Depakote ER Approved for Acute Manic or Mixed Episodes Associated With Bipolar Disorder
Sunday, 11 December 2005
ABBOTT PARK, Ill., December 07, 2005 /PRNewswire-FirstCall/ — Abbott announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Depakote(R) ER (divalproex sodium extended-release tablets) for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. Depakote ER offers patients the convenience of taking this medication once a day. Compared with Depakote(R) (divalproex sodium delayed-release tablets), Depakote ER taken once a day helps provide more consistent levels of medication in the body. Search Google Web / Google News.
Important Product Safety Information for Depakote ER in Acute Mania
Valproate products should not be administered to patients with hepatic disease or significant hepatic dysfunction. Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives, usually during the first six months of treatment.
Valproate may produce teratogenic effects in the offspring of women receiving the drug during pregnancy. Benefits of Depakote should be weighed against risk of injury to the fetus in women of childbearing potential.
Cases of life-threatening pancreatitis, some rapidly progressing to death, have been reported in both adults and children receiving valproate. Valproate is contraindicated in patients with known urea cycle disorders (UCD), a group of uncommon genetic abnormalities, due to reports of sometimes-fatal cases of hyperammonemic encephalopathy. Concomitant administration of valproic acid and topiramate has been associated with hyperammonemia with and without encephalopathy.
The frequency of adverse effects, particularly elevated liver enzymes and thrombocytopenia, may be dose-related. Multi-organ hypersensitivity reactions have been reported after the initiation of valproate therapy. In a clinical trial of valproate in elderly patients with dementia, some patients taking valproate experienced somnolence, sometimes requiring discontinuation.
Common adverse events (greater than 5 percent incidence) associated with Depakote ER or Depakote in clinical studies of acute mania patients were somnolence, dyspepsia, nausea, vomiting, diarrhea, dizziness, pain, abdominal pain, accidental injury, asthenia and pharyngitis
No. 1 — May 21st, 2009 at 9:33 am
Hi, I have just got a lab result back for a valporic acid (Depakote Level) and it came back as 12.5. This is very low and my doctor is very concerned but is unable to provide me with what this low reading may be causing as far as symptoms in my body? He is telling me that I should get back on Depakote and get my levels sustained to at least above 75-100. What is causing this low level of Valporic acid in my body and what is it that a low reading will produce as far as symptoms. I would really appreciate any help you can offer me with respect to this current situation. Thanks in Advance and please let me know if you need me to answer any other questions so that you may be able to give me a better idea of what is going on here, as I am a bit concerned.
Thanks Again,
Justin
No. 2 — May 23rd, 2009 at 10:11 am
Justin,
Your doctor probably is the best person to ask your question and if he is puzzled, then more tests may be needed to determine what is causing the low levels of depakote. Is it because the dose you were on was too low? Is it because you may be taking something else that may be increasing the metabolism of the drug? I don’t know.
As for symptoms of low levels of drug, I’m not sure either, because you would be the first to notice something if anything, and your doctor would conduct a comprehensive physical exam to determine if there are symptoms associated with low levels of the drug.
You can also ask the manufacturer’s medical information to see if there’s some data available about your questions.
Reference: http://rxabbott.com/pdf/depakote.pdf
(depakote prescribing information)