1/7/2023 0 Comments Plugging fentanyl patch mylan![]() ![]() Serious, life-threatening, or fatal respiratory depression may occur with use of fentanyl transdermal system. 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. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Assess each patient’s risk prior to prescribing fentanyl transdermal system, and monitor all patients regularly for the development of these behaviors and conditions. ![]() WARNING: ADDICTION, ABUSE, AND MISUSE RISK EVALUATION AND MITIGATION STRATEGY (REMS) LIFE-THREATENING RESPIRATORY DEPRESSION ACCIDENTAL EXPOSURE NEONATAL OPIOID WITHDRAWAL SYNDROME CYTOCHROME P450 3A4 INTERACTION RISK OF INCREASED FENTANYL ABSORPTION WITH APPLICATION OF EXTERNAL HEAT and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTSįentanyl transdermal system exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. ![]()
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