Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nitroglycerin sublingual tablets are supplied in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles containing 100 tablets each, with color-coded labels, and in color-coded Patient Convenience Packages of 4 bottles of 25 tablets each. 0.3 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "3" on the other side and are supplied in bottles of 100 tablets. Bottle of 100 NDC 60429-839-01 0.4 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "4" on the other side and are supplied in bottles of 25 and 100 tablets. Bottle of 100 NDC 60429-840-01 Convenience Package NDC 60429-840-04 0.6 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "6" on the other side and are supplied in bottles of 100 tablets. Bottle of 100 NDC 60429-841-01 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Rx only Manufactured by: Ingenus Pharmaceuticals NJ, LLC Fairfield, NJ 07004, USA Manufactured for: Dr. Reddy’s Laboratories Inc . Princeton, New Jersey 08540, USA Marketed by: GSMS, Inc. Camarillo, CA 93012 USA Revised: 0217; PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION 0.3 mg : Container Label: 100's 60429-839-01OL - GS000000 - NITROGLYCRIN 0.3MG SUBLINGUAL TABS - Rev. 0624 - Master.jpg; 0.3 mg: Container Carton Label: 100's 60429-839-01CB - GS000000 - NITROGLYCRIN 0.3MG SUBLINGUAL TABS - Rev 0624.jpg; 0.4 mg: Container Label: 25's 60429-840-25LB.jpg; 0.4 mg : Container Carton Label: 4 x 25's count 60429-840-04CN.jpg; 0.6 mg : Container Label: 100's 60429-841-01OL - GS000000 - NITROGLYCRIN 0.6MG SUBLINGUAL TABS - Rev. 0624 - Master.jpg; 0.6 mg: Container Carton Label: 100's 60429-841-01CB - GS000000 - NITROGLYCRIN 0.6MG SUBLINGUAL TABS - Rev 0624.jpg
- HOW SUPPLIED Nitroglycerin sublingual tablets are supplied in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles containing 100 tablets each, with color-coded labels, and in color-coded Patient Convenience Packages of 4 bottles of 25 tablets each. 0.3 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "3" on the other side and are supplied in bottles of 100 tablets. Bottle of 100 NDC 60429-839-01 0.4 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "4" on the other side and are supplied in bottles of 25 and 100 tablets. Bottle of 100 NDC 60429-840-01 Convenience Package NDC 60429-840-04 0.6 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "6" on the other side and are supplied in bottles of 100 tablets. Bottle of 100 NDC 60429-841-01 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Rx only Manufactured by: Ingenus Pharmaceuticals NJ, LLC Fairfield, NJ 07004, USA Manufactured for: Dr. Reddy’s Laboratories Inc . Princeton, New Jersey 08540, USA Marketed by: GSMS, Inc. Camarillo, CA 93012 USA Revised: 0217
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION 0.3 mg : Container Label: 100's 60429-839-01OL - GS000000 - NITROGLYCRIN 0.3MG SUBLINGUAL TABS - Rev. 0624 - Master.jpg
- 0.3 mg: Container Carton Label: 100's 60429-839-01CB - GS000000 - NITROGLYCRIN 0.3MG SUBLINGUAL TABS - Rev 0624.jpg
- 0.4 mg: Container Label: 25's 60429-840-25LB.jpg
- 0.4 mg : Container Carton Label: 4 x 25's count 60429-840-04CN.jpg
- 0.6 mg : Container Label: 100's 60429-841-01OL - GS000000 - NITROGLYCRIN 0.6MG SUBLINGUAL TABS - Rev. 0624 - Master.jpg
- 0.6 mg: Container Carton Label: 100's 60429-841-01CB - GS000000 - NITROGLYCRIN 0.6MG SUBLINGUAL TABS - Rev 0624.jpg
Overview
Nitroglycerin is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin USP; as well as calcium stearate powder, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, and pregelatinized starch. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is: Molecular weight: 227.09 structure
Indications & Usage
Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
Dosage & Administration
One tablet should be dissolved under the tongue or in the buccal pouch at the first sign of an acute anginal attack. The dose may be repeated approximately every 5 minutes until relief is obtained. If the pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, prompt medical attention is recommended. Nitroglycerin may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. During administration the patient should rest, preferably in the sitting position. No dosage adjustment is required in patients with renal failure.
Warnings & Precautions
WARNINGS The benefits of sublingual 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 because of the possibility of hypotension and tachycardia.
Contraindications
Nitroglycerin sublingual tablets are contraindicated in patients who are allergic to it. Sublingual nitroglycerin therapy is contraindicated in patients with early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin. Administration of nitroglycerin sublingual tablets are contraindicated in patients who are using a phosphodiesterase-5 (PDE-5) inhibitor (e.g., sildenafil citrate, tadalafil, vardenafil hydrochloride) since these compounds have been shown to potentiate the hypotensive effects of organic nitrates. Do not use nitroglycerin sublingual tablets in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
Adverse Reactions
Headache that may be severe and persistent may occur immediately after use. Vertigo, dizziness, weakness, palpitation, and other manifestations of postural hypotension may develop occasionally, particularly in erect, immobile patients. Marked sensitivity to the hypotensive effects of nitrates (manifested by nausea, vomiting, weakness, diaphoresis, pallor, and collapse) may occur at therapeutic doses. Syncope due to nitrate vasodilatation has been reported. Flushing, drug rash, and exfoliative dermatitis have been reported in patients receiving nitrate therapy.
Drug Interactions
Concomitant use of nitroglycerin with soluble guanylate cyclasestimulators is contraindicated (see CONTRAINDICATIONS ). Concomitant use of nitrates and alcohol may cause hypotension. The vasodilatory and hemodynamic effects of nitroglycerin may be enhanced by concomitant administration of aspirin. Intravenous administration of nitroglycerin decreases the thrombolytic effect of alteplase. Therefore, caution should be observed in patients receiving sublingual nitroglycerin during alteplase therapy. Intravenous nitroglycerin reduces the anticoagulant effect of heparin and activated partial thromboplastin times (APTT) should be monitored in patients receiving heparin and intravenous nitroglycerin. It is not known if this effect occurs following single sublingual nitroglycerin doses. Tricyclic antidepressants (amitriptyline, desipramine, doxepin, others) and anticholinergic drugs may cause dry mouth and diminished salivary secretions. This may make dissolution of sublingual nitroglycerin difficult. Increasing salivation with chewing gum or artificial saliva products may prove useful in aiding dissolution of sublingual nitroglycerin. Oral administration of nitroglycerin markedly decreases the first-pass metabolism of dihydroergotamine and subsequently increases its oral bioavailability. Ergotamine is known to precipitate angina pectoris. Therefore, patients receiving sublingual nitroglycerin should avoid ergotamine and related drugs or be monitored for symptoms of ergotism if this is not possible. Administration of nitroglycerin is contraindicated in patients who are using PDE-5 inhibitors (e.g., sildenafil citrate, tadalafil, vardenafil hydrochloride). These compounds have been shown to potentiate the hypotensive effects of organic nitrates. A decrease in therapeutic effect of sublingual nitroglycerin may result from use of long-acting nitrates.
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