Clavaseptin Chewable Tablets (500 mg) (Canada)

AMOXICILLIN / CLAVULANIC ACID CHEWABLE TABLETS

FOR VETERINARY USE ONLY

Dosage Form

Divisible tablets.

Clavaseptin Chewable Tablets (500 mg) Indications

Dogs: For the treatment of gingivitis associated with periodontal infections caused by bacteria susceptible to amoxicillin/clavulanic acid.

Cats: For the treatment of skin and soft tissue infections, such as wounds and abscesses, caused by bacteria susceptible strains of Pasteurella spp., Staphylococcus spp. and Streptococcus spp.

Note: To limit the development of antimicrobial resistance this drug should be used as directed. It is recommended to obtain samples for in vitro culture and susceptibility testing prior to treatment.

Clavaseptin Chewable Tablets (500 mg) Dosage And Administration

The recommended dosage of amoxicillin/clavulanic acid is 12.5 mg/kg of body weight twice daily by the oral route in dogs and cats.

Dogs - Periodontal infections should be treated for 7 days.

Cats - Skin and soft tissue infections should be treated for 7 to 14 days depending on the severity of the infection.

The cats should be re-evaluated after 7 days and if necessary, treatment can be extended for an additional 7 days. If no clinical improvement is seen after 3-5 days of treatment, therapy should be discontinued and the case re-evaluated.

Palatability: In palatability studies, 75% of cats and 50% of dogs offered a Clavaseptin 50 mg/62.5 mg/250 mg/500 mg in an empty food bowl spontaneously ate it within 5 minutes (no human stimulation).

Contraindications

Do not use in cases with a history of penicillin or cephalosporin hypersensitivity.

Clavaseptin Chewable Tablets (500 mg) Cautions

The safety of Clavaseptin 50 mg/62.5 mg/250 mg/500 mg/750 mg has not been established during pregnancy, lactation and in breeding animals. Laboratory studies in rats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

In case of anaphylaxis, administer epinephrine and/or steroids.

WARNINGS

Keep out of reach of children.

Adverse Reactions

Vomiting and diarrhea may be observed. Treatment may be continued depending on the severity of the undesirable effect observed, as determined by the attending veterinarian. Hypersensitivity reactions (allergic skin reactions, anaphylaxis) are rarely observed. In such cases, administration should be discontinued and a symptomatic treatment given.

Pharmacology

Amoxicillin is an aminobenzylpenicillin from the β-lactam penicillin family which prevents bacterial cell wall formation by interfering with the final step of peptidoglycan synthesis. