Nitro-bid
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Questions & Answers
Side Effects & Adverse Reactions
Amplification of the vasodilatory effects of nitroglycerin by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.
The benefits of transdermal nitroglycerin in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use nitroglycerin in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Nitroglycerin ointment 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 anginal episode.
History
There is currently no drug history available for this drug.
Other Information
Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is:
and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins.
NITRO-BID® for topical use contains lactose and 2% nitroglycerin in a base of lanolin, white petrolatum and purified water. Each inch (2.5 cm), as squeezed from the tube, contains approximately 15 mg of nitroglycerin.
Sources
Nitro-bid Manufacturers
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E. Fougera & Co., A Division Of Nycomed Us Inc.
![Nitro-bid (Nitroglycerin) Ointment [E. Fougera & Co., A Division Of Nycomed Us Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Nitro-bid | E. Fougera & Co., A Division Of Nycomed Us Inc.
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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Savage Laboratories A Division Of Fougera Pharmaceuticals Inc.
Nitro-bid | Savage Laboratories A Division Of Fougera Pharmaceuticals Inc.
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.
![Nitro-bid (Nitroglycerin) Ointment [Savage Laboratories A Division Of Fougera Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e464e9bb-48e8-4b9f-9fff-e220cfbac0c5&name=f23fd03e-ba6b-4a2b-b362-6a41690b45ca-02.jpg)
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