1.1 Bronchospasm

PROAIR RESPICLICK (albuterol sulfate) inhalation powder is indicated for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease.

1.2 Exercise-Induced Bronchospasm

PROAIR RESPICLICK is indicated for the prevention of exercise-induced bronchospasm in patients 12 years of age and older.

2.1 Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the recommended dosage for adults and adolescents 12 years and 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.

2.2 Exercise-Induced Bronchospasm

For prevention of exercise-induced bronchospasm, the recommended dosage for adults and adolescents 12 years of age or older is 2 inhalations 15 to 30 minutes before exercise.

2.3 Administration Information

Administer PROAIR RESPICLICK by oral inhalation only.

Priming:PROAIR RESPICLICK inhaler does not require priming.

Do not use PROAIR RESPICLICK with a spacer or volume holding chamber.

Cleaning:

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Keep the inhaler clean and dry at all times. Never wash or put any part of your inhaler in water.

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Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed.

Dose Counter: The PROAIR RESPICLICK inhaler has a dose counter attached to the actuator. When the patient receives the inhaler, the number 200 will be displayed. The dose counter will count down each time the inhaler is actuated. When the dose counter reaches 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill. When the dose counter reaches 0, the background will change to solid red. Discard PROAIR RESPICLICK 13 months after opening the foil pouch, when the dose counter displays 0 or after the expiration date on the product, whichever comes first [see Patient Counseling Information (17.8)].

5.1 Paradoxical Bronchospasm

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

5.2 Deterioration of Asthma

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-eva luation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, eg, corticosteroids.

5.3 Use of Anti-Inflammatory Agents

The use of beta-adrenergic-agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, eg, corticosteroids, to the therapeutic regimen.

5.4 Cardiovascular Effects

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. Although such effects are uncommon after administration of PROAIR RESPICLICK at recommended doses, if they occur, the drug may need to be discontinued. 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.

5.5 Do Not Exceed Recommended Dose

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.

5.6 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. PROAIR RESPICLICK contains small amounts of lactose, which may contain trace levels of milk proteins. Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of therapies containing lactose (lactose is an inactive ingredient in PROAIR RESPICLICK). The potential for hypersensitivity must be considered in the clinical eva luation of patients who experience immediate hypersensitivity reactions while receiving PROAIR RESPICLICK.

5.7 Coexisting Conditions

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. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator. Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

5.8 Hypokalemia

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. The decrease is usually transient, not requiring supplementation.

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

In addition to the adverse reactions reported from clinical trials with PROAIR RESPICLICK, the following adverse events have been reported during use of other inhaled albuterol sulfate products: Urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), rare cases of aggravated bronchospasm, lack of efficacy, asthma exacerbation (potentially fatal), muscle cramps, and various oropharyngeal side-effects such as throat irritation, altered taste, glossitis, tongue ulceration, and gagging. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as: angina, hypertension or hypotension, palpitations, central nervous system stimulation, insomnia, headache, nervousness, tremor, muscle cramps, drying or irritation of the oropharynx, hypokalemia, hyperglycemia, and metabolic acidosis.

7.1 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.

7.2 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 beta-agonist 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.

7.3 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 eva luate the serum digoxin levels in patients who are currently receiving digoxin and PROAIR RESPICLICK.

7.4 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.