IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Preferred Pharmaceuticals, Inc.

Via de administração:

RESPIRATORY (INHALATION)

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

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 vials in pouch until time of use. Supplied in cartons as listed below. NDC 68788-7678-03: 30 vials per carton / 1 vial per foil pouch PROTECT FROM LIGHT. The unit-dose vial should remain stored in the protective foil pouch until time of use. Store between 2° and 25° C (36° and 77° F). Protect from light. Rx Only Manufactured by: Nephron Pharmaceuticals Corporation West Columbia, SC 29172 For Customer Service, Call 1-800-443-4313 Relabeled by Preferred Pharmaceuticals, Inc.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL
SULFATE SOLUTION
PREFERRED PHARMACEUTICALS, INC.
----------
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.
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
2
1
13
21
3
2
2
4
20
30
3
2
require dilution prior to administration by nebulization. For
Ipratropium Bromide and Albuterol Sulfate
Inhalation Solution, like all other nebulized treatments, the amount
deli