Drugplain

Trileptal 300 mg/1

oxcarbazepine · TABLET, FILM COATED · Novartis Pharmaceuticals Corporation

No Recall History
Plain English

Trileptal is a tablet, film coated containing oxcarbazepine at 300 mg/1, taken oral. Manufactured by Novartis Pharmaceuticals Corporation.

Key Facts

Brand Name
Trileptal
Generic Name
oxcarbazepine
NDC Code (Product)
0078-0337
Manufacturer
Novartis Pharmaceuticals Corporation
Strength
300 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
NDA021014
Drug Class
Anti-epileptic Agent [EPC]
Marketing Start
01/30/2000

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,818 reports
seizure2,756 reports
off label use1,625 reports
dizziness1,498 reports
convulsion1,455 reports
fatigue1,436 reports
nausea1,284 reports
headache1,269 reports
somnolence1,208 reports
fall1,179 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE TRILEPTAL 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. TRILEPTAL 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 4-16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2-16 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 1200 mg/day ( 2.1 ) Conversion to Monotherapy: Withdrawal concomitant over 3 to 6 weeks; reach maximum dose of TRILEPTAL in 2 to 4 weeks with increments of 600 mg/day at weekly intervals to a recommended daily dose of 2400 mg/day ( 2.2 ) Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1200 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 2-16 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 60 mg/kg/day ( 2.4 ) Conversion to Monother…

Contraindications

4 CONTRAINDICATIONS TRILEPTAL 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: TRILEPTAL may decrease the effectiveness of hormonal contraceptives ( 7.3 ) 7.1 Effect of TRILEPTAL on Other Drugs Phenytoin levels have been shown to increase with concomitant use of TRILEPTAL 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 TRILEPTAL titration and dosage modification. A decrease in the dose of phenytoin may be required. 7.2 Effect of Other Drugs on TRILEPTAL 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 TRILEPTAL (25% to 49%) [see Clinical Pharmacology (12.3)] . If TRILEPTAL and strong CYP3A4 inducers, or UGT inducers are administered concurrently, it is recommended that the plasma levels of MHD be monitored during…

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 Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because …

Frequently Asked Questions

What is Trileptal used for?

Trileptal contains oxcarbazepine. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Trileptal a controlled substance?

Trileptal is not classified as a controlled substance by the DEA.

What is the generic name for Trileptal?

The generic name for Trileptal is oxcarbazepine. There are 11 other brand versions of oxcarbazepine.

What is the NDC code for Trileptal 300 mg/1?

The NDC (National Drug Code) for Trileptal 300 mg/1 is 0078-0337, listed by Novartis Pharmaceuticals Corporation.

Product NDC

0078-0337

Package NDC

0078-0337-05

Other Trileptal Dosages

Other Oxcarbazepine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)