AMOXICILLIN AND CLAVULANATE POTASSIUM powder, for suspension

Amoxicillin and Clavulanate Potassium by

Drug Labeling and Warnings

Amoxicillin and Clavulanate Potassium by is a Animal medication manufactured, distributed, or labeled by Dechra Veterinary Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drops

For veterinary oral suspension
For use in dogs and cats

CAUTION:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

Amoxicillin and Clavulanate Potassium for Oral Suspension is an orally administered formulation comprised of the broad-spectrum antibiotic amoxicillin trihydrate and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid).

Amoxicillin trihydrate is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative, aerobic and anaerobic microorganisms. It does not resist destruction by β-lactamases; therefore, it is not effective against β-lactamase-producing bacteria. Chemically, it is D(-)-α-amino-p-hydroxybenzyl penicillin trihydrate.

Clavulanic acid, an inhibitor of β-lactamase enzymes, is produced by the fermentation of Streptomyces clavuligerus. Clavulanic acid by itself has only weak antibacterial activity. Chemically, clavulanate potassium is potassium z-(3R,5R)-2-β-hydroxyethylidene clavam-3-carboxylate.

CLINICAL PHARMACOLOGY:

Amoxicillin and Clavulanate Potassium for Oral Suspension is stable in the presence of gastric acid and is not significantly influenced by gastric or intestinal contents. The 2 components are rapidly absorbed resulting in amoxicillin and clavulanic acid concentrations in serum, urine, and tissues similar to those produced when each is administered alone.

Amoxicillin and clavulanic acid diffuse readily into most body tissues and fluids with the exception of brain and spinal fluid, which amoxicillin penetrates adequately when meninges are inflamed. Most of the amoxicillin is excreted unchanged in the urine. Clavulanic acid's penetration into spinal fluid is unknown at this time. Approximately 15% of the administered dose of clavulanic acid is excreted in the urine within the first 6 hours.

Amoxicillin and Clavulanate Potassium for Oral Suspension combines the distinctive properties of a broad-spectrum antibiotic and a β-lactamase inhibitor to effectively extend the antibacterial spectrum of amoxicillin to include β-lactamase-producing as well as non-β-lactamase-producing aerobic and anaerobic organisms.

Microbiology:

Amoxicillin is bactericidal in action and acts through the inhibition of biosynthesis of cell wall mucopeptide of susceptible organisms. The action of clavulanic acid extends the antimicrobial spectrum of amoxicillin to include organisms resistant to amoxicillin and other β-lactam antibiotics.

Amoxicillin/clavulanate has been shown to have a wide range of activity which includes β-lactamase-producing strains of both Gram-positive and Gram-negative aerobes, facultative anaerobes, and obligate anaerobes. Many strains of the following organisms, including β-lactamase-producing strains, isolated from veterinary sources, were found to be susceptible to amoxicillin/clavulanate in vitro but the clinical significance of this activity has not been demonstrated for some of these organisms in animals. Aerobic bacteria, including Staphylococcus aureus1, β-lactamase-producing Staphylococcus aureus1 (penicillin resistant), Staphylococcus species1, Staphylococcus epidermidis, Staphylococcus intermedius, Streptococcus faecalis, Streptococcus species1, Corynebacterium pyogenes, Corynebacterium species, Erysipelothrix rhusiopathiae, Bordetella bronchiseptica, Escherichia coli1, Proteus mirabilis, Proteus species, Enterobacter species, Klebsiella pneumoniae, Salmonella dublin, Salmonella typhimurium, Pasteurella multocida1, Pasteurella haemolytica, Pasteurella species1.

Studies have demonstrated that both aerobic and anaerobic flora are isolated from gingival cultures of dogs with clinical evidence of periodontal disease. Both Gram-positive and Gram-negative aerobic and anaerobic subgingival isolates indicate sensitivity to amoxicillin/clavulanic acid during antimicrobial susceptibility testing.

1 The susceptibility of these organisms has also been demonstrated in in vivo studies.

Susceptibility test:

The recommended quantitative disc susceptibility method (FEDERAL REGISTER 37:20527-29; Bauer AW, Kirby WMM, Sherris JC, et al: Antibiotic susceptibility testing by standardized single disc method. Am J Clin Path 45:493, 1966) utilized 30 mcg Augmentin® (AMC) discs for estimating the susceptibility of bacteria to amoxicillin and clavulanate potassium tablets and oral suspension.