ProAir Respiclick (albuterol sulfate)

ProAir Respiclick 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

It is not known if ProAir Respiclick is safe and effective in children under 4 years of age.

ProAir Respiclick may cause serious side effects, including:

• worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens stop using ProAir Respiclick and call your doctor or get emergency help right away. Paradoxical bronchospasm is more likely to happen with your first use of a new asthma inhalation medicine.
• heart problems, including faster heart rate and higher blood pressure
• possible death in people with asthma who use too much ProAir Respiclick
• allergic reactions. Call your doctor right away if you have the following symptoms of an allergic reaction:
  • itchy skin
  • swelling beneath your skin or in your throat
  • rash
  • worsening trouble breathing
• low potassium levels in your blood
• worsening of other medical problems in people who also use ProAir Respiclick including increases in blood sugar

The most common side effects of ProAir Respiclick include:

• back pain
• body aches and pain
• upset stomach
• sinus headache
• urinary tract infection
• your heart feels like it is pounding or racing (palpitations)
• chest pain
• fast heart rate
• shakiness
• nervousness
• headache
• dizziness
• sore throat
• runny nose

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of ProAir Respiclick. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Bronchospasm

• For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the recommended dosage for adults and children 4 years of age or older is 2 inhalations repeated every 4 to 6 hours.
• More frequent administration or a larger number of inhalations is not recommended. In some patients, 1 inhalation every 4 hours may be sufficient.

Exercise-Induced Bronchospasm

• For prevention of exercise-induced bronchospasm, the recommended dosage for adults and children 4 years of age or older is 2 inhalations 15 to 30 minutes before exercise.

Administration Information

• Administer ProAir Respiclick by oral inhalation only.

Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Respiclick. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.

Beta-Blockers

• Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Respiclick, but may produce severe bronchospasm in asthmatic patients.
• Therefore, patients with asthma should not normally be treated with beta-blockers.
• However, under certain circumstances, eg, as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic-blocking agents in patients with asthma. In this setting, consider cardioselective beta-blockers, although they should be administered with caution.

Diuretics

• The ECG changes and/or hypokalemia which may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the betaagonist is exceeded.
• Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics. Consider monitoring potassium levels.

Digoxin

• Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days.
• The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear.
• Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and ProAir Respiclick.

Monoamine Oxidase Inhibitors Or Tricyclic Antidepressants

• ProAir Respiclick should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the cardiovascular system may be potentiated.
• Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.

• There are no randomized clinical studies of use of albuterol during 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.
• There are clinical considerations with use of albuterol in pregnant women.
• The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown.
• In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.