A Chronic Safety and Tolerance Study Using Pyrimethamine with the Sulfone, DFD. Volume One,
OKLAHOMA UNIV HEALTH SCIENCES CENTER OKLAHOMA CITY MCALESTER DIV OF CLINICAL PHARMACOLOGY
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Pyrimethamine in combination with the sulfone DFD is potentially useful in malaria prophylaxis. The study was designed to determine the safety of 25 mg pyrimethamine in combination with 400 mg of DFD when taken orally once each week for one year. During the study, the involved subjects were interviewed, examined, had electrocardiograms and regular laboratory studies. The study demonstrated that in the doses studied, pyrimethamine and DFD were clinically well tolerated and not associated with unpleasant subjective or objective toxic effects. While not clinically significant, a statistically significant increase in methemoglobin and serum creatinine concentration was detected in those subjects receiving active drug. In addition, in the drug treated subjects, there was a trend toward decreasing red blood cell count, hemoglobin and hermatocrit.