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Kesium Chewable Tablets for Dogs & Cats

  • 50mg » Priced per tablet £0.40
  • 62.5mg » Priced per tablet £0.39
  • 250mg » Priced per Tablet £0.79
  • 500mg » Priced per Tablet £1.60
  • 625mg » Priced per Tablet £2.50

Selection of 5 products from

£0.39 to £2.50

Kesium is a broad spectrum antibiotic which is active against a wide range of bacterial infections in dogs and cats. It can be used for infections of the mouth, gastro-intestinal tract, respiratory system, urinary system or skin. Kesium is also effective in treating infected wounds. Normally Kesium is dosed twice daily for as long as is required to clear the infection.

Kesium 250 mg and 500 mg Chewable Tablets for Dogs

Qualitative and quantitative composition

Each Kesium 250 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 200.00 mg and Clavulanic acid (as potassium clavulanate) 50.00 mg

Each Kesium 500 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 400.00 mg and Clavulanic acid (as potassium clavulanate) 100 mg

Pharmaceutical form

Oblong scored beige chewable tablets. The tablets can be divided into equal halves

Clinical particulars

Target species

Dogs

Indications for use

For the treatment of the following infections caused by β lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid and where clinical experience and/or sensitivity testing indicates the product as the drug of choice:

-Skin infections (including superficial and deep pyodermas) associated with Staphylococcus spp.

-Urinary tract infections associated with Staphylococcus spp, Streptococcus spp, Escherichia coli and Proteus mirabilis.

-Respiratory tract infections associated with Staphylococcus spp, Streptococcus spp and Pasteurella spp.

-Digestive tract infections associated with Escherichia coli.

-Infections of the oral cavity (mucous membrane) associated with Pasteurella spp, Streptococcus spp, Escherichia coli.

Contra-indications

Do not use in animals with known hypersensitivity to penicillins or other susbstances of the β-lactam group or to any excipients.

Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria.

Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not use in horses and ruminating animals.

Do not use where resistance to this combination is known to occur.

Special warnings for each target species

None known

Special precautions for use

Official, national and regional antimicrobial policies with respect to the use of broad-spectrum antibiotics should be taken into account.

Do not use in case of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as single substance.

It is advised that upon initiating therapy appropriate sensitivity testing is performed and that therapy is continued only after susceptibility to the combination has been established.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the amoxicillin/clavulanate, and may decrease the effectiveness of treatment with beta-lactam antibiotics

In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated and the use of the product based on a risk/benefit evaluation by the veterinary surgeon.

Caution is advised in the use in small herbivores.

The potential for allergic cross-reactions with other penicillin derivates and cephalosporins should be considered

Adverse reactions

Mild gastrointestinal signs (diarrhoea, and vomiting) may occur after administration of the product. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon.

Allergic reactions (skin reactions, anaphylaxis) may occasionally occur. In these cases, administration should be discontinued and a symptomatic treatment given.

Use during pregnancy or lactation

Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian.

Interactions

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action.

Penicillins may increase the effect of aminoglycosides.

Amounts to be administered and administration route

The recommended dose of the product is 10 mg amoxicillin /2.5 mg clavulanic acid per kg body weight twice a day by the oral route in dogs and cats, i.e. 1 tablet of Kesium 250 mg per 20 kg body weight, or 1 tablet of Kesium 500 mg per 40 kg body weight every 12 h. In refractory cases the dose may be doubled to 20 mg of amoxicillin / 5 mg clavulanic acid/kg bodyweight twice daily, at the clinician’s discretion.

The chewable tablets are flavoured and are accepted by a majority of dogs. The chewable tablets can be administered directly into the mouth of the animals or added to a small quantity of food.

Duration of therapy: The majority of routine cases respond to 5 – 7 days of therapy. In chronic cases, a longer case of therapy is recommended. In such circumstances overall treatment length must be at the clinician’s discretion, but should be long enough to ensure complete resolution of the bacterial disease.

To ensure the correct dosage, body weight should be determined as accurately as possible to avoid under-dosing.

Overdose

In case of overdose diarrhoea, allergic reactions or further symptoms like central nervous excitation manifestations or cramps could appear. Symptomatic treatment should be initiated when necessary.

