A REVIEW OF THE TOXICOLOGY OF SALBUTAMOL (ALBUTEROL)

This paper reviews the published toxicology of salbutamol. Salbutamol is a relatively selective pz-adrenoreceptor stimulant with rapid, pote nt bronchodilator activity and only minor inotropic or chronotropic ef fects. It was not found to be mutagenic. LD(50) values and other acute studies indicated low toxicity. Findings published for repeat dose st udies were mainly uneventful. Tachycardia and flushing of the skin wer e observed in dogs. There were several findings peculiar to the rat - growth of the salivary gland, enlargement of the Harderian gland, an i ncrease in colloid in the pituitary, and mesovarian leiomyomas. Increa ses in heart weights associated with inflammation, hypertrophy of musc le fibres, focal myocardial necrosis and fibrosis were seen in rats. M alformation, in the form of cleft palate, was reported in mice but not in rats or rabbits. These treatment related effects reported for salb utamol are not compound-related but rather are class-related. They are an expression of pharmacological activity brought about by the excess ive beta stimulant action of high dosage with the drug.