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Am. J. Respir. Crit. Care Med., Volume 159, Number 3, March 1999, 932-934

Once-Daily and Twice-Daily Dosing of p-Aminosalicylic Acid Granules

CHARLES A. PELOQUIN, SHAUN E. BERNING, GWEN A. HUITT, JAMES M. CHILDS, MICHAEL D. SINGLETON, and GORDON T. JAMES

Department of Medicine, National Jewish Medical and Research Center, and School of Pharmacy and School of Medicine, University of Colorado, Denver, Colorado

The study objective was to determine the minimum frequency of dosing for standard 4-g doses of p-aminosalicylic acid (PAS) granules. Two sequential six-patient pharmacokinetic studies are described, followed by clinical data from 40 subsequent patients. All patients had multidrug-resistant tuberculosis (MDR-TB). Serum was collected at two to three time points after dosing, and assayed by a validated high performance liquid chromatography (HPLC) assay. Data were analyzed using noncompartmental methods. In six patients, twice-daily dosing produced median serum concentrations at 4, 8, and 12 h post-dose of 25.8, 23.2, and 16.4 µg/ml. In six patients, once-daily dosing produced median serum concentrations at 6, 12, and 24 h post-dose of 23.4, 3.7, and 0 µg/ml. In 40 patients, twice-daily dosing produced median serum concentrations at 4 to 8 and 9 to 12 h post-dose of 24.8 and 20.6 µg/ml. Unlike once-daily dosing, twice-daily PAS maintained serum concentrations in excess of 1 µg/ml, the typical minimal inhibitory concentration against Mycobacterium tuberculosis, for the entire dosing interval. We now use twice-daily PAS granules for our patients with MDR-TB.




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