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Nitro-Dur

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Nitro-Dur

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.

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 to 12 hours daily for at least 1 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 to 12 hours is sufficient (see CLINICAL PHARMACOLOGY). Thus, an appropriate dosing schedule for nitroglycerin patches would include a daily patch-on period of 12 to 14 hours and a daily patch-off period of 10 to 12 hours.

*Release rates were formerly described in terms of drug delivered per 24 hours. In these terms, the supplied NITRO-DUR (nitroglycerin) systems would be rated at 2.5 mg/24 hours (0.1 mg/hour), 5 mg/24 hours (0.2 mg/hour), 7.5 mg/24 hours (0.3 mg/hour), 10 mg/24 hours (0.4 mg/hour), and 15 mg/24 hours (0.6 mg/hour).

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 (ie, 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.

HOW SUPPLIED

NITRO-DUR System Rated Release In Vivo* Total Nitroglycerin Content System Size Package Size
0.1 mg/hr 20 mg 5 cm2 Unit Dose 30
(NDC 0085-3305-30)
Institutional Package 30
(NDC 0085-3305-35)
0.2 mg/hr 40 mg 10 cm2 Unit Dose 30
(NDC 0085-3310-30)
Institutional Package 30
(NDC 0085-3310-35)
0.3 mg/hr 60 mg 15 cm2 Unit Dose 30
(NDC 0085-3315-30)
Institutional Package 30
(NDC 0085-3315-35)
0.4 mg/hr 80 mg 20 cm2 Unit Dose 30
(NDC 0085-3320-30)
Institutional Package 30
(NDC 0085-3320-35)
0.6 mg/hr 120 mg 30 cm2 Unit Dose 3
(NDC 0085-3330-30)
Institutional Package 30
(NDC 0085-3330-35)
0.8 mg/hr 160 mg 40 cm2 Unit Dose 30
(NDC 0085-0819-30)
Institutional Package 30
(NDC 0085-0819-35)
*Release rates were formerly described in terms of drug delivered per 24 hours. In these terms, the supplied NITRO-DUR systems would be rated at 2.5 mg/24 hours (0.1 mg/hour), 5 mg/24 hours (0.2 mg/hour), 7.5 mg/24 hours (0.3 mg/hour), 10 mg/24 hours (0.4 mg/hour), and 15 mg/24 hours (0.6 mg/hour).

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not refrigerate.

Key Pharmaceuticals, Inc. Kenilworth, NJ 07033, USA. Rev. 12/04. FDA Rev date: 4/5/2005

Last reviewed on RxList: 6/30/2008
This monograph has been modified to include the generic and brand name in many instances.

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