Criticism of FDA Recommendations for Theophylline Dosage

To the Editor: After a good deal of prodding, ¹ the FDA recently issued new guidelines² for dosage in patients receiving theophylline. The widespread use of the maintenance dose, 0.9 mg per kilogram of body weight per hour, established in the classic article by Mitenko and Ogilvie, ³ has led to an unacceptable incidence of toxic reactions to theophylline and has necessitated the release of new recommendations. In an attempt to rectify the situation, the FDA has created unnecessary problems: it has provided two sets of maintenance doses, one for the first 12 hours after the loading dose and another for the.