![]() ![]() Postmarketing reports: Deaths due to respiratory depression Cardiovascular Uncommon (0.1% to 1%): Bronchospasm, laryngospasm, respiratory depressionįrequency not reported: Respiratory arrest, dyspnea ![]() Death has also been reported in nursing infants exposed to high levels of morphine in breast milk due to their breastfeeding mother being an ultra-rapid metabolizer of codeine. These children had evidence of being ultra-rapid metabolizers of codeine. Respiratory depression resulting in death has been reported in children who received codeine postoperatively following tonsillectomy and/or adenoidectomy. The most frequently observed adverse reactions include drowsiness lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, sweating, and constipation. For Healthcare ProfessionalsĪpplies to codeine: compounding powder, injectable solution, oral solution, oral tablet. When used at antitussive doses: nausea, vomiting, constipation (with repeated doses), dizziness, sedation, palpitation, pruritus. ![]() When used for pain relief (particularly in ambulatory patients not experiencing severe pain): lightheadedness, dizziness, sedation, nausea, vomiting, sweating. The REMS may apply to one or more preparations of codeine and consists of the following: medication guide and elements to assure safe use. Other changes will also be required in various other sections of the prescribing information to educate clinicians, patients, and caregivers about the risks of these drugs.įDA approved a REMS for codeine to ensure that the benefits outweigh the risk. Information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS). This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal. Updates to the ER/LA opioids recommend that these drugs be reserved for severe and persistent pain requiring an extended period of treatment with a daily opioid pain medicine and for which alternative treatment options are inadequate.Ī new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. Updates to the IR opioids state that these drugs should not be used for an extended period unless the pain remains severe enough to require an opioid pain medicine and alternative treatment options are insufficient, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine. The changes apply to both immediate-release (IR) and extended-release/long-acting preparations (ER/LA). The changes are being made to provide additional guidance for safe use of these drugs while also recognizing the important benefits when used appropriately.
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