mixup; OXcarbazepine Tablet, 150 mg may be potentially mislabeled as traZODone HCl, Tablet, 50 mg, NDC 50111043301, Pedigree: AD54562_1, EXP: 5/20/2014.
Aidapak Services, LLC
Labeling:Label Mixup; OXcarbazepine Tablet, 600 mg may be potentially mislabeled as LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD30028_25, EXP: 5/7/2014.
SUN PHARMACEUTICAL INDUSTRIES INC
Presence of foreign substance
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Boehringer Ingelheim Roxane Inc
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Boehringer Ingelheim Roxane Inc
Resuspension Problems: Recalled lot did not meet resuspendability requirements.
American Health Packaging
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Oxcarbazepine oral suspension 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 in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. Oxcarbazepine oral suspension is indicated for: • Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures • Pediatrics: -Monotherapy in the treatment of partial-onset seizures in children 4 to 16 years -Adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults : Initiate with a dose of 600 mg/day, given twice a day • Adjunctive Therapy: Maximum increment of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1,200 mg/day ( 2.1 ) • Conversion to Monotherapy: Withdrawal concomitant over 3 to 6 weeks; reach maximum dose of oxcarbazepine oral suspension in 2 to 4 weeks with increments of 600 mg/day at weekly intervals to a recommended daily dose of 2,400 mg/day ( 2.2 ) • Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1,200 mg/day ( 2.3 ) • Initiate at one-half the usual starting dose and increase slowly in patients with a creatinine clearance < 30 mL/min ( 2.7 ) Pediatrics : Initiation with 8 to 10 mg/kg/day, given twice a day. For patients aged 2 to < 4 years and under 20 kg, a starting dose of 16 to 20 mg/kg/day may be considered. Recommended daily dose is dependent upon patient weight. • Adjunctive Patients (Aged 2 to 16 Years): For patients aged 4 to 16 years, target maintenance dose should be achieved over 2 weeks ( 2.4 ). For patients aged 2 to < 4 years, maximum maintenance dose should be achieved over 2 to 4 weeks and should not exceed 60mg/k…
Contraindications
4 CONTRAINDICATIONS Oxcarbazepine oral suspension is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [see Warnings and Precautions (5.2, 5.3 )]. Known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate ( 4, 5.2 )
Drug Interactions
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 1,200 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 modification. A decrease in the dose of phenytoin may be required. 7.2 Effect of Other Drugs on Oxcarbazepine Strong inducers of cytochrome P450 enzymes and/or inducers of UGT (e.g., rifampin, carbamazepine, phenytoin and phenobarbital) have been shown to decrease the plasma/serum levels of MHD, the active metabolite of oxcarbazepine (25% to 49%) [see Clinical Pharmacology (12.3) ]. If oxcarbazepine and strong CYP3A4 inducers, or UGT inducers are administered concurrently, it is recommended that the plasma…
Adverse Reactions
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 [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 Warnings and Precautions (5.9) ] The most common (≥ 10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions in adults and pediatrics were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, and abnormal gait ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Be…
Frequently Asked Questions
What is OXCARBAZEPINE used for?
OXCARBAZEPINE contains OXCARBAZEPINE. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is OXCARBAZEPINE a controlled substance?
OXCARBAZEPINE is not classified as a controlled substance by the DEA.
What is the generic name for OXCARBAZEPINE?
The generic name for OXCARBAZEPINE is OXCARBAZEPINE. There are 10 other brand versions of OXCARBAZEPINE.
What is the NDC code for OXCARBAZEPINE 300 mg/1?
The NDC (National Drug Code) for OXCARBAZEPINE 300 mg/1 is 70518-2370, listed by REMEDYREPACK INC..
Other OXCARBAZEPINE Dosages
Other Oxcarbazepine Brands
See all →- Oxcarbazepine300 mg/5mL72162-2088
- Oxcarbazepine150 mg/172888-087
- Oxcarbazepine300 mg/10615-8448
- Oxcarbazepine600 mg/10615-8567
- Trileptal150 mg/10078-0456
- Oxcarbazepine150 mg/127241-237
- Oxcarbazepine300 mg/5mL42806-600
- oxcarbazepine150 mg/168382-691
- oxcarbazepine300 mg/168382-692
- Oxcarbazepine300 mg/170518-3237
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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