Clavaseptin 500 mg for dogs 1 tablet
Treatment of periodontal infections caused by bacteria susceptible to amoxicillin in combination with clavulanic in dogs
Clavaseptin 500 mg Palatable tablets for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF Clavaseptin 500 mg
One tablet contains:
Amoxicillin (as amoxicillin trihydrate)……………….……………..………. 400,000 mg
Clavulanic acid (as potassium salt)……………………………………..… 100,000 mg
Brown iron oxide (E172)………………………………….…..…….….. 0,950 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM OF Clavaseptin 500 mg
Beige scored tablet that can be divided into equal halves.
4. CLINICAL PARTICULARS OF Clavaseptin 500 mg
4.1 Target species
4.2 Indications for use, specifying the target species
In dogs: treatment or adjunctive treatment of periodontal infections caused by bacteria susceptible to amoxicillin in combination with clavulanic acid i.e. Pasteurella spp, Streptococcus spp and Escherichia coli.
Do not use in animals with known hypersensitivity to penicillins or other substances of the β-lactam group.
Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas.
4.4 Special warnings for each target species
4.5 Special precautions for use
Special precautions for use in animals
In addition to section 4.3 contraindications:
In animals with impaired liver and kidney function, the use of the product should be subject to a risk/benefit evaluation by the veterinary surgeon and the posology evaluated carefully.
Caution is advised in the use in small herbivores other than those in 4.3.
Use of the product should be based on susceptibility testing.
Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid. Use of the product should take into account official and local antimicrobial policies.
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.
1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
2. Handle this product with great care to avoid exposure, taking all recommended precautions.
3. If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the doctor this warning.
Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.
Wash hands after handling the tablets.
4.6 Adverse reactions (frequency and seriousness)
Vomiting and diarrhoea may be observed. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon.
Hypersensitivity reactions (allergic skin reactions, anaphylaxis) may be observed. In these cases, administration should be discontinued and a symptomatic treatment given.
4.7 Use during pregnancy, lactation or lay
The safety of the product has not been established during pregnancy and lactation. Laboratory studies in rats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use the product only accordingly to the benefit/risk assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
The bactericidal activity of amoxicillin may be reduced by the simultaneous use of bacteriostatic substances such as macrolides, tetracyclines, sulfonamides and chloramphenicol.
4.9 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, i.e. 1 tablet per 40 kg body weight every 12 h, according to the following table:
Bodyweight (kg): Number of tablets twice daily
[ > 30.1 - 40 ] kg: 1
[ > 40.1 - 60 ] kg: 1 ½
[ > 60.1 - 80 ] kg: 2
In severe infections, the dose may be doubled to 20 mg amoxicillin / 5 mg clavulanic acid/kg body weight twice daily.
Duration of treatment:
- 7 days for the treatment of periodontal infections in dogs.
To ensure the correct dosage, body weight should be determined as accurately as possible to avoid under-dosing.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
At three times the recommended dose for a period of 28 days, diarrhoea was observed in dogs. In the event of an overdose symptomatic treatment is advised.
4.11 Withdrawal period(s)
5. PHARMACOLOGICAL PROPERTIES OF Clavaseptin 500 mg
Pharmacotherapeutic group: anti-infective for systemic use; amoxicillin and enzyme inhibitor.
ATCvet code: QJ01CR02
5.1 Pharmacodynamic properties
Amoxicillin is an aminobenzylpenicillin from the β-lactam penicillin family which prevents the bacterial cell wall formation by interfering with the final step of peptidoglycan synthesis.
Clavulanic acid is an irreversible inhibitor of intracellular and extracellular β-lactamases which protects amoxicillin from inactivation by many β-lactamases.
Amoxicillin/clavulanate has a wide range of activity which includes βlactamase producing strains of both Gram-positive and Gram-negative aerobes, facultative anaerobes and obligate anaerobes.
Amoxicillin/clavulanic acid breakpoints (NCCLS/2002):
Staphylococci: sensitive: MIC < 4/2 µg/ml, resistant: MIC > 8/4 µg/ml
Other organisms: sensitive: MIC < 8/4 µg/ml, resistant: MIC > 32/16 µg/ml
In dog periodontal infections in Europe (isolates of the year 2002 from France, Germany and Belgium) amoxicillin/clavulanic acid combination in a ratio 2/1 showed the following data on sensitivity:
Streptococcus spp.: MIC90: 0.4/0.2 µg/ml,
Pasteurellaceae: MIC90: 0.4/0.2 µg/ml,
Escherichia coli: MIC90: 5.3/2.6 µg/ml,
Enterobacteriaceae: MIC90: 22.6/11.3 µg/ml, except for Enterobacter spp.
Pseudomonadaceae: MIC90: 147.0/73.5 µg/ml,
Enterobacter spp.: MIC90: 49.6/24.8 µg/ml
Resistance to β-lactam antibiotics is mainly mediated by β-lactamases which hydrolyze antibiotics such as amoxicillin. It is mostly shown in Pseudomonadaceae (81.25%) and in Enterobacter spp. (55.5%).
Susceptibility and resistance patterns can vary with geographical area and bacterial strain, and may change over time.
5.2 Pharmacokinetic particulars
After oral administration at the recommended dose in dogs, the absorption of amoxicillin and clavulanic acid is fast. The maximum plasma concentration of amoxicillin of 8.5 µg/ml is reached in 1.4 h and the maximum plasma concentration of clavulanic acid of 0.9 µg/ml is reached in 0.9h. Half life is 1 hour for both substances.
Elimination is also fast. 12 % of the amoxicillin and 17 % of clavulanic acid is excreted in the urine. The remainder is excreted as inactive metabolites.
After repeated oral administration of the recommended dose, there is no accumulation of amoxicillin or clavulanic acid and the steady state is reached rapidly after first administration.
6. PHARMACEUTICAL PARTICULARS OF Clavaseptin 500 mg
6.1 List of excipients
Brown iron oxide E172
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf life after first opening the immediate packaging: 16 hours.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package.
Return any halved tablet to the opened blister-pack and use within 16 hours.