MINITRAN- nitroglycerin patch

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

nitroglycerin (UNII: G59M7S0WS3) (nitroglycerin - UNII:G59M7S0WS3)

זמין מ:

Graceway Pharmaceuticals, LLC

INN (שם בינלאומי):

nitroglycerin

הרכב:

nitroglycerin 2.5 mg in 1 d

מסלול נתינה (של תרופות):

TRANSDERMAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

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

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

MINITRAN- NITROGLYCERIN PATCH
GRACEWAY PHARMACEUTICALS, LLC
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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