Nitroglycerin Film
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Questions & Answers
Side Effects & Adverse Reactions
Amplification of the vasodilatory effects of Nitroglycerin Transdermal System by phosphodiesterase inhibitors, e.g., sildenafil, can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.
The benefits of transdermal nitroglycerin in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use nitroglycerin in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.
A cardioverter/defibrillator should not be discharged through a paddle electrode that overlies a nitroglycerin patch. The arcing that may be seen in this situation is harmless in itself, but it may be associated with local current concentration that can cause damage to the paddles and burns to the patient.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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 cm2 of applied system delivers approximately .02 mg of nitroglycerin per hour. Thus, the 10 cm2 and 18 cm2 systems deliver approximately 0.2 and 0.4 mg of nitroglycerin per hour, respectively. Each 10 cm2 and 18 cm2 system contains 20.8 and 37.4 mg of nitroglycerin, 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 12% of its original content of nitroglycerin.
The Nitroglycerin Transdermal System comprises two layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are 1) polypropylene foil backing layer that is impermeable to nitroglycerin and 2) nitroglycerin in an acrylic-based polymer adhesive with a cross-linking agent to provide a continuous source of active ingredient. Prior to use, a peelable protective liner is removed from the adhesive surface. Each unit is sealed in a paper foil-lined pouch.
Cross section of the system:
Sources
Nitroglycerin Film Manufacturers
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Kremers Urban Pharmaceuticals Inc.
![Nitroglycerin Film, Extended Release [Kremers Urban Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Nitroglycerin Film | Kremers Urban Pharmaceuticals Inc.
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.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.
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