Indications
Levalbuterol tartrate HFA inhalation aerosol is a beta 2 -adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1 )
1.1Bronchospasm
Levalbuterol tartrate HFA inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease.
Contraindications
Levalbuterol tartrate HFA inhalation aerosol is contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol, or any other component of Levalbuterol tartrate HFA inhalation aerosol. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Hypersensitivity to levalbuterol, racemic albuterol or any other component of Levalbuterol tartrate HFA inhalation aerosol.
( 4 )
Warnings and precautions
- Life-threatening paradoxical bronchospasm may occur. Discontinue Levalbuterol tartrate HFA inhalation aerosol immediately and treat with alternative therapy. ( 5.1 )
- Need for more doses of Levalbuterol tartrate HFA inhalation aerosol than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. ( 5.2 )
- Levalbuterol tartrate HFA inhalation aerosol is not a substitute for corticosteroids. ( 5.3 )
- Cardiovascular effects may occur. Consider discontinuation of Levalbuterol tartrate HFA inhalation aerosol if these effects occur. Use with caution in patients with underlying cardiovascular disorders. ( 5.4 )
- Excessive use may be fatal. Do not exceed recommended dose. ( 5.5 )
- Immediate hypersensitivity reactions may occur. Discontinue Levalbuterol tartrate HFA inhalation aerosol immediately. ( 5.6 )
- Hypokalemia and changes in blood glucose may occur. ( 5.7 , 5.8 )
5.1Paradoxical Bronchospasm
Levalbuterol tartrate HFA inhalation aerosol can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, Levalbuterol tartrate HFA inhalation aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.
At a glance
- Brand name
- Xopenex HFA
- Active substance
- levalbuterol tartrate
- Route
- Inhalation
- Dosage form
- Aerosol, metered
- Applicant
- Lupin
- Status
- Prescription
- FDA approval
- 11 Mar 2005
- Application
- NDA021730-001