Sodium valproate tablets

Anti-epileptic effect. The mechanism of anti-epileptic effect has not yet been elucidated, but it may be related to the increased concentration of the inhibitory neurotransmitter γ-aminobutyric acid (GABA) in the brain. Generally, the increase in GABA is achieved by reducing metabolism or reabsorption. In addition, valproic acid acts on the postsynaptic receptor site to simulate or enhance the inhibitory effect of GABA. Its effect on the nerve membrane has not yet been fully elucidated, but it may directly act on the membrane activity related to potassium conduction.

Valproic acid.

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.

1 Oral dosage for adults. 15 mg/kg or 600-1200 mg per day, divided into two doses. Start with 5-10 mg/kg per day, and increase gradually after one week until the seizure is under control. When the daily dosage exceeds 250 mg, it should be taken in divided doses to reduce gastrointestinal irritation. The maximum dosage is generally no more than 30 mg/kg per day. 2 Oral dosage for children. The dosage is the same as that for adults. There are also reports that the dosage is 15 mg/kg per day, and 5-10 mg/kg is increased every other week as needed until it is effective or cannot be tolerated. ① Take it immediately after a meal to reduce the irritation of the drug to the stomach. ② Avoid drinking alcohol during medication. ③ If you plan to stop the drug, you should gradually reduce the dosage to prevent the recurrence of seizures; when replacing other anticonvulsant drugs, the dosage of valproate (sodium) should be gradually increased, and the replaced drug should be gradually reduced to maintain control of the seizure. ④ During surgery or other emergency treatment, the possible prolonged bleeding time or enhanced effect of central nervous system depressants should be considered. Blood cell counts including platelet counts, liver and kidney function tests should be performed before and during medication. Liver function should be reviewed every 1-2 months in the first six months, and the review interval should be extended as appropriate after six months. This group of drugs can be used regardless of whether it is valproate or ester. Mainly based on the control of epileptic seizures and blood drug concentration monitoring, the plasma concentration of valproate should reach 50-100 μg/ml. Taking sodium valproate as an example, the initial dose for children is 20-30 mg/kg, and then gradually increases. Severe cases can reach 40 mg/kg. For adults, it is 200 mg, 3 times a day, and then gradually increase the dose to 1-2 g per day. Sodium valproate can also be slowly injected or dripped intravenously, and 10 mg/kg can be used for adults for the first time. The oral dose of valproamide can refer to sodium valproate. Do not stop the drug suddenly to prevent the aggravation of epileptic seizures.

1 Rare side effects include: ① allergic rash; ② thrombocytopenia or platelet aggregation inhibition leading to abnormal bleeding or ecchymosis; ② liver poisoning with yellowing of eyes and skin. 2 The following reactions should be noted if they continue to occur. ① The more common ones are: diarrhea, indigestion, nausea or vomiting, gastrointestinal spasm, menstrual cycle changes; ② Less common or rare ones are: constipation, drowsiness, generally mild and short-term hair loss, dizziness, fatigue headache, ataxia, abnormal excitement, restlessness and irritability. The most common side effect is gastrointestinal dysfunction, among which half sodium valproate has the least reaction. If the reaction is severe. The drug can be taken with food or the dose can be gradually increased or reduced. Rare side effects include appetite and weight gain, drowsiness and ataxia, dizziness and headache. In the hematopoietic system, there are prolonged bleeding time, thrombocytopenia, leukopenia or bone marrow suppression, and thrombocytopenic purpura. A few patients have liver damage at the beginning of treatment, even hyperammonemia and Reye's syndrome. If there is liver damage, the drug should be discontinued early to avoid hepatic coma. Occasionally, hyperglycemia and decreased serum zinc levels are found. When valproate is used during pregnancy, the fetus is at risk of neural tube defects, and the incidence of spina bifida is 1%, which is 20 times that of the general population. In men, the blood concentration of free testosterone is reduced when this group of drugs is used. This group of drugs can also produce symptoms similar to Vonwinebrand disease. This drug can produce extrapyramidal symptoms of rigidity and tremor, cervical and spinal dystonia, and stupor accompanied by abnormal EEG. Occasionally, pancreatitis occurs, which can occur at any time during the course of treatment. When pancreatic symptoms occur, the drug should be discontinued immediately to avoid death. A few patients have rash, vasculitis (skin), and temporary hair loss. There are manifestations of niacin deficiency. About 1% to 7% of children have nocturia after taking the drug, which may be because this group of drugs affects the sleep cycle, and it will improve after reducing or stopping the drug.

