Home » Drug Information » FDA Approved Drugs » 2000
Medical Areas: Neurology | Pediatrics/Neonatology | Family Medicine | Genetic Disease
View By:YearCompanyConditionsTherapeutic AreasDrug Names
Trileptal (oxcarbazepine) Tablets
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved January 2000
Treatment Area: Adjunctive & monotherapy in adults; adjunctive therapy for children ages 4-16 with partial epileptic seizures
Trileptal, an anticonvulsant or antiepileptic drug (AED), was
approved for use as an adjunctive and monotherapy for the treatment
of partial seizures in adults with epilepsy and for the adjunctive
treatment of partial seizures in children, ages 4-16, with
epilepsy. It is the first AED to be approved as a monotherapy in
2.3 million Americans have been diagnosed with epilepsy. This
year, 181,000 more Americans (children and adults) will
develop epilepsy and seizures.
Recent trials include 6 multi-center randomized double blind
controlled trials that were conducted to determine the
effectiveness of the drug. 4 of the studies investigated the drug
as a monotherapy. Participants in these trials ranged from 8 to 66
years old. Two of the studies tested the drug as an adjunctive
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
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
The most common side effects include, but are not limited
- Somnolence or fatigue
- Viral Infection
Some patients also exhibited hyponatremia (low serum sodium
levels). Most patients who developed this side effect, were
asymptomatic. In clinical trials, patients whose treatment was
discontinued due to hyponatremia, generally experienced
normalization of serum sodium within a few days without additional
Some additional side effects were associated with the central
nervous system (CNS). These include:
- Psychomotor slowing
- Difficulty with concentration
- Speech or language problems
- Coordination abnormalities
In clinical trials, patients' discontinuation of therapy due
to these CNS side effects was dose related when the drug was used
as an adjunctive therapy; higher dosages increased the
discontinuation rate. No discontinuation of treatment due to
similar side effects was found when the drug was used as a
Trileptal should not be used in patients with a known
hypersensitivity to oxcarbazepine or to any of its components.
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. (from FDA Label)
For more information about epilepsy, visit the official web site
of the Epilepsy Foundation, a non-profit volunteer agency devoted
to research, education, advocacy, and services in the community for
people with epilepsy and their families:
where you can find out about everything from dates of international
conferences about epilepsy to
a list of countries where Trileptal is available.
This is what the Epilepsy Foundation says to do
and not to do if you encounter a person having an
What To Do:
- Look for medical identification.
- Protect from nearby hazards.
- Loosen ties or shirt collars.
- Protect head from injury.
- Turn on side to keep airway clear unless injury exists.
- Reassure as consciousness returns.
- If a single seizure lasted less than 5 minutes, ask if hospital
- If there are multiple seizures, or if one seizure lasts longer
than 5 minutes, call an ambulance.
- If person is pregnant, injured, or diabetic, call for aid at
What Not To Do:
- Don't put any hard implement in the mouth.
- Don't try to hold tongue. It can't be swallowed.
- Don't try to give liquids during or just after
- Don't use artificial respiration unless breathing is absent
after muscle jerks subside, or unless water has been inhaled.
- Don't restrain.