Abstract:
STUDY OBJECTIVE:To determine the bioavailability and renal elimination of para-aminosalicylic acid (PAS) and its inactive metabolite acetyl-para-aminosalicylic acid (AcPAS) from a new PAS formulation. DESIGN:(a) Single-dose pharmacokinetic study in healthy volunteers; (b) Day-1 and day-8 pharmacokinetic comparison in patients with multidrug-resistant tuberculosis (MDR-TB). SETTING:Referral hospital that specializes in the treatment of mycobacterial infections. PATIENTS:(a) Twelve healthy male and female volunteers recruited by the investigators. Eleven subjects (92%) completed the study; one subject could not maintain venous access and was removed from the study. (b) Six sequential male and female patients receiving multidrug treatment for advanced MDR-TB. All patients completed the study. INTERVENTIONS:(a) Volunteers received a single 4-g dose of enteric-coated PAS granules administered with food. Blood and urine samples were collected over 24 hours after the dose. (b) Patients received 4-g doses of enteric-coated PAS granules every 8 hours for 7 days as part of their treatment regimen. Blood samples were obtained at approximately 2, 4, and 8 hours after the first dose on day 1 and the twenty-second dose on day 8. MEASUREMENTS AND MAIN RESULTS:Concentrations of PAS and AcPAS were determined using high-performance liquid chromatography. The serum concentration-time curves from volunteers and patients showed sustained PAS concentrations, in contrast to immediate-release sodium PAS tablets. In the six patients with tuberculosis, day 8 concentrations were considerably higher than those on day 1, and all were sustained well above the PAS minimal inhibitory concentration for Mycobacterium tuberculosis. CONCLUSIONS:Para-aminosalicylic acid granules produce adequate serum concentrations and appear to be safe.
journal_name
Pharmacotherapyjournal_title
Pharmacotherapyauthors
Peloquin CA,Henshaw TL,Huitt GA,Berning SE,Nitta AT,James GTdoi
10.1002/j.1875-9114.1994.tb02787.xsubject
Has Abstractpub_date
1994-01-01 00:00:00pages
40-6issue
1eissn
0277-0008issn
1875-9114journal_volume
14pub_type
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