Valproate sodium 250 mg /5ml

Pregnancy and Breastfeeding Warnings
Valproic acid Pregnancy Warnings
-Animal studies have revealed evidence of embryolethality, teratogenicity (i.e., neural tube defects, skeletal, cardiac, urogenital defects), behavioral abnormalities, intrauterine growth retardation, and brain histopathological changes. -The rate of congenital malformations among babies born to epileptic mothers who used this drug during pregnancy has been shown to be about 4 times higher than the rate among babies born to epileptic mothers who used other anti-seizure monotherapies. -Studies have shown that children exposed to this drug in utero have lower IQ scores than children exposed to either another antiepileptic drug or to no antiepileptic drugs. -Exposure to this drug during pregnancy may increase the risk of autism spectrum disorders. -Hepatic failures (sometimes fatal) in mothers and infants have been reported following use of this drug during pregnancy. -In utero exposure has been associated with neonatal hemorrhagic syndrome due to hypofibrinogenemia. Afibrinogenemia, including fatalities, has also been reported. Neonatal platelet counts, plasma fibrinogen levels, and coagulation status should be monitored. -Withdrawal syndrome (such as agitation, irritability, hyperexcitability, jitteriness, hyperkinesia, tonicity disorders, tremor, convulsions and feeding disorders) may occur in neonates. -Cases of hypoglycemia have been reported in neonates, whose mothers have taken this drug during the third trimester of pregnancy. -Cases of hypothyroidism have been reported in neonates whose mothers have taken this drug during pregnancy. To provide information regarding the effects of in utero exposure to this drug, physicians should encourage pregnant patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling toll free 1-888 233 2334, and must be done by the patients themselves. Information on the registry can be found at the website AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
AU: Contraindicated UK, US: This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: D US FDA pregnancy category: D (for epilepsy) Comments: -This drug can harm a developing fetus. -Adequate methods of contraception should be used. -This drug should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition; generally, the benefit of preventing seizures is considered to outweigh the potential risk of fetal harm due to antiepileptic medications. -If this drug is used during pregnancy, it should be administered as monotherapy (if possible) in divided doses, using prolonged-release preparations (to avoid high peak concentrations) and at the lowest effective daily dose, with close monitoring of the patient's clotting parameters. -Women who are planning a pregnancy should be counseled regarding the relative risks and benefits of using this drug during pregnancy, and alternative therapeutic options should be considered for these patients. -Women should be offered routine ultrasound and amniocenteses for prenatal diagnosis of abnormalities. -Supplementation with folic acid 5 mg daily should be recommended prior to conception and during the first trimester of pregnancy to decrease the risk for congenital neural tube defects. -Therapy should not be abruptly discontinued in pregnancy, as this may precipitate status epilepticus, leading to maternal and fetal hypoxia and threat to life. -A pregnancy exposure registry is available; this registry has reported a major malformation rate of 9% to 11% in the offspring of women taking this drug as monotherapy during pregnancy.

Valproic acid Breastfeeding Warnings
No definite adverse reactions to this drug during breastfeeding have been reported. Theoretically, breastfed infants are at risk for hepatotoxicity. Breastfeeding during monotherapy does not appear to adversely affect infant growth or development. Combination therapy with sedating anticonvulsants or psychotropics may result in infant sedation or withdrawal reactions.
AU, UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: Caution is recommended. Excreted into human milk: Yes Comments: -Breastfed infants may be at a higher risk for hepatotoxicity, so they should be monitored for jaundice and other signs of liver damage during maternal therapy. -Some experts recommend monitoring infant serum levels of this drug, platelets, and liver enzymes during therapy.

References for pregnancy information
  1. "Product Information. Depacon (valproic acid)." Abbott Pharmaceutical, Abbott Park, IL.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Depakene (valproic acid)." Abbott Pharmaceutical, Abbott Park, IL.
References for breastfeeding information
  1. "Product Information. Depacon (valproic acid)." Abbott Pharmaceutical, Abbott Park, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Depakene (valproic acid)." Abbott Pharmaceutical, Abbott Park, IL.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Dekadel only for the indication prescribed.