Withdrawal periods

Not Applicable

Pharmacological particulars

Pharmacodynamic properties

Amoxicillin is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins. Amoxicillin shows activity against susceptible Gram-positive bacteria and Gram-negative bacteria.

Beta-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis of growing cells only.

Clavulanic acid is one of the naturally occurring metabolites of the streptomycete Streptomyces clavuligerus. It has a structural similarity to the penicillin nucleus, including possession of a beta-lactam ring. Clavulanic acid is a beta-lactamase inhibitor acting initially competitively but ultimately irreversibly. Clavulanic acid will penetrate the bacterial cell wall binding to both extracellular and intracellular beta-lactamases.

Amoxicillin is susceptible to breakdown by *-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include *-lactamase producing species.

In vitro potentiated amoxicillin is active against a wide range of clinically important aerobic and anaerobic bacteria including:

Gram-positive:

Staphylococcus spp. (including b-lactamase producing strains)

Streptococcus spp

Gram-negative:

Escherichia coli (including most b-lactamase producing strains)

Pasteurella spp

Proteus spp

Resistance is shown among Enterobacter spp, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus.

Dogs diagnosed with Pseudomonas infections should not be treated with this antibiotic combination.

A trend in resistance of E. coli is reported.

Pharmacokinetic properties

After oral administration in dogs and cats, amoxicillin and clavulanic acid are rapidly absorbed. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, a low plasma protein binding (34% in dogs) and a short terminal half-life due to active tubular excretion via the kidneys. Following absorption the highest concentrations are found in the kidneys (urine) and the bile and then in liver, lungs, heart and spleen. The distribution of amoxicillin to the cerebrospinal fluid is low unless the meninges are inflamed.

Clavulanic acid (pKa 2.7) is also well-absorbed following oral administration. The penetration to the cerebrospinal fluid is poor. The plasma protein binding is approximately 25% and the elimination half-life is short. Clavulanic acid is mainly eliminated by renal excretion (unchanged in urine).

After single oral administration of 13 mg/kg amoxicillin and 3.15 mg/kg clavulanic acid in cats:

-The maximal plasma concentration (Cmax) of amoxicillin (9.3 µg/mL) was observed 2 hours following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.1 µg/mL) was observed 50 minutes following administration

After single oral administration of 17 mg/kg amoxicillin and 4.3 mg/kg clavulanic acid in dogs:

-The maximal plasma concentration (Cmax) of amoxicillin (8.6 µg/mL) was observed 1.5 hour following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.9 µg/mL) was observed 54 minutes following administration.

Pharmaceutical particulars

-

Excipients

Pig liver powder, Yeast, Crospovidone (type A), Povidone K 25, Hypromellose, Microcrystalline cellulose, Silica (colloidal anhydrous), Magnesium stearate.

Major incompatibilities

Not applicable.

Shelf life

Kesium 250 mg and Kesium 500 mg: 3 Years

Any divided tablet portions remaining after 12 hours should be discarded

Special precautions for storage

Do not store above 25°C. Divided tablets should be stored in the blister pack

Immediate packaging

Kesium 250 mg Tablet: (PA-AL-PVC – aluminium heat sealed) containing 8 tablets per blister

Cardboard box with 1 blister of 8 tablets; Cardboard box with 2 blisters of 8 tablets; Cardboard box with 4 blisters of 8 tablets; Cardboard box with 6 blisters of 8 tablets; Cardboard box with 8 blisters of 8 tablets; Cardboard box with 10 blisters of 8 tablets; Cardboard box with 12 blisters of 8 tablets; Cardboard box with 30 blisters of 8 tablets.

Kesium 500 mg Tablet: (PA-AL-PVC – aluminium heat sealed) containing 6 tablets per blister

Cardboard box with 1 blister of 6 tablets; Cardboard box with 2 blisters of 6 tablets; Cardboard box with 4 blisters of 6 tablets; Cardboard box with 6 blisters of 6 tablets; Cardboard box with 8 blisters of 6 tablets; Cardboard box with 10 blisters of 6 tablets; Cardboard box with 12 blisters of 6 tablets; Cardboard box with 14 blisters of 6 tablets; Cardboard box with 16 blisters of 6 tablets; Cardboard box with 40 blisters of 6 tablets.

