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Nitroglycerin
Overview
What is NITRO-BID?
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.
What does NITRO-BID look like?
What are the available doses of NITRO-BID?
Sorry No records found.
What should I talk to my health care provider before I take NITRO-BID?
Sorry No records found
How should I use NITRO-BID?
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.
As noted above , 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.
What interacts with NITRO-BID?
Allergic reactions to organic nitrates are extremely rare, but they do occur. Nitroglycerin is contraindicated in patients who are allergic to it.
What are the warnings of NITRO-BID?
Avoid spraying in eyes.
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.
What are the precautions of NITRO-BID?
General:
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
As tolerance to other forms of nitroglycerin develops, the effect of sublingual nitroglycerin on exercise tolerance, although still observable, is somewhat blunted. In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pains, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.
Some clinical trials in angina patients have provided nitroglycerin for about 12 continuous hours of every 24-hour day. During the nitrate-free intervals in some of these trials, anginal attacks have been more easily provoked than before treatment, and patients have demonstrated hemodynamic rebound and exercise tolerance. The importance of these observations to the routine, clinical use of transdermal nitroglycerin is not known.
Information for Patients:
Treatment with nitroglycerin may be associated with lightheadedness on standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol. Patient instruction leaflet is included.
Drug Interactions:
Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Pregnancy Category C:
Nursing Mothers:
Pediatric Use:
What are the side effects of NITRO-BID?
Adverse reactions to nitroglycerin are generally dose-related, and almost all of these reactions are the result of nitroglycerin's activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon.
Allergic reactions to nitroglycerin are also uncommon, and the great majority of those reported have been cases of contact dermatitis or fixed drug eruptions in patients receiving nitroglycerin in ointments or patches. There have been a few reports of genuine anaphylactoid reactions, and these reactions can probably occur in patients receiving nitroglycerin by any route.
Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients; for further discussion of its diagnosis and treatment see .
Data are not available to allow estimation of the frequency of adverse reactions during treatment with nitroglycerin ointment.
What should I look out for while using NITRO-BID?
Allergic reactions to organic nitrates are extremely rare, but they do occur. Nitroglycerin is contraindicated in patients who are allergic to it.
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.
What might happen if I take too much NITRO-BID?
How should I store and handle NITRO-BID?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .NITRO-BID (Nitroglycerin Ointment USP, 2%), is a pale yellow ointment. (Package includes a supply of ruled applicators for convenient application.)Close tightly, immediately after each use.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].NITRO-BID(Nitroglycerin Ointment USP, 2%)E. FOUGERA & CO.A division of Nycomed US Inc.I2326D/ IF2326DR09/07#274NITRO-BID (Nitroglycerin Ointment USP, 2%), is a pale yellow ointment. (Package includes a supply of ruled applicators for convenient application.)Close tightly, immediately after each use.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].NITRO-BID(Nitroglycerin Ointment USP, 2%)E. FOUGERA & CO.A division of Nycomed US Inc.I2326D/ IF2326DR09/07#274NITRO-BID (Nitroglycerin Ointment USP, 2%), is a pale yellow ointment. (Package includes a supply of ruled applicators for convenient application.)Close tightly, immediately after each use.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].NITRO-BID(Nitroglycerin Ointment USP, 2%)E. FOUGERA & CO.A division of Nycomed US Inc.I2326D/ IF2326DR09/07#274NITRO-BID (Nitroglycerin Ointment USP, 2%), is a pale yellow ointment. (Package includes a supply of ruled applicators for convenient application.)Close tightly, immediately after each use.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].NITRO-BID(Nitroglycerin Ointment USP, 2%)E. FOUGERA & CO.A division of Nycomed US Inc.I2326D/ IF2326DR09/07#274NITRO-BID (Nitroglycerin Ointment USP, 2%), is a pale yellow ointment. (Package includes a supply of ruled applicators for convenient application.)Close tightly, immediately after each use.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].NITRO-BID(Nitroglycerin Ointment USP, 2%)E. FOUGERA & CO.A division of Nycomed US Inc.I2326D/ IF2326DR09/07#274NITRO-BID (Nitroglycerin Ointment USP, 2%), is a pale yellow ointment. (Package includes a supply of ruled applicators for convenient application.)Close tightly, immediately after each use.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].NITRO-BID(Nitroglycerin Ointment USP, 2%)E. FOUGERA & CO.A division of Nycomed US Inc.I2326D/ IF2326DR09/07#274NITRO-BID (Nitroglycerin Ointment USP, 2%), is a pale yellow ointment. (Package includes a supply of ruled applicators for convenient application.)Close tightly, immediately after each use.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].NITRO-BID(Nitroglycerin Ointment USP, 2%)E. FOUGERA & CO.A division of Nycomed US Inc.I2326D/ IF2326DR09/07#274
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Pharmacokinetics:
The first products in the metabolism of nitroglycerin are inorganic nitrate and the 1,2- and 1,3-dinitroglycerols. The dinitrates are less effective vasodilators than nitroglycerin, but they are longer-lived in the serum, and their net contribution to the overall effect of chronic nitroglycerin regimens is not known. The dinitrates are further metabolized to (non-vasoactive) mononitrates and, ultimately, to glycerol and carbon dioxide.
To avoid development of tolerance to nitroglycerin, drug-free intervals of 10 - 12 hours are known to be sufficient; shorter intervals have not been well studied. In one well-controlled clinical trial, subjects receiving nitroglycerin appeared to exhibit a rebound or withdrawal effect, so that their exercise tolerance at the end of the daily drug-free interval was less than that exhibited by the parallel group receiving placebo.
Reliable assay techniques for plasma nitroglycerin levels have only recently become available, and studies using these techniques to define the pharmacokinetics of nitroglycerin ointment have not been reported. Published studies using older techniques provide results that often differ, in similar experimental settings, by an order of magnitude. The data are consistent, however, in suggesting that nitroglycerin levels rise to steady state within an hour or so of application of ointment, and that after removal of nitroglycerin ointment, levels wane with a half-life of about half an hour.
The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
The maximal achievable daily duration of anti-anginal activity provided by nitroglycerin ointment therapy has not been studied. Recent studies of other formulations of nitroglycerin suggest that the maximal achievable daily duration of anti-anginal effect from nitroglycerin ointment will be about 12 hours.
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.
Non-Clinical Toxicology
Allergic reactions to organic nitrates are extremely rare, but they do occur. Nitroglycerin is contraindicated in patients who are allergic to it.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.
B
General:
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
As tolerance to other forms of nitroglycerin develops, the effect of sublingual nitroglycerin on exercise tolerance, although still observable, is somewhat blunted. In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pains, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.
Some clinical trials in angina patients have provided nitroglycerin for about 12 continuous hours of every 24-hour day. During the nitrate-free intervals in some of these trials, anginal attacks have been more easily provoked than before treatment, and patients have demonstrated hemodynamic rebound and exercise tolerance. The importance of these observations to the routine, clinical use of transdermal nitroglycerin is not known.
Adverse reactions to nitroglycerin are generally dose-related, and almost all of these reactions are the result of nitroglycerin's activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon.
Allergic reactions to nitroglycerin are also uncommon, and the great majority of those reported have been cases of contact dermatitis or fixed drug eruptions in patients receiving nitroglycerin in ointments or patches. There have been a few reports of genuine anaphylactoid reactions, and these reactions can probably occur in patients receiving nitroglycerin by any route.
Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients; for further discussion of its diagnosis and treatment see .
Data are not available to allow estimation of the frequency of adverse reactions during treatment with nitroglycerin ointment.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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