"By Megan Brooks
Medscape Medical News
The US Food and Drug Administration (FDA) will require makers of prescription testosterone products to clarify the approved uses of these medications on the product label and add information"...
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.
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.
*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).
|NITRO-DUR System Rated Release In Vivo*||Total Nitro- glycerin 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 30 (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.
Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: Sep 2014
Last reviewed on RxList: 10/20/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Nitro-Dur Information
Report Problems to the Food and Drug Administration
Get the latest treatment options.