NITRO-DUR Transdermal patch Ref.[10895] Active ingredients: Glyceryl trinitrate

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

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 NITRO-DUR (nitroglycerin) Transdermal Infusion 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 cm2 of applied system delivers approximately 0.02 mg of nitroglycerin per hour. Thus, the 5-,10-, 15-, 20-, 30-, and 40-cm2 systems deliver approximately 0.1, 0.2, 0.3, 0.4, 0.6, and 0.8 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 6% of its original content of nitroglycerin.

The NITRO-DUR transdermal system contains nitroglycerin in acrylic-based polymer adhesives with a resinous cross-linking agent to provide a continuous source of active ingredient. Each unit is sealed in a paper polyethylene-foil pouch.
Cross section of the system.

How Supplied
NITRO-DUR System Rated Release In Vivo* Total nitroglycerin content System size Package Size
0.1 mg/hr 20 mg 5cm2 Unit Dose 30
(NDC 50742-513-01)
Package 30
(NDC 50742-513-30)
0.2 mg/hr 40 mg 10 cm2 Unit Dose 30
(NDC 50742-514-01)
Package 30
(NDC 50742-514-30)
0.3 mg/hr 60 mg 15 cm2 Unit Dose 30
(NDC 50742-515-01)
Package 30
(NDC 50742-515-30)
0.4 mg/hr 80 mg 20 cm2 Unit Dose 30
(NDC 50742-516-01)
Package 30
(NDC 50742-516-30)
0.6 mg/hr 120 mg 30 cm2 Unit Dose 30
(NDC 50742-517-01)
Package 30
(NDC 50742-517-30)
0.8 mg/hr 160 mg 40 cm2 Unit Dose 30
(NDC 50742-518-01)
Package 30
(NDC 50742-518-30)

* Release rates were formerly described in terms of drug delivered per 24 hours. In these terms, the supplied NITRO-DUR systems would be rated at 2.5 mg/24 hours (0.1 mg/hour), 5 mg/24 hours (0.2 mg/hour), 7.5 mg/24 hours (0.3 mg/hour), 10 mg/24 hours (0.4 mg/hour), and 15 mg/24 hours (0.6 mg/hour).

Drugs

Drug Countries
NITRO-DUR Canada, United States
 
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