"Jan. 13, 2011 - The FDA is warning about the dangers of acetaminophen in popular prescription pain drugs, but did it go far enough?
Acetaminophen, the active ingredient in Tylenol, is found in a wide range of over-the-counter and prescr"...
- Patient Information:
Details with Side Effects
Information for Patients/Caregivers
- Patients should be aware that ROXICET (oxycodone and acetaminophen ) contains oxycodone, which is a morphine-like substance.
- Patients should be instructed to keep ROXICET (oxycodone and acetaminophen ) in a secure place out of the reach of children. In the case of accidental ingestions, emergency medical care should be sought immediately.
- When ROXICET (oxycodone and acetaminophen ) is no longer needed, the unused tablets or oral solution should be destroyed by flushing down the toilet.
- Patients should be advised not to adjust the medication dose themselves. Instead, they must consult with their prescribing physician.
- Patients should be advised that ROXICET (oxycodone and acetaminophen ) may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
- Patients should not combine ROXICET (oxycodone and acetaminophen ) with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless under the recommendation and guidance of a physician. When co-administered with another CNS depressant, ROXICET (oxycodone and acetaminophen ) can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death.
- The safe use of ROXICET (oxycodone and acetaminophen ) during pregnancy has not been established; thus, women who are planning to become pregnant or are pregnant should consult with their physician before taking ROXICET (oxycodone and acetaminophen ) .
- Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue ROXICET (oxycodone and acetaminophen ) because of the potential for serious adverse reactions to nursing infants.
- Patients who are treated with ROXICET (oxycodone and acetaminophen ) for more than a few weeks should be advised not to abruptly discontinue the medication. Patients should consult with their physician for a gradual discontinuation dose schedule to taper off the medication.
- Patients should be advised that ROXICET (oxycodone and acetaminophen ) is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
Last reviewed on RxList: 6/19/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Roxicet Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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