Sodium valproate extended-release tablets

The anti-epileptic effect may be related to the 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 to convulsions caused by various factors.

This product is a compound preparation, and its components are: each tablet contains 0.333g sodium valproate and 0.145g valproic acid (equivalent to 0.5g sodium valproate).

This product is a white oval film-coated tablet with a notch on each side. It appears white after the film coating is removed.

Used to treat generalized and partial epilepsy, as well as special types of syndromes. 1. Generalized epilepsy is suitable for: absence seizures, myoclonic seizures, tonic-clonic seizures, atonic seizures and mixed seizures. 2. Partial epilepsy is suitable for: simple partial seizures; complex partial seizures; partial secondary generalized seizures. 3. Special types of syndromes: West, Lennox-Gastaut syndrome.

1. Anti-epileptic: 1) Adults: 20-30 mg/kg per day according to body weight. 2) Children: 30 mg/kg per day according to body weight. 2. Anti-mania: Adults: Initially 500 mg/day, twice a day, once in the morning and once in the evening. One week to 1500 mg/day. The maintenance dose is 1000 mg-2000 mg/day.

1. Gastrointestinal system abnormalities: (nausea, upper abdominal pain, diarrhea) Some patients often occur at the beginning of treatment. These abnormalities usually disappear after continuing to take the medicine for a few days. 2. Blood and lymphatic system abnormalities: thrombocytopenia occurs. 3. General abnormalities: weight gain.

1. Patients with acute hepatitis; 2. Patients with chronic hepatitis; 3. Patients with a history or family history of severe hepatitis, especially patients with medication-related hepatic porphyrin; 4. Patients with urea cycle disorders.

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.

Taking drugs that induce seizures or lower the seizure threshold at the same time as this product should be carefully considered. Depending on the severity of the potential risk, it may be determined not to use or be prohibited. This type of drug mainly includes most antidepressants (imipramine, SSRI), tranquilizers (phenothiazines and phenoxybenzene drugs), mequinine (see the following chapters), bucycline, tramadol, etc. Prohibited combined use: 1. Combined use with mequinine: When taken in combination with epilepsy patients, mequinine may increase valproic acid metabolism and its own seizure induction effect may cause them to have the risk of epileptic seizures. 2. Combined use with St. John's wort: There is a risk of reduced blood drug concentration and reduced anticonvulsant efficacy. Combined use that requires attention: 1. Combined use with aztreonam, imipenem, and meropenem: There is a risk of spasmodic reactions caused by reduced valproic acid blood drug concentration. During the treatment with anti-infective drugs, clinical monitoring, blood drug concentration measurement, and timely adjustment of the dose of anticonvulsant drugs should be carried out, and monitoring is still required after discontinuation of the drug. 2. Carbamazepine: It can increase the blood concentration of active metabolites of carbamazepine, leading to drug overdose. At the same time, due to the induction of liver metabolism by carbamazepine, the blood concentration of valproate can be reduced. Therefore, clinical drug monitoring is recommended to measure the blood concentration of the two anticonvulsant drugs and adjust their doses: 3. Lamotrigine: The risk of severe skin reactions (Lyell's syndrome) is increased. Valproate can increase the blood concentration of lamotrigine by inhibiting its liver metabolism. If it must be taken together, it should be closely monitored in the clinic. 4. Felbamate: It can increase the blood concentration of valproate, resulting in the risk of drug overdose. During the treatment with felbamate, clinical and biochemical indicators should be monitored and the dose of valproate should be adjusted. The above observation measures should still be taken after discontinuation of the drug. 5. Phenobarbital, primidone: Due to the inhibitory effect of valproate on liver metabolism, the blood concentration of phenobarbital or primidone can be increased, resulting in drug overdose, which is more common in children. At the same time, the blood concentration of valproate can be reduced due to the induction of liver metabolism by phenobarbital or primidone. Clinical monitoring should be carried out within the first 15 days of combined treatment, and the dose of phenobarbital or primidone should be reduced promptly when any symptoms of sedation occur. In particular, the blood concentration of the two anticonvulsant drugs should be monitored. 6. Phenytoin (and by extension, phosphophenytoin): It can cause changes in the blood concentration of phenytoin. At the same time, there is a risk of reduced blood concentration of valproate due to the induction of liver metabolism by phenytoin. Clinical monitoring and blood concentration measurement should be carried out, and the doses of the two anticonvulsant drugs should be adjusted appropriately. 7. Topiramate: There is a risk of hyperammonemia or encephalopathy, which is usually caused by taking valproate at the same time as topiramate. Clinical monitoring and laboratory monitoring should be increased in the early stage of treatment, and signs of this reaction should be noted. 8. Cimetidine and erythromycin: Taking them at the same time may increase the concentration of valproate in the serum. 9. Acetylsalicylic acid: Infants and young children with temperature and sexual dysfunction should not take medicines containing valproic acid and acetylsalicylic acid at the same time. Adolescents with temperature and sexual dysfunction can only take it under the guidance of a doctor. 10. Benzodiazepines, barbiturates and tranquilizers, monoamine oxidase inhibitors and antidepressants: When used in combination, valproic acid can increase the central inhibitory effect of these drugs. Patients should be closely monitored when the above drugs are used in combination. The dosage of the drugs should be adjusted if necessary. 11. Zidovudine: Valproic acid can increase the serum drug concentration of zidovudine, which may lead to increased zidovudine toxicity. Anticoagulants and antiplatelet aggregation drugs: Taking them at the same time with valproic acid-containing drugs may increase the tendency to bleed. Therefore, it is recommended to monitor the coagulation status regularly during the combined use. 12. Diazepam: The results of studies in healthy subjects showed that valproic acid can displace diazepam from its plasma protein binding site and inhibit its metabolism. The plasma concentration of free diazepam in the body may increase, and the plasma clearance and distribution volume of free diazepam may decrease (by 25% and 20%, respectively). However, the half-life remains unchanged. The results of studies in healthy subjects showed that the plasma concentration of lorazepam can be reduced by up to 40% when valproate and lorazepam are taken simultaneously. In children, the level of phenytoin in serum may increase after taking clonazepam and valproic acid at the same time. 13. Nimodipine (administered by oral and intravenous routes): Due to the inhibitory effect of valproic acid on metabolism, the blood concentration of nimodipine may increase, which promotes the hypotensive response of nimodipine. Rifampicin may reduce the blood concentration of valproate, resulting in reduced efficacy. Therefore, when used in combination with rifampicin, it is necessary to adjust the dosage of valproate. Other forms of interaction: With oral contraceptives: Since valproic acid has no enzyme inducing activity, it will not reduce the effect of hormonal contraceptives taken by women on estrogen-progestin.

Seal and keep in a light-proof, dry place.

0.5g (calculated as sodium valproate)

36 months.

Sanofi (Hangzhou) Pharmaceuticals Co., Ltd.

• Founded in:

  1995-11-30

• Address:

  No. 325, Jiangling Road, Binjiang District, Hangzhou City, Zhejiang Province

• Tax NO.:

  91330100609136127P

• Registered Funds:

  $28.8 million

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