Cladaxxa 50-500, analogue Synulox, Clavaseptin
1. Name of the veterinary medicinal product: trade name: Cladaxxa® chewable tablets.
International Non-proprietary Name (INN): amoxicillin, clavulanic acid.
2. Pharmaceutical form: tablets for oral administration.
The medicinal product contains amoxicillin (as trihydrate) and clavulanic acid (as potassium clavulanate) as active substances.
The medicinal product is available in three strengths: Cladaxxa 40 mg/10 mg (containing 40 mg amoxicillin and 10 mg clavulanic acid); Cladaxxa 200 mg/50 mg (containing 200 mg amoxicillin and 50 mg clavulanic acid); and Cladaxxa 400 mg/100 mg (containing 400 mg amoxicillin and 100 mg clavulanic acid). Excipients include erythrosine (E 127), magnesium stearate, colloidal anhydrous silica, dried yeast, sodium starch glycolate (type A), and microcrystalline cellulose.
3. Appearance: Cladaxxa tablets are round, pink, and mottled, with a score line on one side.
The shelf life of the medicinal product is 2 years from the date of manufacture. An unused half-tablet may be returned to the blister pack and used within 24 hours.
Do not use the product after the expiry date.
4. Cladaxa tablets (40 mg/10 mg and 200 mg/50 mg) are supplied in blisters of 10 tablets, packed in cardboard boxes containing 1, 2, 10, or 50 blisters. Cladaxa tablets (400 mg/100 mg) are supplied in blisters of 6 tablets, packed in cardboard boxes containing 2, 10, or 50 blisters.
5. Cladaxa is used to treat bacterial infections in dogs and cats, including:
- skin diseases (specifically deep and superficial pyoderma);
- urinary tract infections;
- respiratory infections of bacterial origin (involving both the upper and lower respiratory tracts);
- enteritis of bacterial origin.
6. Do not use Cladaxa in animals with hypersensitivity to β-lactam antibiotics. Do not use in gerbils, guinea pigs, hamsters, rabbits, or chinchillas.
7. Observe general personal hygiene and safety rules applicable to handling veterinary medicinal products. Do not eat, drink, or smoke while handling the product. Wash hands with soap and running water after handling the product. In case of accidental contact with the skin or mucous membranes, rinse the affected areas with plenty of water. Individuals with hypersensitivity to the product's components should avoid direct contact with Cladaxa. In the event of an allergic reaction or accidental ingestion, seek medical attention immediately (bringing the package insert and label with you).
Dispose of the empty product packaging with household waste.
8. The product may be administered to pregnant and lactating animals under the supervision of a veterinarian.
9. The product is administered orally. Cladaxa may be given to cats and dogs by hand or mixed with food. Food intake does not affect the bioavailability of the product's active ingredients.
The product is administered at a single dose of 12.5 mg (combined active ingredients) per 1 kg of body weight, twice daily.
Doses and method of administration
Cladaxxa tablets 50 mg are administered to sick animals directly into the mouth or crumbled together with feed at a dose of 12.5 mg per 1 kg of animal weight (for example, if an animal weighs 3-5 kg, 1 tablet of Cladaxxa 50 mg is given, with an animal weighing 14-18 kg – 4 tablets of Cladaxxa 50 mg) 2 times a day for 5-7 days. If the disease is difficult to treat, especially with respiratory infections, you can increase the dose of Cladaxxa by 2 times (up to 25 mg per 1 kg of animal weight) twice a day or shorten the intervals between drug administration. In the case of chronic or intractable diseases, often accompanied by significant tissue damage, a longer course of therapy with Cladaxxa is recommended: the duration of treatment for chronic skin diseases and chronic cystitis is 10-28 days, for respiratory diseases – 8-10 days.
*Kilograms to Pounds conversion table
| Kilograms (kg) | Pounds (lb) |
Pounds+Ounces (lb+oz) |
| 0.1 kg | 0.220 lb | 0 lb 3.527 oz |
| 1 kg | 2.205 lb | 2 lb 3.274 oz |
| 5 kg | 11.023 lb | 11 lb 0.370 oz |
| 10 kg | 22.046 lb | 22 lb 0.740 oz |
Cladaxxa tablets 250 mg are administered to sick animals directly into the mouth or crumbled together with feed at a dose of 12.5 mg per 1 kg of animal weight (for example, with an animal weighing 26-35 kg – 1.5 tablets of Cladaxxa 250 mg, with an animal weighing over 50 kg – 3 tablets of Cladaxxa 250 mg) 2 times a day for 5-7 days. If the disease is difficult to treat, especially with respiratory infections, you can increase the dose of Cladaxxa by 2 times (up to 25 mg per 1 kg of animal weight) twice a day or shorten the intervals between drug administration. In the case of chronic or intractable diseases, often accompanied by significant tissue damage, a longer course of therapy with Cladaxxa is recommended: the duration of treatment for chronic skin diseases and chronic cystitis is 10-28 days, for respiratory diseases – 8-10 days.
In cases where the disease is difficult to treat (e.g., respiratory infections), the dosage should be increased to 25 mg/kg of body weight, administered twice daily.
The treatment course lasts 5–7 days. For chronic or refractory conditions—particularly deep pyoderma in dogs—the treatment course may extend to 10–28 days.
10. No adverse reactions or complications are typically observed when the drug is administered according to the instructions. If allergic reactions occur, use of the drug should be discontinued, and antihistamines or other symptomatic treatments administered.
11. Symptoms of overdose have not been established.
12. Concomitant administration of Cladaxa with bacteriostatic antibiotics is not recommended.
13. No specific effects associated with the initiation or discontinuation of the drug have been identified.
14. Missed doses should be avoided, as this may reduce therapeutic efficacy. If a dose is missed, it should be administered as soon as possible. The treatment course should then be resumed according to the prescribed dosage and administration schedule.
15. The drug is not intended for use in food-producing animals or horses.
16. Store the drug in the manufacturer's original sealed packaging, protected from direct sunlight and kept separate from food and animal feed, at a temperature between 0°C and 25°C.