Minitran (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

MINITRAN System Rated Release In Vivo	System Size	Total Nitro- glycerin In System	NDC Number
0.1 mg/hr	3.3 cm2	9 mg	NDC-29336-301-02
0.2 mg/hr	6.7 cm2	18 mg	NDC-29336-302-02
0.4 mg/hr	13.3 cm2	36 mg	NDC-29336-303-02
0.6 mg/hr	20.0 cm2	54 mg	NDC-29336-304-02

MINITRAN (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

631300   April 2007

Manufactured for:
Graceway Pharmaceuticals, LLC
Bristol, TN 37620

by:
3M Drug Delivery Systems
Northridge, CA 91324