Valex is indicated for the treatment of all types of epilepsy, e.g. Partial seizures, Absence seizures (petit mal), Generalized tonic-clonic seizures (grand mal), Myoclonic seizures, Atonic seizures, Mixed seizures that include absence attack, Prophylaxis of febrile convulsion, Prophylaxis of post-traumatic epilepsy. It is also indicated in the treatment of bipolar disorder & prophylaxis of migraine.
The most common side effects are anorexia, nausea and vomiting. However, these side effects are minimized with the use of enteric coated tablets. Effects on the CNS include sedation, ataxia and tremor. These symptoms occur infrequently and usually respond to a decrease in doses. Rash, alopecia and stimulation of appetite have been observed occasionally. Sodium Valproate has several effects on hepatic function of which elevation of liver enzymes in plasma is observed in up to 40% of patients and often occurs asymptomatically during the first few months of therapy. Rarely a fulminate hepatitis that may be fatal may develop. Children below 2 years of age with other medical conditions and those being treated with multiple antiepileptic agents are specially prone to suffer from hepatic injury, acute pancreatitis and hyperammonemia have also been frequently associated with the use of Sodium Valproate.
Liver functions should be monitored before therapy and during first 6 months especially in patients most at risk, No undue potential for bleeding before starting and before major surgery must be ensured, Care should be taken in renal impairment, pregnancy, breast-feeding and systemic lupus erythematosus. Sodium Valproate is partially eliminated in the urine as a ketone metabolite, which may lead to a false interpretation of the urine ketone test. Sudden withdrawal of therapy should be avoided
Sodium Valproate is contraindicated to patients who have known hypersensitivity to the drug and liver dysfunction. Care should be exercised when prescribing Sodium Valproate in women of child bearing age.
Sodium Valproate crosses the placenta and in humans, exposure to valproate in the first trimester has been associated with neural tube defects such as anencephaly and spina bifida in newborn. Pregnant women treated with Valex should be offered to estimate serum a-fetoprotein. Valex is excreted in breast milk. However, breast-feeding by a mother taking Valex probably causes no risk to the child.
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