Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nitroglycerin Transdermal System 0.1 mg/hr is a translucent rectangular patch with rounded corners (registered imprint ‘Nitroglycerin 0.1 mg/hr’ in white ink) affixed to a clear, peelable liner, and is supplied in a foil-lined pouch. NDC 0378-9102-93 Carton of 30 Systems Nitroglycerin Transdermal System 0.2 mg/hr is a translucent rectangular patch with rounded corners (registered imprint ‘Nitroglycerin 0.2 mg/hr’ in white ink) affixed to a clear, peelable liner, and is supplied in a foil-lined pouch. NDC 0378-9104-93 Carton of 30 Systems Nitroglycerin Transdermal System 0.4 mg/hr is a translucent rectangular patch with rounded corners (registered imprint ‘Nitroglycerin 0.4 mg/hr’ in white ink) affixed to a clear, peelable liner, and is supplied in a foil-lined pouch. NDC 0378-9112-93 Carton of 30 Systems Nitroglycerin Transdermal System 0.6 mg/hr is a translucent rectangular patch with rounded corners (registered imprint ‘Nitroglycerin 0.6 mg/hr’ in white ink) affixed to a clear, peelable liner, and is supplied in a foil-lined pouch. NDC 0378-9116-93 Carton of 30 Systems Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Do not store outside of the protective package. Apply immediately upon removal from the protective package. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED NOVEMBER 2014 NTG:R14; PRINCIPAL DISPLAY PANEL – 0.1 mg/hr 30 Systems NDC 0378-9102-93 Rx only Nitroglycerin Transdermal System 0.1 mg/hr Each 4 cm 2 system contains 11.2 mg of nitroglycerin. The inactive components are acrylic pressure sensitive adhesive with a cross-linking agent, polyolefin film, polyester release liner coated on one side with silicone and white ink containing titanium dioxide. FOR TRANSDERMAL USE ONLY. Rated release in vivo 0.1 mg/hr. Patient: See instructions on back panel. Usual Dosage: Each 24 hour period should include a patch-on period of 12 to 14 hours, followed by a patch-free interval, unless otherwise directed by your physician. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Instructions for Application 1. Open pouch at tear mark. 2. Carefully remove the patch. 3. Bend both sides of clear peelable liner. 4. Peel off one strip only of the clear liner. Avoid touching the exposed sticky side of the patch. 5. Apply sticky side of the patch to the chosen skin site. 6. Remove remaining strip and press patch firmly in place with the palm of the hand. 7. APPLY IMMEDIATELY UPON REMOVAL FROM POUCH. Mylan.com Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. M9102:93:30C:R7 Nitroglycerin Transdermal System 0.1 mg/hr Carton; PRINCIPAL DISPLAY PANEL - 0.2 mg/hr 30 Systems NDC 0378-9104-93 Rx only Nitroglycerin Transdermal System 0.2 mg/hr Each 8 cm 2 system contains 22.4 mg of nitroglycerin. The inactive components are acrylic pressure sensitive adhesive with a cross-linking agent, polyolefin film, polyester release liner coated on one side with silicone and white ink containing titanium dioxide. FOR TRANSDERMAL USE ONLY. Rated release in vivo 0.2 mg/hr. Patient: See instructions on back panel. Usual Dosage: Each 24 hour period should include a patch-on period of 12 to 14 hours, followed by a patch-free interval, unless otherwise directed by your physician. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Instructions for Application 1. Open pouch at tear mark. 2. Carefully remove the patch. 3. Bend both sides of clear peelable liner. 4. Peel off one strip only of the clear liner. Avoid touching the exposed sticky side of the patch. 5. Apply sticky side of the patch to the chosen skin site. 6. Remove remaining strip and press patch firmly in place with the palm of the hand. 7. APPLY IMMEDIATELY UPON REMOVAL FROM POUCH. Mylan.com Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. M9104:93:30C:R9 Nitroglycerin Transdermal System 0.2 mg/hr Carton; PRINCIPAL DISPLAY PANEL - 0.4 mg/hr 30 Systems NDC 0378-9112-93 Rx only Nitroglycerin Transdermal System 0.4 mg/hr Each 16 cm 2 system contains 44.8 mg of nitroglycerin. The inactive components are acrylic pressure sensitive adhesive with a cross-linking agent, polyolefin film, polyester release liner coated on one side with silicone and white ink containing titanium dioxide. FOR TRANSDERMAL USE ONLY. Rated release in vivo 0.4 mg/hr. Patient: See instructions on back panel. Usual Dosage: Each 24 hour period should include a patch-on period of 12 to 14 hours, followed by a patch-free interval, unless otherwise directed by your physician. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Instructions for Application 1. Open pouch at tear mark. 2. Carefully remove the patch. 3. Bend both sides of clear peelable liner. 4. Peel off one strip only of the clear liner. Avoid touching the exposed sticky side of the patch. 5. Apply sticky side of the patch to the chosen skin site. 6. Remove remaining strip and press patch firmly in place with the palm of the hand. 7. APPLY IMMEDIATELY UPON REMOVAL FROM POUCH. Mylan.com Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. M9112:93:30C:R9 Nitroglycerin Transdermal System 0.4 mg/hr Carton; PRINCIPAL DISPLAY PANEL - 0.6 mg/hr 30 Systems NDC 0378-9116-93 Rx only Nitroglycerin Transdermal System 0.6 mg/hr Each 24 cm 2 system contains 67.2 mg of nitroglycerin. The inactive components are acrylic pressure sensitive adhesive with a cross-linking agent, polyolefin film, polyester release liner coated on one side with silicone and white ink containing titanium dioxide. FOR TRANSDERMAL USE ONLY. Rated release in vivo 0.6 mg/hr. Patient: See instructions on back panel. Usual Dosage: Each 24 hour period should include a patch-on period of 12 to 14 hours, followed by a patch-free interval, unless otherwise directed by your physician. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Instructions for Application 1. Open pouch at tear mark. 2. Carefully remove the patch. 3. Bend both sides of clear peelable liner. 4. Peel off one strip only of the clear liner. Avoid touching the exposed sticky side of the patch. 5. Apply sticky side of the patch to the chosen skin site. 6. Remove remaining strip and press patch firmly in place with the palm of the hand. 7. APPLY IMMEDIATELY UPON REMOVAL FROM POUCH. Mylan.com Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. M9116:93:30C:R9 Nitroglycerin Transdermal System 0.6 mg/hr Carton
- HOW SUPPLIED Nitroglycerin Transdermal System 0.1 mg/hr is a translucent rectangular patch with rounded corners (registered imprint ‘Nitroglycerin 0.1 mg/hr’ in white ink) affixed to a clear, peelable liner, and is supplied in a foil-lined pouch. NDC 0378-9102-93 Carton of 30 Systems Nitroglycerin Transdermal System 0.2 mg/hr is a translucent rectangular patch with rounded corners (registered imprint ‘Nitroglycerin 0.2 mg/hr’ in white ink) affixed to a clear, peelable liner, and is supplied in a foil-lined pouch. NDC 0378-9104-93 Carton of 30 Systems Nitroglycerin Transdermal System 0.4 mg/hr is a translucent rectangular patch with rounded corners (registered imprint ‘Nitroglycerin 0.4 mg/hr’ in white ink) affixed to a clear, peelable liner, and is supplied in a foil-lined pouch. NDC 0378-9112-93 Carton of 30 Systems Nitroglycerin Transdermal System 0.6 mg/hr is a translucent rectangular patch with rounded corners (registered imprint ‘Nitroglycerin 0.6 mg/hr’ in white ink) affixed to a clear, peelable liner, and is supplied in a foil-lined pouch. NDC 0378-9116-93 Carton of 30 Systems Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Do not store outside of the protective package. Apply immediately upon removal from the protective package. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED NOVEMBER 2014 NTG:R14
- PRINCIPAL DISPLAY PANEL – 0.1 mg/hr 30 Systems NDC 0378-9102-93 Rx only Nitroglycerin Transdermal System 0.1 mg/hr Each 4 cm 2 system contains 11.2 mg of nitroglycerin. The inactive components are acrylic pressure sensitive adhesive with a cross-linking agent, polyolefin film, polyester release liner coated on one side with silicone and white ink containing titanium dioxide. FOR TRANSDERMAL USE ONLY. Rated release in vivo 0.1 mg/hr. Patient: See instructions on back panel. Usual Dosage: Each 24 hour period should include a patch-on period of 12 to 14 hours, followed by a patch-free interval, unless otherwise directed by your physician. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Instructions for Application 1. Open pouch at tear mark. 2. Carefully remove the patch. 3. Bend both sides of clear peelable liner. 4. Peel off one strip only of the clear liner. Avoid touching the exposed sticky side of the patch. 5. Apply sticky side of the patch to the chosen skin site. 6. Remove remaining strip and press patch firmly in place with the palm of the hand. 7. APPLY IMMEDIATELY UPON REMOVAL FROM POUCH. Mylan.com Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. M9102:93:30C:R7 Nitroglycerin Transdermal System 0.1 mg/hr Carton
- PRINCIPAL DISPLAY PANEL - 0.2 mg/hr 30 Systems NDC 0378-9104-93 Rx only Nitroglycerin Transdermal System 0.2 mg/hr Each 8 cm 2 system contains 22.4 mg of nitroglycerin. The inactive components are acrylic pressure sensitive adhesive with a cross-linking agent, polyolefin film, polyester release liner coated on one side with silicone and white ink containing titanium dioxide. FOR TRANSDERMAL USE ONLY. Rated release in vivo 0.2 mg/hr. Patient: See instructions on back panel. Usual Dosage: Each 24 hour period should include a patch-on period of 12 to 14 hours, followed by a patch-free interval, unless otherwise directed by your physician. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Instructions for Application 1. Open pouch at tear mark. 2. Carefully remove the patch. 3. Bend both sides of clear peelable liner. 4. Peel off one strip only of the clear liner. Avoid touching the exposed sticky side of the patch. 5. Apply sticky side of the patch to the chosen skin site. 6. Remove remaining strip and press patch firmly in place with the palm of the hand. 7. APPLY IMMEDIATELY UPON REMOVAL FROM POUCH. Mylan.com Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. M9104:93:30C:R9 Nitroglycerin Transdermal System 0.2 mg/hr Carton
