DESCRIPTION
Combivent® (ipratropium bromide and albuterol
sulfate)
Combivent® Inhalation Aerosol is a combination of
ipratropium bromide and albuterol sulfate. Ipratropium
bromide is an anticholinergic bronchodiiator chemically
described as 8- azoniabicyclo[ 3.2.1] octane, 3-(3-hydroxy-1oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-,
bromide, monohydrate (endo, syn)-,(+): a synthetic quaternary
ammonium compound chemically related to afropine. Ipratropium
bromide is a white to off-white crystalline substance.
freely soluble in water and lower alcohols but insoluble
in lipophilic solvents such as ether, chloroform and fluorocarbons.
Albuterol sulfate, chemically known as (13-benzenedimethanol,
a’- ((1,1-dimethylethyl)amino] methyl]- 4- hydroxy,
sulfate (2:1)(salt), (+)- is a relatively selective beta2-adrenergic
bronchodilator. Albuterol is the official generic name
in the United States. The World Health Organization recommended
name for the drug is salbutamol. Albuterol sulfate is
a white to off-white crystalline powder soluble in water
and slightly soluble in ethanol.
Combivent® Inhalation Aerosol contains a microcrystalline
suspension of ipratropium bromide and albuterol sulfate
in a pressurized metered-dose aerosol unit for oral inhalation
administration. The 200 inhalation unit has a net weight
of 14.7 grams. Each actuation meters 21 mcg of ipratropium
bromide and 120 mcg of albuterol sulfate from the valve
and delivers 18 mcg of ipratropium bromide and 103 mcg of
albuterol sulfate (equivalent to 90 mcg albuterol base)
from the mouthpiece. The excipients are dichlorodifluoromethane,
dichlorotetrafluoroethane, and trichloromonofluoromethane
as propellants and soya lecithin.
|
|
