Pediatric Subjects Aged 4 to 11 Years: The efficacy of VENTOLIN HFA was evaluated in one 2-week, randomized, double-blind, placebo-controlled trial in 135 pediatric subjects aged 4 to 11 years with mild to moderate asthma. In this trial, subjects received VENTOLIN HFA, CFC 11/12-propelled albuterol, or HFA-134a placebo. Serial pulmonary function measurements demonstrated that 2 inhalations of VENTOLIN HFA produced significantly greater improvement in pulmonary function than placebo and that there were no significant differences between the groups treated with VENTOLIN HFA and CFC 11/12-propelled albuterol. In the responder population treated with VENTOLIN HFA, the mean time to onset of a 15% increase in peak expiratory flow rate (PEFR) over the pretreatment value was minutes, and the mean time to peak effect was approximately 90 minutes. The mean duration of effect as measured by a 15% increase in PEFR over the pretreatment value was greater than 3 hours. In some subjects, duration of effect was as long as 6 hours.
To avoid microbial contamination, proper aseptic techniques should be used each time the bottle is opened. Precautions should be taken to prevent contact of the dropper tip of the bottle with any surface, including the nebulizer reservoir and associated ventilatory equipment. In addition, if the solution changes color or becomes cloudy, it should not be used. The safety and effectiveness of albuterol sulfate inhalation solution have not been determined when one or more drugs are mixed with it in a nebulizer. Check with your doctor before mixing any medications in your nebulizer.
In a surveillance study of Michigan Medicaid recipients conducted between 1985 and 1992 involving 229,101 completed pregnancies, 1090 newborns had been exposed to albuterol during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 48 (%) major birth defects were observed (43 expected). Specific data were available for six defect categories, including (observed/expected) 9/11 cardiovascular defects, 2/2 oral clefts, 2/ spina bifida, 1/2 limb reduction defects, 0/3 hypospadias, and 6/3 polydactyly. Only with the latter defect is there a suggestion of a possible association, but other factors, including the mother's disease, concurrent drug use, and chance, may be involved (Class IV).