Source: Health Products Regulatory Authority (ZA) Revision Year: 2025 Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724, South Africa, Tel: +27(0) 12 643 2000
A 20.1.2 Penicillins
RANCLAV 1 g is a combination of amoxicillin and clavulanic acid.
Amoxicillin is a semi-synthetic 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 to be an irreversible inhibitor of beta-lactamases produced by: Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Haemophilus influenzae, Neisseria gonorrhoea 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 diffuses 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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