Kesium Dailymed

Veterinary Indications Section

INDICATIONS: Kesium Chewable Tablets are indicated in the treatment of:

Dogs: Skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: β-lactamase-producing Staphylococcus aureus, non-β-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and E. coli.

Periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria. Kesium has been shown to be clinically effective for treating cases of canine periodontal disease.

Cats: Skin and soft tissue infections such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: β-lactamase-producing Staphylococcus aureus, non-β-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella spp.

Urinary tract infections (cystitis) due to susceptible strains of E. coli.

Therapy may be initiated with Kesium prior to obtaining results from bacteriological and susceptibility studies. A culture should be obtained prior to treatment to determine susceptibility of the organisms to Kesium. Following determination of susceptibility results and clinical response to medication, therapy may be reevaluated.

Dosage And Administration:

The dose should be prescribed using a combination of whole tablet strengths (62.5 mg, 125 mg, 250 mg, 375 mg). Do not remove from foil buler until ready to use. Pierce the foil buler cavity to access the tablet. Even if the tablet is broken, the entire tablet should be consumed.

Dogs: The recommended dosage of Kesium Chewable Tablet is 6.25 mg/lb of body weight twice a day.

Skin and soft tissue infections such as abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and periodontal infections should be treated for 5–7 days or for 48 hours after all symptoms have subsided. If no response is seen after 5 days of treatment, therapy should be discontinued and the case reevaluated. Deep pyoderma may require treatment for 21 days; the maximum duration of treatment should not exceed 30 days.

Cats: The recommended dosage of Kesium Chewable Tablet is 62.5 mg twice a day.

Skin and soft tissue infections such as abscesses and cellulitis/dermatitis should be treated for 5–7 days or for 48 hours after all symptoms have subsided, not to exceed 30 days. If no response is seen after 3 days of treatment, therapy should be discontinued and the case reevaluated.

Urinary tract infections may require treatment for 10 - 14 days or longer. The maximum duration of treatment should not exceed 30 days.

Contraindications Section

CONTRAINDICATIONS: The use of this drug is contraindicated in animals with a history of allergic reaction to any of the penicillins or cephalosporins.

Warnings Section

WARNINGS: Store Kesium out of reach of dogs, cats, and other pets in a secured location in order to prevent accidental ingestion or overdose.

Safe Handling Warning Section

HUMAN WARNINGS: Not for human use. Keep this and all drugs out of reach of children. Antimicrobial drugs, including penicillins and cephalosporins, can cause allergic reactions in sensitized individuals. To minimize the possibility of allergic reactions, those handling such antimicrobials, including amoxicillin and clavulanate potassium, are advised to avoid direct contact of the product with the skin and mucous membranes.

Precautions Section

PRECAUTIONS: Prescribing antibacterial drugs in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to treated animals and may increase the risk of the development of drug-resistant animal pathogens. Safety of use in pregnant or breeding animals has not been determined.

Adverse Reactions Section

ADVERSE REACTIONS: Kesium contains a semisynthetic penicillin (amoxicillin) and has the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids.

Post-Approval Experience (July, 2017): The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse events are reported to FDA/CVM.

It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events reported for dogs and cats are uled in decreasing order of reporting frequency for amoxicillin and clavulanate potassium: Anorexia, lethargy, vomiting and diarrhea.

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Ceva Animal Health, LLC at 1-800-999-0297. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

ACTIONS: 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.

Kesium 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 Section

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 aureusThe susceptibility of these organisms has also been demonstrated in in vivo studies. , β-lactamase-producing Staphylococcus aureus (penicillin resistant), Staphylococcus species, Staphylococcus epidermidis, Staphylococcus intermedius, Streptococcus faecalis, Streptococcus species, Corynebacterium pyogenes, Corynebacterium species, Erysipelothrix rhusiopathiae, Bordetella bronchiseptica, Escherichia coli , Proteus mirabilis, Proteus species, Enterobacter species, Klebsiella pneumoniae, Salmonella dublin, Salmonella typhimurium, Pasteurella multocida, Pasteurella hemolytica, Pasteurella species.

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.