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NITRO-DUR
Overview
What is NITRO-DUR?
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.
The NITRO-DUR (nitroglycerin) Transdermal Infusion System is a flat unit designed to provide continuous controlled release of nitroglycerin through intact skin. The rate of release of nitroglycerin is linearly dependent upon the area of the applied system; each cm of applied system delivers approximately 0.02 mg of nitroglycerin per hour. Thus, the 5-,10-, 15-, 20-, 30-, and 40-cm2 systems deliver approximately 0.1, 0.2, 0.3, 0.4, 0.6, and 0.8 mg of nitroglycerin per hour, respectively.
The remainder of the nitroglycerin in each system serves as a reservoir and is not delivered in normal use. After 12 hours, for example, each system has delivered approximately 6% of its original content of nitroglycerin.
The NITRO-DUR transdermal system contains nitroglycerin in acrylic-based polymer adhesives with a resinous cross-linking agent to provide a continuous source of active ingredient. Each unit is sealed in a paper polyethylene-foil pouch.Cross section of the system.
What does NITRO-DUR look like?
What are the available doses of NITRO-DUR?
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What should I talk to my health care provider before I take NITRO-DUR?
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How should I use NITRO-DUR?
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.
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
). 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 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.
What interacts with NITRO-DUR?
Nitroglycerin is contraindicated in patients who are allergic to it. Allergy to the adhesives used in nitroglycerin patches has also been reported, and it similarly constitutes a contraindication to the use of this product.
Do not use NITRO-DUR in patients who are taking phosphodiesterase inhibitors (such as sildenafil, tadalafil, or vardenafil) for erectile dysfunction or pulmonary arterial hypertension. Concomitant use can cause severe drops in blood pressure.Do not use NITRO-DUR in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
What are the warnings of NITRO-DUR?
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation should be administered as clinically indicated.
Amplification of the vasodilatory effects of the NITRO-DUR patch by phosphodiesterase inhibitors, eg, sildenafil can result in severe hypotension. The time course and dose dependence of this inter action 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.
A cardioverter/defibrillator should not be discharged through a paddle electrode that overlies a NITRO-DUR patch. The arcing that may be seen in this situation is harmless in itself, but it may be associated with local current concentration that can cause damage to the paddles and burns to the patient.
What are the precautions of NITRO-DUR?
General:
Severe hypotension, particularly with upright posture, may occur with even small doses of nitroglycerin, particularly in the elderly. The NITRO-DUR Transdermal Infusion System should therefore be used with caution in elderly patients who may be volume-depleted, are on multiple medications, or who, for whatever reason, are already hypotensive. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris.
Elderly patients may be more susceptible to hypotension and may be at greater risk of falling at the therapeutic doses of nitroglycerin.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy, particularly in the elderly.
In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.
Several clinical trials in patients with angina pectoris have evaluated nitroglycerin regimens which incorporated a 10- to 12-hour, nitrate-free interval. In some of these trials, an increase in the frequency of anginal attacks during the nitrate-free interval was observed in a small number of patients. In one trial, patients had decreased exercise tolerance at the end of the nitrate-free interval. Hemodynamic rebound has been observed only rarely; on the other hand, few studies were so designed that rebound, if it had occurred, would have been detected. The importance of these observations to the routine, clinical use of transdermal nitroglycerin is unknown.
Information for Patients:
Daily headaches sometimes accompany treatment with nitroglycerin. In patients who get these headaches, the headaches may be a marker of the activity of the drug. Patients should resist the temptation to avoid headaches by altering the schedule of their treatment with nitroglycerin, since loss of headache may be associated with simultaneous loss of antianginal efficacy.
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.
After normal use, there is enough residual nitroglycerin in discarded patches that they are a potential hazard to children and pets.
A patient leaflet is supplied with the systems.
Drug Interactions:
The vasodilating effects of nitroglycerin may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.
Concomitant use of NITRO-DUR with phosphodiesterase inhibitors in any form is contraindicated (see ).
Concomitant use of NITRO-DUR with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see ).
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Animal carcinogenesis studies with topically applied nitroglycerin have not been performed.
Rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years developed dose-related fibrotic and neoplastic changes in liver, including carcinomas, and interstitial cell tumors in testes. At high dose, the incidences of hepatocellular carcinomas in both sexes were 52% vs 0% in controls, and incidences of testicular tumors were 52% vs 8% in controls. Lifetime dietary administration of up to 1058 mg/kg/day of nitroglycerin was not tumorigenic in mice.
Nitroglycerin was weakly mutagenic in Ames tests performed in two different laboratories. Nevertheless, there was no evidence of mutagenicity in an in vivo dominant lethal assay with male rats treated with doses up to about 363 mg/kg/day, po, or in in vitro cytogenetic tests in rat and dog tissues.
In a three-generation reproduction study, rats received dietary nitroglycerin at doses up to about 434 mg/kg/day for 6 months prior to mating of the F generation with treatment continuing through successive F and F generations. The high dose was associated with decreased feed intake and body weight gain in both sexes at all matings. No specific effect on the fertility of the F generation was seen. Infertility noted in subsequent generations, however, was attributed to increased interstitial cell tissue and aspermatogenesis in the high-dose males. In this three-generation study there was no clear evidence of teratogenicity.
Pregnancy:
Animal teratology studies have not been conducted with nitroglycerin transdermal systems. Teratology studies in rats and rabbits, however, were conducted with topically applied nitroglycerin ointment at doses up to 80 mg/kg/day and 240 mg/kg/day, respectively. No toxic effects on dams or fetuses were seen at any dose tested. There are no adequate and wellcontrolled studies in pregnant women. Nitroglycerin should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitroglycerin is administered to a nursing woman.