Not all pack sizes may be marketed

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing Authorisation Holder (if different from distributor)

Sogeval SA

Marketing authorisation number

Kesium 250 mg Tablet: Vm 20749/4024.

Kesium 500 mg Tablet: Vm 20749/4025.

Date of the first authorisation or date of renewal

Kesium 250 mg and 500 mg tablets: 5 October 2011

Date of revision of the text

Kesium 250 mg and 500 mg tablets: July 2012

Any other information

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Wash hands after use.

Legal category

POM-V

Kesium 500 mg Chewable Tablets for Dogs

Qualitative and quantitative composition

Each Kesium 500 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 400.00 mg and Clavulanic acid (as potassium clavulanate) 100 mg

Pharmaceutical form

Oblong scored beige chewable tablets. The tablets can be divided into equal halves

Clinical particulars

Target species

Dogs

Indications for use

For the treatment of the following infections caused by β lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid and where clinical experience and/or sensitivity testing indicates the product as the drug of choice:

-Skin infections (including superficial and deep pyodermas) associated with Staphylococcus spp.

-Urinary tract infections associated with Staphylococcus spp, Streptococcus spp, Escherichia coli and Proteus mirabilis.

-Respiratory tract infections associated with Staphylococcus spp, Streptococcus spp and Pasteurella spp.

-Digestive tract infections associated with Escherichia coli.

-Infections of the oral cavity (mucous membrane) associated with Pasteurella spp, Streptococcus spp, Escherichia coli.

Contra-indications

Do not use in animals with known hypersensitivity to penicillins or other susbstances of the β-lactam group or to any excipients.

Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria.

Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not use in horses and ruminating animals.

Do not use where resistance to this combination is known to occur.

Special warnings for each target species

None known

Special precautions for use

Official, national and regional antimicrobial policies with respect to the use of broad-spectrum antibiotics should be taken into account.

Do not use in case of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as single substance.

It is advised that upon initiating therapy appropriate sensitivity testing is performed and that therapy is continued only after susceptibility to the combination has been established.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the amoxicillin/clavulanate, and may decrease the effectiveness of treatment with beta-lactam antibiotics

In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated and the use of the product based on a risk/benefit evaluation by the veterinary surgeon.

Caution is advised in the use in small herbivores.

The potential for allergic cross-reactions with other penicillin derivates and cephalosporins should be considered.

Adverse reactions

Mild gastrointestinal signs (diarrhoea, and vomiting) may occur after administration of the product. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon.

Allergic reactions (skin reactions, anaphylaxis) may occasionally occur. In these cases, administration should be discontinued and a symptomatic treatment given.

Use during pregnancy or lactation

Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian.

Interactions

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action.

Penicillins may increase the effect of aminoglycosides.

Amounts to be administered and administration route

The recommended dose of the product is 10 mg amoxicillin /2.5 mg clavulanic acid per kg body weight twice a day by the oral route in dogs and cats, i.e. 1 tablet of Kesium 500 mg per 40 kg body weight every 12 h. In refractory cases the dose may be doubled to 20 mg of amoxicillin / 5 mg clavulanic acid/kg bodyweight twice daily, at the clinician’s discretion.

The chewable tablets are flavoured and are accepted by a majority of dogs. The chewable tablets can be administered directly into the mouth of the animals or added to a small quantity of food.

Duration of therapy: The majority of routine cases respond to 5 – 7 days of therapy. In chronic cases, a longer case of therapy is recommended. In such circumstances overall treatment length must be at the clinician’s discretion, but should be long enough to ensure complete resolution of the bacterial disease.

To ensure the correct dosage, body weight should be determined as accurately as possible to avoid under-dosing.

Overdose

In case of overdose diarrhoea, allergic reactions or further symptoms like central nervous excitation manifestations or cramps could appear. Symptomatic treatment should be initiated when necessary.

Withdrawal periods

Not Applicable

Pharmacological particulars

Pharmacodynamic properties

Amoxicillin is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins. Amoxicillin shows activity against susceptible Gram-positive bacteria and Gram-negative bacteria.

Beta-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis of growing cells only.

Clavulanic acid is one of the naturally occurring metabolites of the streptomycete Streptomyces clavuligerus. It has a structural similarity to the penicillin nucleus, including possession of a beta-lactam ring. Clavulanic acid is a beta-lactamase inhibitor acting initially competitively but ultimately irreversibly. Clavulanic acid will penetrate the bacterial cell wall binding to both extracellular and intracellular beta-lactamases.

Amoxicillin is susceptible to breakdown by *-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include *-lactamase producing species.

In vitro potentiated amoxicillin is active against a wide range of clinically important aerobic and anaerobic bacteria including:

Gram-positive:

Staphylococcus spp. (including b-lactamase producing strains)

Streptococcus spp

Gram-negative:

Escherichia coli (including most b-lactamase producing strains)

Pasteurella spp

Proteus spp

Resistance is shown among Enterobacter spp, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus.

Dogs diagnosed with Pseudomonas infections should not be treated with this antibiotic combination.

A trend in resistance of E. coli is reported.

Pharmacokinetic properties

After oral administration in dogs and cats, amoxicillin and clavulanic acid are rapidly absorbed. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, a low plasma protein binding (34% in dogs) and a short terminal half-life due to active tubular excretion via the kidneys. Following absorption the highest concentrations are found in the kidneys (urine) and the bile and then in liver, lungs, heart and spleen. The distribution of amoxicillin to the cerebrospinal fluid is low unless the meninges are inflamed.

Clavulanic acid (pKa 2.7) is also well-absorbed following oral administration. The penetration to the cerebrospinal fluid is poor. The plasma protein binding is approximately 25% and the elimination half-life is short. Clavulanic acid is mainly eliminated by renal excretion (unchanged in urine).

After single oral administration of 13 mg/kg amoxicillin and 3.15 mg/kg clavulanic acid in cats:

-The maximal plasma concentration (Cmax) of amoxicillin (9.3 µg/mL) was observed 2 hours following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.1 µg/mL) was observed 50 minutes following administration

After single oral administration of 17 mg/kg amoxicillin and 4.3 mg/kg clavulanic acid in dogs:

-The maximal plasma concentration (Cmax) of amoxicillin (8.6 µg/mL) was observed 1.5 hour following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.9 µg/mL) was observed 54 minutes following administration.

Pharmaceutical particulars

Excipients

Pig liver powder, Yeast, Crospovidone (type A), Povidone K 25, Hypromellose, Microcrystalline cellulose, Silica (colloidal anhydrous), Magnesium stearate.

Major incompatibilities

Not applicable.

Shelf life

Kesium 500 mg: 3 Years

Any divided tablet portions remaining after 12 hours should be discarded

Special precautions for storage

Do not store above 25°C. Divided tablets should be stored in the blister pack

Immediate packaging

Kesium 500 mg Tablet: (PA-AL-PVC – aluminium heat sealed) containing 6 tablets per blister

Cardboard box with 1 blister of 6 tablets; Cardboard box with 2 blisters of 6 tablets; Cardboard box with 4 blisters of 6 tablets; Cardboard box with 6 blisters of 6 tablets; Cardboard box with 8 blisters of 6 tablets; Cardboard box with 10 blisters of 6 tablets; Cardboard box with 12 blisters of 6 tablets; Cardboard box with 14 blisters of 6 tablets; Cardboard box with 16 blisters of 6 tablets; Cardboard box with 40 blisters of 6 tablets.

Not all pack sizes may be marketed

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing authorisation number

Kesium 500 mg Tablet: Vm 20749/4025.

Date of the first authorisation or date of renewal

Kesium 500 mg tablets: 5 October 2011

Date of revision of the text

Kesium 500 mg tablets: July 2012

Any other information

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Wash hands after use.

