IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E), IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

IPRATROPIUM BROMIDE

Composition:

IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 3 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.

Product summary:

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is supplied as a 3-mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Store in pouch until time of use. Supplied in cartons as listed below. Store between 2°C and 25°C (36°F and 77°F). Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL SULFATE SOLUTION
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE INHALATION SOLUTION
0.5 MG / 3 MG PER 3 ML (RDP)
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.
Figure 3.1-2. Chemical structure of ipratropium bromide.
2
1
13
21
3
2
2
4
20
30
3
2
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.
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