Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED NITROGLYCERIN SUBLINGUAL TABLETS, USP 0.4mg/TABLET is supplied in the following dosage forms. NDC 51662-1282-2 NITROGLYCERIN SUBLINGUAL TABLETS, USP 0.4mg/TABLET 25TABS NDC 51662-1282-3 NITROGLYCERIN SUBLINGUAL TABLETS, USP 0.4mg/TABLET 25TABS (BOX OF 24) HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms: 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 43598-435-01 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 43598-436-01 Convenience Package NDC 43598-436-11 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 43598-437-01 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 Revised: 0217; PRINCIPAL DISPLAY PANEL - 51662-1282 - NITROGLYCERIN SUBLINGUAL TABLETS, USP 0.4mg/TABLET BOTTLE LABEL NDC 51662-1282-1 RFID LABEL 51662-1282-2 - POUCH LABELING 51662-1282-3 - SERIALIZED LABELING 51662-1282-3 - BOX LABELING BOTTLE RFID Label POUCH RFID Label BOX LABEL
- HOW SUPPLIED NITROGLYCERIN SUBLINGUAL TABLETS, USP 0.4mg/TABLET is supplied in the following dosage forms. NDC 51662-1282-2 NITROGLYCERIN SUBLINGUAL TABLETS, USP 0.4mg/TABLET 25TABS NDC 51662-1282-3 NITROGLYCERIN SUBLINGUAL TABLETS, USP 0.4mg/TABLET 25TABS (BOX OF 24) HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms: 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 43598-435-01 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 43598-436-01 Convenience Package NDC 43598-436-11 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 43598-437-01 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 Revised: 0217
- PRINCIPAL DISPLAY PANEL - 51662-1282 - NITROGLYCERIN SUBLINGUAL TABLETS, USP 0.4mg/TABLET BOTTLE LABEL NDC 51662-1282-1 RFID LABEL 51662-1282-2 - POUCH LABELING 51662-1282-3 - SERIALIZED LABELING 51662-1282-3 - BOX LABELING BOTTLE RFID Label POUCH RFID Label BOX LABEL
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
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
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.
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