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.
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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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