aternalcondition。
8.4 Pediatric Use
The safety and effectiveness of ProAir Digihaler for the treatment or prevention of bronchospasm in children 12 to17 years of age and older with reversible obstructive airway disease is based on two 12-week clinical trials in 318 patients12 years of age and older with asthma comparing doses of 180 mcg four times daily with placebo, one long-term safetystudy in children 12 years of age and older, and one single-dose crossover study comparing doses of 90 and 180 mcg withalbuterol sulfate inhalation aerosol (ProAir® HFA) in 71 patients [see Clinical Studies (14.1)].
The safety and effectiveness of ProAir Digihaler for treatment of exercise-induced bronchospasm in children 12 years ofage and older is based on one single-dose crossover study in 38 patients age 16 and older with exercise-inducedbronchospasm comparing doses of 180 mcg with placebo [see Clinical Studies (14.2)]. The safety profile for patients ages12 to 17 was consistent with the overall safety profile seen in these studies.
The safety of ProAir Digihaler in children 4 to 11 years of age is based on two single-dose, controlled, crossover studies:one with 61 patients comparing doses of 90 and 180 mcg with matched placebo and albuterol HFA MDI and one with 15patients comparing a dose of 180 mcg with matched albuterol HFA MDI; and one 3-week clinical trial in 185 patients 4 to11 years of age with asthma comparing a dose of 180 mcg four times daily with matched albuterol HFA MDI. Theeffectiveness of albuterol sulfate MDPI in children 4 to 11 years with exercise-induced bronchospasm is extrapolatedfrom clinical trials in patients 12 years of age and older with asthma and exercise-induced bronchospasm, based on datafrom a single-dose study comparing the bronchodilatory effect of albuterol sulfate MDPI 90 mcg and 180 mcg with
placebo in 61 patients with asthma, and data from a 3-week clinical trial in 185 asthmatic children 4 to 11 years of agecomparing a dose of 180 mcg albuterol 4 times daily with placebo [see Clinical Studies (14.1)].
The safety and effectiveness of ProAir Digihaler in pediatric patients below the age of 4 years has not been established.
8.5 Geriatric Use
Clinical studies of albuterol sulfate MDPI did not include sufficient numbers of patients aged 65 and over to determinewhether they respond differently from younger patients. Other reported clinical experience has not identified differencesin responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious,usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiacfunction, and of concomitant disease or other drug therapy [see Warnings and Precautions (5.4, 5.7)].
All beta2-adrenergic agonists, including albuterol, are known to be substantially excreted by the kidney, and the risk oftoxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to havedecreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
10 OVERDOSAGE
The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence orexaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension orhypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth,palpitation, nause |
