Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
Nitroglycerin (UNII: G59M7S0WS3) (Nitroglycerin - UNII:G59M7S0WS3)
Hercon Laboratories Corporation
Nitroglycerin
Nitroglycerin 0.2 mg in 1 h
TRANSDERMAL
PRESCRIPTION DRUG
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. Use of nitroglycerin transdermal system is contraindicated in patients using sildenafil because sildenafil may amplify the vasodilatory effects of nitroglycerin transdermal systems resulting in severe hypotension. Allergic reactions to organic nitrates are extremely rare, but they do occur. Nitroglycerin is contraindicated in patients who are allergic to it. Allergy to the adhesives used in nitroglycerin patches has also been reported, and it similarly constitutes a contraindication to the use of this product.
Nitroglycerin Transdermal System is a transparent outer backing (imprinted with "Nitroglycerin" and the release rate in mg/hr), with a white, translucent, protective peelable liner and is supplied in a foil-lined pouch. Store at controlled room temperature 15°-30°C (59°-86°F). Do not refrigerate.
Abbreviated New Drug Application
NITROGLYCERIN TRANSDERMAL SYSTEM- NITROGLYCERIN PATCH HERCON LABORATORIES CORPORATION ---------- NITROGLYCERIN TRANS DERMAL SYS TEM 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 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 of applied system delivers approximately 0.03 mg of nitroglycerin per hour. Thus, the 7-, 14-, and 21-cm systems deliver approximately 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 approximately 6% of its original content of nitroglycerin. The Nitroglycerin Transdermal System comprises 3 layers; 1) a transparent outer backing layer composed of a composite plastic film and is printed with the name of the drug and strength; 2) nitroglycerin in acrylic-based polymer adhesive with a cross-linking agent; 3) a protective white, translucent peelable liner which covers the second layer and must be removed-prior to use. Each system is sealed in a foil-lined pouch. The 7-, 14-, 21-cm systems contain 37.3 mg, 74.6 mg and 111.9 mg of nitroglycerin, respectively. The inactive ingredients are:polyester film, silicone and acrylic adhesive with a cross-linking agent. Cross section of the system: OUTER BACKING (impermeable) SECOND LAYER (nitroglycerin in adhesive) PROTECTIVE PEELABLE LINER (release liner) CLINICAL PHARMACOLOGY The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins 2 2 2 promotes peripheral pooling of blood and Baca dokumen lengkapnya