• Other short-acting sympathomimetic aerosol bronchodilators andadrenergic drugs: May potentiate effect.
• Beta-blockers: May decrease effectiveness of ProAir Digihaler andproduce severe bronchospasm. Patients with asthma should not normallybe treated with beta-blockers.
• Diuretics, or non-potassium sparing diuretics: May potentiatehypokalemia or ECG changes. Consider monitoring potassium levels.
• Digoxin: May decrease serum digoxin levels. Consider monitoringdigoxin levels.
• Monoamine oxidase (MAO) inhibitors and tricyclic antidepressants:
May potentiate effect of albuterol on the cardiovascular system.
Consider alternative therapy in patients taking MAOs or tricyclicantidepressants.
See 17 for PATIENT COUNSELING INFORMATION and FDAapproved
patient labeling
Revised: 12/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
HIGHLIGHTS OF PRESCRIBING INFORMATION
FULL PRESCRIBING INFORMATION: CONTENTS
1 INDICATIONS AND USAGE
1.1 Bronchospasm
1.2 Exercise-Induced Bronchospasm
2 DOSAGE AND ADMINISTRATION
2.1 Bronchospasm
2.2 Exercise-Induced Bronchospasm
2.3 Administration Information
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Paradoxical Bronchospasm
5.2 Deterioration of Asthma
5.3 Use of Anti-Inflammatory Agents
5.4 Cardiovascular Effects
5.5 Do Not Exceed Recommended Dose
5.6 Immediate Hypersensitivity Reactions
5.7 Coexisting Conditions
5.8 Hypokalemia
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Beta-Blockers
7.2 Diuretics
7.3 Digoxin
7.4 Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Overview of Clinical Studies
14.2 Bronchospasm Associated with Asthma
14.3 Exercise-Induced Bronchospasm
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Bronchospasm
ProAir® DigihalerTM inhalation powder is indicated for the treatment or prevention of bronchospasm in patients 4 years ofage and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm
ProAir Digihaler is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
2 DOSAGE AND ADMINISTRATION
2.1 Bronchospasm
For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, therecommended dosage for adults and children 4 years of age or older is 2 inhalations repeated every 4 to 6 hours. Morefrequent administration or a larger number of inhalations is not recommended. In some patients, 1 inhalation every
4 hours may be sufficient.
2.2 Exercise-Induced Bronchospasm
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