Two new inhaled respiratory products were recently launched following their FDA approval last spring.

The pediatric-specific product AccuNeb is the first premixed, premeasured, reduced-dose formulation of albuterol sulfate, eliminating the need for dilution of higher doses. It was cleared for relief of bronchospasm in patients aged 2 to 12 years with asthma. AccuNeb is supplied in unit-dose vials containing 0.63 or 1.25 mg of albuterol. The usual starting dosage is 1.25 or 0.63 mg administered three or four times daily, as needed, by nebulization.

The second product, DuoNeb, is a fixed-dose combination of the b2-adrenergic bronchodilator albuterol sulfate and the cholinergic bronchodilator ipratropium bromide. It was approved for treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) in patients who require more than one bronchodilator.

Approval was based on a 12-week, randomized, double-blind trial comparing DuoNeb with albuterol alone and with ipratropium alone among 863 patients with COPD. DuoNeb demonstrated significantly greater improvements in FEV1 from baseline to peak as compared with either albuterol or ipratropium alone, labeling notes. It adds that DuoNeb showed the rapid onset associated with albuterol, with a mean time to peak FEV1 of 1.5 hours, and the extended duration associated with ipratropium, with a duration of 15% response in FEV1 of 4.3 hours.

DuoNeb is supplied in 3-ml vials containing 3 mg of albuterol sulfate and 0.5 mg of ipratropium bromide. The recommended dose is one 3-ml vial administered four times daily via nebulizer, with up to two additional 3-ml doses permitted per day if needed.