- PRINCIPAL DISPLAY PANEL - 0.4 mg/hr 30 Systems NDC 0378-9112-93 Rx only Nitroglycerin Transdermal System 0.4 mg/hr Each 16 cm 2 system contains 44.8 mg of nitroglycerin. The inactive components are acrylic pressure sensitive adhesive with a cross-linking agent, polyolefin film, polyester release liner coated on one side with silicone and white ink containing titanium dioxide. FOR TRANSDERMAL USE ONLY. Rated release in vivo 0.4 mg/hr. Patient: See instructions on back panel. Usual Dosage: Each 24 hour period should include a patch-on period of 12 to 14 hours, followed by a patch-free interval, unless otherwise directed by your physician. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Instructions for Application 1. Open pouch at tear mark. 2. Carefully remove the patch. 3. Bend both sides of clear peelable liner. 4. Peel off one strip only of the clear liner. Avoid touching the exposed sticky side of the patch. 5. Apply sticky side of the patch to the chosen skin site. 6. Remove remaining strip and press patch firmly in place with the palm of the hand. 7. APPLY IMMEDIATELY UPON REMOVAL FROM POUCH. Mylan.com Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. M9112:93:30C:R9 Nitroglycerin Transdermal System 0.4 mg/hr Carton
- PRINCIPAL DISPLAY PANEL - 0.6 mg/hr 30 Systems NDC 0378-9116-93 Rx only Nitroglycerin Transdermal System 0.6 mg/hr Each 24 cm 2 system contains 67.2 mg of nitroglycerin. The inactive components are acrylic pressure sensitive adhesive with a cross-linking agent, polyolefin film, polyester release liner coated on one side with silicone and white ink containing titanium dioxide. FOR TRANSDERMAL USE ONLY. Rated release in vivo 0.6 mg/hr. Patient: See instructions on back panel. Usual Dosage: Each 24 hour period should include a patch-on period of 12 to 14 hours, followed by a patch-free interval, unless otherwise directed by your physician. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Instructions for Application 1. Open pouch at tear mark. 2. Carefully remove the patch. 3. Bend both sides of clear peelable liner. 4. Peel off one strip only of the clear liner. Avoid touching the exposed sticky side of the patch. 5. Apply sticky side of the patch to the chosen skin site. 6. Remove remaining strip and press patch firmly in place with the palm of the hand. 7. APPLY IMMEDIATELY UPON REMOVAL FROM POUCH. Mylan.com Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. M9116:93:30C:R9 Nitroglycerin Transdermal System 0.6 mg/hr Carton
Overview
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 nitroglycerin transdermal 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 2 of applied system delivers approximately 0.026 mg of nitroglycerin per hour. Thus, the 4 cm 2 , 8 cm 2 , 16 cm 2 and 24 cm 2 systems deliver approximately 0.1 mg, 0.2 mg, 0.4 mg and 0.6 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 11% of its original content of nitroglycerin. The nitroglycerin transdermal system comprises two layers as shown below. Proceeding from the visible surface towards the surface attached to the skin, these layers are: 1) a polyolefin film backing layer that is impermeable to nitroglycerin and is printed with the name of the drug and strength; 2) nitroglycerin in an acrylic pressure sensitive adhesive. Prior to use, a peelable polyester release liner, which is coated on one side with silicone, is removed from the adhesive surface. Each unit is sealed in a foil-lined pouch. Cross section of the system: Nitroglycerin Structural Formula Patch Cross Section
Indications & 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.
Dosage & Administration
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 one 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 CLINICAL PHARMACOLOGY ). 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. 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 (i.e., 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. PATIENT INSTRUCTIONS FOR APPLICATION OF SYSTEM A patient leaflet is supplied with each carton.
Warnings & Precautions
WARNINGS Amplification of the vasodilatory effects of Nitroglycerin Transdermal Systems by sildenafil may 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. A cardioverter/defibrillator should not be discharged through a paddle electrode that overlies a nitroglycerin transdermal 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.
Contraindications
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 Nitroglycerin Transdermal Systems 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 Nitroglycerin Transdermal Systems in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
Adverse Reactions
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 light-headedness, 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% Light-headedness 4% 6% Hypotension, and/or syncope 0% 4% Increased angina 2% 2%
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 Nitroglycerin Transdermal Systems with phosphodiesterase inhibitors in any form is contraindicated (see CONTRAINDICATIONS ). Concomitant use of Nitroglycerin Transdermal Systems with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see CONTRAINDICATIONS ). 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.
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