Adults and Adolescents ≥ 12 years old

Adverse events reported in ≥ 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 3.

Table 3: Adverse Events Reported in a 4-Week, Controlled Clinical Trial in Adults and Adolescents ≥ 12 years old

The incidence of certain systemic beta-adrenergic adverse effects (e.g., tremor, nervousness) was slightly less in the Xopenex 0.63 mg group compared with theother 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 clin-ically comparable in the Xopenex 1.25 mg and racemic albuterol 2.5 mg groups (see Table 4). Changes in heart rate and plasma glucose were slightly less inthe Xopenex 0.63 mg group compared with the other active treatment groups (see Table 4). The clinical significance of these small differences is unknown. After4 weeks, effects on heart rate, plasma glucose, and plasma potassium were generally diminished compared with day 1 in all active treatment groups.

Table 4: 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

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 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 whoreceived placebo: asthma exacerbation, cough increased, wheezing, sweating, and vomiting.

Children 6-11 years old

Adverse events reported in ≥ 2% of patients in any treatment group and more frequently than in patients receiving placebo in a 3-week, controlled clinical trial arelisted in Table 5.

Table 5: Most Frequently Reported Adverse Events ( ≥ 2% in Any Treatment Group) and Those Reported More Frequently Than in Placebo during the Double-Blind Period (ITT Population, 6-11 Years Old)

Changes in heart rate, plasma glucose, and serum potassium are shown in Table 6. The clinical significance of these small differences is unknown.

Table 6: 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

Postmarketing Adverse Reactions

In addition to the adverse events reported in clinical trials, the following adverse events have been observed in postapproval use of Xopenex InhalationSolution. 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, dyspnea, nausea, nervousness, rash, tachycardia, tremor, urticaria. Because these events have been reported spontaneously from a population of unknown size,estimates of frequency cannot be made.

Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should be used with caution with levalbuterol. If additional adrenergic drugsare to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.

1. 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 withbeta-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 could be considered, although they should be administered with caution.
2. Diuretics: The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazidediuretics) 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.
3. Digoxin: Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of racemicalbuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructiveairway disease who are receiving levalbuterol HCI and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate theserum digoxin levels in patients who are currently receiving digoxin and Xopenex Inhalation Solution.
4. Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: Xopenex Inhalation Solution should be administered with extreme caution to patients beingtreated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of levalbuterolHCI on the vascular system may be potentiated.

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