Document Detail


Bioavailability of syrup and tablet formulations of cefetamet pivoxil.
MedLine Citation:
PMID:  8109939     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Two studies examining the bioavailability of cefetamet pivoxil in healthy male subjects were conducted. In the first, the bioavailabilities of the 250-mg (M250) and M500 tablet formulations of cefetamet pivoxil to be marketed were compared with that of a tablet used in clinical trials. All products were given with food at a dose of 500 mg. In the second study, the bioavailability of the syrup formulation was evaluated under both fasting and nonfasting conditions and compared with that of the M500 tablet formulation given with food. The absolute bioavailabilities of the M500 and M250 tablets (55.0% +/- 8.0% and 55.7% +/- 7.0%, respectively) were not significantly different from that of the clinical-trial formulation (49.8% +/- 8.5%). The newer tablet formulations exhibited faster absorption as evidenced by higher peak concentrations (3.8 [M500] and 3.9 [M250] mg/liter compared with 3.2 mg/liter for the clinical-trial formulation), a shorter time to peak concentration, and a shorter mean absorption time. The syrup formulation was found to have significantly lower absolute bioavailability (37.9% +/- 6.0%) compared with that of the M500 tablet (58.4% +/- 9.0%) when both were given with food. Food had no significant effect on the bioavailability of the syrup, which averaged 34.0% +/- 8.6% under fasting conditions, although absorption was delayed by food (mean absorption time increased from 2.2 to 3.9 h). This contrasts with the results of previous studies documenting significant increases in tablet bioavailability with food. Despite the lower bioavailability of the syrup, unbound-cefetamet concentrations are expected to remain above the MICs for 90% of the strains tested for susceptible organisms for approximately 10 h of the usual 12-h dosing interval with both syrup and tablet formulations of cefetamet pivoxil given with food.
Authors:
M P Ducharme; D J Edwards; P J McNamara; K Stoeckel
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Antimicrobial agents and chemotherapy     Volume:  37     ISSN:  0066-4804     ISO Abbreviation:  Antimicrob. Agents Chemother.     Publication Date:  1993 Dec 
Date Detail:
Created Date:  1994-03-21     Completed Date:  1994-03-21     Revised Date:  2009-11-18    
Medline Journal Info:
Nlm Unique ID:  0315061     Medline TA:  Antimicrob Agents Chemother     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  2706-9     Citation Subset:  IM    
Affiliation:
College of Pharmacy and Allied Health Professions, Wayne State University, Detroit, Michigan 48202.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Adult
Biological Availability
Ceftizoxime / administration & dosage,  analogs & derivatives*,  chemistry,  pharmacokinetics
Chemistry, Pharmaceutical
Dose-Response Relationship, Drug
Humans
Injections, Intravenous
Male
Suspensions
Tablets
Chemical
Reg. No./Substance:
0/Suspensions; 0/Tablets; 65243-33-6/cefetamet pivoxyl; 68401-81-0/Ceftizoxime
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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