Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
nitroglycerin (UNII: G59M7S0WS3) (nitroglycerin - UNII:G59M7S0WS3)
Graceway Pharmaceuticals, LLC
nitroglycerin
nitroglycerin 2.5 mg in 1 d
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. 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.
MINITRAN (nitroglycerin) Transdermal Delivery System, 0.1 mg/hr, 0.2 mg/hr, 0.4 mg/hr, 0.6 mg/hr is available in cartons of 30 patches. Store at controlled room temperature 15°-30°C (59°-86°F). Extremes of temperature and/or humidity should be avoided. Rx only 631300 April 2007 Manufactured for: Graceway Pharmaceuticals, LLC Bristol, TN 37620 by: 3M Drug Delivery Systems Northridge, CA 91324
Abbreviated New Drug Application
MINITRAN- NITROGLYCERIN PATCH GRACEWAY PHARMACEUTICALS, LLC ---------- 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 MINITRAN™ (nitroglycerin) Transdermal Delivery 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 of applied system delivers approximately 0.03 mg of nitroglycerin per hour. Thus, the 3.3, 6.7, 13.3 and 20 cm 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 MINITRAN Transdermal Delivery 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 patch is packaged in foil/polymer film 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. CLINICAL PHARMACOLOGY The principal pharmacological action of nitroglycerin is relaxation of the vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary arteries Baca dokumen lengkap