DESCRIPTION

Combivent ® Inhalation Aerosol is a combination of ipratropium bromide and albuterol sulfate.

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. 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.

Mol. Wt. 430.4

Albuterol sulfate, chemically known as (1, 3-benzenedimethanol, '-[[(1,1dimethylethyl) amino] methyl]-4-hydroxy, sulfate (2: 1)( salt), ( )-is a relatively selective beta 2 -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.

(C 13 H 21 NO 3 ) 2 H 2 SO 4 albuterol sulfate Mol. Wt. 576.7

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.