A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Combivent Indications, Dosage, Storage, Stability - Ipratropium and Albuterol
Combivent Indications, Dosage, Storage, Stability - Ipratropium and Albuterol
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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