NITROGLYCERIN film, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Nitroglycerin (UNII: G59M7S0WS3) (Nitroglycerin - UNII:G59M7S0WS3)

Saatavilla:

Kremers Urban Pharmaceuticals Inc.

INN (Kansainvälinen yleisnimi):

Nitroglycerin

Koostumus:

Nitroglycerin 20.8 mg

Antoreitti:

TRANSDERMAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

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

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

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