Pediatric Use:
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use:
Clinical studies of NITRO-DUR Transdermal Infusion System did not include sufficient information to determine whether subjects 65 years and older respond differently from younger subjects. Additional clinical data from the published literature indicate that the elderly demonstrate increased sensitivity to nitrates, which may result in hypotension and increased risk of falling. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of the decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Array
What are the side effects of NITRO-DUR?
Adverse reactions to nitroglycerin are generally dose related, and almost all of these reactions are the result of nitroglycerins 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. Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred (see ).
Application-site irritation may occur but is rarely severe.
In two placebo-controlled trials of intermittent therapy with nitroglycerin patches at 0.2 to 0.8 mg/hr, the most frequent adverse reactions among 307 subjects were as follows:
To report SUSPECTED ADVERSE REACTIONS, contact USPharma LLC at 1(844)-750-3729 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
| Placebo | Patch | |
| Headache | 18% | 63% |
| Lightheadedness | 4% | 6% |
| Hypotension, and/or Syncope | 0% | 4% |
| Increased Angina | 2% | 2% |
What should I look out for while using NITRO-DUR?
Nitroglycerin is contraindicated in patients who are allergic to it. Allergy to the adhesives used in nitroglycerin patches has also been reported, and it similarly constitutes a contraindication to the use of this product.
Do not use NITRO-DUR in patients who are taking phosphodiesterase inhibitors (such as sildenafil, tadalafil, or vardenafil) for erectile dysfunction or pulmonary arterial hypertension. Concomitant use can cause severe drops in blood pressure.Do not use NITRO-DUR in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
Amplification of the vasodilatory effects of the NITRO-DUR patch by phosphodiesterase inhibitors, eg, sildenafil can result in severe hypotension. The time course and dose dependence of this inter action 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.
A cardioverter/defibrillator should not be discharged through a paddle electrode that overlies a NITRO-DUR patch. The arcing that may be seen in this situation is harmless in itself, but it may be associated with local current concentration that can cause damage to the paddles and burns to the patient.
What might happen if I take too much NITRO-DUR?
How should I store and handle NITRO-DUR?
Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.*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).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The volume of distribution of nitroglycerin is about 3 L/kg, and nitroglycerin is cleared from this volume at extremely rapid rates, with a resulting serum half-life of about 3 minutes. The observed clearance rates (close to 1 L/kg/min) greatly exceed hepatic blood flow; known sites of extrahepatic metabolism include red blood cells and vascular walls.
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 longerlived in the serum, and their net contribution to the overall effect of chronic nitroglycerin regimens is not known. The dinitrates are further metabolized to (nonvasoactive) mononitrates and, ultimately, to glycerol and carbon dioxide.
To avoid development of tolerance to nitroglycerin, drug-free intervals of 10 to 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 than that exhibited by the parallel group receiving placebo.
In healthy volunteers, steady-state plasma concentrations of nitroglycerin are reached by about 2 hours after application of a patch and are maintained for the duration of wearing the system (observations have been limited to 24 hours). Upon removal of the patch, the plasma concentration declines with a half-life of about an hour.
Non-Clinical Toxicology
Nitroglycerin is contraindicated in patients who are allergic to it. Allergy to the adhesives used in nitroglycerin patches has also been reported, and it similarly constitutes a contraindication to the use of this product.Do not use NITRO-DUR in patients who are taking phosphodiesterase inhibitors (such as sildenafil, tadalafil, or vardenafil) for erectile dysfunction or pulmonary arterial hypertension. Concomitant use can cause severe drops in blood pressure.Do not use NITRO-DUR in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
Amplification of the vasodilatory effects of the NITRO-DUR patch by phosphodiesterase inhibitors, eg, sildenafil can result in severe hypotension. The time course and dose dependence of this inter action 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.
A cardioverter/defibrillator should not be discharged through a paddle electrode that overlies a NITRO-DUR patch. The arcing that may be seen in this situation is harmless in itself, but it may be associated with local current concentration that can cause damage to the paddles and burns to the patient.
The vasodilating effects of nitroglycerin may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.
Concomitant use of NITRO-DUR with phosphodiesterase inhibitors in any form is contraindicated (see ).
Concomitant use of NITRO-DUR with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see ).
Severe hypotension, particularly with upright posture, may occur with even small doses of nitroglycerin, particularly in the elderly. The NITRO-DUR Transdermal Infusion System should therefore be used with caution in elderly patients who may be volume-depleted, are on multiple medications, or who, for whatever reason, are already hypotensive. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris.
Elderly patients may be more susceptible to hypotension and may be at greater risk of falling at the therapeutic doses of nitroglycerin.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy, particularly in the elderly.
In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.
Several clinical trials in patients with angina pectoris have evaluated nitroglycerin regimens which incorporated a 10- to 12-hour, nitrate-free interval. In some of these trials, an increase in the frequency of anginal attacks during the nitrate-free interval was observed in a small number of patients. In one trial, patients had decreased exercise tolerance at the end of the nitrate-free interval. Hemodynamic rebound has been observed only rarely; on the other hand, few studies were so designed that rebound, if it had occurred, would have been detected. The importance of these observations to the routine, clinical use of transdermal nitroglycerin is unknown.
Adverse reactions to nitroglycerin are generally dose related, and almost all of these reactions are the result of nitroglycerins 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. Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred (see ).
Application-site irritation may occur but is rarely severe.
In two placebo-controlled trials of intermittent therapy with nitroglycerin patches at 0.2 to 0.8 mg/hr, the most frequent adverse reactions among 307 subjects were as follows:
To report SUSPECTED ADVERSE REACTIONS, contact USPharma LLC at 1(844)-750-3729 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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