Drug Catalog - Product Detail
NITROGLYCERIN TRANSDERMAL PATCH PATCH .1MG/HR 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 47781-0296-03 | ALVOGEN | 30 | 0.1MG/HR | NA |
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Description
DESCRIPTION Nitroglycerin is a 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 Infusion System is a 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 0.03 mg of nitroglycerin per hour. Thus, the 3.3, 6.7, 13.3 and 20 cm 2 system delivers approximately 0.1, 0.2, 0.4 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 about 14% of its original content of nitroglycerin. The Nitroglycerin Transdermal System contains nitroglycerin as the active component. The remaining components of the system (acrylate copolymer adhesive, fatty acid esters, and polyethylene backing) are pharmacologically inactive. Each unit is packaged in a heat-sealed foil pouch produced on line from a paper/foil/polyethylene laminate. Prior to use, a protective peel strip is removed from the adhesive surface. Following use, the patch should be discarded in a manner that prevents accidental application or ingestion by children or others. chemical structure
How Supplied
HOW SUPPLIED Nitroglycerin Transdermal Infusion System System Rated Release In Vivo* System Size Total Nitroglycerin Content NDC Number/ Package Size 0.1 mg/hr 3.3 cm 2 9 mg NDC-47781-296-03 30 count carton 0.2 mg/hr 6.7 cm 2 18 mg NDC-47781-297-03 30 count carton 0.4 mg/hr 13.3 cm 2 36 mg NDC-47781-298-03 30 count carton 0.6 mg/hr 20.0 cm 2 54 mg NDC-47781-299-03 30 count carton *Release rates were formerly described in terms of drug delivered per 24 hours. In these terms, the supplied Nitroglycerin Transdermal Infusion Systems would be rated at 2.5 mg/24 hours (0.1 mg/hour), 5 mg/24 hours (0.2 mg/hour), 10 mg/24 hours (0.4 mg/hour), and 15 mg/24 hours (0.6 mg/hour). Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not refrigerate. Rx only 9439201 668100 Rev. 12/14 Manufactured by: 3M Drug Delivery Systems, Northridge, CA 91324 USA For: Alvogen, Inc., Pine Brook, NJ 07058 USA
Indications & Usage
INDICATIONS AND USAGE Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack.
Dosage and Administration
DOSAGE AND ADMINISTRATION The suggested starting dose is between 0.2 mg/hr* and 0.4 mg/hr*. Doses between 0.4 mg/hr* and 0.8 mg/hr* have shown continued effectiveness for 10 to 12 hours daily for at least 1 month (the longest period studied) of intermittent administration. Although the minimum nitrate-free interval has not been defined, data show that a nitrate-free interval of 10 to 12 hours is sufficient (see CLINICAL PHARMACOLOGY ). Thus, an appropriate dosing schedule for nitroglycerin patches would include a daily patch-on period of 12 to 14 hours and a daily patch-off period of 10 to 12 hours. *Release rates were formerly described in terms of drug delivered per 24 hours. In these terms, the supplied Nitroglycerin Transdermal Infusion Systems would be rated at 2.5 mg/24 hours (0.1 mg/hour), 5 mg/24 hours (0.2 mg/hour), 10 mg/24 hours (0.4 mg/hour), and 15 mg/24 hours (0.6 mg/hour). Although some well-controlled clinical trials using exercise tolerance testing have shown maintenance of effectiveness when patches are worn continuously, the large majority of such controlled trials have shown the development of tolerance (i.e., complete loss of effect) within the first 24 hours after therapy was initiated. Dose adjustment, even to levels much higher than generally used, did not restore efficacy.