Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
Nitroglycerin (UNII: G59M7S0WS3) (Nitroglycerin - UNII:G59M7S0WS3)
General Injectables and Vaccines, Inc.
Nitroglycerin
Nitroglycerin 5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Nitroglycerin Injection is indicated for treatment of peri-operative hypertension; for control of congestive heart failure in the setting of acute myocardial infarction;for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and b-blockers; and for induction of intraoperative hypotension. Allergic reactions to organic nitrates are extremely rare, but they do occur. Nitroglycerin Injection is contraindicated in patients who are allergic to it. In patients with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, cardiac output is dependent upon venous return. Intravenous nitroglycerin is contraindicated in patients with these conditions.
Nitroglycerin Injection, USP, 5mg/mL is available as follows: NDC 0517-4810-25 50mg/10 mL Single Dose Vial Package of 25 PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE. Store at 20°-25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). DISCARD UNUSED PORTION. AMERICAN REGENT LABORATORIES, INC. SHIRLEY, NY 11967 IN4805 Rev. 11/05
Abbreviated New Drug Application
NITROGLYCERIN- NITROGLYCERIN INJECTION, SOLUTION GENERAL INJECTABLES AND VACCINES, INC. ---------- NITROGLYCERIN 5 MG/ML INJECTION USP 10 ML SINGLE DOSE VIAL DESCRIPTION RX ONLY FOR INTRAVENOUS USE ONLY. NOT FOR DIRECT INTRAVENOUS INJECTION. NITROGLYCERIN INJECTION MUST BE DILUTED IN DEXTROSE (5%) INJECTION OR SODIUM CHLORIDE (0.9%) INJECTION PRIOR TO ITS INFUSION (SEE DOSAGE AND ADMINISTRATION SECTION). THE ADMINISTRATION SET USED FOR INFUSION WILL AFFECT THE AMOUNT OF NITROGLYCERIN INJECTION DELIVERED TO THE PATIENT. (SEE WARNINGS, AND DOSAGE AND ADMINISTRATION SECTIONS). CAUTION SEVERAL PREPARATIONS OF NITROGLYCERIN FOR INJECTION ARE AVAILABLE. THEY DIFFER IN CONCENTRATION AND/OR VOLUME PER VIAL. WHEN SWITCHING FROM ONE PRODUCT TO ANOTHER, ATTENTION MUST BE PAID TO THE DILUTION AND DOSAGE AND ADMINISTRATION INSTRUCTIONS. DESCRIPTION: Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is: whose empiric formula is C3H5N3O9, and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Nitroglycerin Injection, USP is a clear, practically colorless additive solution for intravenous infusion after dilution. Each mL contains: Nitroglycerin 5 mg, Alcohol 30% (v/v), Propylene Glycol 30%, and Water for Injection q.s. pH (range 3.0 to 6.5) may have been adjusted with Sodium Hydroxide and/or Hydrochloric Acid. The solution is sterile, non-pyrogenic, and nonexplosive. CLINICAL PHARMACOLOGY The principal pharmacological action of Nitroglycerin Injection is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary a Pročitajte cijeli dokument