The oral median lethal dose of albuterol sulfate in mice is greater than 2,000 mg/kg (approximately 6,300 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis). In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 2,800 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis). In young rats, the subcutaneous median lethal dose is approximately 2,000 mg/kg (approximately 13,000 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis). The inhalation median lethal dose has not been determined in animals.
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.