Proair Digihaler

— THERAPEUTIC CATEGORIES —
  • Asthma/COPD
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Proair Digihaler Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Albuterol sulfate 90mcg/inh; dry pwd for oral inhalation (with a dose counter + built-in electronic module).

    Pharmacological Class

    Beta-2 agonist.

    How Supplied

    Inhaler (w. dose counter + built-in electronic module)—0.65g (200 inh)

    Storage

    Store at room temperature (between 15°C and 25°C; 59°F and 77°F). 

    Avoid exposure to extreme heat, cold, or humidity.

    Manufacturer

    Teva Pharmaceuticals

    Generic Availability

    NO

    Proair Digihaler Indications

    Indications

    Bronchospasm.

    Proair Digihaler Dosage and Administration

    Adults and Children

    <4yrs: not established. ≥4yrs: 2 inh every 4–6hrs; in some patients: 1 inh every 4hrs may suffice. Exercise-induced bronchospasm: 2 inh 15–30mins before exercise.

    Proair Digihaler Contraindications

    Contraindications

    Severe hypersensitivity to milk proteins.

    Proair Digihaler Boxed Warnings

    Not Applicable

    Proair Digihaler Warnings/Precautions

    Warnings/Precautions

    Avoid excessive use. Sensitivity to sympathomimetics. Discontinue if paradoxical bronchospasm or cardiovascular effects occur. Cardiovascular disease (eg, coronary insufficiency, arrhythmias, hypertension). Diabetes. Hyperthyroidism. Seizure disorders. Reevaluate periodically. Elderly. Labor & delivery. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Paradoxical Bronchospasm

    • May occur with treatment; discontinue immediately and start alternative therapy.

    Deterioration of Asthma and Use of Anti-inflammatory Agents

    • If a patient needs more doses, this may be an indication of destabilization of asthma.
    • Reevaluate patient and consider the need for anti-inflammatory treatment (eg, corticosteroids); beta-adrenergic agonist therapy alone may not be adequate to control asthma in many patients.

    Cardiovascular Effects

    • Beta-adrenergic agonists can produce clinically significant cardiovascular effects in some patients.
    • These effects are uncommon following administration at the recommended dose, but if they do occur, the drug may need to be discontinued.
    • Like with all sympathomimetic amines, caution should be used in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

    Immediate Hypersensitivity Reactions

    • May occur after administration of albuterol sulfate.
    • ProAir Digihaler contains small amounts of lactose, which may contain trace levels of milk proteins.
    • The potential for hypersensitivity must be considered in the clinical evaluation of patients who experience immediate hypersensitivity reactions while receiving ProAir Digihaler.

    Coexisting Conditions

    • Like with all sympathomimetic amines, caution should be used in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, hypertension, convulsive disorders, hyperthyroidism, or diabetes; and in patients who are unusually responsive to sympathomimetic amines.
    • Clinically significant changes in systolic and diastolic blood pressure have been seen following beta-adrenergic bronchodilator use.

    Hypokalemia

    • May produce significant hypokalemia in some patients.
    • Decrease is usually transient and does not require supplementation.

    Pregnancy Considerations

    There are no adequate and well-controlled studies of albuterol in pregnant women. Because of the potential for beta-adrenergic agonists to interfere with uterine contractility, the use of ProAir Digihaler for the treatment of bronchospasm during labor should be restricted to those patients for whom the benefits clearly outweigh the risk.

    Nursing Mother Considerations

    There are no available data on the presence of albuterol in human milk, the effects on the breastfed child, or the effects on milk production. Plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, albuterol has a low oral bioavailability. Consider the benefits to the mother vs the potential risks to the breastfed infant.

    Pediatric Considerations

    The safety and effectiveness of ProAir Digihaler in pediatric patients below the age of 4 years have not been established.

    Geriatric Considerations

    Clinical studies did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients.

    As elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

    Renal Impairment Considerations

    Risk of toxic reactions may be greater in patients with impaired renal function as albuterol is substantially excreted by the kidney. It may be useful to monitor renal function in patients with renal impairment. Caution should be used when administering high doses of ProAir Digihaler to patients with renal impairment.

    Hepatic Impairment Considerations

    The effect of hepatic impairment on the pharmacokinetics of ProAir Digihaler has not been evaluated.

