Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Codal-Synto Ltd, 21 Constantinoupoleos, 3011 Limassol, Cyprus
Pharmacotherapeutic group: Combinations of penicillins, incl. beta-lactamase inhibitors
ATC code: J01CR02
Syntoclav is a combination of amoxicillin (as amoxicillin trihydrate) and clavulanic acid (as potassium clavulanate).
Amoxicillin is a semisynthetic penicillin with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. It acts by inhibiting the biosynthesis of cell wall mucopeptide. However, Amoxicillin is susceptible to degradation from ß-lactamases, and therefore its spectrum of activity does not include ß-lactamase producing microorganisms.
Clavulanic acid is a ß-lactam antibiotic, structurally related to the penicillins, which posses the ability to inactivate a wide range of ß-lactamase enzymes, commonly found in microorganisms resistant to penicillins and cephalosporins.
The combination of amoxicillin and clavulanic acid results in the protection of amoxicillin from degradation by ß-lactamase enzymes, and effectively extends the antibiotic spectrum of amoxicillin to include many bacteria, normally resistant to amoxicillin and other ß-lactam antibiotics.
Gram positive (aerobic): Bacillus anthracis, Corynebacterium sp., Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus aureus, coagulase negative Staphylococcus sp., Staphylococcus epidermidis, Streptococcus pneumoniae, Staphylococcus saprophyticus, Streptococcus pyogenes, Streptococcus viridans.
Gram positive (anaerobic): Clostridium sp., Peptococcus sp., Peptostreptococcus sp.
Gram negative (aerobic): Bordetella pertussis, Branhamella (Moraxella) catarrhalis, Brucella sp., Enterobacter sp. (although most are resistant in vitro, clinical efficacy in urinary tract infections has been shown) Escherichia coli, Haemophilus influenzae, Klebsiella sp., Legionella sp., Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida, Proteus mirabilis, Proteus vulgaris, Salmonella sp., Shigella sp.
Gram negative (anaerobic): Bacteroides sp., including Bacteroides fragilis.
For many of the species listed, some strains are beta lactamase producers, which render them insensitive to amoxicillin alone.
The combined administration of amoxicillin and clavulanic acid does not affect the pharmacokinetic properties of each one of the drugs, administered separately.
Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in the serum.
Doubling the dosage of Syntoclav approximately doubles the serum levels achieved.
Nonclinical data reveal no special hazard for humans based on studies of safety pharmacology, genotoxicity and toxicity to reproduction.
Repeat dose toxicity studies performed in dogs with amoxicillin/clavulanic acid demonstrate gastric irritancy and vomiting, and discoloured tongue.
Carcinogenicity studies have not been conducted with Syntoclav or its components.
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