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
Xopenex Side Effects, and Drug Interactions - Levalbuterol
Xopenex Side Effects, and Drug Interactions - Levalbuterol
SIDE EFFECTS
Adverse events reported in ³ 2%
of patients receiving Xopenex Inhalation Solution or racemic
albuterol and more frequently than in patients receiving placebo
in a 4-week, controlled clinical
trial are listed in Table 2.
Table 2 Adverse Events Reported in a 4-Week, Controlled Clinical
Trial
|
Body System
Preferred Term
|
Percent of Patients
|
|
Placebo
(n= 75)
|
Xopenex
1.25 mg
(n= 73)
|
Xopenex
0.63 mg
(n= 72)
|
Racemic albuterol
2.5 mg
(n= 74)
|
|
Body as a Whole
|
|
Allergic reaction
|
1.3
|
0
|
0
|
2.7
|
|
Flu syndrome
|
0
|
1.4
|
4.2
|
2.7
|
|
Accidental injury
|
0
|
2.7
|
0
|
0
|
|
Pain
|
1.3
|
1.4
|
2.8
|
2.7
|
|
Back pain
|
0
|
0
|
0
|
2.7
|
|
Cardiovascular System
|
|
Tachycardia
|
0
|
2.7
|
2.8
|
2.7
|
|
Migraine
|
0
|
2.7
|
0
|
0
|
|
Digestive System
|
|
Dyspepsia
|
1.3
|
2.7
|
1.4
|
1.4
|
|
Musculoskeletal System
|
|
Leg cramps
|
1.3
|
2.7
|
0
|
1.4
|
|
Central Nervous System
|
|
Dizziness
|
1.3
|
2.7
|
1.4
|
0
|
|
Hypertonia
|
0
|
0
|
0
|
2.7
|
|
Nervousness
|
0
|
9.6
|
2.8
|
8.1
|
|
Tremor
|
0
|
6.8
|
0
|
2.7
|
|
Anxiety
|
0
|
2.7
|
0
|
0
|
|
Respiratory System
|
|
Cough increased
|
2.7
|
4.1
|
1.4
|
2.7
|
|
Infection viral
|
9.3
|
12.3
|
6.9
|
12.2
|
|
Rhinitis
|
2.7
|
2.7
|
11.1
|
6.8
|
|
Sinusitis
|
2.7
|
1.4
|
4.2
|
2.7
|
|
Turbinate edema
|
0
|
1.4
|
2.8
|
0
|
The incidence of certain
systemic beta-adrenergic
adverse effects (e.g., tremor,
nervousness) was slightly less in the Xopenex 0.63 mg
group as compared to the other active treatment
groups. The clinical
significance of these small differences is unknown.
Changes in heart rate
15 minutes after drug administration
and in plasma glucose and potassium
one hour after drug administration
on day 1 and day 29 were clinically comparable in the Xopenex 1.25
mg and the racemic
albuterol 2.5 mg groups (see
Table 3). Changes in heart
rate and plasma
glucose were slightly
less in the Xopenex 0.63 mg
group compared to the
other active treatment groups (see Table 3). The clinical
significance of these small differences is unknown. After 4 weeks,
effects on heart rate,
plasma glucose, and plasma
potassium were generally
diminished compared with day 1 in all active treatment
groups.
Table 3
Mean Changes from Baseline in Heart Rate at 15 Minutes and
in Glucose and Potassium at 1 Hour after First Dose (Day 1)
|
Treatment
|
Mean Changes (day 1)
|
|
Heart Rate
(bpm)
|
Glucose
(mg/dL)
|
Potassium
(mEq/L)
|
|
Xopenex 0.63 mg, n= 72
|
2.4
|
4.6
|
–0.2
|
|
Xopenex 1.25 mg, n= 73
|
6.9
|
10.3
|
–0.3
|
|
Racemic albuterol 2.5 mg, n= 74
|
5.7
|
8.2
|
–0.3
|
|
Placebo, n= 75
|
–2.8
|
–0.2
|
–0.2
|
No other clinically relevant laboratory
abnormalities related to administration
of Xopenex Inhalation Solution were observed in this study.
In the clinical trials,
a slightly greater number
of serious adverse events, discontinuations due to adverse events,
and clinically significant ECG changes were reported in patients
who received Xopenex 1.25 mg
compared to the other active treatment
groups.
The following adverse events, considered potentially related to
Xopenex, occurred in less than 2% of the 292 subjects who received
Xopenex and more frequently than in patients who received placebo
in any clinical trial:
| Body as a Whole: |
chills, pain,
chest pain |
| Cardiovascular System: |
ECG abnormal, ECG
change, hypertension,
hypotension, syncope |
| Digestive System: |
diarrhea, dry mouth,
dry throat, dyspepsia,
gastroenteritis, nausea |
| Hemic and Lymphatic System: |
lymphadenopathy |
| Musculoskeletal System: |
leg cramps, myalgia |
| Nervous System: |
anxiety, hypesthesia
of the hand, insomnia, paresthesia, tremor |
| Special Senses: |
eye itch |
The following events, considered potentially
related to Xopenex, occurred in less than 2% of the treated subjects
but at a frequency
less than in patients who received placebo: asthma
exacerbation, cough increased, wheezing,
sweating, and vomiting.
DRUG INTERACTIONS
Other short-acting sympathomimetic
aerosol bronchodilators
or epinephrine should be used with caution with levalbuterol. If
additional adrenergic drugs are to be administered by any route,
they should be used with caution to avoid deleterious
cardiovascular
effects.
Beta-blockers
Beta-adrenergic receptor
blocking agents not
only block the pulmonary
effect of beta agonists
such as Xopenex (levalbuterol
HCl) Inhalation Solution, but may also produce severe bronchospasm
in asthmatic patients. Therefore, patients with asthma
should not normally be treated with beta-blockers. However, under
certain circumstances, e.g., as prophylaxis
after myocardial infarction, there may be no
acceptable alternatives to the use of beta-adrenergic blocking agents
in patients with asthma. In
this setting, cardioselective beta-blockers could be considered,
although they should be administered with caution.
Diuretics
The ECG changes and/or
hypokalemia that
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 coadministration of beta
agonists with non-potassium sparing
diuretics.
Digoxin
Mean decreases of 16% and 22% in serum
digoxin levels were
demonstrated after single-dose intravenous
and oral administration
of racemic albuterol,
respectively, to normal
volunteers who had received digoxin
for 10 days. The clinical
significance of these findings for patients with obstructive airway
disease who are receiving
levalbuterol HCl and digoxin
on a chronic basis is unclear. Nevertheless, it would be prudent
to carefully evaluate the serum
digoxin levels in patients
who are currently receiving digoxin and Xopenex Inhalation Solution.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
Xopenex Inhalation Solution should be administered with extreme
caution to patients being treated with monoamine
oxidase inhibitors or
tricyclic antidepressants, or within 2 weeks of discontinuation
of such agents, because
the action of levalbuterol
HCl on the vascular
system may be potentiated.
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