Clavaseptin
Clavaseptin Palatable Tablets are a potentiated antibiotic composed of two ingredients that work in synergy to increase their effectiveness against certain bacteria. They can be used in particular for the treatment of infections caused by bacteria susceptible to amoxicillin in combination with clavulanic acid.
Clavaseptin Tablets are beige coloured tablets that can be divided into two equal parts for easy and accurate dosing.
The Veterinary Medicinal Product
Clavaseptin contains a combination of amoxicillin in combination with clavulanic acid and a beta-lactomase inhibitor.
Indicated for use for dental infections in dogs, and skin infections in cats. It is also an antibiotic tablet used in dogs and cats.
Indications for Use, Specifying the Target Species
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.
Cats: treatment of skin infections (including wounds and abscesses) caused by bacteria susceptible to amoxicillin in combination with clavulanic acid i.e. Pasteurella spp, Staphylococcus spp, Streptococcus spp and Escherichia coli.
Contraindications
Do not use in case of hypersensitivity to penicillins or other substances of the β-lactam group. Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas.
Special Precautions for Use in Animals
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.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid may decrease the effectiveness of treatment with other β-lactam antibiotics, due to the potential for cross resistance. Use of the product should take into account official and local antimicrobial policies. Do not use in cases of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as a single substance.
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 skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Wash hands after handling the tablets.
Amounts to be Administered and Administration Route
To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid under-dosing. Administration is made easier by the palatable nature of the tablet.
Duration of Treatment: Duration of treatment is 7 days for the treatment of periodontal infections in dogs and 7 to 14 days for the treatment of skin infections in cats (including wounds and abscesses). The clinical status of animals should be re-evaluated after 7 days and the treatment prolonged for a further 7 days if necessary.
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.
Adverse Reactions (Frequency and Seriousness)
Vomiting and diarrhoea may be observed very rarely. 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 very rarely. In these cases, administration should be discontinued and a symptomatic treatment given.
The frequency of adverse reactions is defined using the following convention:
- - very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- - common (more than 1 but less than 10 animals in 100 animals treated)
- - uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- - rare (more than 1 but less than 10 animals in 10,000 animals treated)
- - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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.
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.
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 β‑lactamase producing strains of both Gram-positive and Gram-negative aerobes, facultative anaerobes and obligate anaerobes.
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%).
Pharmacokinetic Particulars
After oral administration at the recommended dose in dogs and cats, the absorption of amoxicillin and clavulanic acid is fast. In dogs, 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.
In cats, the maximum plasma concentration of amoxicillin of 6.6 µg/ml is reached in 1.8 h and the maximum plasma concentration of clavulanic acid of 3.7 µg/ml is reached in 0.75h. Elimination is also fast.
After repeated oral administration of the recommended dose in dogs and cats, there is no accumulation of amoxicillin or clavulanic acid and the steady state is reached rapidly after first administration.
Special Precautions for Storage and Disposal
Do not store above 25°C. Store in the original package. Any unused product or waste material should be disposed of in accordance with national requirements.
Nature and Composition of Immediate Packaging
Clavaseptin 50mg Palatable Tablets: 10 and 50 blisters of 10 tablets
Clavaseptin 250mg Palatable Tablets: 10 and 25 blisters of 10 tablets
Clavaseptin 500mg Palatable Tablets: 10 blisters of 10 tablets.
Aluminium/aluminium blister pack with 10 tablets/blister.