The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex.
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. Prolonged use of opioids 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. Avoid the use of butalbital/acetaminophen/caffeine/codeine in pediatric patients 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine. Butalbital/acetaminophen/caffeine/codeine is contraindicated in pediatric patients <12 years and pediatric patients <18 years following tonsillectomy and/ or adenoidectomy. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. Life-threatening respiratory depression and death have occurred in children who received codeine. Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children Follow patients for signs and symptoms of respiratory depression and sedation. Limit dosages and durations to the minimum required. Reserve concomitant prescribing of butalbital/acetaminophen/caffeine/codeine and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Risks from concomitant use with benzodiazepines or other CNS depressants:Ĭoncomitant use of opioids or a barbiturate with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Monitor for respiratory depression, especially during initiation of therapy or following a dose increase.Īccidental ingestion of even one dose, especially by children, can result in a fatal overdose of codeine. Serious, life-threatening, or fatal respiratory depression may occur with use. Health care 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 pharmacist and consider 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 health care providers. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products. Opioid analgesic risk evaluation and mitigation strategy (REMS):
Assess each patient’s risk prior to prescribing butalbital/acetaminophen/caffeine/codeine and monitor all patients regularly for the development of these behaviors and conditions. Use 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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