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Risks From Concomitant Use With Benzodiazepines Or Other CNS DepressantsĬoncomitant use of opioids or a barbiturate with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Īccidental ingestion of even one dose of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, especially by children, can result in a fatal overdose of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate. Monitor for respiratory depression, especially during initiation of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules or following a dose increase. Serious, life-threatening, or fatal respiratory depression may occur with use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules.
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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):
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Assess each patient’s risk prior to prescribing Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, and monitor all patients regularly for the development of these behaviors and conditions. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
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