Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)
REMEDYREPACK INC.
NITROGLYCERIN
NITROGLYCERIN 0.4 mg
SUBLINGUAL
PRESCRIPTION DRUG
NITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Do not use NITROSTAT 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 NITROSTAT in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. Concomitant use can cause hypotension. NITROSTAT is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). NITROSTAT 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). NITROSTAT is contraindicated in patients who are allergic to nitroglycerin, other nitrat
NITROSTAT is supplied as white, round, flat-faced tablets in 4 mg strength 0.4 mg: Coded "N" on one side and "4" on the other. NDC: 70518-0105-00 PACKAGING: 25 in 1 BOTTLE Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Store at Controlled Room Temperature 20°–25°C (68°–77°F) [see USP]. Nitroglycerin should be kept in the original glass container and must be tightly capped after each use to prevent loss of tablet potency.
New Drug Application
NITROSTAT- NITROGLYCERIN TABLET REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NITROSTAT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NITROSTAT NITROSTAT (NITROGLYCERIN) SUBLINGUAL TABLET INITIAL U.S. APPROVAL: 1981 INDICATIONS AND USAGE NITROSTAT is 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 NITROSTAT 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 PFIZER, INC. AT 1-800-438-1985 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-APPROVED PATIENT LABELING. REVISED: 2/2020 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND Læs hele dokumentet