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 Side Effects, and Drug Interactions - Ipratropium and Albuterol
Combivent Side Effects, and Drug Interactions - Ipratropium and Albuterol
SIDE EFFECTS
Adverse reaction information
concerning Combivent® lnhalation Aerosol is derived from two
12-week controlled clinical
trials (N= 358 for Combivent® Inhalation Aerosol).
|
All Adverse Events (in percentages), from
Two Large Double-Blind, Parallel,
12-week Studies of Patients with COPD
|
| |
Combivent®
Ipratropium Bromide
36 mcg/ Aluterol Sulfate
206 mcg q. i. d.
N=
358
|
lpratropium Bromide
36 mcg q. i. d.
N= 362
|
Albuterol Sulfate
206 mcg q. i. d.
N= 347
|
| Body as A Whole-
General Disorders |
| Headache |
5.6
|
3.9
|
6.6
|
| Pain |
2 5
|
1.9
|
1.2
|
| Influenza |
1.4
|
2.2
|
2.9
|
| Chest Pain |
0.3
|
1.4
|
2.9
|
| Gastrointestinal
System Disorders |
| Nausea |
2.0
|
2.5
|
2.6
|
| Respiratory System
Disorders (lower) |
| Bronchitis |
12.3
|
12.4
|
17.9
|
| Dyspnea |
4.5
|
3.9
|
4.0
|
| Coughing |
4.2
|
2.8
|
2.6
|
| Respiratory Disorders
|
2.5
|
1.7
|
2.3
|
| Pneumonia |
1.4
|
2.5
|
0.6
|
| Bronchospasm |
0.3
|
3.9
|
1.7
|
| Respiratory System
Disorders (Upper) |
| Tract Infection |
10.9
|
12.7
|
13.0
|
| Pharyngitis |
2.2
|
3.3
|
2.3
|
| Sinusitis |
2.3
|
1.9
|
0.9
|
| Rhinitis |
1.1
|
2.5
|
2.3
|
All adverse events, regardless of drug
relationship, reported by two patients in one or more treatment
group in the 12-week controlled
percent or more clinical
trials.
Additional adverse reactions, reported in less than two percent
of the patients in the Combivent® Inhalation Aerosol treatment
group include edema, fatigue,
hypertension, dizziness,
nervousness, paresthesia
tremor, dysphonia, insomnia,
diarrhea, dry mouth,
dyspepsia, vomiting,
arrhythmia, palpitation, tachycardia,
arthralgia, angina,
increased sputum, taste
perversion, and urinary
tract infection/dysuria.
Allergic-type reactions such
as skin rash,
angioedema of tongue,
lips and face; urticaria
(including giant urticaria),
laryngospasm and
anaphylactic reaction have been reported, with postive rechallenge
in some cases. Many of these patients had a history
of allergies to other drugs and/or foods including soybean (See
CONTRAINDICATIONS).
Additional information derived from the published literature and
postmarketing surveillance on the use of ipratropium or albuterol
inhalation aerosol
singly or in combination that is not included in the lists above
includes: cases of precipitation
or worsening of narrow-angle glaucoma,
acute eye pain, blurred
vision, nasal congestion,
drying of secretions, mucosal ulcers, irritation from aerosol,
paradoxical bronchospasm,
wheezing, exacerbation
of COPD symptoms, heartburn,
drowsiness, CNS
stimulation, coordination difficulty, weakness, itching, flushing,
alopecia, hypotension,
gastrointestinal distress constipation,
and urinary difficulties.
DRUG INTERACTIONS
Combivent® Inhalation Aerosol has been used concomitantly with
other drugs, including sympathomimetic
bronchodilators, methylxanthines and steroids, commonly used in
the treatment of COPD,
without adverse drug reactions.
No formal drug interaction
studies have been performed with Combivent® Inhalation Aerosol
and these or other medications commonly used in the treatment of
COPD.
Anticholinergic agents: Although ipratropium bromide
is minimally absorbed into the systemic
circulation, there
is some potential for an additive
interaction with concomitantly used anticholinergic
medications. Caution is therefore advised in the co-administration
of Combivent® Inhalation Aerosol with other anticholinergic-containing
drugs.
Beta-adreneraic agents: Caution is advised in the
co-administration of Combivent® Inhalation Aerosol and other
sympathomimetic
agents due to the increased risk
of adverse cardiovascular
effects.
Beta-receptor blocking
agents and albuterol inhabit the effect of each other. Beta-receptor
blocking agents should
be used with caution in patients with hyperreactive
airways.
Diuretics: The ECG
changes and/or hypokalemia
which may result from the administration
of non-potassium sparing
diuretics (such as loop
or thiazide diuretics) can be acutely worsened by beta-agonists,
especially when the recommended dose
of the beta-agonist is exceeded. Although the clinical
significance of these effects is not known, caution is advised in
the co-administration of beta-agonist-containing drugs, such
as Combivent® Inhalation Aerosol, with non-potassium sparing
diuretics.
Monoamine oxidase
inhibitors or tricyclic antidepressants: Combivent®
Inhalation Aerosol should be administered with extreme caution to
patients being treated with monoamine
oxidase inhibitors or
tricyclic antidepressants or within two weeks of discontinuation
of such agents because
the action of albuterol
on the cardiovascular
system may be potentiated.
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