Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: UNIMED HEALTHCARE (PTY) LTD, Corner Birch Road & Bluegum Avenue, Anchorville, Lenasia, 1827, South Africa, Tel: +27 11 056 6999
A 20.1.2 Penicillins
Pharmacotherapeutic group: Combinations of penicillins, incl. beta-lactamase Inhibitors
ATC code: J01CR02
CLAVUMED is a combination of amoxicillin and clavulanic acid. Amoxicillin is a semi-synthetic semisynthetic beta-lactamase-susceptible penicillin which has in vitro bactericidal activity against a broad spectrum of non beta-lactamase-producing Gram-positive and Gram-negative organisms. The spectrum of activity does not include those organisms which produce beta-lactamases, namely resistant staphylococci and all strains of Pseudomonas, Klebsiella and Enterobacter.
Clavulanic acid has been shown in vitro to be an irreversible inhibitor of beta-lactamases produced by: Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Haemophilus inluenzae, Neisseria gonorrhoae and Bacteroides fragilis. Clavulanic acid does not inactivate the chromosomally mediated (Sykes Type 1 Cephalosporinase) beta-lactamases produced by Acinetobacter species, Citrobacter species, Enterobacter, indole positive Proteus, Providencia species and Serratia marcescens. In vitro the formulation showed synergism against amoxicillin-resistant organisms, with no evidence of antagonism and the activity was not reduced in the presence of serum. (In vitro activity does not necessarily imply in vivo efficacy). The clavulanic acid component has very little bactericidal action.
Amoxicillin is stable in the presence of acidic gastric secretions. Peak blood levels are achieved 1-2 hours after administration. There is a linear dose response in peak serum levels. The pharmacokinetics of amoxicillin and clavulanic acid are closely allied and neither is adversely affected by the presence of food in the stomach.
Approximately 18% of the total amoxicillin content is protein bound. Amoxicillin diffuse readily into most body tissues with the exception of the brain and spinal fluid. Inflammation generally increases the permeability of the meninges to penicillin and this may apply to amoxicillin.
The elimination half-life of amoxicillin is approximately 1 hour. Co-administration of probenecid has little effect on the excretion of the clavulanic acid component of the formulation. Small amounts of amoxicillin are also excreted in the faeces and bile.
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