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Xopenex

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Xopenex

Xopenex

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of the drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults and Adolescents 12 Years of Age and Older

Adverse reaction information concerning XOPENEX Inhalation Solution in adults and adolescents is derived from one 4-week, multicenter, randomized, double-blind, active-, and placebo-controlled trial in 362 patients with asthma 12 years of age and older. Adverse reactions reported in ≥ 2% of patients receiving XOPENEX Inhalation Solution or racemic albuterol and more frequently than in patients receiving placebo are listed in Table 1.

Table 1: Adverse Reactions Reported in a 4-Week, Controlled Clinical Trial in Adults and Adolescents ≥ 12 Years Old

Body System
Preferred Term
Percentof Patientsa
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
a One treatment group, racemic albuterol 1.25 mg, with 68 subjects is omitted

The incidence of certain systemic beta-adrenergic adverse reactions (e.g., tremor, nervousness) was slightly less in the XOPENEX Inhalation Solution 0.63 mg group compared with 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 1 hour after drug administration on day 1 and day 29 were clinically comparable in the XOPENEX Inhalation Solution 1.25 mg and racemic albuterol 2.5 mg groups (see Table 2). Changes in heart rate and plasma glucose were slightly less in the XOPENEX Inhalation Solution 0.63 mg group compared with the other active treatment groups (see Table 2). 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 2: Mean Changes from Baseline Heart Rate at 15 Minutes and Glucose and Potassium at 1 Hour after First Dose (Day 1) in Adults and Adolescents ≥ 12 Years Old

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 with the other active treatment groups.

The following adverse reactions, 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, hyperesthesia of the hand, insomnia, paresthesia, tremor

Special Senses: eye itch

The following reactions, 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.

Pediatric Patients 6 to 11 Years of Age

Adverse reaction information concerning XOPENEX Inhalation Solution in pediatric patients is derived from one 3-week, multicenter, randomized, double-blind, active-, and placebo-controlled trial in 316 pediatric patients 6 to 11 years of age. Adverse reactions reported in ≥ 2% of patients in any treatment group and more frequently than in patients receiving placebo are listed in Table 3.

Table 3: Most Frequently Reported Adverse Reactions ( ≥ 2% in Any Treatment Group) and Those Reported More Frequently Than in Placebo during the Double-Blind Period (ITT Population, 6-11 Years Old)

Body System Preferred Term Percent of Patients
Placebo
(n=59)
XOPENEX 0.31 mg
(n=66)
XOPENEX 0.63 mg
(n=67)
Racemic albuterol 1.25 mg
(n=64)
Racemic albuterol 2.5 mg
(n=60)
Body as a Whole
  Abdominal pain 3.4 0 1.5 3.1 6.7
  Accidental injury 3.4 6.1 4.5 3.1 5
  Asthenia 0 3 3 1.6 1.7
  Fever 5.1 9.1 3 1.6 6.7
  Headache 8.5 7.6 11.9 9.4 3.3
  Pain 3.4 3 1.5 4.7 6.7
  Viral infection 5.1 7.6 9 4.7 8.3
Digestive System
  Diarrhea 0 1.5 6 1.6 0
Hemic and Lymphatic
  Lymphadenopathy 0 3 0 1.6 0
Musculoskeletal System
  Myalgia 0 0 1.5 1.6 3.3
Respiratory System
  Asthma 5.1 9.1 9 6.3 10
  Pharyngitis 6.8 3 10.4 0 6.7
  Rhinitis 1.7 6.1 10.4 3.1 5
Skin and Appendages
  Eczema 0 0 0 0 3.3
  Rash 0 0 7.5 1.6 0
  Urticaria 0 0 3 0 0
Special Senses
  Otitis media 1.7 0 0 0 3.3
Note: Subjects may have more than one adverse event per body system and preferred term.

Changes in heart rate, plasma glucose, and serum potassium are shown in Table 4. The clinical significance of these small differences is unknown.

Table 4: Mean Changes from Baseline Heart Rate at 30 Minutes and Glucose and Potassium at 1 Hour after First Dose (Day 1) and Last Dose (Day 21) in Children 6-11 Years Old

Treatment Mean Changes(Day 1)
Heart Rate (bpm) Glucose (mg/dL) Potassium (mEq/L)
XOPENEX 0.31 mg, n=66 0.8 4.9 -0.31
XOPENEX 0.63 mg, n=67 6.7 5.2 -0.36
Racemic albuterol 1.25 mg, n=64 6.4 8 -0.27
Racemic albuterol 2.5 mg, n=60 10.9 10.8 -0.56
Placebo, n=59 -1.8 0.6 -0.05
  Mean Changes (Day 21)
Treatment Heart Rate (bpm) Glucose (mg/dL) Potassium (mEq/L)
XOPENEX 0.31 mg, n=60 0 2.6 -0.32
XOPENEX 0.63 mg, n=66 3.8 5.8 -0.34
Racemic albuterol 1.25 mg, n=62 5.8 1.7 -0.18
Racemic albuterol 2.5 mg, n=54 5.7 11.8 -0.26
Placebo, n=55 -1.7 1.1 -0.04

Post-marketing Experience

In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been observed in postapproval use of XOPENEX Inhalation Solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to their seriousness, their frequency of reporting, or their likely beta-mediated mechanism: angioedema, anaphylaxis, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), asthma, chest pain, cough increased, dysphonia, dyspnea, gastrooesophageal reflux disease (GERD), metabolic acidosis, nausea, nervousness, rash, tachycardia, tremor, urticaria.

In addition, XOPENEX Inhalation Solution, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, sleeplessness, headache, and drying or irritation of the oropharynx.

Read the Xopenex (levalbuterol) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Short-Acting Bronchodilators

Avoid concomitant use of other short-acting sympathomimetic bronchodilators or epinephrine in patients being treated with XOPENEX Inhalation Solution. 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-adrenergic agonists such as XOPENEX Inhalation Solution, 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., 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 should be considered, although they should be administered with caution.

Diuretics

The ECG changes or hypokalemia that may result from the administration of non-potassiumsparing diuretics (such as loop and 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 betaagonists with non-potassium-sparing diuretics. Consider monitoring potassium levels.

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 XOPENEX Inhalation Solution 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 on the vascular system may be potentiated. Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.

Read the Xopenex Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 4/11/2014
This monograph has been modified to include the generic and brand name in many instances.

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