Life-threatening respiratory depression and death have occurred in children who received codeine. Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children Monitor for respiratory depression, especially during initiation of acetaminophen and codeine phosphate tablets or following a dose increase (seeĪccidental ingestion of acetaminophen and codeine phosphate tablets, especially by children, can result in a fatal overdose of acetaminophen and codeine phosphate tablets (see Serious, life-threatening, or fatal respiratory depression may occur with use of acetaminophen and codeine phosphate tablets. consider other tools to improve patient, household, and community safety.emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and.counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,.

complete a REMS-compliant education program,.

Healthcare providers are strongly encouraged to 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 [see Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): Assess each patient’s risk prior to prescribing acetaminophen and codeine phosphate tablets, and monitor all patients regularly for the development of these behaviors and conditions (see

WARNING: ADDICTION, ABUSE, AND MISUSE RISK EVALUATION AND MITIGATION STRATEGY (REMS) LIFE-THREATENING RESPIRATORY DEPRESSION ACCIDENTAL INGESTION ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN NEONATAL OPIOID WITHDRAWAL SYNDROME INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES HEPATOTOXICITY and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTSĪcetaminophen and codeine phosphate tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.

Antidote for benzodiazepine toxicity