NITROGLYCERIN TRANSDERMAL SYSTEM- nitroglycerin patch

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Hercon Laboratories Corporation

DCI (Dénomination commune internationale):

Nitroglycerin

Composition:

Nitroglycerin 0.2 mg in 1 h

Mode d'administration:

TRANSDERMAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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. Use of nitroglycerin transdermal system is contraindicated in patients using sildenafil because sildenafil may amplify the vasodilatory effects of nitroglycerin transdermal systems resulting in severe hypotension. 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.

Descriptif du produit:

Nitroglycerin Transdermal System is a transparent outer backing (imprinted with "Nitroglycerin" and the release rate in mg/hr), with a white, translucent, protective peelable liner and is supplied in a foil-lined pouch. Store at controlled room temperature 15°-30°C (59°-86°F). Do not refrigerate.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

NITROGLYCERIN TRANSDERMAL SYSTEM- NITROGLYCERIN PATCH
HERCON LABORATORIES CORPORATION
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NITROGLYCERIN
TRANS DERMAL
SYS TEM
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; 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 liner which covers the second layer and must be
removed-prior to use. Each system
is sealed in a foil-lined pouch. The 7-, 14-, 21-cm systems contain
37.3 mg, 74.6 mg and 111.9 mg of
nitroglycerin, respectively. The inactive ingredients are:polyester
film, silicone and acrylic adhesive
with a cross-linking agent.
Cross section of the system:
OUTER BACKING
(impermeable)
SECOND LAYER
(nitroglycerin in adhesive)
PROTECTIVE PEELABLE LINER
(release liner)
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
2
2
2
promotes peripheral pooling of blood and