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The Food and Drug Administration-FDA of the United States has
officially released the approval of the anti-epileptic branded
medication Trileptal made from Oxcarbazepine by the world renowned
pharmaceutical corporation Novartis, during January 2000. The drug
has been approved for use in treatment as Mono-therapy and
Adjunctive therapy in adults, adjunctive therapy for children of age
between 4 and 16 years suffering from partial epileptic seizures.
Trileptal-Oxcarbazepine is the anticonvulsant or anti-epileptic drug
– AED which received the FDA approval for its use as above.
Recent clinical trials incorporate 6 multi-center randomized double
blind controlled trials that were carried out for ascertaining the
efficacy of Trileptal-Oxcarbazepine. Four of these studies
investigated the medication as the mono-therapy, while two of the
studies tested this drug as the adjunctive therapy. People that
participated in the trials ranged between 8 and 66 years of age. The
studies in which the drug was compared with the4 placebo, patients
administered this drug lasted remarkably longer without having
certain seizure episodes than the patients not taking this drug.
Moreover, the higher dose of Trileptal showed the significantly
longer period before the patients showed typical seizure symptoms.
In addition, two trials wherein the drug examined as an adjunct
therapy of which in one case the patients were aged between 15 and
66 years and in the other the patients were between age of 3 and 17
years. Each of the patients in these trials was on 1-3 concomitant
Anti-Epileptic Drugs. The dose was increased over a period of two
weeks until the patient reached the assigned dosage or experienced
the intolerance to the dosage in both the studies.
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