Sodium valproate oral solution

1. This product can inhibit the metabolism of phenytoin sodium, phenobarbital, primidone, and clonazepam, which can easily lead to poisoning. Therefore, the dosage should be adjusted when used in combination. 2. Drinking alcohol can aggravate the sedative effect. Avoid drinking alcohol during medication. 3. When used in combination with anticoagulants such as warfarin or heparin, as well as thrombolytic drugs, 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 carbamazepine, the induction of liver enzymes can accelerate drug metabolism, which can reduce the blood concentration and half-life of the two drugs. Therefore, the blood concentration must be monitored to determine whether the dosage needs to be adjusted. 6. 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 the attack.

The main ingredient of this product is: sodium valproate.

Syrup

This product is mainly used for simple or complex absence seizures, myoclonic seizures and generalized tonic-clonic seizures (grand mal seizures) of epilepsy. It also has a certain effect on complex partial seizures.

Oral 1 Common dosage for adults: 15 mg/kg per day or 600-1200 mg per day, divided into two doses. Start with 5-10 mg/kg per day, increase gradually after one week until the attack is controlled. 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, or 1.8-2.4 g per day. 2 Common 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. Rare reactions include: (1) allergic rash; (2) thrombocytopenia or platelet aggregation inhibition leading to abnormal bleeding or ecchymosis; (3) liver poisoning with yellowing of eyes and skin. 2. If the following reactions persist, attention should be paid. (1) The more common ones include: diarrhea, indigestion, nausea or vomiting, gastrointestinal spasm, and changes in menstrual cycle. (2) The less common or rare ones include: constipation, drowsiness, generally mild and short-term hair loss, dizziness, fatigue, headache, ataxia, abnormal excitement, restlessness and irritability.

Contraindicated in patients with liver disease or significant liver impairment.

Precautions for children: See other items below, or follow your doctor's advice. Precautions for pregnancy and lactation: Women of childbearing age: The decision to use this product for women of childbearing age must be made after careful evaluation, weighing whether the benefits outweigh the risk of congenital abnormalities in the future fetus. This decision needs to be made before the first use of this product, and before women who have been treated with valproate plan to become pregnant. Pregnancy · Risks associated with epilepsy and antiepileptic drugs Studies have shown that the incidence of malformations in the offspring of mothers treated with any antiepileptic drug is 2-3 times higher than that reported in the general population (approximately 3%). The number of malformations reported during multiple drug treatments has increased, with the most common malformations being cleft lip and cardiovascular malformations. Developmental delays have been reported in very few children born to mothers with epilepsy. It is impossible to distinguish whether the above conditions are caused by genetic, social, environmental factors, the mother's epilepsy or antiepileptic drug treatment. Despite the above potential risks, antiepileptic treatment should not be terminated abruptly because it may cause epileptic seizures, which can have serious consequences for both the mother and the fetus. During pregnancy, hypoxia caused by maternal tonic-clonic seizures and status epilepticus may increase the risk of death for the mother and unborn child. · Hazards associated with this drug In animals: Teratogenicity has been demonstrated in mice, rats and rabbits. In humans: Data show an increased incidence of mild or severe malformations, particularly neural tube defects, craniofacial defects, limb malformations, cardiovascular malformations and multiple anomalies including multisystem malformations, in infants born to mothers treated for epilepsy with valproic acid compared with other antiepileptic drugs. Data show an increased incidence of malformations when combined with other antiepileptic drugs for multidrug therapy compared with valproic acid monotherapy. Data show that prenatal exposure to this drug is associated with developmental delays, particularly in language and IQ, in infants born to mothers treated for epilepsy with valproic acid. Developmental delays are often accompanied by malformations and/or deformities. However, it is difficult to determine causality because there are other possible confounding factors, such as low maternal or paternal intelligence, other genetic, social and environmental factors, and poor control of maternal epilepsy during pregnancy. Autism spectrum disorders have been reported in children exposed to valproate in utero. -In summary, women of childbearing age should be informed of the details of the risks and benefits of using valproate during pregnancy. Before the first prescription of this product, and before women who have been treated with this product plan to become pregnant, expert advice is required, and physicians are strongly encouraged to discuss the issue of having children with their patients. If a woman plans to become pregnant, treatment with this product should be re-evaluated regardless of the indication. When there is an indication for bipolar disorder, discontinuation of this product for prevention should be considered. For any indication, if this product is continued after further risk-benefit evaluation, the minimum effective daily dose should be used, taken in divided doses. In addition, if appropriate, folic acid supplementation should be started before pregnancy, at an appropriate dose (5 mg per day). Because it can reduce the risk of neural tube defects. During pregnancy, valproate treatment should not be stopped without re-weighing the benefits and risks. Special prenatal monitoring should be performed to detect possible neural tube defects or other malformations. -Neonatal risks There have been occasional reports of neonatal hemorrhagic syndrome in mothers who used sodium valproate during pregnancy. This bleeding syndrome is associated with a lack of fibrinogen; fibrinogen deficiency has also been reported and can be fatal. Low fibrinogen deficiency may be associated with reduced coagulation factors. However, this syndrome must be differentiated from the reduction of vitamin K factor induced by phenobarbital and enzyme inducers, which is caused by phenobarbital and enzyme inducers. Therefore, the platelet count, plasma fibrinogen concentration, coagulation tests and coagulation factors should be measured in neonates. Breastfeeding: The concentration of valproic acid in breast milk is very low, only 1% to 10% of the maternal serum concentration. So far, based on information from the literature and clinical experience, breastfeeding can be considered in consideration of the safety of this product, especially in the case of blood diseases. (See [Adverse Reactions]) Elderly precautions: Although the pharmacokinetics of valproate are altered in the elderly population, the clinical significance is limited. The dose should be determined according to the control of epilepsy. The volume of distribution of the drug in the elderly is increased, and the proportion of free drug increases due to the reduced serum self-protein binding rate. This will affect the clinical interpretation of plasma valproic acid levels.

1. This product can inhibit the metabolism of phenytoin sodium, phenobarbital, primidone, and clonazepam, which can easily lead to poisoning. Therefore, the dosage should be adjusted when used in combination. 2. Drinking alcohol can aggravate the sedative effect. Avoid drinking alcohol during medication. 3. When used in combination with anticoagulants such as warfarin or heparin, as well as thrombolytic drugs, 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 carbamazepine, the induction of liver enzymes can accelerate drug metabolism, which can reduce the blood concentration and half-life of the two drugs. Therefore, the blood concentration must be monitored to determine whether the dosage needs to be adjusted. 6. 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 the attack.

Keep away from light and store in airtight container.

300 ml: 12 g

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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