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. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Assess each patient’s risk prior to prescribing XTAMPZA ER and monitor all patients regularly for the development of these behaviors or conditions. XTAMPZA ER 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 RISK EVALUATION AND MITIGATION STRATEGY (REMS) LIFE-THREATENING RESPIRATORY DEPRESSION ACCIDENTAL INGESTION NEONATAL OPIOID WITHDRAWAL SYNDROME CYTOCHROME P450 3A4 INTERACTION and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
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