Legal category

POM-V

GTIN (Global Trade Item No)

Kesium 500mg Chewable Tablet

03660176018291

Kesium 50 mg and 62.5 mg Chewable Tablets for Dogs and Cats

Qualitative and quantitative composition

Each Kesium 50 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 40.00 mg and Clavulanic acid (as potassium clavulanate) 10.00 mg

Each Kesium 62.5 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 50.00 mg and Clavulanic acid (as potassium clavulanate) 12.50 mg

Pharmaceutical form

Oblong scored beige chewable tablets. The tablets can be divided into equal halves

Clinical particulars

Target species

Cats and dogs

Indications for use

For the treatment of the following infections caused by β lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid and where clinical experience and/or sensitivity testing indicates the product as the drug of choice:

-Skin infections (including superficial and deep pyodermas) associated with Staphylococcus spp.

-Urinary tract infections associated with Staphylococcus spp, Streptococcus spp, Escherichia coli and Proteus mirabilis.

-Respiratory tract infections associated with Staphylococcus spp, Streptococcus spp and Pasteurella spp.

-Digestive tract infections associated with Escherichia coli.

-Infections of the oral cavity (mucous membrane) associated with Pasteurella spp, Streptococcus spp, Escherichia coli.

Contra-indications

Do not use in animals with known hypersensitivity to penicillins or other susbstances of the β-lactam group or to any excipients.

Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria.

Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not use in horses and ruminating animals.

Do not use where resistance to this combination is known to occur.

Special warnings for each target species

None known

Special precautions for use

Official, national and regional antimicrobial policies with respect to the use of broad-spectrum antibiotics should be taken into account.

Do not use in case of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as single substance.

It is advised that upon initiating therapy appropriate sensitivity testing is performed and that therapy is continued only after susceptibility to the combination has been established.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the amoxicillin/clavulanate, and may decrease the effectiveness of treatment with beta-lactam antibiotics

In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated and the use of the product based on a risk/benefit evaluation by the veterinary surgeon.

Caution is advised in the use in small herbivores.

The potential for allergic cross-reactions with other penicillin derivates and cephalosporins should be considered

Adverse reactions

Mild gastrointestinal signs (diarrhoea, and vomiting) may occur after administration of the product. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon.

Allergic reactions (skin reactions, anaphylaxis) may occasionally occur. In these cases, administration should be discontinued and a symptomatic treatment given.

Use during pregnancy or lactation

Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian.

Interactions

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action.

Penicillins may increase the effect of aminoglycosides.

Amounts to be administered and administration route

The recommended dose of the product is 10 mg amoxicillin /2.5 mg clavulanic acid per kg body weight twice a day by the oral route in dogs and cats, i.e. 1 tablet of Kesium 50 mg per 4 kg body weight, or 1 tablet of Kesium 62.5 mg per 5 kg body weight every 12 h. In refractory cases the dose may be doubled to 20 mg of amoxicillin / 5 mg clavulanic acid/kg bodyweight twice daily, at the clinician’s discretion.

The chewable tablets are flavoured and are accepted by a majority of cats and dogs. The chewable tablets can be administered directly into the mouth of the animals or added to a small quantity of food.

Duration of therapy: The majority of routine cases respond to 5 – 7 days of therapy. In chronic cases, a longer case of therapy is recommended. In such circumstances overall treatment length must be at the clinician’s discretion, but should be long enough to ensure complete resolution of the bacterial disease.

To ensure the correct dosage, body weight should be determined as accurately as possible to avoid under-dosing.

Overdose

In case of overdose diarrhoea, allergic reactions or further symptoms like central nervous excitation manifestations or cramps could appear. Symptomatic treatment should be initiated when necessary.

Withdrawal periods

Not Applicable

Pharmacological particulars

Pharmacodynamic properties

Amoxicillin is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins. Amoxicillin shows activity against susceptible Gram-positive bacteria and Gram-negative bacteria.

Beta-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis of growing cells only.

Clavulanic acid is one of the naturally occurring metabolites of the streptomycete Streptomyces clavuligerus. It has a structural similarity to the penicillin nucleus, including possession of a beta-lactam ring. Clavulanic acid is a beta-lactamase inhibitor acting initially competitively but ultimately irreversibly. Clavulanic acid will penetrate the bacterial cell wall binding to both extracellular and intracellular beta-lactamases.

