NITROGLYCERIN injection, solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

Nitroglycerin (UNII: G59M7S0WS3) (Nitroglycerin - UNII:G59M7S0WS3)

可用日期:

General Injectables and Vaccines, Inc.

INN（国际名称）:

Nitroglycerin

组成:

Nitroglycerin 5 mg in 1 mL

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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.

產品總結:

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

授权状态:

Abbreviated New Drug Application

产品特点

NITROGLYCERIN- NITROGLYCERIN INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
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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