Rapid bolus injection of gadopentetate dimeglumine: absence of side effects in normal volunteers.

Abstract

The safety and tolerance of gadopentetate dimeglumine 0.1 mmol/kg when injected at a bolus rate (10 ml/15 sec; four times the recommended rate) was studied in 12 normal men between the ages of 20 and 36 years. Each of the subjects received a single injection of either gadopentetate dimeglumine (0.2 ml/kg) or a placebo (normal saline, 0.2 ml/kg), followed by a 7-day washout and a single injection of the alternative treatment (six subjects per sequence). Measurement parameters included blood pressure, pulse rate, ECG, cardiographic rhythm strips, hematology and blood chemistry evaluations, physical examinations, and adverse drug experiences. Variations of greater than or equal to +/- 15 mm Hg in diastolic blood pressure and greater than or equal to +/- 15 beats per min in heart rate were observed in some subjects after injection of either gadopentetate dimeglumine or the placebo, but no clinically significant changes from baseline were observed for any parameter. Post-gadopentetate dimeglumine results were not significantly different statistically from post-placebo results. No adverse experiences were reported for any subject. It is concluded that gadopentetate dimeglumine is safe and well tolerated when administered to normal men at a rapid injection rate of 10 ml/15 sec.