home > drugs a-z list > xopenex hfa (levalbuterol tartrate inhalation aerosol) drug center > xopenex hfa (levalbuterol tartrate inhalation aerosol) drug - side effects and drug interactions

Adverse event information concerning XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol in adults and adolescents is derived from two 8-week, multicenter, randomized, double-blind, active- and placebo-controlled trials in 748 adult and adolescent patients with asthma that compared XOPENEX HFA (levalbuterol tartrate inhalation aerosol) Inhalation Aerosol, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler. Table 2 lists the incidence of all adverse events (whether considered by the investigator to be related or unrelated to drug) from these trials that occurred at a rate of 2% or greater in the group treated with XOPENEX HFA (levalbuterol tartrate inhalation aerosol) Inhalation Aerosol and more frequently than in the HFA-134a placebo inhaler group.

Table 2: Adverse Event Incidence (% of Patients) in Two 8-Week Clinical Trials in Adults and Adolescents ≥ 12 Years of Age*

Adverse events reported by less than 2% and at least 2 or more of the adolescent and adult patients receiving XOPENEX HFA (levalbuterol tartrate inhalation aerosol) Inhalation Aerosol and by a greater proportion than receiving HFA-134a placebo inhaler include cyst, flu syndrome, viral infection, constipation, gastroenteritis, myalgia, hypertension, epistaxis, lung disorder, acne, herpes simplex, conjunctivitis, ear pain, dysmenorrhea, hematuria, and vaginal moniliasis. There were no significant laboratory abnormalities observed in these studies.

Adverse event information concerning XOPENEX HFA (levalbuterol tartrate inhalation aerosol) Inhalation Aerosol in children is derived from a 4-week, randomized, double-blind trial of XOPENEX HFA (levalbuterol tartrate inhalation aerosol) Inhalation Aerosol, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler in 150 children aged 4 to 11 years with asthma. Table 3 lists the adverse events reported for XOPENEX HFA (levalbuterol tartrate inhalation aerosol) Inhalation Aerosol in children at a rate of 2% or greater and more frequently than for placebo.

Table 3: Adverse Event Incidence (% of Patients) in a 4-Week Trial in Children Aged 4-11 Years*

The incidence of systemic beta-adrenergic adverse effects (e.g., tremor, nervousness) was low and comparable across all treatment groups, including placebo.

Postmarketing

In addition to the adverse events reported in clinical trials, the following adverse events have been observed in postapproval use of levalbuterol inhalation solution. 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.

In addition, XOPENEX HFA (levalbuterol tartrate inhalation aerosol) Inhalation Aerosol, 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.

Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should be used with caution with XOPENEX HFA (levalbuterol tartrate inhalation aerosol) Inhalation Aerosol. If additional adrenergic drugs are 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-adrenergic agonists, such as XOPENEX HFA (levalbuterol tartrate inhalation aerosol) Inhalation Aerosol, 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 should 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 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 beta-agonists with non-potassium-sparing diuretics.
3. Digoxin: Mean decreases of 16% to 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 HFA (levalbuterol tartrate inhalation aerosol) Inhalation Aerosol 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 HFA (levalbuterol tartrate inhalation aerosol) Inhalation Aerosol.
4. Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: XOPENEX HFA Inhalation Aerosol 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.

Last reviewed on RxList: 3/6/2008
This monograph has been modified to include the generic and brand name in many instances.