Rx Item-Oxcarbazepine Oral Sus 300 MG/5ML 250ml Gen Trileptal by Amneal Phar

Clinical Information
Gen. Code and Des.33724 oxcarbazepine ORAL ORAL SUSP 300 MG/5ML
GCN and Des.21723 oxcarbazepine ORAL ORAL SUSP 300 MG/5ML
Strength300MG-5ML
Dose FormSUSPENSION, ORAL (FINAL DOSE FORM)
Product CategoryRX Pharmaceuticals
Fine Line Class850085008510 All Rx Products
DEA ClassNCOMP Family
AHFS Class28129200 ANTICONVULSANTS, MISCELLANEOUS
Active Ingredients6035 oxcarbazepine 28721075
Inactive Ingredients2468 propylene glycol 57556
2599 sorbitol 50704
2600 saccharin 81072
3203 paraben 99967

These highlights do not include all the information needed to use OXCARBAZEPINE ORAL SUSPENSION safely and effectively. See full prescribing information for OXCARBAZEPINE ORAL SUSPENSION.



OXCARBAZEPINE oral suspension

Initial U.S. Approval: 2000
INDICATIONS AND USAGE

Oxcarbazepine 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 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 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 to exceed 60 mg/kg/day ( 2.4)
Conversion to Monotherapy for Patients (Aged 4 to 16 Years)
Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks ( 2.5)
Initiation of Monotherapy for Patients (Aged 4 to 16 Years) Increments of 5 mg/kg/day every third day ( 2.6)

DOSAGE FORMS AND STRENGTHS

Oral suspension: 300 mg/5 mL (60 mg/mL) ( 3)

CONTRAINDICATIONS

Known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate (4, 5.2)

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, coordination abnormalities. Use caution when operating machinery ( 5.7)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Monitor and discontinue if another cause cannot be established ( 5.8)
Hematologic Events: Consider discontinuing ( 5.9)
Seizure Control During Pregnancy: Active metabolite may decrease ( 5.10)
Risk of Seizure Aggravation: Discontinue if occurs ( 5.11)

ADVERSE REACTIONS

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 Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

Phenytoin: Increased phenytoin levels. Reduced dose of phenytoin may be required ( 7.1)
Carbamazepine, Phenytoin, 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 ( 7.2)

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm ( 8.1)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 8/2022

Oxcarbazepine Oral Sus 300 MG/
Oxcarbazepine Oral Sus 300 MG/5ML 250ml Gen Trileptal by Amneal Phar NDC No.: 65162-0649-78 65162064978 6516264978 65162-649-78 UPC No. 3-65162-64978-9 365162649789 365162-649789

Oxcarbazepine Oral Sus 300 MG/
NDC No.: 65162-0649-78 65162064978 6516264978 65162-649-78 UPC No. 3-65162-64978-9 365162649789 365162-649789 Oxcarbazepine Oral Sus 300 MG/5ML 250ml Gen Trileptal by Amneal Phar

Rx Item-Oxcarbazepine 150MG 1000 TAB-Coo
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica

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Oxcarbazepine 150MG 1000 TAB-Cool Store- by Sun Gen Trileptal

Oxcarbazepine 150MG 1000 TAB-C
Oxcarbazepine 150MG 1000 TAB-Cool Store- by Sun Gen Trileptal Item No. RX769986, 769986, NDC No.: 62756-0183-18, 62756-183-18, 6275618318, 62756018318, 0183-18, 018318 UPC No. 3-62756-18318-6, 362756-

Rx Item-Oxcarbazepine 150MG 1000 TAB-Coo
Item No. RX769986, 769986, NDC No.: 62756-0183-18, 62756-183-18, 6275618318, 62756018318, 0183-18, 018318 UPC No. 3-62756-18318-6, 362756-183186, 362756183186

Rx Item-Oxcarbazepine 150MG 1000 TAB-Coo
Item No. RX769986, 769986, NDC No.: 62756-0183-18, 62756-183-18, 6275618318, 62756018318, 0183-18, 018318 UPC No. 3-62756-18318-6, 362756-183186, 362756183186

Oxcarbazepine Oral Sus 300 MG/
NDC No.: 69452-0125-50 69452-125-50 69452012550 6945212550 UPC No. 3-69452-12550-2 369452-125502 369452125502 Oxcarbazepine Oral Sus 300 MG/5ML 250ml Gen Trileptal by Bion Phar

Oxcarbazepine Oral Sus 300 MG/
NDC No.: 69452-0125-50 69452-125-50 69452012550 6945212550 UPC No. 3-69452-12550-2 369452-125502 369452125502 Oxcarbazepine Oral Sus 300 MG/5ML 250ml Gen Trileptal by Bion Phar