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
Albuterol Side Effects, and Drug Interactions - Albuterol
Albuterol Side Effects, and Drug Interactions - Albuterol
SIDE EFFECTS
Syrup and Tablets
In addition to the reactions
listed separately below, albuterol, like other sympathomimetic
agents, can cause adverse reactions
such as hypertension, angina, vomiting, vertigo, CNS
stimulation, unusual taste, and drying or irritation of the oropharynx.
The reactions are generally transient
in nature, and it is usually not necessary to discontinue treatment
with albuterol. In selected cases,
however, dosage may be reduced temporarily; after the reaction
has subsided, dosage should be increased in small increments to the optimal
dosage.
Syrup
The adverse reactions to albuterol are similar in nature to those to
other sympathomimetic
agents. The most frequent adverse reactions to albuterol syrup in adults
and older children were tremor, 10 of 100 patients; nervousness and shakiness,
each 9 of 100 patients. Other reported adverse reactions were headache,
4 of 100 patients; dizziness
and increased appetite, each 3 of 100 patients; hyperactivity and excitement,
each 2 of 100 patients; tachycardia, epistaxis, irritable
behavior, and sleeplessness, each 1 of 100 patients. The following adverse
effects occurred in less than 1 of 100 patients each: muscle
spasm; disturbed sleep; epigastric pain; cough; palpitations; stomach
ache; irritable behavior;
dilated pupils; sweating; chest pain; weakness.
In young children 2 to 6 years of age, some adverse reactions were noted
more frequently than in adults and older children. Excitement was noted
in approximately 20% of patients and nervousness
in 15%. Hyperkinesia occurred in 4% of patients; insomnia, tachycardia,
and gastrointestinal
symptoms in 2% each. Anorexia, emotional lability, pallor, fatigue, and
conjunctivitis were seen in 1%.
Immediate-Release Tablets
In clinical trials, the
most frequent adverse reactions to albuterol tablets were as shown in
TABLE 1.
|
TABLE 1 Percent Incidence of Adverse REACTIONS
|
| Reaction |
Percent Incidence |
| Central Nervous System |
|
| Nervousness |
20% |
| Tremor |
20% |
| Headache |
7% |
| Sleeplessness |
2% |
| Weakness |
2% |
| Dizziness |
2% |
| Drowsiness |
<1% |
| Restlessness |
<1% |
| Irritability |
<1% |
| Cardiovascular |
|
| Tachycardia |
5% |
| Palpitations |
5% |
| Chest discomfort |
<1% |
| Flushing |
<1% |
| Musculoskeletal |
|
| Muscle cramps |
3% |
| Gastrointestinal |
|
| Nausea |
2% |
| Genitourinary |
|
| Difficulty in micturition |
<1% |
Cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal edema,
and arrhythmias (including atrial
fibrillation, supraventricular
tachycardia, extrasystoles) have been reported after the use of albuterol
immediate-release tablets.
Extended-Release Tablets
The adverse reactions to albuterol are similar in nature to those of
other sympathomimetic
agents. The most frequent adverse reactions to albuterol tablets were
nervousness and tremor,
with each occurring in approximately 20 of 100 patients (20%). Other reported
reactions were headache, 7 of 100 patients (7%); tachycardia
and palpitations, 5 of 100 patients (5%); muscle cramps, 3 of 100 patients
(3%); insomnia, nausea, weakness, and dizziness, each occurred in 2 of
100 patients (2%). Drowsiness, flushing, restlessness, irritability, chest
discomfort, and difficulty in micturition each occurred in fewer than
1 of 100 patients (less than 1%).
In a clinical study of 1
week duration comparing a
4 mg albuterol extended-release
tablet administered every 12 hours to a 2 mg
albuterol immediate-release tablet administered every 6 hours, the following
adverse reactions considered to be possibly or probably treatment
related were reported: nervousness in 1 of 50 (2%) and 3 of 50 patients
(6%) for albuterol extended-release and albuterol immediate-release tablets,
respectively; nausea in 2 of
50 (4%) for both; vomiting
in 1 of 50 (2%) and 2 of 50 (4%) for albuterol extended-release and albuterol
immediate-release tablets, respectively; somnolence in 1 of 50 (2%) for
both. The following adverse reactions were reported for albuterol immediate-release
tablets only: tremor in 3 of
50 patients (6%), tinnitus, dyspepsia, and rash
each occurred in 1 of 50 patients (2%).
Although not reported for albuterol extended-release tablets in the above
study, there have been reports of tremor
in other trials. When all clinical experience
is considered, the incidence
of tremor is approximately
the same as that seen with albuterol tablets.
A placebo-controlled trial of 4 weeks duration
in 157 mild-to-moderate asthmatic children aged
6 to 12 years, demonstrated the safety of escalating doses of albuterol
extended-release tablets. In this
study, the starting dose of albuterol extended-release tablets was 4 mg
twice daily. Patients were advanced to a maximum
of 12 mg albuterol extended-release
tablets twice daily by the investigator, based on patient
tolerance and response.
Only one of the 79 children treated with albuterol extended-release tablets
advanced to the maximum daily
dose of 12 mg
twice daily. The following treatment-related adverse events occurred in
more than 5% of treated patients and were greater in albuterol extended-release
tablets patients when compared to placebo: headache
(22% albuterol extended-release tablets, 9% placebo); tremor (10% albuterol
extended-release tablets, 1% placebo); tachycardia and palpitations (8%
albuterol extended-release tablets, 1% placebo); and nervousness (13%
albuterol extended-release tablets, 6% placebo). Other adverse events
were found in 5% or fewer patients, or had equal or greater rates of occurrence
in placebo patients than in
albuterol extended-release tablets patients.
DRUG INTERACTIONS
Syrup and Tablets
The concomitant use of
albuterol and other oral sympathomimetic
agents is not recommended since such combined use may lead
to deleterious cardiovascular
effects. This recommendation does not preclude the judicious use of an
aerosol bronchodilator
of the adrenergic stimulant
type in patients receiving albuterol
tablets or syrup. Such concomitant
use, however, should be individualized and not given on a routine basis.
If regular coadministration
is required, then alternative therapy should be considered.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants:
Albuterol 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 albuterol on the vascular
system may be potentiated.
Syrup and Extended-Release Tablets
Beta-receptor blocking agents
and albuterol inhibit the effect
of each other.
Since albuterol may lower serum
potassium, care should be taken in patients also using other drugs which
lower serum potassium
as the effects may be additive.
After single-dose administration
of albuterol to normal volunteers
who had received digoxin for
10 days, a 16% to 22% decrease in serum
digoxin levels was demonstrated. The clinical
significance of these findings for patients with obstructive airway disease
who are receiving albuterol and digoxin on a chronic
basis is unclear. Nevertheless,
it would be prudent to carefully evaluate the serum
digoxin levels in patients
who are concurrently receiving digoxin
and albuterol.
Tablets
Beta-Blockers: Beta-adrenergic receptor
blocking agents not only
block the pulmonary effect
of beta-agonists, such as albuterol, but may 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 nonpotassium-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 nonpotassium-sparing diuretics.
Digoxin: Mean decreases of 16% to 22% in serum
digoxin levels were demonstrated after single-dose intravenous
and oral administration of 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 albuterol and digoxin
on a chronic basis is unclear.
Nevertheless, it would be prudent to carefully evaluate the serum
digoxin levels in patients
who are concurrently receiving digoxin and albuterol.
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