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DURAGESIC® (fentanyl) Transdermal System

DESCRIPTION

DURAGESIC (fentanyl transdermal system) is a transdermal system containing fentanyl. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide.

DURAGESIC is a rectangular transparent unit comprising a protective liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin

DURAGESIC® (Fentanyl) Structural Formula Illustration
The molecular weight of fentanyl base is 336.5, and the empirical formula is C22H28N2O. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4.

System Components And Structure
The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/h per 10.5 cm²). The composition per unit area of all system sizes is identical

INDICATIONS

DURAGESIC is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.

Dosage Forms And Strengths
DURAGESIC 100 mcg/hour Transdermal System (system size 42 cm²).

Storage And Handling
DURAGESIC (fentanyl transdermal system) is supplied in cartons containing 5 individually packaged systems.

Administration Of DURAGESIC
DURAGESIC patches are for transdermal use, only.

Proper handling of DURAGESIC is necessary in order to prevent serious adverse outcomes, including death, associated with accidental secondary exposure to DURAGESIC [see WARNINGS AND PRECAUTIONS].

Application And Handling Instructions:
-Patients should apply DURAGESIC to intact, non-irritated, and non-irradiated skin on a flat surface such as the chest, back, flank, or upper arm. In young children and persons with cognitive impairment, adhesion should be monitored and the upper back is the preferred location to minimize the potential of inappropriate patch removal. Hair at the application site may be clipped (not shaved) prior to system application. If the site of DURAGESIC application must be cleansed prior to application of the patch, do so with clear water. Do not use soaps, oils, lotions, alcohol, or any other agents that might irritate the skin or alter its characteristics. Allow the skin to dry completely prior to patch application.

-Patients should apply DURAGESIC immediately upon removal from the sealed package. The patch must not be altered (e.g., cut) in any way prior to application. DURAGESIC should not be used if the pouch seal is broken or if the patch is cut or damaged.

-The transdermal system is pressed firmly in place with the palm of the hand for 30 seconds, making sure the contact is complete, especially around the edges.

-Each DURAGESIC patch may be worn continuously for 72 hours. The next patch is applied to a different skin site after removal of the previous transdermal system.

-If problems with adhesion of the DURAGESIC patch occur, the edges of the patch may be taped with first aid tape. If problems with adhesion persist, the patch may be overlayed with a transparent adhesive film dressing.

-If the patch falls off before 72 hours, dispose of it by folding in half and flushing down the toilet. A new patch may be applied to a different skin site.

-Patients (or caregivers who apply DURAGESIC) should wash their hands immediately with soap and water after applying DURAGESIC.

-Contact with unwashed or unclothed application sites can result in secondary exposure to DURAGESIC and should be avoided. Examples of accidental exposure include transfer of a DURAGESIC patch from an adult’s body to a child while hugging, sharing the same bed as the patient, accidental sitting on a patch and possible accidental exposure of a caregiver’s skin to the medication in the patch while applying or removing the patch.

-Instruct patients, family members, and caregivers to keep patches in a secure location out of the reach of children and of others for whom DURAGESIC was not prescribed.

Limitations Of Use:
-Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve DURAGESIC for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.