Oxcarbazepine Tablets

Although the exact mechanism of action of most anti-epileptic drugs has not been fully understood, it can still be considered that this class of drugs produces its effect by changing the activity of the basic mediators of neuronal excitability, that is, the voltage of the brain and the regulation of neurotransmitter ion channels. According to recent studies, the anticonvulsant effect of oxcarbazepine and its monohydroxy derivative (MHD) is mainly due to the blocking of the voltage-dependent sodium ion channels of the brain. At therapeutic concentrations, these two compounds inhibited the sustained high-frequency repetitive discharge of sodium-dependent action potentials of rat neurons in cell culture, and this effect may help block the propagation of epileptic electrical activity in epileptic foci. In addition, the results of in vitro studies on rat hippocampal tissue slices showed that the anti-epileptic effect of racemic MHD and its two enantiomers is also regulated by the participation of potassium ion channels.

The main ingredient of this product is oxcarbazepine, and its chemical name is 10,11-dihydro-10-oxo-5H-dibenzo[b,f]azepine-5-carboxamide

This product is a yellow oval film-coated tablet, which appears white to off-white after the film coating is removed.

This product is indicated for the treatment of primary generalized tonic-clonic seizures and partial seizures with or without secondary generalized seizures in adults and children aged 5 years and over.

This product is suitable for use alone or in combination with other antiepileptic drugs. In monotherapy and combination therapy, this product should be started at a clinically effective dose, divided into two doses within 1 day. Increase the dose according to the patient's clinical response. If this product is used in combination with other antiepileptic drugs, due to the increase in the patient's overall antiepileptic drug dose, it is necessary to reduce the dose of other antiepileptic drugs or/and increase the dose of this product more slowly. This product can be taken on an empty stomach or with food. For patients without renal impairment, the recommended therapeutic dose is as follows. The pharmacokinetics of oxcarbazepine are characterized by the need to monitor blood drug concentrations, making treatment with this product more convenient. Adults-Monotherapy: For treatment with this product, the starting dose can be 600 mg a day (8-10 mg/kg/day), administered in two doses

In clinical trials, most adverse reactions were mild to moderate and transient, occurring mainly at the beginning of treatment.

Patients with known allergy to any component of this product; patients with atrioventricular block are contraindicated.

Precautions for children: Not yet clear. Precautions for pregnancy and lactation: 1. Pregnancy: 1. There is definite evidence that oxcarbazepine tablets (Trileptin) are dangerous to human embryos, but the benefits of the drug to mothers with epilepsy may outweigh its risks. 2. There is not enough evidence and clinical human controlled studies to further evaluate the safety of taking oxcarbazepine tablets (Trileptin) during pregnancy. For women during treatment, or women who are given this product during pregnancy, the pros and cons of using the drug must be carefully weighed. 3. Oxcarbazepine and its active metabolite MHD can pass through the placental barrier. 4. When using this drug in the last few weeks of pregnancy, the mother should take vitamin K1, and the newborn should also take it. 5. Vitamin B12 deficiency should be excluded or treated. 2. Breastfeeding: 1. During breastfeeding, the pros and cons of using this product for treatment should be evaluated. Precautions for the elderly: Not yet clear.

1. Enzyme inhibition: Oxcarbazepine or MHD has an inhibitory effect on the following cytochrome-P450 complexes present in the microsomes of human liver, but it is very rare or mild. 2. Enzyme induction: Studies on enzyme induction in human liver cells have shown that oxcarbazepine and MHD have a weak induction effect on CYP2B isoenzymes and CYP3A4 subgroups. It is not yet clear whether oxcarbazepine and MHD also have the ability to induce other CYP isoenzymes. 3. Interaction with other antiepileptic drugs: No self-induction effect of this product has been observed. 4. Hormonal contraceptives: See [Precautions]. 5. Calcium ion blockers: Repeated use with oxcarbazepine tablets (Trileptin) reduced the AUC of felodipine by 28%, but the serum concentration remained within the recommended therapeutic range. 6. With

Keep away from light and store in sealed container.

0.3 g

36 months.