Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than one acetaminophen-containing product. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Monitor patients receiving ENDOCET and any CYP3A4 inhibitor or inducer. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Ĭytochrome P450 3A4 Interaction The concomitant use of ENDOCET with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Neonatal Opioid Withdrawal Syndrome Prolonged use of ENDOCET during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Īccidental Ingestion Accidental ingestion of ENDOCET, especially by children, can result in a fatal overdose of ENDOCET. Monitor for respiratory depression, especially during initiation of ENDOCET or following a dose increase. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of ENDOCET. Healthcare providers are strongly encouraged toĬomplete a REMS-compliant education program,Ĭounsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,Įmphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, andĬonsider other tools to improve patient, household, and community safety. 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 ENDOCET, 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 INGESTION NEONATAL OPIOID WITHDRAWAL SYNDROME, CYTOCHROME P450 3A4 INTERACTION HEPATOTOXICITY, and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTSĪddiction, Abuse, and Misuse ENDOCET exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |