Proair Hfa

— 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 Hfa Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Albuterol sulfate 90mcg/inh; metered-dose aerosol (with a dose counter); CFC-free.

    Pharmacological Class

    Beta-2 agonist.

    How Supplied

    Inhalation aerosol (w. dose counter)—8.5g (200 inh)

    How Supplied

    Proair HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator with a dose counter and white dust cap each in boxes of one.

    Each canister contains 8.5 g of the formulation and provides 200 actuations.

    Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).

    Storage

    Store between 15° and 25°C (59° and 77°F). Contents under pressure. Do not puncture or incinerate. Protect from freezing temperatures and prolonged exposure to direct sunlight. Exposure to temperatures above 120°F may cause bursting. For best results, canister should be at room temperature before use.

    Manufacturer

    Teva Pharmaceuticals

    Mechanism of Action

    Albuterol sulfate is a beta2-adrenergic agonist. The pharmacologic effects of albuterol sulfate are attributable to activation of beta2-adrenergic receptors on airway smooth muscle. Activation of beta2-adrenergic receptors leads to the activation of adenylcyclase and to an increase in the intracellular concentration of cyclic-3', 5'-adenosine monophosphate (cAMP). This increase of cAMP is associated with the activation of protein kinase A, which in turn inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in muscle relaxation. Albuterol relaxes the smooth muscle of all airways, from the trachea to the terminal bronchioles.

    Proair Hfa Indications

    Indications

    Bronchospasm.

    Proair Hfa 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 Hfa Contraindications

    Not Applicable

    Proair Hfa Boxed Warnings

    Not Applicable

    Proair Hfa Warnings/Precautions

    Warnings/Precautions

    Avoid excessive use. Sensitivity to sympathomimetics. Discontinue if paradoxical bronchospasm or cardiovascular effects occur. Cardiovascular disorders (eg, coronary insufficiency, arrhythmias, hypertension). Diabetes. Hyperthyroidism. Seizure disorders. Reevaluate periodically. Elderly. Labor & delivery. Pregnancy. Nursing mothers: not recommended.

    Warnings/Precautions

    Paradoxical Bronchospasm

    • May cause life-threatening, paradoxical bronchospasm, and this frequently occurs with the first use of a new canister. Discontinue immediately if paradoxical bronchospasm occurs and initiate alternative therapy.

    Deterioration of Asthma 

    • Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. 

    • Need for more doses of Proair HFA than usual may be a sign of deterioration of asthma and requires reevaluation of treatment.

    Use of Anti-inflammatory Agents

    • Consider adding anti-inflammatory agents (eg, corticosteroids) early to the regimen.

    Cardiovascular Effects

    • May produce clinically significant cardiovascular effects as measured by pulse rate, BP, and/or symptoms.

    • Use caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

    Do Not Exceed Recommended Dose 

    • Excessive use may be fatal. Do not exceed the recommended dose.

    Immediate Hypersensitivity Reactions 

    • Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. 

    Coexisting Conditions

    • Use caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines.

    • Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. 

    Hypokalemia

    • May produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. This is usually transient and does not require supplementation.

    Pregnancy Considerations

    Pregnancy Exposure Registry 

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy.

    • For more information, contact the Mothers To Baby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1-877-311-8972 or visit http://mothertobaby.org/pregnancystudies/. 

    Risk Summary

    • Available data from published epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. 

    Clinical Considerations  

    • Disease-Associated Maternal and/or Embryo/Fetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control. 

    • Labor or Delivery: Only use Proair HFA during labor in patients in whom the benefits clearly outweigh the risk.

    Nursing Mother Considerations

    Risk Summary

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for albuterol and any potential adverse effects on the breastfed child from albuterol or from the underlying maternal condition.

    Pediatric Considerations

    The safety and effectiveness of Proair HFA Inhalation Aerosol in pediatric patients below the age of 4 years have not been established. 

    Geriatric Considerations

    In general, use caution when selecting the dose in elderly patients usually starting at the low end of the dosing range.

    Proair Hfa Pharmacokinetics

    Metabolism

    Metabolized by SULTIA3 (sulfotransferase).

    Elimination

    Renal (80–100%), fecal (<20%). Terminal plasma half-life: ~6 hours.

    Proair Hfa 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.

    Proair Hfa Adverse Reactions

    Adverse Reactions

    Headache, tachycardia, pain, dizziness, pharyngitis, rhinitis; hypokalemia, paradoxical bronchospasm, cardiovascular effects, immediate hypersensitivity reactions (eg, rash, urticaria, angioedema).

    Proair Hfa Clinical Trials

    Clinical Trials

    Bronchospasm Associated with Asthma – Adult and Adolescent Patients ≥12 Years of Age 

    • A 6-week, randomized, double-blind, placebo-controlled trial compared Proair HFA inhalation aerosol to a matched placebo HFA inhalation aerosol in 116 asthmatic patients 12 to 76 years of age. Patients received a dose of 180mcg albuterol 4 times a day.

    • Results showed that 2 inhalations of Proair HFA achieved a significantly greater improvement in FEV1 over the pretreatment value vs placebo, along with a comparable bronchodilator. Moreover, 31 out of 58 patients who received Proair HFA achieved a 15% increase in FEV1 within 30 minutes post-dose on Day 1. 

    • The median time to onset was 8.2 minutes. The median time to peak effect was 47 minutes. The median duration of effect was ~3 hours, with some lasting as long as 6 hours.

    Bronchospasm Associated with Asthma – Pediatric Patients 4 to 11 Years of Age 

    • A 6-week, randomized, double-blind, placebo-controlled trial compared Proair HFA inhalation aerosol to a matched placebo HFA inhalation aerosol in 95 asthmatic patients 4 to 11 years of age. Patients received a dose of 180mcg albuterol 4 times a day.

    • Results showed that 21 out of 50 patients who received Proair HFA achieved a 15% increase in FEV1 within 30 minutes post-dose on Day 1. 

    • The median time to onset was 10 minutes. The median time to peak effect was 31 minutes. The median duration of effect was ~4 hours, with some lasting as long as 6 hours.

    Exercise-Induced Bronchospasm

    • A randomized, single-dose, crossover study evaluated the effect of Proair HFA in 24 adults and adolescents with exercise-induced bronchospasm (EIB). Patients received 2 inhalations of Proair HFA taken 30 minutes before exercise. 

    • 83% of patients treated with Proair HFA prevented EIB for the hour following exercise (defined as maintenance of FEV1 within 80% of post-dose, pre-exercise baseline values) vs 25% of those treated with placebo.

    Proair Hfa Note

    Not Applicable

    Proair Hfa Patient Counseling

    Patient Counseling

    Frequency of Use

    • Proair HFA should last for 4 to 6 hours. Do not exceed the recommended dosage. Seek medical attention immediately if treatment with Proair HFA becomes less effective, worse, and/or becomes more frequently used.

    Priming and Cleaning 

    • Instruct patients to prime the inhaler prior to using it for the first time, and in cases where the inhaler has not been used for more than 2 weeks.

    • Instruct patients to wash the red plastic actuator mouthpiece and dry thoroughly at least once a week to ensure proper dosing and prevent blockage.

    Paradoxical Bronchospasm 

    • Advise patients that paradoxical bronchospasm may occur. Discontinue use if this occurs.

    Common Adverse Events  

    • Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, or nervousness.

    Pregnancy

    • Contact your healthcare provider in patients who are pregnant or nursing before using Proair HFA. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy.

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