HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to usePROAIR DIGIHALER safely and effectively. See full prescribinginformation for PROAIR DIGIHALER.
PROAIR DIGIHALERTM(albuterol sulfate)inhalation powder, for oral
inhalation use
Initial U.S. Approval: 1981
INDICATIONS AND USAGE
ProAir Digihaler is a drug product containing a beta2-adrenergic agonistindicated for:
• Treatment or prevention of bronchospasm in patients 4 years of age andolder with reversible obstructive airway disease.
• Prevention of exercise-induced bronchospasm in patients 4 years of ageand older.
DOSAGE AND ADMINISTRATION
For oral inhalation only
• Treatment or prevention of bronchospasm in adults and children 4 yearsof age and older: 2 inhalations every 4 to 6 hours. In some patients, 1inhalation every 4 hours may be sufficient.
• Prevention of exercise-induced bronchospasm in adults and children 4years of age and older: 2 inhalations 15 to 30 minutes before exercise.
• ProAir Digihaler does not require priming.
• Do not use with a spacer or volume holding chamber.
• Keep the inhaler clean and dry at all times. Routine maintenance is notrequired. If the mouthpiece needs cleaning, gently wipe the mouthpiecewith a dry cloth or tissue as needed. Never wash or put any part of theinhaler in water.
Discard 13 months after opening the foil pouch, when the dose counterdisplays 0, or after the expiration date on the product, whichever comesfirst.
• ProAir Digihaler contains a built-in electronic module which detects,records, and stores data on inhaler events for transmission to the mobileApp. Use of the App is not required for administration of medication tothe patient.
DOSAGE FORMS AND STRENGTHS
Inhalation powder: ProAir Digihaler is a dry powder inhaler that meters 117mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) from thedevice reservoir and delivers 108 mcg of albuterol sulfate (equivalent to90 mcg of albuterol base) from the mouthpiece per actuation. The inhaler issupplied for 200 inhalation doses. ProAir Digihaler includes a built-inelectronic module.
CONTRAINDICATIONS
• Patients with hypersensitivity to albuterol.
• Patients with severe hypersensitivity to milk proteins.
WARNINGS AND PRECAUTIONS
• Life-threatening paradoxical bronchospasm may occur. DiscontinueProAir Digihaler immediately and treat with alternative therapy.
• Need for more doses of ProAir Digihaler than usual may be a sign ofdeterioration of asthma and requires reeva luation of treatment.
• ProAir Digihaler is not a substitute for corticosteroids.
• Cardiovascular effects may occur. Use with caution in patients sensitiveto sympathomimetic drugs and patients with cardiovascular orconvulsive disorders.
• Excessive use may be fatal. Do not exceed recommended dose.
• Immediate hypersensitivity reactions may occur. Discontinue ProAirDigihaler immediately.
• Hypokalemia and changes in blood glucose may occur.
ADVERSE REACTIONS
Most common adverse reactions (≥1% and >placebo) are back pain, pain,gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis,oropharyngeal pain and vomiting.
To report SUSPECTED ADVERSE REACTIONS, contact TevaRespiratory, LLC at 1-888-483-8279 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG INTERACTIONS |
