A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Transderm Nitro Indications, Dosage, Storage, Stability - Nitroglycerin
Transderm Nitro Indications, Dosage, Storage, Stability - Nitroglycerin
INDICATIONS AND USAGE
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.
DOSAGE AND ADMINISTRATION
The suggested starting dose is between 0.2 mg/hr*, and 0.4 mg/hr*. Doses between 0.4 mg/hr* and 0.8 mg/hr* have shown continued effectiveness for 10-12 hours daily for at least one month (the longest period studied) of intermittent administration. Although the minimum nitrate-free interval has not been defined, data show that a nitrate-free interval of 10-12 hours is sufficient (see CLINICAL PHARMACOLOGY). Thus, an appropriate dosing schedule for nitroglycerin patches would include a daily patch-on period of 12-14 hours and a daily patch-off period of 10-12 hours.
Although some well-controlled clinical trials using exercise tolerance testing have shown maintenance of effectiveness when patches are worn continuously, the large majority of such controlled trials have shown the development of tolerance (i.e., complete loss of effect) within the first 24 hours after therapy was initiated. Dose adjustment, even to levels much higher than generally used, did not restore efficacy.
PATIENT INSTRUCTIONS FOR APPLICATION OF SYSTEM
A patient leaflet is supplied with each carton.
HOW SUPPLIED
Nitroglycerin Transdermal System 0.1 mg/hr-tan, round (imprinted Transderm-Nitro 0.1 mg/hr), supplied in a foil-lined pouch
30 Systems.............................................................................NDC 0078-0332-85
Nitroglycerin Transdermal System 0.2 mg/hr-tan, oblong (imprinted Transderm-Nitro 0.2 mg/hr), supplied in a foil-lined pouch
30 Systems.............................................................................NDC 0078-0333-85
Nitroglycerin Transdermal System 0.4 mg/hr-tan, oblong (imprinted Transderm-Nitro 0.4 mg/hr), supplied in a foil-lined pouch
30 Systems.............................................................................NDC 0078-0334-85
Nitroglycerin Transdermal System 0.6 mg/hr-tan, oblong (imprinted Transderm-Nitro 0.6 mg/hr), supplied in a foil-lined pouch
30 Systems.............................................................................NDC 0078-0335-85
*Rated release in vivo. Release rates were formerly described in terms of drug delivered per 24 hours. In these terms, the supplied Transderm-Nitro systems would be rated at 2.5 mg/24 hr (0.1 mg/hr), 5 mg/24 hr (0.2 mg/hr), 10 mg/24 hr (0.4 mg/hr), 15 mg/24 hr (0.6 mg/hr), and 20 mg/24 hr (0.8 mg/hr).
Do not store above 30°C (86°F).
Do not store unpouched. Apply immediately upon removal from the pouch.
T2000-35 REV: JUNE 2000 Printed in U.S.A., 89002802, Distributed by : Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936, © 2000 Novartis
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