DOSAGE AND ADMINISTRATION:
As noted above (
CLINICAL PHARMACOLOGY
), controlled trials have demonstrated that nitroglycerin ointment can effectively reduce exercise-related angina for up to 7 hours after a single application. Doses used in clinical trials have ranged from 1/2 inch (1.3 cm; 7.5 mg) to 2 inches (5.1 cm; 30 mg), typically applied to 36 square inches (232 square centimeters) of truncal skin.
It is reasonable to believe that the rate and extent of nitroglycerin absorption from ointment may vary with the site and square measure of the skin over which a given dose of ointment is spread, but these relationships have not been adequately studied.
Controlled trials with other formulations of nitroglycerin have demonstrated that if plasma levels are maintained continuously, all anti-anginal efficacy is lost within 24 hours. This tolerance cannot be overcome by increasing the dose of nitroglycerin. As a result, any regimen of NITRO-BID® administration should include a daily nitrate-free interval. The minimum necessary length of such an interval has not been defined, but studies with other nitroglycerin formulations have shown that 10 to 12 hours is sufficient.
Thus, one appropriate dosing schedule for NITRO-BID® would begin with two daily 1/2- inch (7.5 mg) doses, one applied on rising in the morning and one applied six hours later. The dose could be doubled, and even doubled again, in patients tolerating this dose but failing to respond to it. The foilpac is intended as a unit dose package only and is equivalent to approximately 1 inch as squeezed from the tube. Use entire contents of foilpac to obtain full dose and discard immediately after use.
Each tube of ointment and each box of foilpacs is supplied with a pad of ruled, impermeable, paper applicators. These applicators allow ointment to be absorbed through a much smaller area of skin than that used in any of the reported clinical trials, and the significance of this difference is not known. To apply the ointment using one of the applicators, place the applicator on a flat surface, printed side down. Squeeze the necessary amount of ointment from the tube onto the applicator, place the applicator (ointment side down) on the desired area of the skin, and tape the applicator into place.
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