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 (intranasal)
Atrovent Side Effects, and Drug Interactions - Ipratropium Bromide (intranasal)
SIDE EFFECTS
Ipratropium Bromide Nasal Spray 0.03%
Adverse reaction information
on ipratropium bromide
nasal spray 0.03% in patients
with perennial rhinitis
was derived from four multicenter, vehicle-controlled clinical
trials involving 703 patients (356 patients on ipratropium bromide
nasal spray 0.03% and
347 patients on vehicle), and a one-year, open-label, follow-up
trial. In three of the trials,
patients received ipratropium bromide
nasal spray 0.03% three
times daily, for eight weeks. In
the other trial, ipratropium bromide
nasal spray 0.03% was
given to patients two times daily for four weeks. Of the 285 patients
who entered the open-label, follow-up
trial, 232 were treated for 3 months, 200 for 6 months, and 159
up to one year. The majority (>86%) of patients treated for one
year were maintained on 42 mcg
per nostril, two or three
times daily, of ipratropium bromide
nasal spray 0.03%.
TABLE 1 shows adverse events, and the frequency that these adverse
events led to the discontinuation of treatment, reported for patients
who received ipratropium bromide
nasal spray 0.03% at the
recommended dose of 42
mcg per nostril, or vehicle
two or three times daily for four or eight weeks. Only adverse events
reported with an incidence
of at least 2.0% in the ipratropium bromide
nasal spray 0.03% group
and higher in the ipratropium bromide nasal
spray 0.03% group than
in the vehicle group
are shown.
| TABLE 1 % of Patients Reporting
Events* |
| |
Nasal Spray 0.03% |
Vehicle Control |
| |
(n=356) |
(n=347) |
| |
Incidence% |
Discontinued% |
Incidence% |
Discontinued% |
| Headache |
9.8 |
0.6 |
9.2 |
|
| Upper Respiratory Tract Infection |
9.8 |
1.4 |
7.2 |
1.4 |
| Epistaxis† |
9.0 |
0.3 |
4.6 |
0.3 |
| Rhinitis‡ |
|
|
5.1 |
|
0.9 |
0.3 |
|
|
2.0 |
|
1.7 |
0.6 |
|
|
3.1 |
1.1 |
1.7 |
0.3 |
| Pharyngitis |
8.1 |
0.3 |
4.6 |
|
| Nausea |
2.2 |
0.3 |
0.9 |
|
| * This table
includes adverse events which occurred at an incidence
rate of at least
2.0% in the ipratropium bromide nasal spray 0.03% group
and more frequently in the ipratropium bromide nasal spray
0.03% group than
in the vehicle
group. |
| † Epistaxis reported by 7.0%
of ipratropium bromide patients and 2.3% of vehicle
patients, blood-tinged mucus
by 2.0% of ipratropium bromide
patients and 2.3% of vehicle
patients. |
| ‡ All events are listed by their
WHO term; rhinitis
has been presented by descriptive terms for clarification. |
| § Nasal irritation
includes reports of nasal
itching, nasal burning,
nasal irritation
and ulcerative
rhinitis. |
| || Other nasal
symptoms include reports of nasal
congestion, increased rhinorrhea, increased rhinitis, posterior
nasal drip, sneezing, nasal
polyps and nasal
edema. |
Ipratropium bromide
nasal spray 0.03% was
well tolerated by most patients. The most frequently reported nasal
adverse events were transient
episodes of nasal dryness
or epistaxis. These adverse events were mild or moderate in nature,
none was considered serious, none resulted in hospitalization and
most resolved spontaneously or following a dose
reduction. Treatment for nasal
dryness and epistaxis
was required infrequently (2% or less) and consisted of local
application of pressure
or a moisturizing agent (e.g., petroleum
jelly or saline nasal
spray). Patient discontinuation for epistaxis
or nasal dryness was infrequent
in both the controlled (0.3% or less) and one-year, open-label (2%
or less) trials. There was no evidence of nasal
rebound (i.e.,
a clinically significant
increase in rhinorrhea, posterior nasal
drip, sneezing or nasal
congestion severity
compared to baseline) upon discontinuation of double-blind therapy
in these trials.
Adverse events reported by less than 2% of the patients receiving
ipratropium bromide nasal
spray 0.03% during the controlled clinical
trials or during the open-label follow-up
trial, which are potentially related to ipratropium bromide's local
effects or systemic
anticholinergic
effects include: dry mouth/throat, dizziness, ocular
irritation, blurred vision, conjunctivitis, hoarseness, cough
and taste perversion.
