Trileptal 150 film coated tablet

Trileptal (Novartis Pharmaceuticals), manufactured drug form of Oxcarbazepine, 150mg/tablet oxcarbazepine film coated tablet, NDC 0078-0456

Available in:

NDC Product ID:

  • 0078-0456

Manufacturer:

Manufactured drug form

Manufactured form of:

Generic drug:

  • No

Label date:

  • Mar 17, 2011

Label link:

Label sections:

Section name Section URI Prominent warning Highlight text Section LOINC code
  • 1 Indications And Usage
  • No
  • Trileptal is an antiepileptic drug indicated for: Adults: - Monotherapy or adjunctive therapy in the treatment of partial seizures Children: - Monotherapy in the treatment of partial seizures in children 4-16 years - Adjunctive therapy in the treatment of partial seizures in children 2-16 years (1)
  • 34067-9
  • 2 Dosage And Administration
  • No
  • ADULTS: initiated with a dose of 600 mg/day, given in twice-a-day regimen 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 The recommended daily dose is 1200 mg/day (2.1) Conversion to Monotherapy: Concomitant AEDs should be completely withdrawn over 3-6 weeks, while maximum dose of Trileptal should be reached in about 2-4 weeks. Maximum increment of 600 mg/day at approximately 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) CHILDREN: initiation with 8-10 mg/kg/day, given in twice-a-day regimen. For patients aged 2 - <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 4-16 years, target maintenance dose should be achieved over 2 weeks (2.4). For patients aged 2 - <4 years, maximum maintenance dose should be achieved over 2-4 weeks and should not to exceed 60mg/kg/day (2.4) Conversion to Monotherapy for Patients (Aged 4-16 Years) Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs can be completely withdrawn over 3-6 weeks (2.5) Initiation of Monotherapy for Patients (Aged 4-16 Years) Increments of 5 mg/kg/day every third day (2.6)
  • 34068-7
  • 3 Dosage Forms And Strengths
  • No
  • Film-coated tablets: 150 mg, 300 mg and 600 mg (3) Oral suspension a 300 mg/5 mL (60 mg/mL) (3)
  • 43678-2
  • 4 Contraindications
  • No
  • Trileptal should not be used in patients with a known hypersensitivity to oxcarbazepine or to any of its components (4)
  • 34070-3
  • 5 Warnings And Precautions
  • No
  • Hyponatremia (5.1) Anaphylactic Reactions and Angioedema (5.2) Patients with a Past History of Hypersensitivity Reaction to Carbamazepine (5.3) Serious Dermatological Reactions (5.4) Suicidal Behavior and Ideation (5.5) Withdrawal of AEDs (5.6) Cognitive/Neuropsychiatric Adverse Events (5.7) Multi-Organ Hypersensitivity (5.8) Hematologic Events (5.9) Seizure Control During Pregnancy (5.10) Laboratory Tests (5.11)
  • 43685-7
  • 6 Adverse Reactions
  • No
  • The most commonly observed (≥5%) adverse experiences were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, abnormal gait, and in pediatric patients <4 years old, also infections and infestations. (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.
  • 34084-4
  • 7 Drug Interactions
  • No
  • Phenytoin: Increased phenytoin levels. Reduced dose of phenytoin may be required. (7.1) Carbamazepine: Decreased plasma levels of MHD (the active metabolite). Dose adjustments may be necessary. (7.1) Phenobarbital: Decreased plasma levels of MHD. Dose adjustments may be necessary. (7.1) Oral Contraceptive: Patients should be advised that Trileptal may decrease the effectiveness of hormonal contraceptives. (7.2)
  • 34073-7
  • 8 Use In Specific Populations
  • No
  • Pregnancy: Plasma levels of MHD may be decreased. Monitor patients. Based on animal data, may cause fetal harm. To enroll in the North American Antiepileptic Drug Pregnancy Registry call (888) 233-2334 (toll free). (8.1 ) In patients with a creatinine clearance <30mL/min, Trileptal should be started at one-half the usual starting dose and increased slowly (2, 8.6, 12.3)
  • 43684-0
  • 9 Drug Abuse And Dependence
  • No
  • 42227-9
  • 10 Overdosage
  • No
  • 34088-5
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Discontinued:

  • No

Marketing start date:

  • Jan 30, 2000

Patents:

Patent expiry date:

  • Aug 12, 2018

FDA application number:

  • NDA021014

Color:

Shape:

Size:

  • 11 mm (0.43 in )

Scoring:

  • 2

Imprint:

  • T;D;C;G

Therapeutic equivalents:

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