Kesium

Chewable Tablets

Antimicrobial For Oral Use In Dogs and Cats

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

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.

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.

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 listed 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.

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 amoxicilln and clavulanate potassium tablets.

Approved by FDA under ANADA # 200-749
Augmentin is a trademark owned by GlaxoSmithKline.
Marketed by: Ceva Animal Health, LLC, Lenexa, KS 66215
Kesium trademark is the property of Ceva Santé Animale S.A.
Made in Germany

Rev # 11/23
Package Code # C66210B 08-A1-v1
23002177