NITROGLYCERIN patch

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Mylan Pharmaceuticals Inc.

SNN (starptautisko nepatentēto nosaukumu):

NITROGLYCERIN

Kompozīcija:

NITROGLYCERIN 0.1 mg in 1 h

Ievadīšanas:

TRANSDERMAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 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.

Produktu pārskats:

Nitroglycerin Transdermal System 0.1 mg/hr is a translucent rectangular patch with rounded corners (registered imprint ‘Nitroglycerin 0.1 mg/hr’ in white ink) affixed to a clear, peelable liner, and is supplied in a foil-lined pouch. NDC 0378-9102-93 Carton of 30 Systems Nitroglycerin Transdermal System 0.2 mg/hr is a translucent rectangular patch with rounded corners (registered imprint ‘Nitroglycerin 0.2 mg/hr’ in white ink) affixed to a clear, peelable liner, and is supplied in a foil-lined pouch. NDC 0378-9104-93 Carton of 30 Systems Nitroglycerin Transdermal System 0.4 mg/hr is a translucent rectangular patch with rounded corners (registered imprint ‘Nitroglycerin 0.4 mg/hr’ in white ink) affixed to a clear, peelable liner, and is supplied in a foil-lined pouch. NDC 0378-9112-93 Carton of 30 Systems Nitroglycerin Transdermal System 0.6 mg/hr is a translucent rectangular patch with rounded corners (registered imprint ‘Nitroglycerin 0.6 mg/hr’ in white ink) affixed to a clear, peelable liner, and is supplied in a foil-lined pouch. NDC 0378-9116-93 Carton of 30 Systems Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Do not store outside of the protective package. Apply immediately upon removal from the protective package. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED NOVEMBER 2014 NTG:R14

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

NITROGLYCERIN- NITROGLYCERIN PATCH
MYLAN PHARMACEUTICALS INC.
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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 0.026 mg of nitroglycerin per
hour. Thus, the 4 cm , 8 cm ,
16 cm and 24 cm systems deliver approximately 0.1 mg, 0.2 mg, 0.4 mg
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 11% of its original content
of nitroglycerin.
The nitroglycerin transdermal system comprises two layers as shown
below. Proceeding from the
visible surface towards the surface attached to the skin, these layers
are: 1) a polyolefin film backing
layer that is impermeable to nitroglycerin and is printed with the
name of the drug and strength; 2)
nitroglycerin in an acrylic pressure sensitive adhesive. Prior to use,
a peelable polyester release liner,
which is coated on one side with silicone, is removed from the
adhesive surface. Each unit is sealed in
a foil-lined pouch.
Cross section of the system:
2
2
2
2
2
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 reduces systemic vascular resistance, s