XOPENEX HFA

A population pharmacokinetic model was developed using plasma concentrations of (R)-albuterol obtained from 632 asthmatic patients aged 4 to 81 years in three large trials. For adolescent and adult patients 12 years and older, following 90 mcg dose of XOPENEX HFA, yielded mean peak plasma concentrations (C max ) and systemic exposure (AUC 0-6 ) of approximately 199 pg/mL and 695 pg

• h/mL, respectively, compared to approximately 238 pg/mL and 798 pg
• h/mL, respectively, following 180 mcg dose of Ra...

14.1 Bronchospasm Associated with Asthma Adults and Adolescent Patients 12 Years of Age and Older The efficacy and safety of XOPENEX HFA were established in two 8-week, multicenter, randomized, double-blind, active- and placebo-controlled trials in 748 adults and adolescents with asthma between the ages of 12 and 81 years. In these two trials, XOPENEX HFA (403 patients) was compared to an HFA-134a placebo MDI (166 patients), and the trials included a marketed albuterol HFA-134a MDI (179 patients) as an active control. Serial forced expiratory volume in 1 second (FEV 1 ) measurements demonstrat...

Use of XOPENEX HFA may be associated with the following: Paradoxical bronchospasm [see Warnings and Precautions (5.1 )] Cardiovascular effects [see Warnings and Precautions (5.4 )] Immediate hypersensitivity reactions [see Warnings and Precautions (5.6 )] Hypokalemia [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥ 2% and > placebo) are accidental injury, bronchitis, dizziness, pain, pharyngitis, rhinitis, and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact L...

XOPENEX HFA is contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol, or any other component of XOPENEX HFA. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Hypersensitivity to levalbuterol, racemic albuterol or any other component of XOPENEX HFA Inhalation Aerosol. ( 4 )

Life-threatening paradoxical bronchospasm may occur. Discontinue XOPENEX HFA immediately and treat with alternative therapy. ( 5.1 ) Need for more doses of XOPENEX HFA than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. ( 5.2 ) XOPENEX HFA is not a substitute for corticosteroids. ( 5.3 ) Cardiovascular effects may occur. Consider discontinuation of XOPENEX HFA if these effects occur. Use with caution in patients with underlying cardiovascular disorders. ( ...

7 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. Other short-acting sympathomimetic aerosol bronchodilators and adrenergic drugs : May potentiate effect. ( 7 ...