KESIUM- amoxicillin and clavulanate potassium tablet, chewable

Kesium by

Drug Labeling and Warnings

Kesium by is a Animal medication manufactured, distributed, or labeled by Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Chewable Tablets

Antimicrobial For Oral Use In Dogs and Cats

SPL UNCLASSIFIED SECTION

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

DESCRIPTION

DESCRIPTION: Kesium Chewable Tablet (amoxicillin and clavulanate potassium tablets) 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.

VETERINARY INDICATIONS

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 blister until ready to use. Pierce the foil blister 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

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

WARNINGS

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

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

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

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 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

SPL UNCLASSIFIED SECTION

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

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 coli 1, Proteus mirabilis, Proteus species, Enterobacter species, Klebsiella pneumoniae, Salmonella dublin, Salmonella typhimurium, Pasteurella multocida, Pasteurella hemolytica, 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.

SPL UNCLASSIFIED SECTION

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.

STORAGE AND HANDLING

STORAGE INFORMATION: Do not store above 25°C (77°F). Do not remove from foil blister until ready to use.

HOW SUPPLIED

HOW SUPPLIED: Kesium Chewable Tablets in the following strengths of 62.5 mg, 125 mg, 250 mg and 375 mg are supplied in foil blister cards. Each carton of 62.5 mg and 125 mg strength holds 10 blister cards with10 tablets (100 tablets per carton). Each carton of 250 mg and 375 mg strength holds 12 blister cards with 8 tablets (96 tablets per carton).

Each 62.5-mg tablet contains amoxicillin trihydrate equivalent to 50 mg of amoxicillin activity and 12.5 mg of clavulanic acid as the potassium salt. For use in dogs and cats.

Each 125-mg tablet contains amoxicillin trihydrate equivalent to 100 mg of amoxicillin activity and 25 mg of clavulanic acid as the potassium salt. For use in dogs only.

Each 250-mg tablet contains amoxicillin trihydrate equivalent to 200 mg of amoxicillin activity and 50 mg of clavulanic acid as the potassium salt. For use in dogs only.

Each 375-mg tablet contains amoxicillin trihydrate equivalent to 300 mg of amoxicillin activity and 75 mg of clavulanic acid as the potassium salt. For use in dogs only.

Dispense according to recommendations outlined in Dosage and Administration section.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 62.5 mg Tablet Blister Pack Carton

62.5 mg
Chewable Tablets

Kesium®
(amoxicillin and clavulanate potassium tablets)
Antimicrobial For Oral Use In Dogs and Cats

Each chewable tablet contains amoxicillin trihydrate equivalent to 50 mg of amoxicillin activity and 12.5 mg
of clavulanic acid as the potassium salt.

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

Approved by FDA under ANADA # 200-749

Net Contents: 10 blister cards, 10 chewable tablets each
100 chewable tablets
ceva

PRINCIPAL DISPLAY PANEL - 125 mg Tablet Blister Pack Carton

125 mg
Chewable Tablets

Kesium®
(amoxicillin and clavulanate potassium tablets)
Antimicrobial For Oral Use In Dogs

Each chewable tablet contains amoxicillin trihydrate equivalent to 100 mg of amoxicillin activity and 25 mg of clavulanic
acid as the potassium salt.

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

Approved by FDA under ANADA # 200-749

Net Contents: 10 blister cards, 10 chewable tablets each
100 chewable tablets
ceva

PRINCIPAL DISPLAY PANEL - 250 mg Tablet Blister Pack Carton

250 mg
Chewable Tablets

Kesium®
(amoxicillin and clavulanate potassium tablets)
Antimicrobial For Oral Use In Dogs

Each chewable tablet contains amoxicillin trihydrate equivalent to 200 mg of amoxicillin activity and
50 mg of clavulanic acid as the potassium salt.

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

Approved by FDA under ANADA # 200-749

Net Contents: 12 blister cards, 8 chewable tablets each
96 chewable tablets
ceva

PRINCIPAL DISPLAY PANEL - 375 mg Tablet Blister Pack Carton

375 mg
Chewable Tablets

Kesium®
(amoxicillin and clavulanate potassium tablets)
Antimicrobial For Oral Use In Dogs

Each chewable tablet contains amoxicillin trihydrate equivalent to 300 mg of amoxicillin activity and 75 mg of clavulanic
acid as the potassium salt.

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

Approved by FDA under ANADA # 200-749

Net Contents: 12 blister cards, 8 chewable tablets each
96 chewable tablets
ceva

INGREDIENTS AND APPEARANCE

KESIUM 
amoxicillin and clavulanate potassium tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13744-540
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Amoxicillin (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	50 mg
CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)	CLAVULANIC ACID	12.5 mg

Product Characteristics
Color	BROWN (Beige)	Score	2 pieces
Shape	OVAL (Oblong)	Size	11mm
Flavor		Imprint Code	K;62;5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-540-01	10 in 1 CARTON
1		10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200749	10/28/2024

KESIUM 
amoxicillin and clavulanate potassium tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13744-541
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Amoxicillin (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	100 mg
CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)	CLAVULANIC ACID	25 mg

Product Characteristics
Color	BROWN (Beige)	Score	2 pieces
Shape	CLOVER	Size	13mm
Flavor		Imprint Code	K;125
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-541-01	10 in 1 CARTON
1		10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200749	10/28/2024

KESIUM 
amoxicillin and clavulanate potassium tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13744-542
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Amoxicillin (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	200 mg
CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)	CLAVULANIC ACID	50 mg

Product Characteristics
Color	BROWN (Beige)	Score	2 pieces
Shape	CLOVER	Size	17mm
Flavor		Imprint Code	K;250
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-542-01	12 in 1 CARTON
1		8 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200749	10/28/2024

KESIUM 
amoxicillin and clavulanate potassium tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13744-543
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Amoxicillin (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	300 mg
CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)	CLAVULANIC ACID	75 mg

Product Characteristics
Color	BROWN (Beige)	Score	2 pieces
Shape	CLOVER	Size	18mm
Flavor		Imprint Code	K;375
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13744-543-01	12 in 1 CARTON
1		8 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200749	10/28/2024

Labeler - Ceva Sante Animale (261126049)