MYLAN-traMADol/ACET (Oral)

Addiction, Abuse, and MisuseTraMADol hydrochloride/acetaminophen exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing traMADol hydrochloride/acetaminophen, and monitor all patients regularly for the development of these behaviors or conditions .Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)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. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety.Life-threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of traMADol hydrochloride/acetaminophen. Monitor for respiratory depression, especially during initiation of traMADol hydrochloride/acetaminophen or following a dose increase.Accidental IngestionAccidental ingestion of even one dose of traMADol hydrochloride/acetaminophen, especially by children, can result in a fatal overdose of traMADol.Ultra-Rapid Metabolism of TraMADol and Other Risk Factors for Life-Threatening Respiratory Depression in ChildrenLife-threatening respiratory depression and death have occurred in children who received traMADol. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the childr..