SPL Set ID: e98a2692-1cb9-4994-98d8-1d8d9ef1a256

1 drug(s) with this SPL Set ID

Open DailyMed details

Nitroglycerin NITROGLYCERIN
MYLAN PHARMACEUTICALS INC. FDA Rx Only

Nitroglycerin is 1,2,3-propanetriol, trinitrate, an organic nitrate whose structural formula is: and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins. The nitroglycerin transdermal system is a flat unit designed to provide continuous controlled release of nitroglycerin through intact skin. The rate of release of nitroglycerin is linearly dependent upon the area of the applied system; each cm 2 of applied system delivers approximately 0.026 mg of nitroglycerin per hour. Thus, the 4 cm 2 , 8 cm 2 , 16 cm 2 and 24 cm 2 systems deliver approximately 0.1 mg, 0.2 mg, 0.4 mg and 0.6 mg of nitroglycerin per hour, respectively. The remainder of the nitroglycerin in each system serves as a reservoir and is not delivered in normal use. After 12 hours, for example, each system has delivered approximately 11% of its original content of nitroglycerin. The nitroglycerin transdermal system comprises two layers as shown below. Proceeding from the visible surface towards the surface attached to the skin, these layers are: 1) a polyolefin film backing layer that is impermeable to nitroglycerin and is printed with the name of the drug and strength; 2) nitroglycerin in an acrylic pressure sensitive adhesive. Prior to use, a peelable polyester release liner, which is coated on one side with silicone, is removed from the adhesive surface. Each unit is sealed in a foil-lined pouch. Cross section of the system: Nitroglycerin Structural Formula Patch Cross Section

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