Magnesium valproate extended-release tablets

Animal experiments have shown that magnesium valproate sustained-release tablets have anticonvulsant and antimanic effects. Its anti-epileptic effect may be related to competitive inhibition of γ-aminobutyric acid transferase, which reduces its metabolism and increases the content of γ-aminobutyric acid in the brain. It has different degrees of antagonism against convulsions caused by various factors.

Magnesium valproate.

This product is white or off-white tablets.

It is used to treat all types of epilepsy, especially the following types: absence seizures; myoclonic seizures; tonic-clonic seizures; atonic seizures; mixed seizures; partial epilepsy; simple or complex seizures; secondary generalized seizures; special types of syndromes. It can also be used to treat manic episodes of bipolar disorder.

Adults: 250 mg each time, twice a day, adjusted appropriately according to individual differences and blood drug concentration. The maximum dose does not exceed 1600 mg per day. Children over 6 years old should take 20-30 mg/kg per day according to body weight, divided into 3-4 times.

Common symptoms include nausea, vomiting, loss of appetite, diarrhea, etc. A few may experience lethargy, tremor, ataxia, hair loss, abnormal excitement and irritability, etc. Occasionally, allergic rash, thrombocytopenia or platelet aggregation inhibition causing abnormal bleeding, leukopenia or toxic liver damage may occur.

It is contraindicated for patients with leukopenia and severe liver disease. It is contraindicated for children under 6 years old.

Precautions for children: This product can accumulate in developing bones and should be used with caution in children under 6 years old. Precautions for pregnancy and lactation: The risks associated with epileptic women receiving valproate treatment during pregnancy are as follows: Risks associated with epilepsy and epilepsy drugs The overall incidence of malformations in infants born to mothers receiving anti-epileptic treatment has been shown to be 2 to 3 times higher than that of ordinary pregnant women (3%). Although there are reports that the rate of infant malformations increases during multi-drug treatment, the treatment and diseases related to malformations have not yet been formally determined. The most common malformations are cleft lip and cardiovascular malformations. Sudden interruption of anti-epileptic drug treatment may cause the mother's condition to worsen and cause adverse effects on the fetus. The risks associated with valproate have been confirmed to be teratogenic in animals, mice, rats and rabbits. In humans, the overall risk of malformations in women receiving sodium valproate treatment in the first three months of pregnancy is not higher than other anti-epileptic drugs. Cases of facial malformations have been reported. The incidence of those effects has not yet been fully determined. Valproic acid has a tendency to cause neural tube defects, spinal meningocele, spina bifida, etc. The incidence of these adverse effects is estimated to be 1-2%. Looking at the above data, if women are planning to become pregnant, the indications for antiepileptic treatment should be reviewed. Folic acid supplementation should be considered. During pregnancy, antiepileptic treatment with valproate should not be stopped if effective. Monotherapy is recommended, and the minimum effective daily dose should be used in divided doses. If neural tube defects or other malformations are found, special antenatal examinations should be performed. Risks to the newborn There have been reports of hemorrhagic syndrome in newborns of pregnant mothers who used valproate. The hemorrhagic syndrome is related to hypofibrinogenemia. Hypofibrinemia has been reported and may be fatal. Hypofibrinemia may occur with a decrease in coagulation factors. This syndrome should be differentiated from a decrease in vitamin-dependent factors, which is induced by phenobarbital and enzyme inducers. The secretion of valproate in breast milk during lactation is low, approximately 1-10% of the mother's serum level. So far, no clinical side effects have been found in infants and young children who are breastfed during the neonatal period. Precautions for the elderly: Same as adults. The minimum effective daily dose is recommended.

1 This product can inhibit the metabolism of phenytoin sodium, phenobarbital, primidone, and ethosuximide, increasing the blood concentration. 2 This product combined with clonazepam can cause absence epileptic status and should not be used together. 3 Antacids can reduce the blood concentration of this product. 4 Aspirin can increase the efficacy and toxicity of this product. 5 When used in combination with anticoagulants such as warfarin or heparin, as well as thrombolytics, the risk of bleeding increases. 6 When used in combination with carbamazepine, the induction of liver enzymes can accelerate drug metabolism, which can reduce the blood concentration and half-life of the two. 7 When used in combination with haloperidol and thioxanthenes, phenothiazine antipsychotics, tricyclic antidepressants, and monoamine oxidase inhibitors, it can increase the inhibition of the central nervous system, reduce the convulsion threshold and the anticonvulsant effect of valproic acid.

Sealed, store in a dry place.

0.25 g

36 months

Hunan Xiangzhong Pharmaceutical Co., Ltd.

• Founded in:

  1998-03-05

• Address:

  No. 18, Daxing South Road, Baoqing Industrial Concentration Zone, Shaoyang City, Hunan Province

• Tax NO.:

  91430500185569358T

• Registered Funds:

  69 million yuan

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