Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
Nitroglycerin (UNII: G59M7S0WS3) (Nitroglycerin - UNII:G59M7S0WS3)
Kremers Urban Pharmaceuticals Inc.
Nitroglycerin
Nitroglycerin 20.8 mg
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.
Nitroglycerin Transdermal System 0.2 mg/hr is a translucent, square patch with rounded corners imprinted with “nitroglycerin” and “0.2 mg/hr”, affixed to a translucent, peelable liner and is supplied in a foil-lined pouch. Nitroglycerin Transdermal System 0.4 mg/hr is a translucent, square patch with rounded corners imprinted with “nitroglycerin” and “0.4 mg/hr”, affixed to a translucent, peelable liner and is supplied in a foil-lined pouch. Nitroglycerin Transdermal Systems are available as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate. Manufactured for: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA By LTS Lohmann Therapie-Systeme AG Andernach, Federal Republic of Germany L2826D Rev. 2E 02/2011 4013835 11/346 2393
Abbreviated New Drug Application
NITROGLYCERIN- NITROGLYCERIN FILM, EXTENDED RELEASE KREMERS URBAN PHARMACEUTICALS INC. ---------- NITROGLYCERIN TRANSDERMAL SYSTEM 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 .02 mg of nitroglycerin per hour. Thus, the 10 cm and 18 cm systems deliver approximately 0.2 and 0.4 mg of nitroglycerin per hour, respectively. Each 10 cm and 18 cm 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: 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 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 red Lesen Sie das vollständige Dokument