देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)
Major Pharmaceuticals
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. 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. Do not use Nitroglycerin Transdermal Systems in patients who are taking phosphodiesterase inhibitors (such as sildenafil, tadalafil, or vardenafil) for erectile dysfunction or pulmonary arterial hypertension. Concomitant use can cause severe drops in blood pressure. Do not use Nitroglycerin Transdermal Systems in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
Nitroglycerin Transdermal System 0.2 mg/hr is a white, translucent round patch (registered imprint 'Nitroglycerin 0.2 mg/hr'), supplied in a foil-lined pouch 30 Systems………………………...…..... NDC 0904-5495-46 Nitroglycerin Transdermal System 0.4 mg/hr is a white, translucent round patch (registered imprint 'Nitroglycerin 0.4 mg/hr'), supplied in a foil-lined pouch 30 Systems………………………...…..... NDC 0904-5496-46 Nitroglycerin Transdermal System 0.6 mg/hr is a white, translucent round patch (registered imprint 'Nitroglycerin 0.6 mg/hr'), supplied in a foil-lined pouch 30 Systems………………………...…..... NDC 0904-5497-46 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not store unpouched. Apply immediately upon removal from the pouch. Manufactured by: Hercon Pharmaceuticals, LLC Emigsville, PA 17318 Distributed by: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 1000015 Rev : 07/18
Abbreviated New Drug Application
NITROGLYCERIN TRANSDERMAL SYSTEM- NITROGLYCERIN PATCH MAJOR PHARMACEUTICALS ---------- NITROGLYCERIN TRANSDERMAL SYSTEM RX ONLY PRESCRIBING INFORMATION 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 as shown below. Proceeding from the visible surface towards the surface attached to the skin, these layers are: 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 silicone treated polystyrene release liner which covers the second layer and must be removed-prior to use. The inactive ingredients are: multilayer plastic film (polyolefin/EVA/PVDC), silicone coated polystyrene film, acrylic adhesive with a cross-linking agent and blue ink. Cross section of the system: OUTER BACKING (impermeable) SECOND LAYER (nitroglycerin in acrylic-based adhesive) PROTECTIVE PEELABLE LINER (release liner) CLINICAL PHARMACOLOGY The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle and 2 2 consequent dilatation of peripheral a पूरा दस्तावेज़ पढ़ें