Levetiracetam Tablets

Levetiracetam is a pyrrolidone derivative whose chemical structure is not related to existing antiepileptic drugs. The exact mechanism of levetiracetam's antiepileptic effect is still unclear. The antiepileptic effect of levetiracetam has been evaluated in a variety of animal models of epilepsy. Levetiracetam has no inhibitory effect on simple epileptic seizures induced by maximal stimulation of electric current or various convulsants, and only shows weak activity in submaximal stimulation and threshold tests. However, protective effects were observed against generalized seizures secondary to focal seizures induced by pilocarpine and kainic acid, two chemical convulsants that can mimic the characteristics of some people's complex partial seizures with secondary generalized seizures. Levetiracetam has an inhibitory effect on both the kindling process and the kindling state in the rat kindling model of complex partial seizures. The predictive value of these animal models for specific types of epilepsy in humans is still unclear.

Levetiracetam. Molecular weight: C8H14N2O2

This product is an oval film-coated tablet (250 mg is a blue tablet, 500 mg is a yellow tablet, and 1000 mg is a white tablet), which appears white after removing the coating.

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(1) Route of administration: Oral. It should be swallowed with an appropriate amount of water and the administration is not affected by eating. (2) Administration method and dosage: The initial treatment dose for adults (18 years old) and adolescents (12-17 years old) weighing ≥50kg is 500mg each time, twice a day. Based on clinical effects and tolerability, the daily dose can be increased to 1500mg each time, twice a day. The dose should be increased or decreased by 500mg/time, twice a day every 2-4 weeks. For the elderly (≥65 years old), the dose should be adjusted according to the renal function status (see the description of patients with impaired renal function below for details). The initial treatment dose for children aged 4-11 years and adolescents (12-17 years old) weighing ≤50kg is 10mg/kg, twice a day. Based on clinical effects and tolerability, the dose can be increased to 30

The safety data summarized from adult clinical studies showed that the incidence of adverse reactions in the drug group and the placebo group were similar, at 46.4% and 42.2%, respectively. Among them, serious adverse reactions were 2.4% and 2.0%, respectively. The most common adverse reactions were drowsiness, fatigue, and dizziness, which often occurred at the beginning of treatment. Over time, the incidence and severity of adverse reactions related to the central nervous system will decrease. There is no obvious dose-related adverse reaction to levetiracetam.

It is contraindicated in patients who are allergic to levetiracetam or to pyrrolidone derivatives or any of the other ingredients.

Precautions for children: See [Usage and Dosage]. Precautions for pregnancy and lactation: There is currently no data on pregnant women taking this product. Animal experiments have shown that the drug has certain reproductive toxicity. The potential danger to humans is not yet clear. Pregnant women should not use levetiracetam unless necessary. Sudden interruption of anti-epileptic treatment may worsen the condition and is also harmful to the mother and fetus. Animal experiments have shown that levetiracetam can be excreted from breast milk, so it is not recommended that patients breastfeed while taking the drug. Precautions for the elderly: See [Usage and Dosage].

In vitro data show that levetiracetam and its major metabolites are neither inhibitors of human liver cytochrome P450, epoxide hydrolase or uridine diphosphate-glucosidase nor substrates with high affinity at concentrations above the Cmax level obtained within the therapeutic dose range. Therefore, pharmacokinetic interactions are not likely to occur. In addition, levetiracetam does not affect the in vitro glucosidase action of valproic acid.

Keep sealed.

0.25 g

24 months

Zhejiang Jingxin Pharmaceutical Co., Ltd.

• Founded in:

  1999-02-13

• Address:

  No. 800, Xinchang Avenue East Road, Yulin Street, Xinchang County, Zhejiang Province

• Tax NO.:

  91330000704503984N

• Registered Funds:

  861.02914 million yuan

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