Amoxicillin is susceptible to breakdown by *-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include *-lactamase producing species.

In vitro potentiated amoxicillin is active against a wide range of clinically important aerobic and anaerobic bacteria including:

Gram-positive:

Staphylococcus spp. (including b-lactamase producing strains)

Streptococcus spp

Gram-negative:

Escherichia coli (including most b-lactamase producing strains)

Pasteurella spp

Proteus spp

Resistance is shown among Enterobacter spp, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus.

Dogs and cats diagnosed with Pseudomonas infections should not be treated with this antibiotic combination.

A trend in resistance of E. coli is reported.

Pharmacokinetic properties

After oral administration in dogs and cats, amoxicillin and clavulanic acid are rapidly absorbed. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, a low plasma protein binding (34% in dogs) and a short terminal half-life due to active tubular excretion via the kidneys. Following absorption the highest concentrations are found in the kidneys (urine) and the bile and then in liver, lungs, heart and spleen. The distribution of amoxicillin to the cerebrospinal fluid is low unless the meninges are inflamed.

Clavulanic acid (pKa 2.7) is also well-absorbed following oral administration. The penetration to the cerebrospinal fluid is poor. The plasma protein binding is approximately 25% and the elimination half-life is short. Clavulanic acid is mainly eliminated by renal excretion (unchanged in urine).

After single oral administration of 13 mg/kg amoxicillin and 3.15 mg/kg clavulanic acid in cats:

-The maximal plasma concentration (Cmax) of amoxicillin (9.3 µg/mL) was observed 2 hours following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.1 µg/mL) was observed 50 minutes following administration

After single oral administration of 17 mg/kg amoxicillin and 4.3 mg/kg clavulanic acid in dogs:

-The maximal plasma concentration (Cmax) of amoxicillin (8.6 µg/mL) was observed 1.5 hour following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.9 µg/mL) was observed 54 minutes following administration.

Pharmaceutical particulars

-

Excipients

Pig liver powder, Yeast, Crospovidone (type A), Povidone K 25, Hypromellose, Microcrystalline cellulose, Silica (colloidal anhydrous), Magnesium stearate

Major incompatibilities

Not applicable.

Shelf life

Kesium 50 mg: 24 months

Kesium 62.5 mg: 21 months

Any divided tablet portions remaining after 12 hours should be discarded

Special precautions for storage

Do not store above 25°C. Divided tablets should be stored in the blister pack

Immediate packaging

Kesium 50 mg Tablet: (PA-AL-PVC – aluminium heat sealed) containing 10 tablets per blister

Cardboard box with 1 blister of 10 tablets; Cardboard box with 2 blisters of 10 tablets; Cardboard box with 4 blisters of 10 tablets; Cardboard box with 6 blisters of 10 tablets; Cardboard box with 8 blisters of 10 tablets; Cardboard box with 10 blisters of 10 tablets; Cardboard box with 24 blisters of 10 tablets.

Kesium 62.5 mg Tablet: (PA-AL-PVC – aluminium heat sealed) containing 10 tablets per blister

Cardboard box with 1 blister of 10 tablets; Cardboard box with 2 blisters of 10 tablets; Cardboard box with 4 blisters of 10 tablets Cardboard box with 6 blisters of 10 tablets; Cardboard box with 8 blisters of 10 tablets; Cardboard box with 10 blisters of 10 tablets; Cardboard box with 24 blisters of 10 tablets.

Not all pack sizes may be marketed

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing Authorisation Holder (if different from distributor)

Sogeval SA

Marketing authorisation number

Kesium 50 mg Tablet Vm 20749/4023

Kesium 62.5 mg Tablet Vm 20749/4026

Date of the first authorisation or date of renewal

Kesium 50 mg and 62.5 mg tablets: 5 October 2011

Date of revision of the text

Kesium 50 mg tablets - October 2011; 62.5 mg tablets - October 2012

Any other information

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Wash hands after use.

