Oxycodone/apap

Oxycodone and Acetaminophen Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] Have not been tolerated, or are not expected to be tolerated Have not provided adequate analgesia, or are not expected to provide adequate analgesia

The following adverse reactions have been identified during post approval use of oxycodone and acetaminophen tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious adverse reactions that may be associated with oxycodone and acetaminophen tablets use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock [see OVERDOSAGE]. The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting.

Addiction, Abuse, and Misuse - Oxycodone and acetaminophen tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess ... 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 CN... Addiction, Abuse, and Misuse Oxycodone and acetaminophen tablets contain oxycodone, a Schedule II controlled substance. As an opioid, oxycodone and acetaminophen tablets expose users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed oxycodone and acetaminophen tablets. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing oxycodone and acetaminophen tablets, and monitor all patients receiving oxycodone and acetaminophen tablets for the development of these behaviors and conditions. Oxycodone and acetaminophen tablets are contraindicated in patients with: Significant respiratory depression [see WARNINGS] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS] Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS] Hypersensitivity to oxycodone, acetaminophen, or any other componen...