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
Atrovent Side Effects, and Drug Interactions - Ipratropium Bromide (inhalation)
Atrovent Side Effects, and Drug Interactions - Ipratropium Bromide (inhalation)
SIDE EFFECTS
Adverse reaction information
concerning ipratropium bromide
inhalation solution is derived from 12-week active-controlled clinical
trials. Additional information is derived from foreign post-marketing
experience and the
published literature.
All adverse events, regardless of drug
relationship, reported by three percent or more patients in the
12-week controlled clinical
trials appear in TABLE 1A , TABLE 1B and TABLE 1C below.
Additional adverse reactions reported in less than three percent
of the patients treated with ipratropium bromide
include tachycardia, palpitations, eye pain, urinary retention,
urinary tract infection
and urticaria. A single case of anaphylaxis
thought to be possibly related to ipratropium bromide has been reported.
Cases of precipitation
or worsening of narrow-angle glaucoma and acute
eye pain
have been reported.
Lower respiratory adverse reactions (bronchitis, dyspnea
and bronchospasm) were the most common events leading to discontinuation
of ipratropium bromide therapy in the 12-week trials. Headache,
mouth dryness and aggravation
of COPD symptoms are more
common when the total daily dose
of ipratropium bromide equals or exceeds 2,000 mcg.
| TABLE 1A All Adverse Events, from
a Double-Blind, Parallel, 12-Week Study of Patients with COPD* |
| |
PERCENT OF PATIENTS |
| |
Atrovent |
Alupent |
| |
(500 mcg
t.i.d.) |
(15 mg
t.i.d) |
| |
n=219 |
n=212 |
|
|
| Headache |
6.4 |
5.2 |
| Pain |
4.1 |
3.3 |
| Influenza-like symptoms |
3.7 |
4.7 |
| Back pain |
3.2 |
1.9 |
| Chest pain |
3.2 |
4.2 |
|
|
| Hypertension/Hypertension Aggravated |
0.9 |
1.9 |
|
|
| Dizziness |
2.3 |
3.3 |
| Insomnia |
0.9 |
0.5 |
| Tremor |
0.9 |
7.1 |
| Nervousness |
0.5 |
4.7 |
|
|
| Mouth Dryness |
3.2 |
0.0 |
| Nausea |
4.1 |
3.8 |
| Constipation |
0.9 |
0.0 |
|
|
| Arthritis |
0.9 |
1.4 |
|
|
| Coughing |
4.6 |
8.0 |
| Dyspnea |
9.6 |
13.2 |
| Bronchitis |
14.6 |
24.5 |
| Bronchospasm |
2.3 |
2.8 |
| Sputum Increased |
1.4 |
1.4 |
| Respiratory Disorder |
0.0 |
6.1 |
|
|
| Upper Respiratory Tract Infection |
13.2 |
11.3 |
| Pharyngitis |
3.7 |
4.2 |
| Rhinitis |
2.3 |
4.2 |
| Sinusitis |
2.3 |
2.8 |
| * All adverse events, regardless
of drug relationship, reported by three percent
or more patients in the 12-week controlled clinical
trials. |
| TABLE 1B Ipratropium Bromide,
Adverse REACTIONS |
| All Adverse Events, from a Double-Blind,
Parallel, 12-Week Study of Patients with COPD* |
| |
PERCENT OF PATIENTS |
| |
Atrovent/Alupent |
Albuterol |
| |
(500 mcg
t.i.d./15 mg t.i.d.) |
(2.5 mg
t.i.d.) |
| |
n=108 |
n=205 |
|
|
| Headache |
6.5 |
6.3 |
| Pain |
0.9 |
2.9 |
| Influenza-like symptoms |
6.5 |
0.5 |
| Back pain |
1.9 |
2.4 |
| Chest pain |
5.6 |
2.0 |
|
|
| Hypertension/Hypertension Aggravated |
0.9 |
1.5 |
|
|
| Dizziness |
1.9 |
3.9 |
| Insomnia |
4.6 |
1.0 |
| Tremor |
8.3 |
1.0 |
| Nervousness |
6.5 |
1.0 |
|
|
| Mouth Dryness |
1.9 |
2.0 |
| Nausea |
1.9 |
2.9 |
| Constipation |
3.7 |
1.0 |
|
|
| Arthritis |
0.9 |
0.5 |
|
|
| Coughing |
6.5 |
5.4 |
| Dyspnea |
16.7 |
12.7 |
| Bronchitis |
15.7 |
16.6 |
| Bronchospasm |
4.6 |
5.4 |
| Sputum Increased |
4.6 |
3.4 |
| Respiratory Disorder |
6.5 |
2.0 |
|
|
| Upper Respiratory Tract Infection |
9.3 |
12.2 |
| Pharyngitis |
5.6 |
2.9 |
| Rhinitis |
1.9 |
2.4 |
| Sinusitis |
0.9 |
5.4 |
| * All adverse events, regardless
of drug relationship, reported by three percent
or more patients in the 12-week controlled clinical
trials. |
| TABLE 1C All Adverse Events, from
a Double-Blind, Parallel, 12-week Study of Patients with COPD* |
| |
PERCENT OF PATIENTS |
| |
Atrovent/Albuterol |
| |
(500 mcg
t.i.d./2.5 mg t.i.d.) |
| |
n=100 |
|
|
| Headache |
9.0 |
| Pain |
5.0 |
| Influenza-like symptoms |
1.0 |
| Back pain |
0.0 |
| Chest pain |
1.0 |
|
|
| Hypertension/Hypertension Aggravated |
4.0 |
|
|
| Dizziness |
4.0 |
| Insomnia |
1.0 |
| Tremor |
0.0 |
| Nervousness |
1.0 |
|
|
| Mouth Dryness |
3.0 |
| Nausea |
2.0 |
| Constipation |
1.0 |
|
|
| Arthritis |
3.0 |
|
|
| Coughing |
6.0 |
| Dyspnea |
9.0 |
| Bronchitis |
20.0 |
| Bronchospasm |
5.0 |
| Sputum Increased |
0.0 |
| Respiratory Disorder |
4.0 |
|
|
| Upper Respiratory Tract Infection |
16.0 |
| Pharyngitis |
4.0 |
| Rhinitis |
0.0 |
| Sinusitis |
4.0 |
| * All adverse events, regardless
of drug relationship, reported by three percent
or more patients in the 12-week controlled clinical
trials. |
DRUG INTERACTIONS
Ipratropium bromide
has been shown to be a safe and effective bronchodilator when used
in conjunction with beta
adrenergic bronchodilators.
Ipratropium bromide has also been used with other pulmonary medications,
including methylxanthines and corticosteroids, without adverse drug
interactions.
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