NITRO-DUR
Generic: NITROGLYCERIN
Basic Information
Manufacturer
Ingenus Pharmaceuticals, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TRANSDERMAL
FDA Set ID
5e15296c-5acd-4bcc-80a8-b49cb1ef3eb0
Indications & Usage
INDICATIONS AND USAGE 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 onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack.
Warnings
WARNINGS 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.
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.
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 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.
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.
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.
Adverse Reactions
ADVERSE REACTIONS 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 OVERDOSAGE ).
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: Placebo Patch Headache 18% 63% Lightheadedness 4% 6% Hypotension, and/or Syncope 0% 4% Increased Angina 2% 2% To report SUSPECTED ADVERSE REACTIONS, contact USPharma Ltd at 1(844)-750-3729 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 OVERDOSAGE ).
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: Placebo Patch Headache 18% 63% Lightheadedness 4% 6% Hypotension, and/or Syncope 0% 4% Increased Angina 2% 2% To report SUSPECTED ADVERSE REACTIONS, contact USPharma Ltd at 1(844)-750-3729 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.