文档介绍：dn1873v2-proposed-depakote-er-2009-oct-13
HIGHLIGHTS OF PRESCRIBING INFORMATION ————— WARNINGS AND PRECAUTIONS —————
These highlights do not include all the information needed to use • Hepatotoxicity; monitor liver function tests ()
Depakote Er safely and effectively. See full prescribing information for
Teratogenic effects; weigh Depakote ER benefits of use during
Depakote Er. •
pregnancy against risk to the fetus ()
Depakote Er (divalproex sodium) Tablet, Extended Release for Oral
• Pancreatitis; Depakote ER should ordinarily be discontinued ()
use
Initial . Approval: 2000
• Suicidal behavior or ideation; Antiepileptic drugs, including Depakote
ER, increase the risk of suicidal thoughts or behavior ()
WARNING: LIFE THREATENING ADVERSE REACTIONS • Thrombocytopenia; monitor platelet counts and coagulation tests ()
See full prescribing information for complete boxed warning.
• Hyperammonemia and hyperammonemic encephalopathy; measure
• Hepatotoxicity, including fatalities, usually during first 6 ammonia level if unexplained lethargy and vomiting or changes in
months of treatment. Children under the age of two years mental status, and also with concomitant topiramate use; consider
are at considerably higher risk of fatal hepatotoxicity.