ProAir Digihaler 90 ug/1

albuterol sulfate · INHALANT · Teva Respiratory, LLC

No Recall HistoryCurrently in Shortage

Plain English

ProAir Digihaler is a inhalant containing albuterol sulfate at 90 ug/1, taken respiratory (inhalation). Manufactured by Teva Respiratory, LLC.

Key Facts

Brand Name: ProAir Digihaler
Generic Name: albuterol sulfate
NDC Code (Product): 59310-117
Manufacturer: Teva Respiratory, LLC
Strength: 90 ug/1
Dosage Form: INHALANT
Route: RESPIRATORY (INHALATION)
Marketing Status
Application #: NDA205636
Marketing Start: 10/04/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea12,436 reports

wrong technique in product usage process10,573 reports

no adverse event8,271 reports

device delivery system issue7,770 reports

drug dose omission by device7,507 reports

asthma6,648 reports

cough5,924 reports

drug ineffective5,043 reports

fatigue4,790 reports

product dose omission issue4,720 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ProAir Digihaler is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in patients 4 years of age and older. ( 1.2 ) 1.1 Bronchospasm ProAir ® Digihaler ® is indicated for the treatment or prevention of bronchospasm in patients 4 years of age 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.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For oral inhalation only Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours by oral inhalation. In some patients, 1 inhalation every 4 hours may be sufficient. ( 2.1 ) Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise by oral inhalation. ( 2.2 ) ProAir Digihaler does not require priming. ( 2.3 ) Do not use with a spacer or volume holding chamber. ( 2.3 ) Keep the inhaler clean and dry at all times. Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed. Never wash or put any part of the inhaler in water. ( 2.3 ) Discard 13 months after opening the foil pouch, when the dose counter displays 0, or after the expiration date on the product, whichever comes first. ( 2.3 ) ProAir Digihaler contains a built-in electronic module which detects, records, and stores data on inhaler events for transmission to the mobile App. Use of the App is not required for administration of medication to the patient. ( 2.3 ) 2.1 Recommended Do…

Contraindications

4 CONTRAINDICATIONS ProAir Digihaler is contraindicated in patients with a history of hypersensitivity to albuterol and/or severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose [see Warnings and Precautions ( 5.6 )] . Patients with hypersensitivity to albuterol. ( 4 ) Patients with severe hypersensitivity to milk proteins. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler. 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 ) Beta-blockers: May decrease effectiveness of ProAir Digihaler and produce severe bronchospasm. Patients with asthma should not normally be treated with beta-blockers. ( 7.1) Diuretics, or non-potassium sparing diuretics: May potentiate hypokalemia or ECG changes. Consider monitoring potassium levels. ( 7.2 ) Digoxin: May decrease serum digoxin levels. Consider monitoring digoxin levels. ( 7.3 ) Monoamine oxidase (MAO) inhibitors and tricyclic antidepressants: May potentiate effect of albuterol on the cardiovascular system. Consider alternative therapy in patients taking MAOs or tricyclic antidepressants. ( 7.4 ) 7.1 Beta-Blockers Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients.…

Adverse Reactions

6 ADVERSE REACTIONS Use of ProAir Digihaler 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 (≥1% and >placebo) are back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis, oropharyngeal pain and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Respiratory, LLC at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience A total of 1289 subjects were treated with albuterol sulfate inhalation powder (ProAir RespiClick hereafter referred to as albuterol sulfate MDPI) during the clinical development program. The most common adverse reactions (≥1% and >placebo) were back pain, pain, gastroenteritis viral, sinus headache, and urinary tract infection. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates i…

Frequently Asked Questions

What is ProAir Digihaler used for?

ProAir Digihaler contains albuterol sulfate. It is a inhalant taken respiratory (inhalation). Consult your doctor for specific uses.

Is ProAir Digihaler a controlled substance?

ProAir Digihaler is not classified as a controlled substance by the DEA.

What is the generic name for ProAir Digihaler?

The generic name for ProAir Digihaler is albuterol sulfate. There are 12 other brand versions of albuterol sulfate.

What is the NDC code for ProAir Digihaler 90 ug/1?

The NDC (National Drug Code) for ProAir Digihaler 90 ug/1 is 59310-117, listed by Teva Respiratory, LLC.

Product NDC

59310-117

Package NDC

59310-117-20

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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