Oxcarbazepine Tablets

Active ingredient: Oxcarbazepine. The chemical name of oxcarbazepine is 10,11-dihydro-10-oxo-5H-diphenyl[b,f]azepine-5-carboxamide

This product is an oval film-coated tablet in light gray-green (0.15g), yellow (0.3g) or light pink (0.6g). When the film coating is removed, the tablet appears white or off-white.

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 and 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 fact that there is no need to monitor blood drug concentrations, making treatment with this product more convenient.

In clinical trials, most adverse reactions were mild to moderate and transient, mainly occurring at the beginning of treatment. The evaluation of the adverse reaction characteristics of each system is based on adverse events that occurred in clinical trials of this product. In addition, important clinical adverse reaction reports in the effective case continuation treatment program and post-marketing reports are also included. The estimated frequency of adverse reactions according to CIOMSIII classification: Very common ≥ (greater than orequalto) 10%: Common 1-10%; Uncommon 0.1-1%; Rare 0.01-0.1%; Very rare

0.3 g