• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Trileptal (oxcarbazepine)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Trileptal (oxcarbazepine)

  • Profile

Profile

Contact Information

Contact: Novartis
Website: https://www.novartis.us/sites/www.novartis.us/files/trileptal.pdf

Currently Enrolling Trials

    Show More

    General Information

    Trileptal (oxcarbazepine) is an anti-convulsant.

    Trileptal is specifically 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

    Trileptal is supplied as tablets and as an oral suspension. The recommended dosing is as follows:

    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
    • 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
    • Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1200 mg/day
    • Initiate at one-half the usual starting dose and increase slowly in patients with a creatinine clearance < 30 mL/min

    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. 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.
    • Conversion to Monotherapy for Patients (Aged 4-16 Years): Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs (AEDs) can be completely withdrawn over 3 to 6 weeks
    • Initiation of Monotherapy for Patients (Aged 4-16 Years): Increments of 5 mg/kg/day every third day

    Mechanism of Action

    The pharmacological activity of Trileptal (oxcarbazepine) is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine… The precise mechanism by which oxcarbazepine and MHD exert their antiseizure effect is unknown; however in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in the stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and dimunition of propagation of synaptic impulses. These actions are thought to be important in the prevention of seizure spread in the intact brain. In addition, increased potassium conduction and modulation of high-voltage activated calcium channels may contribute to the anticonvulsive effects of the drug. No significant interactions of oxcarbazepine or MHD with brain neurotransmitter or modulator receptor sites have been demonstrated. 

    Side Effects

    Adverse effects associated with the use of Trileptal may include the following:

    • dizziness
    • somnolence
    • diplopia
    • fatigue
    • nausea
    • vomiting
    • ataxia
    • abnormal vision
    • headache
    • nystagmus
    • tremor
    • abnormal gait

    Clinical Trial Results

    In studies in which the drug was compared to a placebo, patients given the drug lasted significantly longer without having certain seizures than did those patients not taking the drug.

    Furthermore, a higher dosage of the drug yielded a significantly longer period before the patient demonstrated specific seizure symptoms.

    In addition, two trials, one in which patients were ages 15-66 and the other in which patients were ages 3-17, examined Trileptal as an adjunctive therapy. Every patient in these trials was on 1-3 concomitant Anti-Epileptic Drugs. In both studies, dosage was increased over a period of two weeks until the patient reached the assigned dose or experienced an intolerance to the dosage.

    Results of the pediatric trial indicated that compared to a placebo, patients taking the study medication experienced over 25% greater reduction of frequency of partial seizures.

    In the adult study, the reduction of frequency of partial seizures for those taking the study drug at the lowest dose was over 18% greater than those taking the placebo, while at the highest dose was over 42% greater than those taking the placebo.

     

    Approval Date: 2000-01-01
    Company Name: Novartis
    Back to Listings

    Upcoming Events

    • 24May

      Powering an Effective Oversight Strategy with Clinical and Operational Insights

    • 25May

      2022 WCG Avoca Quality & Innovation Summit: Own the Future

    • 28Jun

      Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

    • 16Oct

      WCG MAGI's Clinical Research Hybrid Conference - 2022 West

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Protocol-360x240.png

      Avoid Deviations by Making Protocol Review a Team Effort

    • SelectionProcess-360x240.png

      Give Us a Voice: Sites Clamor for a Say on Vendor Selection

    • Convince-360x240.png

      Use Data and Details to Convince Site Leadership to Add Staff

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing