Adult Dosing

Acute bronchospasm

Xopenex

• Start dose: 0.63-1.25 mg NEB q6-8 hrs prn
• If severe asthma: 1.25 NEB tid
• For Acute asthma exacerbation: oral inhalation, 1.25 to 2.5 mg every 20 min for 3 doses, then 1.25 to 5 mg every 1-4 hr as needed

• Levalbuterol 0.31 mg/3 mL = 0.01%; 0.63 mg/3 mL = 0.021%; 1.25 mg/3 mL = 0.042%
• Administer xopenex via nebulizer. Not for injection or oral use
• Do not dilute nebulization solution before administration

Xopenex HFA

• 2 inhalations (90 mcg) q4-6 hrs
• Alt: 1 inhalation (45 mcg) q4 hrs

Pediatric Dosing

Acute bronchospasm

Xopenex

• Children 6-11 yrs: 0.31-0.63 mg NEB tid prn
• Children >11 yrs: 0.63-1.25 mg NEB tid prn, if severe asthma: 1.25 NEB tid prn
• For Acute asthma exacerbation: oral inhalation, 0.075 mg/kg every 20 minutes for 3 doses, then 0.075 to 0.15 mg/kg up to 5 mg every 1-4 hours as needed

• Levalbuterol 0.31 mg/3 mL = 0.01%; 0.63 mg/3 mL = 0.021%; 1.25 mg/3 mL = 0.042%
• Administer xopenex via nebulizer. Not for injection or oral use
• Do not dilute nebulization solution before administration

Xopenex HFA

• Children >4 yrs: 2 inhalations (90 mcg) q4-6 hrs
• Alt: 1 inhalation (45 mcg) q4 hrs

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment or prevention of bronchospasm in patients 6 years with reversible obstructive airway disease (Xopenex)
• Treatment or prevention of bronchospasm in patients 4 years with reversible obstructive airway disease (levalbuterol, Xopenex HFA)

• Hypersensitivity to any of the ingredients of the product, including racemic albuterol
• MAO inhibitor use within 14 days
• phenothiazines

• N/A

Renal Dose Adjustment

• Renal impairment: Caution advised if high doses are used, dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Life threatening paradoxical bronchospasm may occur. Discontinue use immediately and institute alternative therapy if paradoxical bronchospasm occurs
• Deterioration of asthma may occur. Need for increased dosage/frequency of levoalbuterol indicates destabilization of asthma and may require re-evaluation of the patient and treatment regimen
• Consider adding anti-inflammatory agents, e.g. corticosteroids, to the therapeutic regimen, as use of a beta-adrenergic agonist alone may not be adequate to control asthma, in many patients
• Levoalbuterol can produce clinically significant cardiovascular effects in some patients, as measured by pulse rate, blood pressure, ECG changes and/or symptoms. Use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
• Do not exceed recommended doses. Excessive use can cause fatalities in patients with asthma
• Immediate hypersensitivity reactions manifested as urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema can occur after administration of racemic albuterol

Cautions: Use cautiously in

• Renal impairment
• Hypertension
• CAD
• Cardiac arrhythmias
• Diabetes mellitus
• Hyperthyroidism
• Convulsive disorder
• Hypokalemia
• Patients responsive to sympathomimetic amines

Supplemental Patient Information

• Advise patients not to use levalbuterol inhaler more frequently than recommended
• Advise patient to consult their physician, if inhalation aerosol becomes less effective for symptomatic relief, or symptoms become worse, or if they need to use the product more frequently than usual

Pregnancy Category:C

Breastfeeding: No published data exists on the use of oral or inhaled levalbuterol during lactation. However, inhaled bronchodilators are considered acceptable for use during breastfeeding, due to low bioavailability and maternal serum levels after use. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 26 May 2011). Manufacturer advises caution.

• CV: Tachycardia, cardiac arrest, arrhythmias, chest pain, ST segment depression, prolong QT interval
• CNS: Migraine, dizziness, hypertonia, nervousness, tremor, anxiety, headache
• GI: Dyspepsia, dry mouth, diarrhea
• RESP: Paradoxical bronchospasm, increase cough, rhinitis, sinusitis, turbinate edema, viral infection
• DERM: Angioedema, urticaria, rash
• METABOLIC: Hypokalemia
• HEMA: Lymphadenopathy
• MUSC: Back pain, leg cramps, myalgia
• MISC: Allergic reaction, flu syndrome, accidental injury, pain, asthenia

• Beta₂-adrenergic receptor agonist; activates beta₂-adrenergic receptor on airway smooth muscle leading to increase in cyclic AMP with the activation of protein kinase A, this inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in muscle relaxation. Increased cyclic AMP also inhibits the release of mediators from mast cells in the airways
• Some systemic absorption following inhalation
• Metabolized by liver
• Primarily excreted renally (80-100%); feces: <20%
• Half-life: 3-4 hrs

US Trade Name(s)

• Xopenex
• Xopenex HFA

US Availability

levalbuterol(generic)

• SOLN for INH: 0.021%
• SOLN for INH: 0.042%
• SOLN for INH: 0.0103%
• SOLN for INH: 0.25%

Xopenex

• SOLN for INH: 0.021%
• SOLN for INH: 0.042%
• SOLN for INH: 0.0103%
• SOLN for INH: 0.25%

Xopenex HFA

• Aerosol MDI: 0.045 mg/INH

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Pulmonary

Bronchodilators

Beta Agonists (Inhaled)

Allergy & Immunology

Bronchodilators

Beta Agonists (Inhaled)

Pricing data from www.DrugStore.com in U.S.A.

• Xopenex HFA 45 MCG/ACT AERO [Inhaler] (SUNOVION PHARMACEUTICALS)
  15 act = $59.99
  45 act = $155.97
• Xopenex 1.25 MG/3ML NEBU [Box] (SUNOVION PHARMACEUTICALS)
  72 3ml = $160.99
  216 3ml = $459.96
• Xopenex 0.63 MG/3ML NEBU [Box] (SUNOVION PHARMACEUTICALS)
  72 3ml = $157
  216 3ml = $451.99
• Xopenex 0.31 MG/3ML NEBU [Box] (SUNOVION PHARMACEUTICALS)
  72 3ml = $139.98
  216 3ml = $399.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.