Sodium valproate extended-release tablets

Valproate exerts its pharmacological effects primarily through the central nervous system. Animal studies have shown that it can combat a variety of seizures. Laboratory and clinical studies have shown that valproate produces anticonvulsant effects in two ways. The first mode of action is a direct pharmacological effect related to plasma and brain valproate concentrations. The second mode of action is indirect and may be related to valproate metabolites in the brain, or to changes in neurotransmitters or direct membrane effects. The widely accepted hypothesis is that valproate administration can lead to an increase in gamma-aminobutyric acid (GABA) levels in the body. Valproate can reduce the duration of the mid-sleep period and increase the period of slow-wave sleep.

Each tablet contains 333 mg of sodium valproate and 145 mg of valproic acid. Chemical name: 2-sodium valproate Molecular weight: C8H15NaO2

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

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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 those with medication-related hepatic porphyrin. 4. Patients with urea cycle disorders.

Precautions for children: Monotherapy with sodium valproate is recommended for children, but the possible benefits of this drug should be weighed against the risk of liver damage or pancreatitis before starting treatment in such patients (see [Precautions]). Due to the risk of liver toxicity and bleeding, acetylsalicylic acid should be avoided when children take this product. Children with unexplained liver and digestive tract disorders (such as anorexia, vomiting, cell lysis), depression or coma, mental retardation, or children with neonatal or infant deaths in the family must undergo metabolic index tests before receiving any valproate treatment, especially fasting and postprandial blood ammonia levels. The safety and effectiveness of this drug for the treatment of mania associated with bipolar disorder has not been studied for children and adolescents under 18 years of age. Precautions during pregnancy and lactation: 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 anti-epileptic treatment has been shown to be 2-3 times higher than that of ordinary pregnant women (3%), although there are reports of increased rates of malformations in infants treated with multiple drugs. However, the relationship between treatment and disease (related to malformations) has not yet been formally determined. The most common malformations are cleft lip and cardiovascular malformations. Sudden discontinuation of anti-epileptic drug treatment may cause the mother's condition to worsen and cause adverse effects on the fetus. The risks associated with this product have been confirmed in animals to have teratogenic effects on mice, rats and rabbits. In humans, women treated with this product. The overall risk of malformations in the first three months of pregnancy is not higher than other anti-epileptic drugs. Precautions for the elderly: Compared with young adult patients, the ability of elderly patients (over 68 years old) to clear sodium valproate is reduced, and the incidence may increase, so in these patients, the initial dose should be reduced. At the same time, the dosage should be increased more slowly, and regular monitoring of fluid and nutrient intake, dehydration, somnolence, and other adverse events is required. If the patient's food and fluid intake decreases or the patient develops excessive somnolence, then the sodium valproate dosage should be reduced or the sodium valproate treatment should be discontinued. The final treatment dose should be determined based on tolerability and clinical response.

The use of drugs that induce seizures or lower the seizure threshold at the same time as this product should be carefully considered, and may be determined not to be used or prohibited depending on the severity of the potential risks. Such drugs mainly include most antidepressants (imipramine, SSRI), tranquilizers (phenothiazines and butyrophenones), mequine (see the following chapters), buspirone, tramadol, etc. Prohibited combined use: Combination with mequine: When taken in combination with epileptic patients, mequine may increase the metabolism of valproate and its own seizure-inducing effect may put them at risk of epileptic seizures. Combination with St. John's wort: There is a risk of reduced blood drug concentrations and reduced anticonvulsant efficacy. Combination with caution: Combination with aztreonam, imipenem, and meropenem: There is a risk of reduced blood valproate concentrations.

seal.

0.5g

36 months