Xopenex

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 9/9/2021
Xopenex Side Effects Center

What Is Xopenex?

Xopenex (levalbuterol HCl) is a bronchodilator used to treat reversible obstructive airway conditions such as asthma, bronchitis, and emphysema. Xopenex is available in generic form in some strengths.

What Are Side Effects of Xopenex?

Common side effects of Xopenex include:

Tell your doctor if you have serious side effects of Xopenex including:

  • fast or pounding heartbeat.

Dosage for Xopenex

The recommended dosage of Xopenex Inhalation Solution for patients 6-11 years old is 0.31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0.63 mg three times a day. The recommended starting dosage of Xopenex for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.

What Drugs, Substances, or Supplements Interact with Xopenex?

Xopenex may interact with beta-blockers, tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), diuretics (water pills), digoxin, other inhaled bronchodilators, caffeine, diet pills, or decongestants.

Xopenex During Pregnancy and Breastfeeding

Xopenex should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Xopenex (levalbuterol HCl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Asthma is a chronic respiratory disease. See Answer
Xopenex Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medicine;
  • pounding heartbeats or fluttering in your chest;
  • worsening asthma symptoms; or
  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • dizziness, nervousness, tremors;
  • runny nose, sore throat;
  • chest pain or tightness, irregular heartbeats;
  • pain; or
  • vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xopenex (Levalbuterol)

SLIDESHOW

What Is Asthma? Symptoms, Causes, and Treatments See Slideshow
Xopenex Professional Information

SIDE EFFECTS

Use of XOPENEX HFA may be associated with the following:

  • Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
  • Cardiovascular effects [see WARNINGS AND PRECAUTIONS]
  • Immediate hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Hypokalemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a 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 HFA in adults and adolescents is derived from two 8-week, multicenter, randomized, doubleblind, active- and placebo-controlled trials in 748 adult and adolescent patients with asthma that compared XOPENEX HFA, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler. Table 1 lists the incidence of all adverse reactions (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 and more frequently than in the HFA-134a placebo inhaler group.

Table 1: Adverse Reaction Incidence (% of Patients) in Two 8-Week Clinical Trials in Adults and Adolescents ≥ 12 Years of Age*

Body System Preferred Term XOPENEX HFA
90 mcg
(n=403)
Racemic Albuterol
HFA
180 mcg
(n=179)
Placebo
(n=166)
Respiratory System Asthma 9% 7% 6%
Pharyngitis 8% 2% 2%
Rhinitis 7% 2% 3%
Body as a Whole Pain 4% 3% 4%
Central Nervous System Dizziness 3% 1% 2%
*This table includes all adverse reactions (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 and more frequently than in the HFA-134a placebo inhaler group.

Adverse reactions reported by less than 2% and at least 2 or more of the adolescent and adult patients receiving XOPENEX HFA 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.

Pediatric Patients 4 To 11 Years Of Age

Adverse reaction information concerning XOPENEX HFA in children is derived from a 4-week, randomized, double-blind trial of XOPENEX HFA, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler in 150 children aged 4 to 11 years with asthma. Table 2 lists the adverse reactions reported for XOPENEX HFA in children at a rate of 2% or greater and more frequently than for placebo.

Table 2: Adverse Reaction Incidence (% of Patients) in a 4-Week Clinical Trial in Children 4-11 Years of Age*

Body System Preferred Term XOPENEX HFA
90 mcg
(n=76)
Racemic Albuterol HFA
180 mcg
(n=39)
Placebo
(n=35)
Digestive System Vomiting 115 8% 6%
Body as a Whole Accidental injury 9% 6% 10% 6%
Respiratory System Pharyngitis 7% 13% 6%
Bronchitis 35 0% 0%
*This table includes all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from the trial that occurred at a rate of 2% or greater in the group treated with XOPENEX HFA and more frequently than in the HFA-134a placebo inhaler group.

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

Post-Marketing Experience

In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been observed in post-approval use of levalbuterol 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 HFA, 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.

DRUG INTERACTIONS

Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with XOPENEX HFA. 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-blockers: Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-adrenergic agonists, such as XOPENEX HFA, 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.

Diuretics

The ECG changes 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. Consider monitoring potassium levels.

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 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.

Monoamine Oxidase Inhibitors Or Tricyclic Antidepressants

XOPENEX HFA 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. Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.

Read the entire FDA prescribing information for Xopenex (Levalbuterol)

© Xopenex Patient Information is supplied by Cerner Multum, Inc. and Xopenex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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