Additional anticholinergic
effects noted with other ipratropium bromide
dosage forms (ipratropium
bromide inhalation solution, ipratropium bromide
inhalation aerosol,
and ipratropium bromide nasal
spray 0.06%) include: precipitation
or worsening of narrow angle glaucoma, urinary retention, prostatic
disorders, tachycardia, constipation, and bowel
obstruction.
There were infrequent reports of skin
rash in both the controlled
and uncontrolled clinical
studies. Other allergic-type reactions such as angioedema of the
throat, tongue, lips and face, urticaria, laryngospasm
and anaphylactic reactions have been reported with other ipratropium
bromide products.
No controlled trial was conducted to address the relative incidence
of adverse events of b.i.d. versus t.i.d therapy.
Ipratropium Bromide Nasal Spray 0.06%
Adverse reaction information
on ipratropium bromide
nasal spray 0.06% in patients
with the common cold was
derived from two multi-center, vehicle-controlled clinical trials
involving 1276 patients (195 patients on ipratropium bromide nasal
spray 0.03%, 352 patients on ipratropium bromide
nasal spray 0.06%, 189
patients on ipratropium bromide
nasal spray 0.12%, 351
patients on vehicle and 189 patients receiving no treatment).
The TABLE 2 shows adverse events reported for patients who received
ipratropium bromide
nasal spray 0.06% at the
recommended dose of 84
mcg per nostril, or vehicle, administered three or four times daily,
where the incidence
is 1% or greater in the ipratropium bromide
group and higher in the
ipratropium bromide
group than in the vehicle
group.
| TABLE 2 % of Patients Reporting
Events* |
| |
Nasal Spray 0.06% |
Vehicle Control |
| |
(n=352) |
(n=351) |
| Epistaxis† |
8.2% |
2.3% |
| Dry Mouth/Throat |
1.4% |
0.3% |
| Nasal Congestion |
1.1% |
0.0% |
| Nasal Dryness |
4.8% |
2.8% |
| * This table
includes adverse events for which the incidence
was 1% or greater in the ipratropium bromide
group and higher in the ipratropium bromide
than in the vehicle
group. |
| † Epistaxis reported by 5.4%
of ipratropium bromide patients and 1.4% of vehicle
patients, blood
tinged mucus by
2.8% of ipratropium bromide
patients and 0.9% of vehicle
patients. |
Ipratropium bromide
nasal spray 0.06% was
well tolerated by most patients. The most frequently reported adverse
events were transient
episodes of nasal dryness or epistaxis. The majority of these adverse
events (96%) were mild or moderate in nature, none was considered
serious, and none resulted in hospitalization. No patient
required treatment
for nasal dryness, and
only three patients (<1%) required treatment
for epistaxis, which consisted of local
application of pressure
or a moisturizing agent
(e.g., petroleum jelly). No patient
receiving ipratropium bromide
nasal spray 0.06% was
discontinued from the trial due to either nasal
dryness or bleeding.
Adverse events reported by less than 1% of the patients receiving
ipratropium bromide nasal
spray 0.06% during the controlled clinical
trials which are potentially related to the local
or systemic anticholinergic
effects of ipratropium bromide
nasal spray 0.06% include:
taste perversion, nasal
burning, conjunctivitis, coughing, dizziness, hoarseness, palpitation,
pharyngitis, tachycardia, thirst, tinnitus
and blurred vision. Additional anticholinergic effects noted with
other ipratropium bromide
dosage forms (ipratropium
bromide inhalation
solution, ipratropium bromide
inhalation aerosol and ipratropium bromide
nasal spray 0.03%) include:
precipitation or worsening of narrow-angle glaucoma, urinary retention,
prostate disorders,
constipation and bowel
obstruction.
There were no reports of allergic-type reactions in the controlled
clinical trials. Allergic-type reactions such as skin
rash, angioedema
of the tongue, lips and face, urticaria, laryngospasm
and anaphylactic reactions have been reported with other ipratropium
bromide products.
No controlled trial was conducted to address the relative incidence
of adverse events for t.i.d. versus q.i.d. therapy.
DRUG INTERACTIONS
No controlled clinical
trials were conducted to investigate drug-drug interactions. Ipratropium
bromide nasal
spray, 0.03%and 0.06%, is minimally absorbed into the systemic
circulation; nonetheless, there is some potential for an additive
interaction with other concomitantly administered anticholinergic
medications, including ipratropium bromide
for oral inhalation.
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