SPL Set ID: e15a7e9b-8025-49dd-9a6d-bafcccf1959f
1 drug(s) with this SPL Set ID
Fentanyl transdermal system contains fentanyl, an opioid agonist, available as a patch for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 7.8 cm 2 ). The composition per unit area of all system sizes is identical. Strength (mcg/hr) Size (cm 2 ) Fentanyl Content (mg) Color of Printing on Back of Patch 12 Nominal delivery rate is 12.5 mcg/hr 3.9 1.375 Green 25 Nominal delivery rate per hour 7.8 2.75 Green 37.5 11.7 4.125 Green 50 15.6 5.50 Green 62.5 19.6 6.875 Green 75 23.4 8.25 Green 100 31.3 11.0 Green The n‑octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is: Fentanyl transdermal systems are a rectangular, opaque patch with rounded corners: 12 mcg/hr: Fentanyl Transdermal System 12 mcg/hr printed in green 25 mcg/hr: Fentanyl Transdermal System 25 mcg/hr printed in green 37.5 mcg/hr: Fentanyl Transdermal System 37.5 mcg/hr printed in green 50 mcg/hr: Fentanyl Transdermal System 50 mcg/hr printed in green 62.5 mcg/hr: Fentanyl Transdermal System 62.5 mcg/hr printed in green 75 mcg/hr: Fentanyl Transdermal System 75 mcg/hr printed in green 100 mcg/hr: Fentanyl Transdermal System 100 mcg/hr printed in green The 12 mcg/hour system has a green border and the 25, 37.5, 50, 62.5, 75 and 100 mcg/hour systems have green stripes that increase in number with each sequential increasing dosage strength. Fentanyl transdermal system is a rectangular opaque unit comprising a protective liner and four functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are: 1) a backing layer of PET foil; 2) a drug containing layer of fentanyl and dipropylene glycol with hydroxypropyl cellulose; 3) an ethylene vinyl-acetate copolymer membrane that controls the rate of fentanyl delivery to the skin surface; and 4) a silicone adhesive. Before use, a protective liner covering the adhesive layer is removed and discarded. Chemical Structure Fentanyl Transdermal System Rectangular Unit