FROM OUR EXPERTS
Earlier this month, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee overwhelmingly voted against recommending approval of Zohydro ER, an extended-release version of hydrocodone. If approved, Zohydro ER would have been the first hydrocodone medication available that did not also contain a non-opioid analgesic such as acetaminophen or ibuprofen.
While the FDA does not have to follow the recommendation of its advisory committee, it usually does. The final determination is expected to be made by March 1, 2013.
Despite the fact that Zohydro ER was studied in nearly 1,500 patients––some for as long as a year––and found to be generally safe and well-tolerated with no new or unexpected safety problems, panel members expressed concerns with potential abuse, addiction and long-term safety.
It was noted that the manufacturer didn't offer any solution as to how they would limit unintended use other than the already tight distributio...
Generic Name: TRAMADOL EXTENDED-RELEASE - ORAL Pronounced: (TRAH-muh-dall) Tramadol Oral Uses
This medication is used to help relieve moderate to
moderately severe pain. Tramadol is similar to narcotic analgesics. It works in
the brain to change how your body feels and responds to pain.
How To Use Tramadol Oral
Take this medication by mouth as directed by your doctor,
usually every 4 to 6 hours as needed for pain relief. You may take this drug
with or without food. If you have nausea, it may help to take this drug with
food. Ask your doctor or pharmacist about other ways to decrease nausea (such
as lying down for 1 to 2 hours with as little head movement as
The dosage is based on your medical condition and response
to treatment. To reduce your risk of side effects, your doctor may direct you
to start this medication at a low dose and gradually increase your dose. Follow
your doctor's instructions carefully. The maximum rec...
The FDA issued a notice that one lot of hydrocodone bitartrate and acetaminophen tablets with a dosage of 10 mg/500 mg has been recalled because some of them may contain a higher dosage of acetaminophen.
The affected tablets were manufactured by Qualitest, a subsidiary of Endo Health Solutions, and are from Lot Number C1440512A, with an expiration date of 12/13. The tablets are approximately 16.51 mm in length, pink, capsule-shaped tablets, with "3600" debossed on one side of the tablet and "V" on the other.
Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than three alcoholic beverages a day.
If you are taking hydrocodone/acetaminophen in the 10/500 mg dosage and are not sure if your medication came from the recalled lot, check with your pharmacist.
You should know
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