País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)
General Injectables & Vaccines, 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. 4.1 PDE-5-Inhibitors and sGC-Stimulators 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. 4.2 Severe Anemia NITROSTAT is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). 4.3 Increased Intracranial Pressure 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). 4.4 Hypersensitivity NITRO
NITROSTAT is supplied as white, round, flat-faced tablets 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. 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 General Injectables & Vaccines, Inc ---------- NITROSTAT® (NITROGLYCERIN SUBLINGUAL TABLETS, USP) Read this information carefully before you start NITROSTAT® (NYE-troe-stat) and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about NITROSTAT, ask your doctor. Your doctor will know if NITROSTAT is right for you. What is NITROSTAT? NITROSTAT is a type of medicine known as an organic nitrate and is a vasodilating agent. It is used to treat a type of chest pain called angina. What is Angina? Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. NITROSTAT can relieve this pain. Who should not use NITROSTAT? Do not use NITROSTAT if you are allergic to organic nitrates (like the active ingredient in NITROSTAT). You should not take NITROSTAT if you have the following conditions: • very recent heart attack • severe anemia • increased pressure in the head Do not take NITROSTAT with drugs for erectile dysfunction, like VIAGRA® (sildenafil citrate), CIALIS®(tadalafil), or LEVITRA® (vardenafil hydrochloride), as this may lead to extreme lowering of your blood pressure. Do not take NITROSTAT if you take medicines called guanylate cyclase stimulators which include riociguat, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension. What should I tell my doctor before taking NITROSTAT? Before using NITROSTAT, tell your doctor if: • You are taking any medicines that are used to treat angina, heart failure, or an irregular heartbeat. • You are taking any medicines that reduce blood pressure. • You are taking any diuretics (water pills). • You are taking medicines that can cause dry mouth such as tricyclic antidepress Leer el documento completo
NITROSTAT- NITROGLYCERIN TABLET GENERAL INJECTABLES & VACCINES, INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION NITROSTAT® (NITROGLYCERIN SUBLINGUAL TABLETS, USP) 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) (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) (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) (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. (6) DRUG INTERACTIONS Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use. (7.2) (7) SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. (7) REVISED: 2/2018 Leer el documento completo