Albuterol sulfate was not mutagenic in the Ames test with or without metabolic activation using tester strains S. typhimurium TA1537, TA1538, and TA98 or E. Coli WP2, WP2uvrA, and WP67. No forward mutation was seen in yeast strain S. cerevisiae S9 nor any mitotic gene conversion in yeast strain S. cerevisiae JD1 with or without metabolic activation. Fluctuation assays in S. typhimurium TA98 and E. Coli WP2, both with metabolic activation, were negative. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay at intraperitoneal doses of up to 200 mg/kg.
to mg via oral inhalation every 4 to 6 hours as needed for symptoms of bronchospasm is recommended by the National Asthma Education and Prevention Program (NAEPP) Expert Panel. For acute asthma exacerbations, the NAEPP recommends mg/kg/dose (Min: mg/dose) via oral inhalation every 20 minutes for 3 doses, then to mg/kg/dose (Max: 10 mg/dose) every 1 to 4 hours as needed or mg/kg/hour by continuous nebulization. The Global Initiative for Asthma (GINA) guidelines recommend mg via nebulization with mouthpiece (and facemask in those younger than 4 years) every 20 minutes for the first hour for acute exacerbations, with reassessment thereafter (further dosing not specified). According to FDA-approved labeling, initial dosing for albuterol % solution is to mg/kg/dose, with subsequent dosing titrated to achieve desired clinical response. Max: mg/dose 3 to 4 times daily; do not exceed 4 doses/day. For patients weighing at least 15 kg, the % solution may be used at a dose of mg via oral inhalation 3 to 4 times daily as needed. Doses should be delivered over 5 to 15 minutes.
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