NITROGLYCERIN IN DEXTROSE- nitroglycerin injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Baxter Healthcare Company

INN (International Name):

NITROGLYCERIN

Composition:

NITROGLYCERIN 10 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitroglycerin in 5% Dextrose Injection is indicated for treatment of peri-operative hypertension; for control of heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and ß-blockers; and for induction of intraoperative hypotension. Nitroglycerin in 5% Dextrose 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 is also contraindicated in patients with increased intracranial pressure. Do not use Nitroglycerin in 5% Dextrose Injection in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors) such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not us

Product summary:

Nitroglycerin in 5% Dextrose Injection is supplied in glass container as follows: Code Size (mL) NDC Product Name 1A0692 250 0338-1047-02 25 mg Nitroglycerin in 5% Dextrose Injection 1A0694 250 0338-1049-02 50 mg Nitroglycerin in 5% Dextrose Injection 1A0696 250 0338-1051-02 100 mg Nitroglycerin in 5% Dextrose Injection Minimize exposure of pharmaceutical products to heat. Avoid excessive heat. Protect from freezing. Store the product at room temperature (25°C). Brief exposure up to 40°C does not adversely affect the product. Protect from light until time of use. Discard any unused portion. Baxter Healthcare Corporation Deerfield, IL 60015 Printed in USA Baxter is a registered trademark of Baxter International Inc. 07-19-76-571 Rev. August 2016

Authorization status:

New Drug Application

Summary of Product characteristics

NITROGLYCERIN IN DEXTROSE- NITROGLYCERIN INJECTION
BAXTER HEALTHCARE COMPANY
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NITROGLYCERIN IN 5% DEXTROSE INJECTION
FOR INTRAVENOUS USE ONLY
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.
Dextrose (Dextrose Hydrous, USP) is D-glucose monohydrate, a hexose
sugar whose structural
formula is
whose empiric formula is C H O • H O, and whose molecular weight is
198.17.
Dextrose is derived from corn.
Nitroglycerin in 5% Dextrose Injection is a sterile, nonpyrogenic
solution of nitroglycerin and dextrose
in water for injection. The solution is clear and practically
colorless. Each 100 mL contains 10 mg, 20
mg, or 40 mg nitroglycerin (added as Diluted Nitroglycerin, USP with
propylene glycol); 5 g Dextrose
Hydrous, USP; 0.84 mL Alcohol, USP (added as a dissolution aid); and
105 mg Citric Acid Hydrous,
USP (added as a buffer). The pH of the solution is adjusted with
sodium hydroxide and, if necessary,
hydrochloric acid.
Although dry nitroglycerin is explosive, nitroglycerin in 5% dextrose
is not.
Composition, osmolarity and pH are given in Table 1.
Table 1
Composition
Osmolarity
(mOsmol/L)
(calc)
pH
Nitroglycerin
(mcg/mL)
Dextrose
Hydrous, USP
(g/L)
25 mg Nitroglycerin
in 5% Dextrose Injection
100
50
428
4.0
(3.0 to 5.0)
50 mg Nitroglycerin
in 5% Dextrose Injection
200
50
440
4.0
(3.0 to 5.0)
3
5
3
9
6
12
6
2
*
*
100 mg Nitroglycerin
in 5% Dextrose Injection
400
50
465
4.0
(3.0 to 5.0)
CLINICAL PHARMACOLOGY
The principal pharmacological action of nitroglycerin 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
relaxatio