Cladaxxa (for animals) tablets 200 mg/50 mg, 10 pieces

1 tablet (875 mg) contains the following active ingredients:

• amoxicillin (in the form of amoxicillin trihydrate) – 200 mg,
• clavulanic acid (in the form of diluted sodium clavulanate) – 50 mg.

Excipients: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium starch glycolate (type A), dried autolyzed yeast, erythrosine (E127).

ATC vet classification code QJ01- antibacterial veterinary drugs for systemic use. QJ01CR02 – Amoxicillin and enzyme inhibitor.

Amoxicillin is a semi-synthetic aminopenicillin (ß-lactam antibiotic) with a broad spectrum of antimicrobial activity. The mechanism of action is to disrupt the synthesis of the bacterial cell wall, which leads to lysis of the bacterial cell, when ß-lactam antibiotics freely pass through the peptidoglycan layer in gram-positive bacteria and the hydrophobic barrier in gram-negative bacteria to the cytoplasmic membrane.

Clavulanic acid inactivates the ß-lactamase of the bacterial cell and, thereby, restores the sensitivity of the bacteria to the bactericidal action of amoxicillin at concentrations that are easily achieved in animal tissues after administration of the drug.

The combination of amoxicillin/clavulanic acid has a broad spectrum of bactericidal activity against gram-positive (Staphylococcus spp., Clostridium spp., Corynebacterium spp., Peptostreptococcus spp., Streptococcus spp.) and gram-negative (Escherichia coli, Salmonella spp., Klebsiella spp., Pasteurella spp.) bacteria, including ß-lactamase-producing strains of microorganisms.

The Clinical and Laboratory Standards Institute (CLSI) has established MICs for amoxicillin/clavulanate for staphylococci and streptococci causing skin and soft tissue infections and urinary tract infections in cats and dogs as follows: <0.25/0.12 µg/mL – susceptible; >1/0.5 µg/mL – resistant. The MICs for amoxicillin/clavulanate for susceptible strains of E. coli causing skin and soft tissue infections in cats and dogs are <0.25/0.12 µg/mL and for urinary tract infections are <8/4 µg/mL. For susceptible strains of P. multocida from cats, the MICs for amoxicillin/clavulanate are <0.25/0.12 µg/mL and for resistant strains are >1/0.5 µg/mL.

Amoxicillin is well absorbed after oral administration. In dogs, bioavailability is 60–70%. Amoxicillin has a relatively small volume of distribution, low plasma protein binding (34% in dogs), and a short half-life by active tubular excretion through the kidneys. After absorption, its highest concentrations are found in the kidneys (urine) and bile, followed by the liver, lungs, heart, and spleen. Distribution of amoxicillin in the cerebrospinal fluid is low unless the meninges are inflamed.

Following oral administration of amoxicillin to dogs, peak plasma concentrations (Cmax) of 7.31 μg/mL were reached after approximately 1.37 hours. The mean elimination half-life of amoxicillin was 1.21 hours.

In cats, the mean Cmax of amoxicillin is 5.87 μg/ml and is reached after approximately 1.59 hours, and the mean half-life of amoxicillin is 1.18 hours.

Clavulanic acid is well absorbed after oral administration. It penetrates poorly into the cerebrospinal fluid. Plasma protein binding is approximately 25% and the half-life is short. Clavulanic acid is mainly excreted unchanged in the urine.

Following oral administration to dogs, the mean Cmax of clavulanic acid (1.33 μg/ml) is reached after approximately 1.02 hours. The mean elimination half-life of clavulanic acid is 0.83 hours.

In cats, the mean Cmax of clavulanic acid (3.16 μg/ml) was reached after approximately 0.70 hours. The mean elimination half-life of clavulanic acid was 0.81 hours.

Treatment of dogs and cats for diseases of the skin (including the treatment of deep and superficial pyoderma), soft tissues (abscesses and anal sacculitis), oral cavity (e.g. gingivitis), urinary tract, respiratory tract (upper and lower respiratory tract diseases), digestive tract (enteritis) caused by microorganisms sensitive to amoxicillin and clavulanic acid.

Orally at a dose of 10 mg amoxicillin and 2.5 mg clavulanic acid per 1 kg of body weight, twice a day, i.e. 12.5 mg of combined active substances per 1 kg of body weight), twice a day (corresponding to 25 mg of combined active substances per 1 kg per day) or:

To ensure correct dosing, body weight should be determined as accurately as possible to avoid underdosing.

If the animal does not take the tablet from your hand or bowl, then the tablets can be crushed and added to a small amount of food, and then fed immediately.

In most cases, the course of treatment is 5-7 days. Chronic diseases may require longer treatment at the discretion of the veterinarian.

• Hypersensitivity to penicillins and other β-lactams, to any excipients.
• Do not use the drug on horses, rabbits, guinea pigs, hamsters, chinchillas and small herbivores.
• Do not use in animals with severe renal impairment accompanied by anuria and oliguria.
• Do not use simultaneously with chloramphenicol, cephalosporin antibiotics, tetracyclines, macrolides.
• Do not use in case of known resistance to the combination of amoxicillin/clavulanic acid.

Very rarely, hypersensitivity reactions to penicillins may occur in treated animals; in such cases, the use of the drug should be discontinued and symptomatic treatment should be administered.

Very rarely, gastrointestinal disorders (diarrhea, vomiting) may occur after administration of the product. Treatment may be discontinued depending on the severity of side effects and the benefit/risk assessment by the veterinarian.

Special precautions for use

In animals with impaired liver and kidney function, the drug should be used only after a risk assessment by a veterinarian, and the dosage should be carefully considered. The use of the drug should be based on a test for the susceptibility of the causative microorganisms to the combination of amoxicillin/clavulanic acid.

Use of the drug deviating from the SPC may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid and may decrease the effectiveness of treatment with other beta-lactam antibiotics due to possible cross-resistance.

When using this drug, it is necessary to take into account the rules of official and local policies on antibiotic therapy. There is evidence of an increase in antibiotic resistance of E. coli, including multi-resistance.

Do not use if bacteria are found that are sensitive to narrow-spectrum penicillins or to amoxicillin alone.

The chewable tablets are flavored. To prevent any accidental ingestion of the tablets, they should be kept out of the reach of animals.

Use during pregnancy, lactation, and egg production

Laboratory studies in rats and mice have shown no evidence of teratogenic, fetotoxic, or maternotoxic effects.

The safety of the drug has not been evaluated in pregnant and lactating females.

It is recommended to use the drug in animals during pregnancy and lactation only when the benefits of the drug outweigh the possible risks, as decided by a veterinarian.

Interaction with other means or other forms of interaction

There is a possibility for allergic cross-reactivity with other penicillins.

Penicillins may increase the antibacterial activity of aminoglycosides.

Special precautions for persons and service personnel

Penicillins and cephalosporins can cause hypersensitivity (allergy) after injection, inhalation, ingestion, or skin contact. Hypersensitivity to penicillins can lead to cross-reactions with cephalosporins and vice versa. Allergic reactions to these substances can be serious.

If you are known to be hypersensitive to amoxicillin, you should not work with such drugs. The drug should be used with caution. If you come into contact with the drug and develop symptoms of allergy (redness of the skin), you should seek medical advice. Itching of the face, eyes or lips, difficulty breathing are more serious symptoms and require immediate medical attention. Wash your hands after working with the drug.

Dry, dark place inaccessible to children at a temperature of 0 °C to 25 °C.

The tablets are pink, speckled, round in shape with a break line on one side.

The tablet can be divided into halves.

2 years.

The unused half tablet should be returned to the blister and used within 24 hours.

For use in veterinary medicine!