levalbuterol

(redirected from Xopenex HFA)

levalbuterol

 [lev″al-bu´ter-ol]
R-albuterol; a β-adrenergic agent used as the hydrochloride salt as a bronchodilator for treatment and prophylaxis of bronchospasm in reversible obstructive airway disease.

levalbuterol

(leev-al-byoo-ter-ole) ,

Xopenex

(trade name),

Xopenex HFA

(trade name)

Classification

Therapeutic: bronchodilators
Pharmacologic: adrenergics
Pregnancy Category: C

Indications

Bronchospasm due to reversible airway disease (short-term control agent).

Action

R-enantiomer of racemic albuterol. Binds to beta-2 adrenergic receptors in airway smooth muscle leading to activation of adenylcyclase and increased levels of cyclic-3', 5'-adenosine monophosphate (cAMP). Increases in cAMP activate kinases, which inhibit the phosphorylation of myosin and decrease intracellular calcium. Decreased intracellular calcium relaxes bronchial smooth muscle.

Therapeutic effects

Relaxation of airway smooth muscle with subsequent bronchodilation.
Relatively selective for beta-2 (pulmonary) receptors.

Pharmacokinetics

Absorption: Some absorption occurs following inhalation.
Distribution: Unknown.
Metabolism and Excretion: Metabolized in the liver to an inactive sulfate and 3–6% excreted unchanged in the urine.
Half-life: 3.3–4 hr.

Time/action profile (bronchodilation)

ROUTEONSETPEAKDURATION
Inhaln10–17 min90 min5–6 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity to levalbuterol or albuterol.
Use Cautiously in: Cardiovascular disorders (including coronary insufficiency, hypertension, and arrhythmias);History of seizures;Hypokalemia;Hyperthyroidism;Diabetes mellitus;Unusual sensitivity to adrenergic amines; Obstetric / Lactation / Pediatric: Pregnancy, lactation, or children <6 yr (for nebulized solution) or <4 yr (for metered-dose inhaler) (safety not established).
Exercise Extreme Caution in: Concurrent use or use within 2 weeks of tricyclic antidepressants or MAO inhibitors (may ↑ risk of adverse cardiovascular reactions).

Adverse Reactions/Side Effects

Central nervous system

  • anxiety
  • dizziness
  • headache
  • nervousness

Respiratory

  • paradoxical bronchospasm (excessive use of inhalers) (life-threatening)
  • increased cough
  • turbinate edema

Cardiovascular

  • tachycardia

Gastrointestinal

  • dyspepsia
  • vomiting

Endocrinologic

  • hyperglycemia

Fluid and Electrolyte

  • hypokalemia

Neurologic

  • tremor

Interactions

Drug-Drug interaction

Concurrent use or use within 2 weeks of tricyclic antidepressants or MAO inhibitors may ↑ risk of adverse cardiovascular reactions (use with extreme caution).Beta blockers block the beneficial pulmonary effects of adrenergic bronchodilators (choose cardioselective beta blockers if necessary and with caution).May ↑ risk of hypokalemia from potassium-losing diuretics.May ↓ serum digoxin levels.May ↑ risk of arrhythmias with hydrocarbon inhalationanesthetics or cocaine.Use with caffeine-containing herbs (guarana, tea, coffee) ↑ stimulant effect.

Route/Dosage

Inhalation (Adults and Children ≥4 yr) 2 inhalations q 4–6 hr; some patients may respond to 1 inhalation q 4 hr.
Inhalation (Adults and Children >12 yr) 0.63 mg via nebulization 3 times daily (every 6–8 hr); may be ↑ to 1.25 mg 3 times daily (every 6–8 hr).
Inhalation (Children 6–11 yr) 0.31 mg via nebulization 3 times daily (not to exceed 0.63 mg 3 times daily).

Availability (generic available)

Metered-dose inhaler: 45 mcg/actuation in 15-g (200 metered actuations) canisters Cost: $54.23 / 15 g
Inhalation solution: 0.31 mg/3 mL in green foil pouch containing 12 vials, 0.63 mg/3 mL in yellow foil pouch containing 12 vials, 1.25 mg/3 mL in red foil pouch containing 12 vials, 1.25 mg/0.5 mL in unit-dose vials Cost: Generic — All strengths $6.71 / 3 mL

Nursing implications

Nursing assessment

  • Assess lung sounds, pulse, and BP before administration and during peak of medication. Note amount, color, and character of sputum produced. Closely monitor patients on higher dose for adverse effects.
  • Monitor pulmonary function tests before initiating therapy and periodically during course to determine effectiveness of medication.
  • Observe for paradoxical bronchospasm (wheezing, dyspnea, tightness in chest). If condition occurs, withhold medication and notify health care provider immediately.
  • Lab Test Considerations: May cause ↑ serum glucose and ↓ serum potassium.

Potential Nursing Diagnoses

Ineffective airway clearance (Indications)

Implementation

  • Inhalation: Allow at least 1 min between inhalations of aerosol medication.
    • For nebulization, levalbuterol solution does not require dilution prior to administration. Once the foil pouch is opened, vials must be used within 2 weeks; open vials may be stored for 1 week. Discard vial if solution is not clear or colorless.

Patient/Family Teaching

  • Instruct patient in the proper use of metered-dose inhaler and nebulizer (see ) and to take levalbuterol as directed. Caution patient not to exceed recommended dose; may cause adverse effects, paradoxical bronchospasm, or loss of effectiveness of medication.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any OTC medications or alcoholic beverages concurrently with this therapy. Caution patient also to avoid smoking and other respiratory irritants.
  • Instruct patient to contact health care professional immediately if shortness of breath is not relieved by medication or is accompanied by diaphoresis, dizziness, palpitations, or chest pain.
  • Advise patients to use levalbuterol first if using other inhalation medications, and allow 5 min to elapse before administering other inhalant medications unless otherwise directed.
  • Advise patient to rinse mouth with water after each inhalation dose to minimize dry mouth.
  • Instruct patient to notify health care professional if no response to the usual dose of levalbuterol.

Evaluation/Desired Outcomes

  • Prevention or relief of bronchospasm.
References in periodicals archive ?
XOPENEX HFA(TM) (levalbuterol tartrate) MDI - XOPENEX HFA is a hydrofluoroalkane (HFA) metered-dose inhaler (MDI), which is a portable, hand-held device consisting of a pressurized canister containing medication and a mouthpiece through which the medication is inhaled.
short-acting bronchodilator MDI market potential, at XOPENEX HFA branded prices, is approximately $2.9 billion.
Xopenex HFA Metered-Dose Inhaler (levalbuterol tartrate inhalation aerosol, Sepracor Inc.)
The FDA approved Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, a hydrofluoroalkane metered-dose inhaler (MDI) for treatment or prevention of bronchospasm in adults, adolescents, and children at least 4 years old with reversible obstructive airway disease.
Use Xopenex HFA with caution in patients with cardiovascular conditions, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Xopenex HFA Metered Dose Inhaler (levalbuterol tartrate inhalation aerosol, Sepracor Inc.)
Use of 13-adrenergic agonists like Xopenex HFA alone may not be sufficient for asthma control in many patients; consider addition of anti-inflammatory agents.
Approval of Xopenex HFA as a portable MDI is helpful "if you want to use Xopenex in older children without requiring a nebulizer.
Food and Drug Administration (FDA) approved Sepracor's New Drug Application (NDA) for XOPENEX HFA (hydrofluoroalkane) MDI (metered-dose inhaler) for the treatment or prevention of bronchospasm in adults, adolescents and children 4 years of age and older with reversible obstructive airway disease.
Sepracor continues to work to resolve outstanding manufacturing issues and complete process validation work relating to XOPENEX HFA. Sepracor is targeting launch of XOPENEX HFA by the end of the year.
In each of the three, large-scale, pivotal Phase III trials that Sepracor conducted, the XOPENEX HFA MDI was well tolerated and met the targeted efficacy endpoints in both adults and children with asthma.