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.

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, the dose of other antiepileptic drugs needs to be reduced or/and the dose of this product needs to be increased more slowly due to the increase in the patient's overall antiepileptic drug dose. 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 do not require monitoring of blood drug concentrations, making this product more convenient for treatment. Adults-monotherapy: For treatment with this product, the starting dose can be 600 mg a day (8-10 mg/kg/day), divided into two doses. In order to obtain the ideal effect, the daily dose can be increased every 1 week, and the dose increase should not exceed 600 mg each time. The daily maintenance dose range is between 600-2400 mg, and most patients respond to a daily dose of 900 mg.

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

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

Precautions for children: See [Dosage and Administration], or follow the doctor's advice. Precautions for pregnancy and lactation: There is no sufficient research on the effect of this product on pregnant women. However, the structure of this product is similar to that of carbamazepine, which is teratogenic to humans. Based on this fact and the results of animal studies, this product may also be teratogenic to humans. Therefore, pregnant women can only take this product when it is determined that the benefits of this product to the fetus outweigh the potential risks. This product and MHD can be secreted into breast milk and may have serious side effects on breastfeeding infants. Therefore, breastfeeding mothers should decide to stop breastfeeding or stop taking the drug based on whether the medication is necessary for the patient. Precautions for the elderly: It is recommended to adjust the drug dosage for elderly people with renal impairment (see [Dosage and Administration] Patients with renal impairment). For patients prone to hyponatremia, see [Precautions].

1. Enzyme inhibition: Oxcarbazepine or MHD has an inhibitory effect on the following cytochrome-P450 complexes present in human liver microsomes, 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. Interaction with other antiepileptic drugs: No self-induction effect of this product has been observed. 3. Hormonal contraceptives: See [Precautions] Calcium ion antagonists: Repeated use with oxcarbazepine tablets (Trileptin) reduces the AUC of felodipine by 28%, but the serum concentration remains within the recommended therapeutic range. 4. Interaction with other drugs: In clinical trials, patients who were treated with tricyclic antidepressants at the same time were not observed to interact with this product. The combined use of lithium and oxcarbazepine can lead to increased neurotoxic reactions.

Keep away from light and store in sealed container.

0.3g

36 months.

Beijing Sihuan Pharmaceutical Co., Ltd.

• Founded in:

  1995-12-26

• Address:

  Room 101, 1st-5th Floor, Building 5, No. 13 Guangyuan West Street, Tongzhou District, Beijing

• Tax NO.:

  91110112102444497K

• Registered Funds:

  250 million yuan

• Email:

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