Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)
REMEDYREPACK INC.
NITROGLYCERIN
NITROGLYCERIN 400 ug
ORAL
PRESCRIPTION DRUG
Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Do not use Nitroglycerin Lingual Spray in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [ see Drug Interactions (7.1) ]. Do not use Nitroglycerin Lingual Spray in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use can cause hypotension. Nitroglycerin Lingual Spray is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). Nitroglycerin Lingual Spray 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). Nitroglycerin Lingual Spray is contraindicated in pati
Each box of Nitroglycerin Lingual Spray contains one glass bottle coated with orange transparent plastic which assists in containing the glass and medication should the bottle be shattered. Each bottle contains 4.9 g or 12 g (Net Content) of nitroglycerin lingual spray which will deliver 60 or 200 metered sprays containing 400 mcg of nitroglycerin per spray after priming. Nitroglycerin Lingual Spray is available as: Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Note: Nitroglycerin Lingual Spray contains 20% alcohol. Do not forcefully open or burn container after use. Do not spray toward flames. Rx Only
Abbreviated New Drug Application
NITROGLYCERIN LINGUAL- NITROGLYCERIN SPRAY REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NITROGLYCERIN LINGUAL SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NITROGLYCERIN LINGUAL SPRAY. NITROGLYCERIN LINGUAL SPRAY INITIAL U.S. APPROVAL: 1997 INDICATIONS AND USAGE Nitroglycerin Lingual Spray is a nitrate vasodilator indicated for acute 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 onto or under the tongue. Repeat every 5 minutes as needed (2.1). Do up to three metered sprays within a 15-minute period. If chest pain persists, advise prompt medical attention (2.1). May be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack (2.1). DOSAGE FORMS AND STRENGTHS Lingual spray, 400 mcg per spray, available in 60 or 200 metered sprays per container. (3) CONTRAINDICATIONS Use of phosphodiesterase type 5 (PDE5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). (4.1) Severe anemia. (4.2) Increased intracranial pressure. (4.3) History of hypersensitivity to Nitroglycerin Lingual Spray or to other nitrates or nitrites or any excipient. (4.4) WARNINGS AND PRECAUTIONS Tolerance: Excessive use may lead to tolerance. (5) Hypotension: Severe hypotension may occur. (5) 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 Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/me dwatch. DRUG INTERACTIONS Antihypertensives: Possible additive hypotensive effects. (7.2) Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use (7.4) SEE 17 FOR PATIENT COUNSELING INFORMATION AND PATIENT COUNSELING INFORMATION. REVISED: 8/2019 FULL PRESCRIBING Baca dokumen lengkap