Last week Zogenix, Inc., a pharmaceutical company that develops products for treating central nervous system disorders and pain, announced positive results from its pivotal Phase 3 efficacy study of Zohydro (hydrocodone bitartrate) extended-release capsules. Hydrocodone is an opioid pain reliever used to treat moderate to severe pain. Currently in the U.S., hydrocodone is only available in immediate-release form and is always combined with acetaminophen. The purpose of including acetaminophen with some opioid medications is to boost their pain-relieving effects. However, the problem with including acetaminophen in opioid medications is that too much acetaminophen over time can cause liver toxicity and damage. If Zohydro receives FDA approval, it could achieve two firsts:
The first extended-release hydrocodone treatment, which is better for the treatment of chronic round-the-clock pain. (It would provide 12-hour pain relief rather than the 4 t...
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.
Definition Hydrocodone and acetaminophen overdose occurs when someone accidentally or intentionally takes more than the normal or recommended amount of a painkiller containing both the opioid medication, hydrocodone, and acetaminophen (Tylenol). This is for information only and not for use in the treatment or management of an actual poison exposure. If you have an exposure, you should call your local emergency number (such as 911) or the National Poison Control Center at 1-800-222-1222. Alternative Names Lorcet overdose; Lortab overdose Poisonous Ingredient Acetaminophen (Tylenol) Hydrocodone (narcotic) Where Found Acetaminophen with hydrocodone is the main ingredient in many prescription painkillers, including: Anexsia Anolor DH Lortab Lorcet Norco Vicodin Zydone Note: This list may not include all sources of hydrocodone and acetaminophen.
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