NITROGLYCERIN TRANSDERMAL SYSTEM patch, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

NITROGLYCERIN

Composition:

NITROGLYCERIN 0.2 mg in 1 h

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. 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.

Product summary:

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 68382-309-30 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 68382-310-30 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 68382-311-30 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: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 1000084 Rev : 07/18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROGLYCERIN TRANSDERMAL SYSTEM- NITROGLYCERIN TRANSDERMAL
SYSTEM PATCH, EXTENDED RELEASE
ZYDUS PHARMACEUTICALS USA INC.
----------
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)
2
2
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
mus