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. (medlineplus.gov)
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. (medlineplus.gov)
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. (medlineplus.gov)
A new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. (medlineplus.gov)
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). (medlineplus.gov)
CLINICAL PHARMACOLOGY Mechanism Of Action Fentanyl is an opioid agonist whose principal therapeutic action is analgesia. (clustermed.info)
Concentration-Adverse Reaction Relationships There is a relationship between increasing fentanyl plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. (clustermed.info)
Respiratory System All opioid mu-receptor agonists, including fentanyl, produce dose-dependent respiratory depression. (clustermed.info)
Nonopioid and opioid analgesics are the main drugs used to treat pain. (msdmanuals.com)
Occur2
It should be used only to treat breakthrough cancer pain (sudden episodes of pain that occur despite around-the-clock treatment with pain medication) in cancer patients at least 18 years of age who are taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications. (medlineplus.gov)
Serious or fatal respiratory depression can occur even at recommended doses. (clustermed.info)
Respiratory depression1
Pharmacodynamics Effects On The Central Nervous System Fentanyl produces respiratory depression by direct action on brain stem respiratory centers. (clustermed.info)
Acute2
Pain has sensory and emotional components and is often classified as acute or chronic. (msdmanuals.com)
This medication should not be used to treat pain other than chronic cancer pain, especially short-term pain such as migraines or other headaches, pain from an injury, or pain after a medical or dental procedure. (medlineplus.gov)
Antidepressants, antiseizure drugs, and other central nervous system (CNS)-active drugs may also be used for chronic or neuropathic pain and are first-line therapy for some conditions. (msdmanuals.com)
Effects6
Fentanyl sublingual spray may cause serious breathing problems or death, especially if it is used by people who have not been treated with other narcotic medications or who are not tolerant (used to the effects of the medication) to narcotic medications. (medlineplus.gov)
Effects On The Gastrointestinal Tract And Other Smooth Muscle Fentanyl causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. (clustermed.info)
Effects On The Cardiovascular System Fentanyl produces peripheral vasodilation which may result in orthostatic hypotension or syncope. (clustermed.info)
Concentration-Efficacy Relationships The analgesic effects of fentanyl are related to the blood level of the drug, if proper allowance is made for the delay into and out of the CNS (a process with a 3- to 5-minute half-life). (clustermed.info)
Peak respiratory depressive effects may be seen as early as 15 to 30 minutes from the start of oral transmucosal fentanyl citrate product administration and may persist for several hours. (clustermed.info)
These interventions include counseling to refocus a patient's thoughts from the effects and limitations of pain to the development of personal coping strategies and may include counseling to help patients and their family work together to manage pain. (msdmanuals.com)
Risk1
There is a greater risk that you will overuse fentanyl sublingual spray if you have or have ever had any of these conditions. (medlineplus.gov)
Загальні відомості про біль Pain is the most common reason patients seek medical care. (msdmanuals.com)
Time2
Do not use a larger dose of fentanyl, use the medication more often, or use it for a longer period of time than prescribed by your doctor. (medlineplus.gov)
The minimum effective analgesic concentration of fentanyl for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome, and/or the development of analgesic tolerance. (clustermed.info)
Manage1
While using fentanyl sublingual spray, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. (medlineplus.gov)
Patients2
Fentanyl sublingual spray should be prescribed by doctors who are experienced in treating pain in cancer patients. (medlineplus.gov)
Cognitive-behavioral interventions may reduce pain and pain-related disability and help patients cope. (msdmanuals.com)