Atrovent Suspension Ipratropium Bromide Aerosol 10 ML

ATROVENT® is indicated as a bronchodilator for the maintenance treatment of the
rnbronchospasm associated with chronic obstructive pulmonary disease, including bronchitis
rnchronic, emphysema and asthma.
rnPHARMACOKINETICS AND PHARMACODYNAMICS:

Pharmacokinetics:
rnThe therapeutic effect of ATROVENT® in aerosol is produced through a local action on the
rnair ways. Therefore, the time periods of bronchodilation and pharmacokinetics
rnsystemic are not parallel.

After inhalation of dose portions from 10 to 30%, which depend on the
rnformulation and inhalation technique are generally deposited in the lungs. The biggest
rnpart of the dose is swallowed and passes the gastrointestinal tract.
rnDue to the negligible gastrointestinal absorption of ipratropium bromide, the bioavailability of
rnthe swallowed dose portion is only counted as -2% of the administered dose.
rnThis dose fraction does not make a significant contribution to the plasma concentrations of the
rndrug.

The portion of the dose deposited in the lungs reaches the circulation rapidly (in minutes) and
rnit has almost complete systemic availability.
rnFrom the accumulated renal excretion data (0-24 h) the total systemic bioavailability
rn(pulmonary and gastrointestinal portions) of the inhaled dose of Ipratropium bromide was estimated in the

range from 7 to 28%. This is also true for the HFA aerosol inhalation range, as
rnthat the results in the kinetics (renal excretion, AUC and Cmax) of the HFA formulation, is
rnComparable to conventional CFC formulation.