![]() 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.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. A new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines.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.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. As part of its ongoing efforts to address the nation's opioid crisis, FDA is requiring several updates to the prescribing information of opioid pain medicines.You may report side effects to FDA at 1-80. Call your doctor for medical advice about side effects. ![]() This is not a complete list of side effects and others may occur. Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders. high levels of serotonin in the body-agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.low cortisol levels- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness o.liver problems-nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).a light-headed feeling, like you might pass out.noisy breathing, sighing, shallow breathing, breathing that stops.Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. This could occur even if you have taken acetaminophen in the past and had no reaction. In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. Opioid medicine can slow or stop your breathing, and death may occur. Get emergency medical help if you have signs of an allergic reaction: hives difficulty breathing swelling of your face, lips, tongue, or throat. Side Effects What are the side effects of Norco (Acetaminophen And Hydrocodone)?
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