Epilepsan Special Precautions

valproic acid




Full Prescribing Info
Special Precautions
Liver Disorders (Hepatotoxicity): Fatal liver disorders can occur in patients receiving Valproic Acid. These events usually occur during the first six months of treatment with Valproic Acid. Serious or fatal hepatotoxicity can be preceded by non-specific symptoms, such as loss of control of seizures, malaise, weakness, lethargy, facial edema, anorexia and vomiting. Patients must be closely monitored for these symptoms.
Liver function tests should be done before therapy and at sufficient intervals after, especially during the first 6months of therapy. However, doctors should not rely entirely on the results of serum biochemical tests because these tests may not show abnormal results in some cases, but must also consider the results of medical records and physical examinations carefully.
Be careful if Valproic Acid is given to patients who have history of liver disease. Patients who use two or more anticonvulsants, pediatrics, patients who have congenital metabolic disorders, patients with severe seizure disorders with mental retardation, and patients with organic mental disorders (organic brain diseases) are at high risk of hepatotoxicity. The use of Valproic Acid in children under 2 years old can increase the risk of fatal hepatotoxicity, especially in pediatric patients with conditions above. When Valproic Acid is used in this group of patients, it must be used with extreme caution and as a single compound. The benefits of therapy must be considered against the risks. The risk of fatal hepatotoxicity decreases in groups of patients older than 2years old.
This medication should be stopped immediately if there is a suspected or impaired liver function. In some cases, liver dysfunction develops although drug use has been stopped.
Due to reports of thrombocytopenia, inhibition of the secondary phase of platelet aggregation and the presence of abnormal coagulation parameters, it is recommended to test platelet counts and coagulation before starting therapy and at periodic intervals. Patients who receive Valproic Acid are recommended to be monitored for platelet counts and coagulation parameters before surgery begins. The presence of bruising or haemostasis/coagulation disorders is an indication for a reduction in the dose of Valproic Acid or a replacement of therapy.
Hyperammonemia with or without lethargy or coma has been reported to occur and appear without any abnormal liver function tests. If there is a clinically significant improvement, Valproic Acid must be stopped.
Because Valproic Acid can interact with antiepileptic drugs that are given together, it is recommended to measure levels of antiepileptic drugs in serum periodically during the beginning of therapy.
Valproic Acid is partially eliminated in urine as a ketone metabolite that can cause misinterpretation of ketone and urine tests.
There have been several reports of changes in the results of thyroid gland function tests related to Valproic Acid. The clinical effect of this is unknown.
Valproic Acid can cause CNS depression, especially if combined with other CNS depressants (for example: alcohol), patients should be advised not to engage in dangerous activities, such as driving a car or operating a dangerous machine, until it is certain that the patient is not sleepy due to drug use.
Fertility: The effect of Valproic Acid on testicular development and sperm production and fertility in humans is unknown.
Use in Pregnancy: The use of Valproic Acid in pregnancy has not been proven safe. Valproic Acid is used in pregnant woman with seizures or woman with seizure who will get pregnant, only if this drug is needed in seizure management. Antiepileptic drugs should not be stopped in patients where the administration of these drugs with the aim of preventing the occurrence of more severe seizures because of the possibility of accelerating the occurrence of status epilepticus in the presence of hypoxia and can be life threatening. In individual cases where the severity and frequency of seizures are such that drug withdrawal does not pose a serious threat to the patient, drug withdrawal can be considered before and during pregnancy, although it is not certain that mild seizures are not harmful to the embryo or fetus.
Doctors are expected to consider this or provide counseling to women who suffer from epilepsy and have the potential to become pregnant.
Use in Lactation: Valproic acid is excreted in breast milk. Concentrations in breast milk are reported to be 1-10% of the concentration in serum. There is no known effect of the drug on breastfeeding babies. Be careful if Valproic Acid is given to nursing mothers.
Use in Children: The occurrence of hepatotoxicity appears more common in children, especially those aged less than 2 years and children who use 2 or more anti-epileptic drugs. This drug must be used with extreme caution and be used as a single drug in children under the age of 2 years, and the benefits of using Valproic Acid in children must considered against the risk.
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