    Proair Digihaler Pharmacokinetics

    Metabolism

    Published literature suggests that the primary enzyme responsible for the metabolism of albuterol in humans is SULT1A3 (sulfotransferase).

    Elimination

    The primary route of elimination of albuterol is through renal excretion.

    Less than 20% of the drug is detected in the feces.

    Half-life: ~5 hours.

    Proair Digihaler Interactions

    Interactions

    During or within 2 weeks of MAOIs or tricyclics (increased cardiovascular effects); consider alternative therapy. Oral sympathomimetics: not recommended. Antagonized by β-blockers. Monitor digoxin. Caution with non-potassium sparing diuretics (eg, loop or thiazide); monitor.

    Interactions

    Avoid concomitant use of other short-acting sympathomimetic bronchodilators or epinephrine; if needed, use with caution to avoid deleterious cardiovascular effects.

    Patients with asthma should not normally be treated with beta blockers as these agents block the pulmonary effect of beta-adrenergic agonists and may produce severe bronchospasm.  

    • Under certain circumstances (eg, prophylaxis after MI), consider cardioselective beta blockers; use with caution.

    Use extreme caution when administered to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents.

    • Action of albuterol on the vascular system may be potentiated.
    • Consider alternative therapy in patients taking MAOIs or tricyclic antidepressants.

    Use caution if beta-agonists are coadministered with non-potassium-sparing diuretics; consider monitoring potassium levels as hypokalemia may be worsened.

    Carefully evaluate serum digoxin levels in patients who are currently receiving digoxin and albuterol.

    Proair Digihaler Adverse Reactions

    Adverse Reactions

    Back pain, pain, viral gastroenteritis, sinus headache, urinary tract infection; children: nasopharyngitis, oropharyngeal pain, vomiting; hypokalemia, paradoxical bronchospasm, cardiovascular effects, immediate hypersensitivity reactions (eg, rash, urticaria, angioedema).

    Proair Digihaler Clinical Trials

    Clinical Trials

    The use of ProAir Digihaler for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease and in the prevention of exercise-induced bronchospasm in patients 4 years of age and older is supported by adequate and well-controlled studies in adults and pediatric patients of albuterol sulfate inhalation powder (albuterol sulfate MDPI).

    Adult and Adolescent Patients 12 Years of Age and Older

    Two 12-week, randomized, double-blind, placebo-controlled studies of identical design (Study 1 and Study 2) compared albuterol sulfate MDPI (n=153) with a matched placebo dry powder inhaler (n=163); patients were maintained on inhaled corticosteroid treatment. Consistent results were seen in both trials. Results showed that 2 inhalations of albuterol sulfate MDPI produced significantly greater improvement in FEV1 AUC0-6hr over the pre-treatment value than placebo.

    Pediatric Patients 4 to 11 Years of Age

    In a 3-week double-blind, placebo-controlled trial, albuterol sulfate MDPI (n=92) was compared with a matched placebo (n=92) in children 4 to 11 years of age. Results showed that 2 inhalations of albuterol sulfate MDPI produced significantly greater improvement in FEV1 over the pre-treatment value than the matched placebo. 

    Exercise-Induced Bronchospasm

    In a single-dose, crossover study in 38 adult and adolescent patients with exercise-induced bronchospasm (EIB), 2 inhalations of albuterol sulfate MDPI taken 30 minutes before exercise prevented EIB for the hour following exercise in 97% of patients as compared with 42% of those who received placebo.

    Proair Digihaler Note

    Not Applicable

    Proair Digihaler Patient Counseling

    Patient Counseling

    Do not use ProAir Digihaler more frequently than recommended; if treatment becomes less effective, reevaluation may be needed. The action of ProAir Digihaler should last for 4-6 hours.

    Review instructions for use of the electronic module and mobile App. as well as proper storage of the inhaler. The dose counter on a new inhaler will display the number 200. The dose counter will count down each time the mouthpiece cap is opened and closed. The dose counter window displays the number of actuations left in the inhaler in units of 2. 

    Do not use a spacer or volume holding chamber with ProAir Digihaler.

    Discard the inhaler 13 months after opening the foil pouch, when the dose counter displays 0,  or after the expiration date, whichever comes first.

    Discontinue if paradoxical bronchospasm occurs.

    Inform patients of potential drug interactions.

    Palpitations, chest pain, fast heart rate, headache, dizziness, tremor and nervousness may occur with use.

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