If patients find that treatment with ProAir Respiclick becomes less effective for symptomatic relief, symptoms become worse, and/or they need to use the product more frequently than usual, they should seek medical attention immediately.Advise patients to keep their inhaler dry and clean at all times. The dose counter will count down each time the mouthpiece cap is opened and closed. Patients should be instructed on the proper use of the inhaler. Cleaning instructions: Take the canister out of the actuator, and take the cap off the mouthpiece. 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. In a cumulative dose study, the AUCThe volume of distribution has not been determined for ProAir Respiclick. ProAir RespiClick is for use in adults and children at least 4 years old. Patients should never try to alter the numbers for the dose counter. The clinical significance of these findings is unknown.In two 12-week, randomized, double-blind, placebo-controlled studies of identical design (Study 1 and Study 2), ProAir Respiclick (153 patients) was compared to a matched placebo dry powder inhaler (163 patients) in asthmatic patients 12 to 76 years of age at a dose of 180 mcg albuterol four times daily. The dose counter window displays the number of actuations left in the inhaler in units of two (eg, 200, 198, 196, etc). 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 decrease is usually transient, not requiring supplementation.A total of 1289 subjects were treated with ProAir Respiclick during the clinical development program. 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.Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Respiclick. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Adults and Adolescents 12 years of Age and Older: The adverse reaction information presented in Table 1 below concerning ProAir Respiclick is derived from the 12-week blinded treatment period of three studies which compared ProAir Respiclick 180 mcg four times daily with a double-blinded matched placebo in 653 asthmatic patients 12 to 76 years of age.In a long-term study of 168 patients treated with ProAir Respiclick for up to 52 weeks (including a 12-week double-blind period), the most commonly reported adverse events greater than or equal to 5% were upper respiratory infection, nasopharyngitis, sinusitis, bronchitis, cough, oropharyngeal pain, headache, and pyrexia.In a small cumulative dose study, tremor, palpitations, and headache were the most frequently occurring (≥5%) adverse events.Pediatric Patients 4 to 11 Years of Age: The adverse reaction information presented in Table 2 below concerning ProAir Respiclick is derived from a 3‑week pediatric clinical trial which compared ProAir Respiclick 180 mcg albuterol 4 times daily with a double‑blinded matched placebo in 185 asthmatic patients 4 to 11 years of age.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.
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