Be especially careful to keep hydrocodone out of the reach of children. Keep hydrocodone in a safe place so that no one else can take it accidentally or on purpose. Hydrocodone may harm or cause death to other people who take your medication, especially children. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.ĭo not allow anyone else to take your medication. Talk to your health care provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. There is a greater risk that you will overuse hydrocodone if you have or have ever had any of these conditions. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness. While taking hydrocodone, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. Hydrocodone can be habit forming, especially with prolonged 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.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.
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