Legal category

POM-V

Kesium 250 mg and 625 mg Chewable Tablets for Dogs

Qualitative and quantitative composition

Each Kesium 250 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 200.00 mg and Clavulanic acid (as potassium clavulanate) 50.00 mg

Each Kesium 625 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 500.00 mg and Clavulanic acid (as potassium clavulanate) 125 mg

Pharmaceutical form

Clover-shaped beige chewable tablet. The tablets can be divided into four equal parts.

Clinical particulars

Target species

Dogs

Indications for use

For the treatment of the following infections caused by β lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid and where clinical experience and/or sensitivity testing indicates the product as the drug of choice:

-Skin infections (including superficial and deep pyodermas) associated with Staphylococcus spp.

-Urinary tract infections associated with Staphylococcus spp, Streptococcus spp, Escherichia coli and Proteus mirabilis.

-Respiratory tract infections associated with Staphylococcus spp, Streptococcus spp and Pasteurella spp.

-Digestive tract infections associated with Escherichia coli.

-Infections of the oral cavity (mucous membrane) associated with Pasteurella spp, Streptococcus spp, Escherichia coli.

Contra-indications

Do not use in animals with known hypersensitivity to penicillins or other susbstances of the β-lactam group or to any excipients.

Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria.

Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not use in horses and ruminating animals.

Do not use where resistance to this combination is known to occur.

Special warnings for each target species

None known

Special precautions for use

Official, national and regional antimicrobial policies with respect to the use of broad-spectrum antibiotics should be taken into account.

Do not use in case of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as single substance.

It is advised that upon initiating therapy appropriate sensitivity testing is performed and that therapy is continued only after susceptibility to the combination has been established.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the amoxicillin/clavulanate, and may decrease the effectiveness of treatment with beta-lactam antibiotics

In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated and the use of the product based on a risk/benefit evaluation by the veterinary surgeon.

Caution is advised in the use in small herbivores.

The potential for allergic cross-reactions with other penicillin derivates and cephalosporins should be considered.

Adverse reactions

Mild gastrointestinal signs (diarrhoea, and vomiting) may occur after administration of the product. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon.

Allergic reactions (skin reactions, anaphylaxis) may occasionally occur. In these cases, administration should be discontinued and a symptomatic treatment given.

Use during pregnancy or lactation

Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian.

Interactions

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action.

Penicillins may increase the effect of aminoglycosides.

Amounts to be administered and administration route

The recommended dose of the product is 10 mg amoxicillin /2.5 mg clavulanic acid per kg body weight twice a day by the oral route in dogs and cats, i.e. 1 tablet of Kesium 250 mg per 20 kg body weight, or 1 tablet of Kesium 625mg per 50 kg body weight every 12 h. In refractory cases the dose may be doubled to 20 mg of amoxicillin / 5 mg clavulanic acid/kg bodyweight twice daily, at the clinician’s discretion.

The chewable tablets are flavoured and are accepted by a majority of dogs. The chewable tablets can be administered directly into the mouth of the animals or added to a small quantity of food.

Duration of therapy: The majority of routine cases respond to 5 – 7 days of therapy. In chronic cases, a longer case of therapy is recommended. In such circumstances overall treatment length must be at the clinician’s discretion, but should be long enough to ensure complete resolution of the bacterial disease.

To ensure the correct dosage, body weight should be determined as accurately as possible to avoid under-dosing.

Overdose

In case of overdose diarrhoea, allergic reactions or further symptoms like central nervous excitation manifestations or cramps could appear. Symptomatic treatment should be initiated when necessary.

Withdrawal periods

Not Applicable

Pharmacological particulars

Pharmacodynamic properties

Amoxicillin is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins. Amoxicillin shows activity against susceptible Gram-positive bacteria and Gram-negative bacteria.

Beta-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis of growing cells only.

Clavulanic acid is one of the naturally occurring metabolites of the streptomycete Streptomyces clavuligerus. It has a structural similarity to the penicillin nucleus, including possession of a beta-lactam ring. Clavulanic acid is a beta-lactamase inhibitor acting initially competitively but ultimately irreversibly. Clavulanic acid will penetrate the bacterial cell wall binding to both extracellular and intracellular beta-lactamases.

Amoxicillin is susceptible to breakdown by *-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include *-lactamase producing species.

