IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

A-S Medication Solutions

Antoreitti:

RESPIRATORY (INHALATION)

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

Product: 50090-1669 NDC: 50090-1669-0 3 mL in a VIAL, SINGLE-DOSE / 30 in a POUCH

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL SULFATE SOLUTION
A-S MEDICATION SOLUTIONS
----------
IPRATROPIUM BROMIDE 0.5 MG AND ALBUTEROL SULFATE 3 MG* INHALATION
SOLUTION
*Equivalent to 2.5 mg albuterol base.
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’s recommended name for albuterol base is
salbutamol.
Ipratropium bromide is an anticholinergic bronchodilator chemically
described as 8-
azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-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
Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation
Solution contains
3 mg (0.1%) of albuterol sulfate (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 sodium chloride and 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 delivered t