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PATIENTS WHO HAVE EXPERIENCED SERIOUS ADVERSE EVENTS SHOULD BE MONITORED FOR AT LEAST 24 HOURS AFTER DUROGESIC REMOVAL OR MORE, AS CLINICAL SYMPTOMS DICTATE, BECAUSE SERUM FENTANYL CONCENTRATIONS DECLINE GRADUALLY AND ARE REDUCED BY ABOUT 50% 17 (RANGE 13-22) HOURS LATER.
DUROGESIC should be kept out of reach of children before and after use.
Do not cut DUROGESIC patches. A patch that has been divided, cut, or damaged in any way should not be used.
Opioid-naïve and not opioid-tolerant states: Use of DUROGESIC transdermal system in the opioid-naïve patient has been associated with very rare cases of significant respiratory depression and/or fatality when used as initial opioid therapy. The potential for serious or life-threatening hypoventilation exists even if the lowest dose of DUROGESIC transdermal system is used in initiating therapy in opioid naïve patients. It is recommended that DUROGESIC be used in patients who have demonstrated opioid tolerance. (See Initial dosage selection, Adults and Pediatrics under Dosage & Administration).
Respiratory depression: As with all potent opioids, some patients may experience significant respiratory depression with DUROGESIC; patients must be observed for these effects. Respiratory depression may persist beyond the removal of the DUROGESIC patch. The incidence of respiratory depression increases as the DUROGESIC dose is increased (see Overdosage). CNS active drugs may increase the respiratory depression (see Interactions).
Chronic pulmonary disease:
DUROGESIC may have more severe adverse effects in patients with chronic obstructive, or other pulmonary disease. In such patients, opioids may decrease respiratory drive and increase airway resistance.
Drug dependence and potential for abuse: Tolerance, physical dependence, and psychological dependence may develop upon repeated administration of opioids. Iatrogenic addiction following opioid administration is rare.
Fentanyl can be abused in a manner similar to other opioid agonists. Abuse or intentional misuse of DUROGESIC may result in overdose and/or death. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require monitoring for signs of misuse, abuse, or addiction.
Increased intracranial pressure: DUROGESIC should be used with caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure, impaired consciousness, or coma. DUROGESIC should be used with caution in patients with brain tumors.
Cardiac disease: Fentanyl may produce bradycardia and should therefore be administered with caution to patients with bradyarrhythmias
Hepatic impairment: Because fentanyl is metabolized to inactive metabolites in the liver, hepatic impairment might delay its elimination. If patients with hepatic impairment receive DUROGESIC, they should be observed carefully for signs of fentanyl toxicity and the dose of DUROGESIC reduced if necessary (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: Less than 10% of fentanyl is excreted unchanged by the kidney and, unlike morphine, there are no known active metabolites eliminated by the kidney. If patients with renal impairment receive DUROGESIC, they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary (see Pharmacology: Pharmacokinetics under Actions).
Fever/external heat application: A pharmacokinetic model suggests that serum fentanyl concentrations may increase by about one-third if the skin temperature increases to 40°C. Therefore, patients with fever should be monitored for opioid side effects and the DUROGESIC dose should be adjusted if necessary. There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death. A clinical pharmacology trial conducted in healthy adult subjects has shown that the application of heat over the DUROGESIC system increased mean fentanyl AUC values by 120% and mean Cmax values by 61%.
All patients should be advised to avoid exposing the DUROGESIC application site to direct external heat sources such as heating pads, electric blankets, heated water beds, heat or tanning lamps, intensive sunbathing, hot water bottles, prolonged hot baths, saunas and hot whirlpool spa baths.
Serotonin syndrome: Caution is advised when DUROGESIC is co-administered with drugs that affect the serotonergic neurotransmitter systems.
The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with drugs which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]). This may occur within the recommended dose.
Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
If serotonin syndrome is suspected, treatment with DUROGESIC should be discontinued.
Accidental exposure by patch transfer: Accidental transfer of a fentanyl patch to the skin of a non patch wearer (particularly a child), while sharing a bed or being in close physical contact with a patch wearer, may result in an opioid overdose for the non patch wearer. Patients should be advised that if accidental patch transfer occurs, the transferred patch must be removed immediately from the skin of the non patch wearer. (see Overdose).
Use in elderly patients: Data from intravenous studies with fentanyl suggest that elderly patients may have reduced clearance, a prolonged half-life, and they may be more sensitive to the drug than younger patients. If elderly patients receive DUROGESIC, they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary (see Pharmacology: Pharmacokinetics under Actions).
Gastrointestinal tract: Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract. The resultant prolongation in gastrointestinal transit time may be responsible for the constipating effect of fentanyl. Patients should be advised on measures to prevent constipation and prophylactic laxative use should be considered. Extra caution should be used in patients with chronic constipation. If paralytic ileus is present or suspected, treatment with DUROGESIC should be stopped.
Use in children: DUROGESIC was not studied in children under 2 years of age. DUROGESIC should be administered only to opioid-tolerant children age 2 years or older (see Dosage & Administration).
To guard against accidental ingestion by children, use caution when choosing the application site for DUROGESIC (see Instructions for Use, Handling, and Disposal, under CAUTIONS FOR USAGE) and monitor adhesion of the patch closely.
Effects on ability to drive and use machines: DUROGESIC may impair mental and/or physical ability required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
