Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, a Sun Pharma Company, 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724, South Africa
A. 20.1.1 Broad and medium spectrum antibiotics.
Cefpodoxime proxetil is a semi-synthetic β-lactam antibiotic belonging to the third generation oral cephalosporin group. Cefpodoxime proxetil is the prodrug of the bactericidal antibiotic cefpodoxime.
The antibacterial action of cefpodoxime is through inhibition of bacterial cell wall synthesis probably by acylation of membrane bound transpeptidase enzymes; this prevents cross linkage of peptidoglycan chains, which is necessary for bacterial cell wall strength and rigidity.
In vitro studies have demonstrated the susceptibility of most strains of the following micro-organisms to cefpodoxime proxetil. However, such in vitro activity does not necessarily imply in vivo efficacy.
Gram-positive organisms:
Streptococcus pneumoniae, S. pyogenes, S. agalactiae, S. mitis, S. sanguis and S. salivarius; Propionibacterium acnes; Corynebacterium diphtheriae; methicillin-sensitive penicillinase and non-penicillinase producing strains of S. aureus.
Gram negative organisms:
β-lactamase and non-β-lactamase producing strains of Haemophilus influenzae, Haemophilus para-influenzae, Moraxella catarrhalis (Branhamella catarrhalis) and Neisseria gonorrhoea; Escherichia coli; Klebsiella pneumoniae; Klebsiella oxytoca; Proteus mirabilis.
The following organisms are not sensitive: Group D streptococci, Methicillin-resistant staphylococci (S. aureus and S. epidermidis), Staphylococcus saprophyticus, Corynebacteria, groups J and K, Listeria monocytogenes, Pseudomonas aeruginosa and Pseudomonas spp., Acinetobacter baumanii, Clostridium difficile, Bacteroides fragilis and related species.
Cefpodoxime proxetil is absorbed orally and rapidly hydrolysed by non-specific esterases in the gastro-intestinal wall to cefpodoxime, the active acid. Absorption is decreased in conditions of low gastric acidity.
After oral administration of a single 5 mg/kg (200 mg maximum) dose of cefpodoxime proxetil suspension in children, the maximum plasma concentration (Cmax) obtained is on average 2,6 mg/l.
With cefpodoxime proxetil tablets the time taken to reach the maximum concentration (Tmax) is about 2,7 hours.
With the suspension the time taken to reach the maximum concentration (Tmax) is about 2 to 4 hours.
The drug diffuses well into respiratory tissues.
The serum half-life is about 2,46 hours.
About 27% of cefpodoxime in the plasma is bound to plasma proteins
The volume of distribution is about 0,46 l/kg.
The clearance is around 2,4 ml/min/kg.
About 81% of unchanged cefpodoxime is excreted in the urine.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
