NITROGLYCERIN TRANSDERMAL DELIVERY SYSTEM- nitroglycerin patch

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Alvogen, Inc.

INN（国際名）:

nitroglycerin

構図:

nitroglycerin 0.1 mg in 1 h

投与経路:

TRANSDERMAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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. 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 Infusion System 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 Infusion System in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

製品概要:

System Rated Release In Vivo* System Size Total Nitroglycerin Content NDC Number/ Package Size 0.1 mg/hr 3.3 cm2 9 mg NDC-47781-296-03 30 count carton 0.2 mg/hr 6.7 cm2 18 mg NDC-47781-297-03 30 count carton 0.4 mg/hr 13.3 cm2 36 mg NDC-47781-298-03 30 count carton 0.6 mg/hr 20.0 cm2 54 mg NDC-47781-299-03 30 count carton *Release rates were formerly described in terms of drug delivered per 24 hours. In these terms, the supplied Nitroglycerin Transdermal Infusion Systems would be rated at 2.5 mg/24 hours (0.1 mg/hour), 5 mg/24 hours (0.2 mg/hour), 10 mg/24 hours (0.4 mg/hour), and 15 mg/24 hours (0.6 mg/hour). Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not refrigerate. Rx only 9439201 668100 Rev. 12/14 Manufactured by: 3M Drug Delivery Systems, Northridge, CA 91324 USA For: Alvogen, Inc., Pine Brook, NJ 07058 USA

認証ステータス:

Abbreviated New Drug Application

製品の特徴

NITROGLYCERIN TRANSDERMAL DELIVERY SYSTEM- NITROGLYCERIN PATCH
ALVOGEN, INC.
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NITROGLYCERIN TRANSDERMAL INFUSION SYSTEM
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 Nitroglycerin Transdermal Infusion 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 Nitroglycerin Transdermal 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 unit is packaged in a heat-sealed
foil pouch produced on line from a
paper/foil/polyethylene 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