Duragesic - Side Effects, Uses, Dosage, Overdose, Pregnancy, Alcohol. WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE- THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P4. A4 INTERACTION; and EXPOSURE TO HEATAddiction, Abuse, and Misuse. The Duragesic or fentanyl transdermal patch is an extremely powerful opioid painkiller that has been linked to numerous overdose deaths and injuries.A study conducted with the DURAGESIC patch in elderly patients demonstrated that. What is Duragesic Pain Patch? Duragesic is a transdermal. Duragesic - Get up-to-date information on Duragesic side effects, uses, dosage, overdose, pregnancy, alcohol and more. Learn more about Duragesic. July 15, 2005 -- The FDA today has issued a health advisory regarding the safe use of fentanyl skin patches (brand name Duragesic) in. IMPORTANT SAFETY INFORMATION. What is the most important information I need to know about DURAGESIC ? Get emergency help right away if you use too much DURAGESIC. DURAGESIC exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing DURAGESIC, and monitor all patients regularly for the development of these behaviors or conditions. Life- threatening Respiratory Depression. Serious, life- threatening, or fatal respiratory depression may occur with use of DURAGESIC, even when used as recommended. Monitor for respiratory depression, especially during initiation of DURAGESIC or following a dose increase. Because of the risk of respiratory depression, DURAGESIC is contraindicated for use as an as- needed analgesic, in non- opioid tolerant patients, in acute pain, and in postoperative pain. Accidental Exposure. Deaths due to a fatal overdose of fentanyl have occurred when children and adults were accidentally exposed to DURAGESIC. Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure. Neonatal Opioid Withdrawal Syndrome. Prolonged use of DURAGESIC 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. 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. Cytochrome P4. 50 3. A4 Interaction. The concomitant use of DURAGESIC with all cytochrome P4. A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P4. A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving DURAGESIC and any CYP3. A4 inhibitor or inducer. Exposure to Heat. Exposure of the DURAGESIC application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl and death. Patients wearing DURAGESIC systems who develop fever or increased core body temperature due to strenuous exertion are also at risk for increased fentanyl exposure and may require an adjustment in the dose of DURAGESIC to avoid overdose and death.
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