IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)

Предлага се от:

REMEDYREPACK INC.

INN (Международно Name):

IPRATROPIUM BROMIDE

Композиция:

IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 3 mL

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL
SULFATE SOLUTION
REMEDYREPACK INC.
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IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE INHALATION SOLUTION
IPRATROPIUM BROMIDE
AND ALBUTEROL SULFATE
INHALATION SOLUTION
0.5 MG/3 MG PER 3 ML
RX ONLY
DESCRIPTION
The active components in Ipratropium Bromide and Albuterol Sulfate
Inhalation Solution are albuterol
sulfate and ipratropium bromide.
Albuterol sulfate, is a salt of racemic albuterol and a relatively
selective β
-adrenergic bronchodilator
chemically described as α
-[( _tert_-butylamino)methyl]-4-hydroxy- _m_-xylene-α, α'-diol
sulfate (2:1)
(salt). It has a molecular weight of 576.7 and the empirical formula
is (C
H
NO
)
•H
SO
. It is a
white crystalline powder, soluble in water and slightly soluble in
ethanol. The World Health
Organization recommended name for albuterol base is salbutamol.
Figure 3.1-1. Chemical structure of albuterol sulfate
Ipratropium bromide is an anticholinergic bronchodilator chemically
described as 8-azoniabicyclo
[3.2.1]-octane,
3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-,
bromide,
monohydrate ( _endo, syn_)-, (±)-; a synthetic quaternary ammonium
compound, chemically related to
atropine. It has a molecular weight of 430.4 and the empirical formula
is C
H
BrNO
•H
O. It is a
white crystalline substance, freely soluble in water and lower
alcohols, and insoluble in lipophilic
solvents such as ether, chloroform, and fluorocarbons.
2
1
13
21
3
2
2
4
20
30
3
2
Figure 3.1-2. Chemical structure of ipratropium bromide.
Each 3 mL Sterile Unit-dose Vial contains 0.5 mg of ipratropium
bromide (0.017%) and 3 mg* albuterol
sulfate (0.083%) in an isotonic, sterile, aqueous solution containing
sodium chloride and 1 N
hydrochloric acid to adjust to pH 4.
*Equivalent to 2.5 mg albuterol base
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a
clear, colorless solution. It does not
require dilution prior to administration by nebulization. For
Ipratropium Bromide and Albuterol Sulfa