![]() Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. ![]() ![]() Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): Assess each patient’s risk prior to prescribing PERCOCET, and monitor all patients regularly for the development of these behaviors and conditions. PERCOCET exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Do not stop using any medication without first talking to your doctor.WARNING: ADDICTION, ABUSE, AND MISUSE RISK EVALUATION AND MITIGATION STRATEGY (REMS) LIFE-THREATENING RESPIRATORY DEPRESSION ACCIDENTAL INGESTION NEONATAL OPIOID WITHDRAWAL SYNDROME, CYTOCHROME P450 3A4 INTERACTION HEPATOTOXICITY, and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not use more than the recommended dose of ox圜ODONE, and avoid activities requiring mental alertness such as driving or operating hazardous machinery until you know how the medication affects you. Talk to your doctor or pharmacist if you have questions on how to take this or other medications you are prescribed. You may also want to avoid or limit the consumption of grapefruit and grapefruit juice, which can significantly increase the blood levels of oxycodone in some people. In severe cases, low blood pressure, respiratory distress, fainting, coma, or even death may occur. This may increase nervous system side effects such as drowsiness, dizziness, lightheadedness, difficulty concentrating, and impairment in thinking and judgment. Switch to professional interaction data Drug and food interactionsĪpplies to: Percocet (acetaminophen / oxycodone)ĭo not use alcohol or medications that contain alcohol while you are receiving treatment with ox圜ODONE. Do not stop using any medications without first talking to your doctor. ![]() Also, because these medications may cause dizziness, drowsiness, difficulty concentrating, and impairment in judgment, reaction speed and motor coordination, you should avoid driving or operating hazardous machinery until you know how they affect you. Do not drink alcohol or self-medicate with these medications without your doctor's approval, and do not exceed the doses or frequency and duration of use prescribed by your doctor. Your doctor may be able to prescribe alternatives that do not interact, or you may need a dose adjustment or more frequent monitoring to safely use both medications. Talk to your doctor if you have any questions or concerns. Using narcotic pain or cough medications together with other medications that also cause central nervous system depression can lead to serious side effects including respiratory distress, coma, and even death. Applies to: Percocet (acetaminophen / oxycodone) and Flexeril (cyclobenzaprine)
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