In vitro potentiated amoxicillin is active against a wide range of clinically important aerobic and anaerobic bacteria including:

Gram-positive:

Staphylococcus spp. (including b-lactamase producing strains)

Streptococcus spp

Gram-negative:

Escherichia coli (including most b-lactamase producing strains)

Pasteurella spp

Proteus spp

Resistance is shown among Enterobacter spp, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus.

Dogs diagnosed with Pseudomonas infections should not be treated with this antibiotic combination.

A trend in resistance of E. coli is reported.

Pharmacokinetic properties

After oral administration in dogs and cats, amoxicillin and clavulanic acid are rapidly absorbed. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, a low plasma protein binding (34% in dogs) and a short terminal half-life due to active tubular excretion via the kidneys. Following absorption the highest concentrations are found in the kidneys (urine) and the bile and then in liver, lungs, heart and spleen. The distribution of amoxicillin to the cerebrospinal fluid is low unless the meninges are inflamed.

Clavulanic acid (pKa 2.7) is also well-absorbed following oral administration. The penetration to the cerebrospinal fluid is poor. The plasma protein binding is approximately 25% and the elimination half-life is short. Clavulanic acid is mainly eliminated by renal excretion (unchanged in urine).

After single oral administration of 13 mg/kg amoxicillin and 3.15 mg/kg clavulanic acid in cats:

-The maximal plasma concentration (Cmax) of amoxicillin (9.3 µg/mL) was observed 2 hours following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.1 µg/mL) was observed 50 minutes following administration

After single oral administration of 17 mg/kg amoxicillin and 4.3 mg/kg clavulanic acid in dogs:

-The maximal plasma concentration (Cmax) of amoxicillin (8.6 µg/mL) was observed 1.5 hour following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.9 µg/mL) was observed 54 minutes following administration.

Pharmaceutical particulars

Excipients

Pig liver powder, Yeast, Crospovidone (type 1A), Povidone K 25, Hypromellose, Microcrystalline cellulose, Silica (colloidal anhydrous), Magnesium stearate.

Major incompatibilities

Not applicable.

Shelf life

Kesium 250 mg: 3Years and Kesium 625 mg: 2 Years

Any divided tablet portions remaining after 12 hours should be discarded

Special precautions for storage

Do not store above 25°C. Divided tablets should be stored in the blister pack

Immediate packaging

Kesium 250 mg Tablet: (PA-AL-PVC – aluminium heat sealed) containing 8 tablets per blister

Cardboard box with 1 blister of 8 tablets; Cardboard box with 2 blisters of 8 tablets; Cardboard box with 4 blisters of 8 tablets; Cardboard box with 6 blisters of 8 tablets; Cardboard box with 8 blisters of 8 tablets; Cardboard box with 10 blisters of 8 tablets; Cardboard box with 12 blisters of 8 tablets; Cardboard box with 30 blisters of 8 tablets.

Kesium 625mg Tablet: (PA-AL-PVC – aluminium heat sealed) containing 6 tablets per blister

Cardboard box with 1 blister of 6 tablets; Cardboard box with 2 blisters of 6 tablets; Cardboard box with 4 blisters of 6 tablets; Cardboard box with 6 blisters of 6 tablets; Cardboard box with 8 blisters of 6 tablets; Cardboard box with 10 blisters of 6 tablets; Cardboard box with 12 blisters of 6 tablets; Cardboard box with 14 blisters of 6 tablets; Cardboard box with 16 blisters of 6 tablets; Cardboard box with 40 blisters of 6 tablets.

Not all pack sizes may be marketed

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing authorisation number

Kesium 250 mg Tablet: Vm 20749/4024.

Kesium 625mg Tablet: Vm 20749/4033.

Date of the first authorisation or date of renewal

Kesium 250 mg 5th October 2011: Kesium 625mg tablets 24th October 2013

Date of revision of the text

Kesium 250 mg July 2013; Kesium 625mg tablets October 2013

Any other information

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Wash hands after use.

Legal category

POM-V

GTIN (Global Trade Item No)

Kesium 250mg Chewable Tablet

03660176018284

Kesium 625mg Chewable Tablet

03660176019724

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