[Clinical evaluation of the isotonic solution of theophylline for intravenous injection]

The safety and tolerance of intravenous theophylline in asthmatic patients was investigated. The effect upon the lung function tests and frequency of cardiac arrhythmias were evaluated in 15 patients after five days treatment with theophylline 300 mg twice a day. Measurements of the peak expiratory flow (PEF) were obtained prior to theophylline administration, immediately after first intravenous infusion and 1.3 and 6 hours later and before and after second infusion, while serum theophylline levels were determined at the same time by enzyme immunoassay (Diagnostica Merc). The same measurements were made at the fifth day of observation. Continuous 24 hour Holter monitoring of the electrocardiogram before the study and at the fifth day of the treatment was performed. Biochemical investigations included aspartate and alanine aminotransferase (GGTPi GOT), sodium and potassium ion concentrations, serum levels of creatinine, glucose and bilirubin hematocrit, hemoglobin concentration, MCHC, red blood cells count and white blood cell differential count were determined. The therapeutic concentration of theophylline in serum were found in all subject treated with theophylline 300 mg twice a day. The improvement in lung function and no changes in cardiac rhythm were observed the biochemical findings did not demonstrate any significant differences after five days of the study. The study confirm safety and good tolerance of intravenous theophylline used in the doses 300 mg twice a day.