Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)
Alvogen Inc.
SUBLINGUAL
PRESCRIPTION DRUG
Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Do not use nitroglycerin sublingual tablets in patients who are taking PDE-5 Inhibitors, such as avanafil, sildenafil, tadalafil, vardenafil hydrochloride. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1)]. Do not use nitroglycerin sublingual tablets in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. Concomitant use can cause hypotension. Nitroglycerin sublingual tablets are contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). Nitroglycerin sublingual tablets may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e.g., cerebral hemorrhage or traumatic brain injury). Nitr
Nitroglycerin sublingual tablets, USP are supplied in 3 strengths in color-coded labeled bottles containing 100 tablets each (0.3 mg, 0.4 mg, and 0.6 mg), and in one strength in color-coded Patient Convenience Packages of 4 bottles of 25 tablets each (0.4 mg). The 0.3 mg sublingual tablets are a white, round, flat faced tablet debossed with “3” on one side and “V” on other side. They are supplied as: NDC 47781-456-01 Bottle of 100 tablets The 0.4 mg sublingual tablets are a white, round, flat faced tablet debossed with “4” on one side and “V” on other side. They are supplied as: NDC 47781-457-01 Bottle of 100 tablets NDC 47781-457-04 Patient Convenience Package of 4 bottles of 25 tablets The 0.6 mg sublingual tablets are a white, round, flat faced tablet debossed with “6” on one side and “V” on other side. They are supplied as: NDC 47781-458-01 Bottle of 100 tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Nitroglycerin should be kept in the original glass container and must be tightly capped after each use to prevent loss of tablet potency.
Abbreviated New Drug Application
NITROGLYCERIN- NITROGLYCERIN TABLET ALVOGEN INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NITROGLYCERIN SUBLINGUAL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NITROGLYCERIN SUBLINGUAL TABLETS. NITROGLYCERIN SUBLINGUAL TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1981 INDICATIONS AND USAGE Nitroglycerin sublingual tablets are a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. (1) DOSAGE AND ADMINISTRATION • At the onset of an attack, administer one tablet under the tongue or buccal pouch. One additional tablet may be administered every 5 minutes as needed. No more than 3 total tablets are recommended within a 15 minute period. (2) • If chest pain persists after three tablets, seek prompt medical attention. (2) • May be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. (2) DOSAGE FORMS AND STRENGTHS Sublingual tablets, 0.3 mg; 0.4 mg; 0.6 mg (3) CONTRAINDICATIONS • Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulators. (4.1, 7.1) • Severe anemia (4.2) • Increased intracranial pressure (4.3) • Hypersensitivity to nitroglycerin sublingual tablets or to other nitrates or nitrites or any excipient (4.4) • Circulatory failure and shock (4.5) WARNINGS AND PRECAUTIONS • Tolerance: Excessive use may lead to tolerance. (5.1) • Hypotension: Severe hypotension may occur. (5.2) ADVERSE REACTIONS Most common adverse reactions occurring at a frequency greater than 2% are headache, dizziness and paresthesia. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALVOGEN, INC. AT 1-866-770-3024 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use. (7.2) SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA Lire le document complet