Generic Trileptal

1. Denomination

Trileptal

2. Active Substance

Oxcarbazepine

3. Indications for Use.

– simple and complicated partial epileptic fits (with the loss and without the loss of consciousness), with secondary generalization or without it – generalized tonoclonic epileptic fits.

4. Action

Oxcarbazepine is an anti-epileptic medical drug which has a minimal number of side effects.

5. Posology and Administration

Oxcarbazepine should be administered strictly individually and on clinical indications!
In adults and in elderly patients the starting dose should be 600 mg/a day (8-10 mg/kg of the body mass a day), divided into two intakes as a monotherapy. A good therapeutic effect was noticed in a dosage range of 600-2400 mg/daily. A dosage may gradually increase but not more than 600 mg/a day with a week intervals up to the achievement of the desired therapeutic response. In in-patient hospitals swift increase of a dose up to 2400 mg/a day during 48 hours is possible.
In administration within a combined therapy the starting dose is 600 mg/a day (8-10 mg/kg/a day), divided into two intakes. A good therapeutic response was noticed in a dosage range of 600-2400 mg/a day. If there are clinical indications a dose may be increased gradually but not more than 600 mg/daily with some weekly intervals up to the achievement of the desired therapeutic response.
In controlled clinical trials there have not been studied the use of daily doses of more than 2400 mg. There exists a limited experience of the use of daily doses up to 4200 mg.
In children a recommended starting dose is 8-10 mg/kg of the body mass a day, divided into two intakes both in monotherapy and in the use of Oxcarbazepine within a combined therapy. In combination with other anti-epileptic medical drugs a good therapeutic effect was noticed in an average supporting dose of Oxcarbazepine of 30 mg/kg of the body mass/a day. For attainment of the desired therapeutic response it is possible a gradual increase of a dose by 10 mg/kg/daily a week - up to the maximal daily dose of 46 mg/kg of the body mass.
In patients with light and moderate compromised liver function no correction of a dosage regimen is needed. The use of Oxcarbazepine in patients with severe compromised liver function has not been studied.
In patients with compromised kidneys function a recommended starting dose is 300 mg/a day and should be increased slowly up to the desired therapeutic response.

6. Counterindications

Hypersensitivity, pregnancy, lactation period, children less than 2 years of age.

7. Should Be Taken with Precautions, if…

In case of the development of allergic reactions Oxcarbazepine should be immediately withdrawn. Care should be taken while administering the drug in patients with compromised kidneys function, if there is an assumption of hepatitis development in the period of the treatment the drug should be withdrawn, in the period of the treatment it is necessary to control the body mass in patients with chronic heart failure. The drug should be withdrawn gradually (there is a risk of a frequency increase of epileptic fits).
 

8. Interface with Other Medications

Oxcarbazepine might be combined but only with specific medications, for the right administration a medical education is needed, do not self-medicate and always consult your doctor.

9. Overdosing

Symptoms: drowsiness, dizziness, nausea, vomiting, balance problem in standing, high speed unintentional oscillating movements of eyes (up to several hundreds a minute).

10. Side Effects

Side effects are usually weakly or moderately evidenced; they are of a transitory character and mainly are observed in the beginning of the therapy.
Such manifestations as increased fatigability, dizziness, headache, deficit in attention concentration, nausea, vomiting, constipation, pains in stomach, diarrhea, and foggy vision are likely.

11. Pregnancy and Lactation

The experience of the use of Oxcarbazepine in pregnancy is limited. In this case it is necessary to weigh accurately the prospective benefits against possible aggravations, especially in the I-st trimester of pregnancy in the case if in a woman receiving Oxcarbazepine becomes pregnant, or if the matter on the administration of Oxcarbazepine arises during pregnancy. Minimal efficient doses should be used. The patient should be warned on possible disorders of the fetus development. Oxcarbazepine should not be used while breastfeeding.

12. Driving

In the period of treatment it is necessary to avoid potentially hazardous activities, which require elevated attention concentration, as Oxcarbazepine gives a series of symptoms which suppress sensory acuity and perception of the outside world.

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