Pharmacokinetics and pharmacodynamics of three sustained-release theophylline preparations (350 mg Theograd, 350 mg Theolair Retard and 300 mg Theodur) in steady state in healthy volunteers and asthmatics--Part I: Theophylline plasma levels.
The pharmacokinetic profiles of three oral sustained-release theophylline preparations in steady state (350 mg Theograd, 350 mg Theolair Retard [= Nuelin Retard], and 300 mg Theolin Retard [= Theodur]) were compared in a group of six normal subjects and six patients with moderately severe asthmatic bronchitis. All preparations were given twice daily for 7 days. Before this study, an intravenous infusion of aminophylline had been administered (5.6 mg theophylline per kg body wt.). The plasma theophylline levels after oral administration were rather low from a clinical point of view (below 55 mumol/l = 10 mg/l). The mean plasma theophylline level of the three different oral preparations in steady state did not show a statistically significant difference. The group of six healthy volunteers reached higher mean theophylline levels than the group of six patients, possibly due to differences in mean weight and smoking habits. This difference was only statistically significant (p = 0.001) for Theograd. Between Theograd, Theolair (Nuelin) Retard, and Theolin (Theodur) Retard no statistically significant difference in absolute bioavailability was observed, and virtually no side effects were reported.
D000328:Adult; D000428:Alcohol Drinking; D001249:Asthma / Q000097:blood* / Q000188:drug therapy; D001682:Biological Availability; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D007700:Kinetics; D008297:Male; D008875:Middle Aged; D012907:Smoking; D013806:Theophylline / Q000008:administration & dosage / Q000097:blood*; D013997:Time Factors
D003692:Delayed-Action Preparations; D013806:Theophylline