Sodium valproate extended-release tablets

Animal experiments have shown that valproic acid has anticonvulsant and antimanic effects. The mechanism is generally believed to be that valproic acid drugs increase GABA in the whole brain or cranial nerve endings. Valproic acid drugs and their valproic acid metabolites both inhibit GABA degradation and increase GABA synthesis.

The main ingredient of this product is sodium valproate, its chemical name is: 2-sodium valproate, molecular formula: C8H15NaO2, molecular weight: 166.20. Each tablet contains 333 mg of valproic acid (equivalent to 500 mg of sodium valproate).

This product is a white sugar-coated tablet, which appears white or off-white after removing the sugar coating.

It is mainly used for the treatment of simple or complex absence seizures, myoclonic seizures, and grand mal seizures as a single drug or in combination. It sometimes also has a certain effect on complex partial seizures.

Common dosage for adults: 15 mg/kg per day or 600~1200 mg per day divided into 2~3 times. Start with 5~10 mg/kg, increase gradually after one week until the attack can be controlled. When the daily dosage exceeds 250 mg, it should be taken in divided doses to reduce gastrointestinal irritation. The maximum daily dosage is no more than 30 mg/kg per day, or 1.8~2.4 g per day. Common dosage for children: The same as that for adults, 20~30 mg/kg per day, divided into 2~3 times or 15 mg/kg per day, increase by 5~10 mg/kg every other week as needed, until effective or intolerable.

1 Common adverse reactions include diarrhea, indigestion, nausea, vomiting, gastrointestinal spasm, and changes in menstrual cycle. 2 Less common are transient hair loss, constipation, drowsiness, dizziness, fatigue, headache, ataxia, mild tremor, abnormal excitement, restlessness and irritability. 3 Long-term use may occasionally cause pancreatitis and acute liver necrosis. 4 It may cause thrombocytopenia, purpura, bleeding and prolonged bleeding time, and blood tests should be conducted regularly. 5 It may damage liver function, causing elevated serum alkaline phosphatase and aminotransferase. Liver function tests should be conducted after 2 months of use. 6 Occasionally allergic reactions occur. 7 Occasionally there may be hearing loss and reversible hearing damage.

1. Acute hepatitis, chronic hepatitis, personal or family history of severe hepatitis, especially drug-induced hepatitis. 2. Allergic to sodium valproate. 3. Porphyria.

Precautions for children: The safety and efficacy of Depakine for the treatment of mania associated with bipolar disorder in children and adolescents under 18 years of age have not been studied. Pregnancy and lactation precautions: The risks associated with pregnant women with epilepsy 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 antiepileptic treatment has been shown to be 2-3 times higher than that of ordinary pregnant women (3%), although there have been reports of increased rates of malformations in infants treated with multiple drugs. However, the relationship between treatment and disease (related to malformations) has not been formally established. The most common malformations are cleft lip and cardiovascular malformations. Sudden discontinuation of antiepileptic drug treatment may cause the mother's condition to worsen and cause adverse effects on the fetus. Risks associated with this product In animals, teratogenic effects have been confirmed in mice, rats and rabbits. In humans, women treated with this product. The overall risk of malformations in the first three months of pregnancy is no higher than that of other antiepileptic drugs. There have been reports of complex malformations, especially cases of limb malformations. The incidence of those effects has not been fully determined. This product has a tendency to cause neural tube defects: spinal meningocele, spina bifida, etc. The incidence of these adverse reactions is estimated to be 1-2%. Looking at the above data, if a woman plans to get pregnant, she should review the indications for anti-epileptic treatment and consider supplementing folic acid. During pregnancy, anti-epileptic treatment with valproate should not be stopped if it is effective. Monotherapy is recommended; the minimum effective daily dose should be used in divided doses. Special prenatal monitoring should be performed to detect the possible risk of neural tube defects or other malformations in newborns. There are reports of hemorrhagic syndrome in newborns when pregnant mothers use sodium valproate. This hemorrhagic syndrome is related to too little fibrinogen; hypofibrinogenemia has been reported and may be fatal. Hypofibrinogenemia may occur with a decrease in coagulation factors. This syndrome should be differentiated from a decrease in vitamin K-dependent factors, which is induced by phenobarbital and enzyme inducers. The amount of this product secreted in breast milk during lactation is low. It is about 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 in the neonatal period. Note for the elderly: Elderly patients should reduce the dosage as appropriate.

1. Drinking alcohol can increase the sedative effect. 2. When general anesthetics or central nervous system depressants are used in combination with valproic acid, the clinical effect of the former can be more obvious. 3. When used in combination with anticoagulants such as warfarin or heparin, as well as thrombolytics, the risk of bleeding increases. 4. When used in combination with aspirin or dipyridamole, the bleeding time can be prolonged due to reduced platelet aggregation. 5. When used in combination with phenobarbital, the metabolism of the latter slows down and the blood concentration increases, thereby increasing the sedative effect and causing drowsiness. 6. When used in combination with primidone, it can also cause an increase in blood concentration and lead to poisoning. If necessary, the dosage of primidone needs to be reduced. 7. When used in combination with clonazepam to prevent absence seizures, a few cases have been reported to induce absence states. 8. When used in combination with phenytoin, the blood concentrations of both drugs can change due to competition with protein binding. Since the concentration of phenytoin varies greatly, it needs to be measured frequently. However, whether the dose needs to be adjusted should depend on the clinical situation and blood concentration. 9 When used in combination with carbamazepine, the induction of liver enzymes will accelerate drug metabolism, which can reduce the blood concentration and half-life of both drugs. Therefore, the blood concentration must be monitored to determine whether the dosage needs to be adjusted. 10 When used in combination with drugs that are toxic to the liver, there is a potential risk of liver poisoning. Patients with a history of liver disease must have their liver function checked regularly for long-term use. 11 When used in combination with haloperidol, loxapine, maprotiline, monoamine oxidase inhibitors, phenothiazines, thioxanthenes and tricyclic antidepressants, it can increase the inhibition of the central nervous system, reduce the convulsion threshold and the effect of valproic acid, and the dosage must be adjusted in time to control seizures.

Store in bottle at room temperature (below 25°C).

0.2 g

36 months.

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

• Founded in:

  1997-04-28

• Address:

  No. 38 Huanghe Road, Lianyungang Economic and Technological Development Zone

• Tax NO.:

  9132070070404786XB

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  6,379,002,274 yuan

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