NITROGLYCERIN TRANSDERMAL SYSTEM- nitroglycerin patch NITROGLYCERIN TRANSDERMAL SYSTEM- nitroglycerin patch

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)

Dostupné z:

Major Pharmaceuticals

INN (Medzinárodný Name):

Nitroglycerin

Zloženie:

Nitroglycerin 0.2 mg in 1 h

Spôsob podávania:

TRANSDERMAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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.

Prehľad produktov:

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

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

NITROGLYCERIN TRANSDERMAL SYSTEM- NITROGLYCERIN PATCH
MAJOR PHARMACEUTICALS
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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