Indicated for:

Bronchospasm:

• Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Exercise-Induced Bronchospasm:

• Prevention of exercise-induced bronchospasm in patients 4 years of age and older.

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

PROAIR RESPICLICK can produce paradoxical bronchospasm that may be life-threatening.PROAIR. If paradoxical bronchospasm occurs, PROAIR RESPICLICK should be discontinued immediately and alternative therapy instituted.

PROAIR RESPICLICK, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms.In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, PROAIR RESPICLICK, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of PROAIR RESPICLICK, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, eg, corticosteroids.

As with other beta-agonists, PROAIR RESPICLICK may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.

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

PROAIR RESPICLICK, like all sympathomimetic amines, should be used with 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.

Beta-blockers may decrease effectiveness of  PROAIR RESPICLICK and produce severe bronchospasm. Patients with asthma should not normally be treated with beta-blockers.

Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with PROAIR RESPICLICK.

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.

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 beta-agonist is exceeded.

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.

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. Animal studies: cleft palate and cranioschisis.

Plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast
milk, albuterol has a low oral bioavailability.

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• Use in patients under 4 years of age. GoToSource

• Hyperkalemia. GoToSource

Palpitations, tremor, increased risk of cardiovascular death, ischemic heart disease and cardiac failure. GoToSource

Hypokalemia (low blood potassium level), hypomagnesemia (low blood magnesium level), hypophosphatemia (low blood phosphate level) and hypocalcemia (low blood calcium level). GoToSource

Anaphylaxis (life-threatening allergic reaction) and angioedema (swelling in deep layers of skin). GoToSource

Lactic acidosis (excess acid in the body). GoToSource

Paradoxical bronchospasm. GoToSource

Upper respiratory tract infection, nasopharyngitis and sinusitis. GoToSource

Takotsubo cardiomyopathy (sudden weakening of the left ventricle). GoToSource

Lawsuits filed for heart attacks.