1. This drug can pass through the placenta barrier. There are reports of teratogenicity in animal experiments, but it has not been confirmed in humans. Pregnant women need to weigh the pros and cons when using it. 2. Valproic acid can be secreted into breast milk through the mammary glands, and the concentration is 110% of the maternal blood drug concentration. Lactating women should pay attention. 3. It is forbidden to use in patients with liver disease or obvious liver damage. Use with caution in patients with blood disease, liver disease history, renal damage, and organic encephalopathy. Use with caution in patients with liver disease.

Precautions for children: This product can accumulate in developing bones, so be careful. Precautions for pregnancy and lactation: This drug can pass through the placenta, and there are reports of teratogenicity in animal experiments. Pregnant women should weigh the pros and cons and use it with caution. This product can also be secreted into breast milk, with a concentration of 1-10% of the maternal blood drug. It should be used with caution. Precautions for the elderly: This experiment has not been conducted and there are no reliable references.

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 may be more obvious. 3 When used in combination with anticoagulants such as warfarin or heparin, as well as thrombolytics, it may increase the effect of anticoagulants; valproic acid can cause hypoprothrombinemia and inhibit platelet aggregation. When anticoagulants or thrombolytics are given, the risk of bleeding increases. 4 When used in combination with aspirin or dipyridamole, it can prolong bleeding time due to reduced platelet aggregation. 5 When used in combination with phenobarbital drugs, the latter's metabolism slows down and the blood drug 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 drug concentration and lead to poisoning. If necessary, the dosage of primidone needs to be reduced. 7 When used in combination with clonazepam to prevent and treat absence seizures, there have been reports of a few cases where it has induced absence states. 8 When used in combination with phenytoin, the competition with protein binding may change the blood concentration of both drugs. Since the concentration of phenytoin varies greatly, it needs to be measured frequently, but whether the dosage needs to be adjusted depends on the clinical situation and blood concentration. 9 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 both drugs. Therefore, it is necessary to monitor the blood concentration 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. Long-term use in patients with a history of liver disease requires regular liver function checks. 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 needs to be adjusted in time to control seizures. Salicylic acid can inhibit the metabolism of valproate, prolonging its half-life, and the combination of the two can affect blood coagulation and platelet function. Salicylic acid cannot be used in combination with valproate in children to avoid Reye syndrome. Naproxen interferes with the protein binding of valproate. The combination of erythromycin and valproate is prone to toxic symptoms of valproate. Carbamazepine, phenytoin, and phenobarbital can reduce serum valproate concentrations; and valproate inhibits phenobarbital metabolism, which increases phenobarbital blood concentrations. The combination of valproate with clonazepam, nitrazepam, etc. can aggravate drowsiness. Taking the antimalarial drug mefloquine can greatly reduce the blood concentration of valproate. The bioavailability of valproate preparations is increased after using aluminum hydroxide or magnesium hydroxide, and other antacids are not effective. Cimetidine prolongs the half-life of valproate, while ranitidine does not have this effect. Avoid using it in combination with aspirin and warfarin.

Keep tightly closed.

0.2 g

30 months.

Gansu Lanyao Pharmaceutical Co., Ltd.

• Founded in:

  2006-12-22

• Address:

  No. 1739, Middle Section of Kunlunshan Avenue, Lanzhou New District, Lanzhou City, Gansu Province

• Tax NO.:

  916200007948829218

• Registered Funds:

  84.5 million yuan

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