![]() ![]() Serious, life-threatening, or fatal respiratory depression may occur with use of Oxycodone and Acetaminophen Tablets. Healthcare providers are strongly encouraged toĬomplete a REMS-compliant education program,Ĭounsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,Įmphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, andĬonsider other tools to improve patient, household, and community safety. 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 Oxycodone and Acetaminophen Tablets, and monitor all patients regularly for the development of these behaviors and conditions. Oxycodone and Acetaminophen Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. WARNING: ADDICTION, ABUSE, AND MISUSE 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 DEPRESSANTSĪDDICTION, ABUSE, AND MISUSE: RISK EVALUATION AND MITIGATION STRATEGY (REMS) ![]()
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