NITROGLYCERIN TRANSDERMAL INFUSION SYSTEM- nitroglycerin patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr. Reddy's Laboratories, Inc.

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

 Nitroglycerin Transdermal Infusion System Rated Release In Vivo* Total nitroglycerin content System size Package Size 0.1 mg/hr 20 mg 5 cm2 Unit Dose 30 (NDC 43598-896-11) Package 30 (NDC 43598-896-30) 0.2 mg/hr 40 mg 10 cm2 Unit Dose 30 (NDC 43598-895-11) Package 30 (NDC 43598-895-30) 0.4 mg/hr 80 mg 20 cm2 Unit Dose 30 (NDC 43598-894-11) Package 30 (NDC 43598-894-30) 0.6 mg/hr 120 mg 30 cm2 Unit Dose 30 (NDC 43598-893-11) Package 30 (NDC 43598-893-30) *Release rates were formerly described in terms of drug delivered per 24 hours. In these terms, the supplied nitroglycerin transdermal system 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 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not refrigerate.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

NITROGLYCERIN TRANSDERMAL INFUSION SYSTEM- NITROGLYCERIN PATCH
DR. REDDY'S LABORATORIES, INC.
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NITROGLYCERIN TRANSDERMAL INFUSION 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 infusion 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 0.02 mg of
nitroglycerin per hour. Thus, the 5-,10-, 15-, 20-, 30- and 40 cm
systems deliver approximately 0.1,
0.2, 0.3, 0.4, 0.6 and 0.8 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 infusion system contains nitroglycerin
in acrylic-based polymer
adhesives with a resinous cross-linking agent to provide a continuous
source of active ingredient. Each
unit is sealed in a paper polyethylene-foil 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 reduces systemic vascular resistance, systolic arterial
pressure, and mean arterial pressure
(afterload). Dilatation of the coronary arteries also occurs. The
relative importance of preload
reduction, afterload reduction, and coronary dilatation remains
undefined.
Dosing r