NITROGLYCERIN injection, solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)

Доступна с:

American Regent, Inc.

ИНН (Международная Имя):

NITROGLYCERIN

состав:

NITROGLYCERIN 5 mg in 1 mL

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 β -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.

Обзор продуктов:

Nitroglycerin Injection, USP, 5 mg/mL is available as follows: PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). DISCARD UNUSED PORTION. AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN4805 Rev. 11/05 MG #6925

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

NITROGLYCERIN- NITROGLYCERIN INJECTION, SOLUTION
AMERICAN REGENT, INC.
----------
NITROGLYCERIN
INJECTION, USP
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 C H N O , 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
3
5
3
9
pulmonary capillary wedge pressure (preload). Arteriolar relaxation
reduces systemic
vascular resistance, systolic arterial pressure, and mean arterial
pressure (afterload).
Dilatation of the coronary arteries also occurs. The relative
importance of pre