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Comparison study of sustained-release theophylline products: Slo-bid capsules versus Theo-Dur tablets in 20 children and young adults with asthma

1986; Elsevier BV; Volume: 77; Issue: 3 Linguagem: Inglês

10.1016/0091-6749(86)90180-6

1097-6825

P HANNAWAY, G HOPPER,

Respiratory and Cough-Related Research

Recause there are few published studies on capsulized sustained-release theophylline (SRTJ products in children, we compured Slo-bid capsules to Theo-Dur tablets in a group of school uge children and young adults with asthma in an &week rundomized crossover study design with patients maintuining daily symptom diary curds and peak expiratory flow rates.Theophylline 1cvel.swere obtained at 8 hours after the morning dose on day 7, 14, and 28 of each study period.Dam were analyzed by one-wuy analysis of variance, regression equation, and Student's t test.Roth products were demonstrated to have grossly similar absorption characteristics and &icacy at 12-hour intervals in the age group studied.Average daily dose requirement was 717 mglduy.Considerable week-to-week intrapatient variation in &hour theophylline levels was noted in both products, implying that precise dose adjustments cannot be made from a given level.Our literature review reveals the need for more data to support the current widespread practice of dosing children less than 8 years of age at 12-hour intervals.A retrospective review of ingestion before and after breakfast reveuled no vuriation between the seven patients ingesting SRT before breakfast compared to 13 patients routinely ingesting SRT after a typical childhood breakfast.(J ALLERGY CLAY IMMUNOL 77:456-64 ( I986. ) ln the past decade, high-dose theophylline has become a leading method for the pharmacologic management of asthma in the United States.In tertiary care settings theophylline alone stabilizes 70% of children with chronic asthma.'Despite a narrow therdpeutic index and significant intrasubject variation.innovative alternations in thcophylline tablet and capsuie configuration have led to the development of SRI ..l-.