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Nitroglycerin Transdermal (Nitroglycerin Transdermal) - Indications and Dosage

 
 



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 Delivery System
Rated
Release
In Vivo



System
Size

Total
Nitro-
glycerin
in System



NDC
Number

0.1 mg/hr

3.3 cm2

9 mg

NDC-47781-296-03

0.2 mg/hr

6.7 cm2

18 mg

NDC-47781-297-03

0.4 mg/hr

13.3 cm2

36 mg

NDC-47781-298-03

0.6 mg/hr

20.0 cm2

54 mg

NDC-47781-299-03

Nitroglycerin Transdermal Delivery System, 0.1 mg/hr, 0.2 mg/hr, 0.4 mg/hr, 0.6 mg/hr is available in cartons of 30 patches.

STORAGE CONDITIONS

Store at controlled room temperature 15°-30°C (59°-86°F). Extremes of temperature and/or humidity should be avoided.

Rx only

663500

Rev. 03/13

Distributed by:
Alvogen, Inc., Pine Brook, NJ 07058 USA

Manufactured by:
3M Drug Delivery Systems, Northridge, CA 91324 USA

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