Proair HFA

What is Proair HFA?

• Proair HFA (albuterol sulfate) Inhalation Aerosol is a beta2-adrenergic agonist used for treatment or prevention of bronchospasm and for Prevention of exercise-induced bronchospasm.

Albuterol Inhaler

What are the uses of this medicine?

PROAIR HFA is a prescription medicine used in people 4 years of age and older to:

• treat or prevent bronchospasm in people who have reversible obstructive airway disease.
• prevent exercise-induced bronchospasm.

How does this medicine work?

• Albuterol sulfate is a beta2-adrenergic agonist.
• These agents act by engaging the beta-2 adrenergic receptors on smooth muscle of bronchial tissue, relieving bronchospasm and reducing airway resistance.
• They also act on smooth muscle of the vascular system, intestines and uterus.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• with a history of hypersensitivity to albuterol and any other PROAIR HFA Inhalation Aerosol components.

What drug interactions can this medicine cause?

PROAIR HFA and other medicines may affect each other and cause side effects. PROAIR HFA may affect the way other medicines work, and other medicines may affect the way PROAIR HFA works.

Especially tell your doctor if you take:

• other inhaled medicines or asthma medicines
• beta-blocker medicines
• diuretics
• digoxin
• monoamine oxidase inhibitors
• tricyclic antidepressants

Is this medicine FDA approved?

• It was approved for medical use in the United States in 1982.

How should this medicine be used?

Recommended dosage:

• Treatment or prevention of [bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours. In some patients, one inhalation every 4 hours may be sufficient.
• Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise.

Administration:

• Use PROAIR HFA exactly as your doctor tells you to use it.
• Prime PROAIR HFA before using for the first time, or when the inhaler has not been used for more than 2 weeks. To prime PROAIR HFA, release 3 sprays into the air away from the face. Shake well before each spray.
• If your child needs to use PROAIR HFA, watch your child closely to make sure your child uses the inhaler correctly. Your doctor will show you how your child should use PROAIR HFA.
• Each dose of PROAIR HFA should last up to 4 hours to 6 hours.
• At least once a week, wash the actuator with warm water, shake off excess, and air dry thoroughly.
• PROAIR HFA inhaler should be discarded when the dose counter displays 0 or after the expiration date on the product, whichever comes first.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Inhalation Aerosol: Each actuation delivers 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Supplied in 8.5-g canister containing 200 actuations.

This medicine is available in fallowing brand namesː

• PROAIR HFA

What side effects can this medication cause?

The most common side effects of this medicine include:

• your heart feels like it is pounding or racing (palpitations)
• chest pain
• fast heart rate
• shakiness
• nervousness
• headache
• dizziness
• sore throat
• runny nose

PROAIR HFA may cause serious side effects, including:

• paradoxical bronchospasm
• heart problems including faster heart rate and higher blood pressure
• possible death in people with asthma who use too much PROAIR HFA
• allergic reactions
• low potassium levels in your blood
• worsening of other medical problems in people who also use PROAIR HFA including increases in blood sugar

What special precautions should I follow?

• Life-threatening paradoxical bronchospasm may occur. Discontinue PROAIR HFA immediately and treat with alternative therapy.
• 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.
• The use of beta-adrenergic-agonist bronchodilators alone may not be adequate to control asthma in many patients. PROAIR HFA is not a substitute for corticosteroids.
• PROAIR HFA Inhalation Aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. Use with caution in patients sensitive to sympathomimetic drugs and patients with cardiovascular or convulsive disorders.
• Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. Do not exceed recommended dose.
• Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Discontinue PROAIR HFA immediately.
• Hypokalemia and changes in blood glucose may occur.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia.
• Hypokalemia may also occur.

Management of overdosage:

• Treatment consists of discontinuation of PROAIR HFA Inhalation Aerosol together with appropriate symptomatic therapy.
• The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm.
• There is insufficient evidence to determine if dialysis is beneficial for overdosage of PROAIR HFA Inhalation Aerosol.

Can this medicine be used in pregnancy?

• 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.
• It is not known if PROAIR HFA will harm your unborn baby.

Can this medicine be used in children?

• It is not known if PROAIR HFA is safe and effective in children under 4 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: albuterol sulfate
• Inactive ingredients: propellant HFA-134a and ethanol.

Who manufactures and distributes this medicine?

Distributed by:

• Teva Pharmaceuticals USA, Inc.
• Parsippany, NJ

What should I know about storage and disposal of this medication?

• Store PROAIR HFA at room temperature between 59° F and 77° F (15° C and 25° C).
• Avoid exposure to extreme heat and cold.
• Shake the PROAIR HFA canister well before use.
• Do not puncture the PROAIR HFA canister.
• Do not store the PROAIR HFA canister near heat or a flame. Temperatures above 120° F may cause the canister to burst.
• Do not throw the PROAIR HFA canister into a fire or an incinerator.
• Avoid spraying PROAIR HFA in your eyes.

• Dailymed label info on Proair HFA
• FDA Proair HFA

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