General practitioner surveillance of azatadine maleate/pseudoephedrine sulphate ('Congesteze') for the treatment of upper respiratory tract congestion.

A post-marketing, general practitioner surveillance programme involving 12,679 patients with upper respiratory congestion was carried out to assess how well tolerated was symptomatic treatment with a combination oral preparation containing azatadine maleate (1 mg) and pseudoephedrine sulphate (120 mg) given twice daily for up to 15 days. The improvement which patients experienced in the symptoms of sneezing, running nose, stuffy nose, watery eyes and itchy eyes was also evaluated. Analysis of the results showed that 97% of the patients experienced some relief. The incidence of drug-related side-effects was 4% but only 253 (2%) patients discontinued treatment for this reason. The side-effect most frequently reported was drowsiness and this was considered to be probably or possibly due to treatment in 332 (3%) of the patients.