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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