IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Teva Pharmaceuticals USA Inc

INN (שם בינלאומי):

IPRATROPIUM BROMIDE

הרכב:

IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 3 mL

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL
SULFATE SOLUTION
TEVA PHARMACEUTICALS USA INC
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IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE INHALATION SOLUTION
6723
RX ONLY
DESCRIPTION
The active components in ipratropium bromide and albuterol sulfate
inhalation solution are albuterol
sulfate, USP and ipratropium bromide.
Albuterol sulfate, USP 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 is a white crystalline powder, soluble in
water and slightly soluble in ethanol. The
World Health Organization recommended name for albuterol base is
salbutamol. It has the following
structural formula:
(C
H NO ) •H SO M.W. 576.7
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 is a white crystalline substance, freely soluble in water
and lower alcohols, and insoluble in
lipophilic solvents such as ether, chloroform, and fluorocarbons. It
has the following structural
formula:
C
H BrNO •H O M.W. 430.4
Each 3 mL vial of ipratropium bromide and albuterol sulfate inhalation
solution contains 3 mg (0.1%) of
albuterol sulfate, USP (equivalent to 2.5 mg (0.083%) of albuterol
base) and 0.5 mg (0.017%) of
ipratropium bromide in an isotonic, sterile, aqueous solution
containing disodium edetate dihydrate,
hydrochloric acid, sodium chloride, and water for injection.
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 sulfate
inhalation solution, like all other nebulized treatments, the amount
delivered to the lungs will depend on
patient factors, the jet nebul