INDICATIONS
Combivent® Inhalation Aerosol is indicated for use in
patients with chronic obstructive pulmonary disease (COPD)
on a regular aerosol bronchodilator who continue to have
evidence of bronchospasm and who require a second bronchodilator.
DOSAGE AND ADMINISTRATION
The dose of Combivent® Inhalation Aerosol is two
inhalations four times a day. Patients may take additional
inhalations as required; however, the total number of
inhalations should not exceed 12 in 24 hours. Safety and
efficacy of additional doses of Combivent® Inhalation
Aerosol beyond 12 puffs in 24 hours have not been studied.
Also, safety and efficacy of extra doses of ipratropium
or albuterol in addition to the recommended doses of Combivent®
Inhalation Aerosol have not been studied. It is recommended
to “test spray” three times before using for
the first time and in cases where the aerosol has not
been used for more than 24 hours.
HOW SUPPLIED
Combivent® Inhalation Aerosol is supplied as a metered-dose
inhaler with a white mouthpiece which has a clear, colorless
sleeve and an orange protective cap. The Combivent®
Inhalation Aerosol canister should be used with the Combivent®
Inhalation Aerosol actuator only. The actuator should
not be used with other aerosol medications. 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. Each 14.7
gram canister provides sufficient medication for 200 inhalations
(NDC 0597-0013-14). The canister should be discarded after
the labeled number of actuations have been used. The amount
of medication in each actuation cannot be assured after
this point.
Store between 59o F (15o C) and 86o F (30o C). Avoid
excessive humidity. For optimal results, the canister
should be at room temperature before use. Shake well before
using.
Note: The statement below is
required by the Federal government’s Clean Air Act
for all products containing or manufactured with chlorofluorocarbons
(CFCs):
Warning: Contains trichloromonofluoromethane
(CFC-11), dichlorodifluoromethane (CFC-12) and dichlorotetrafluoroethane
( CFC-114), substances which harm public health and the
environment by destroying ozone in the upper atmosphere.
A notice similar to the above Warning has been placed
in the information for the patient of this product under
the Environmental Protection Agency’s (EPA’s)
regulations. The patient’s warning states that the
patient should consult his or her physician if there are
any questions about alternatives.
CAUTION: Federal law prohibits
dispensing without prescription.
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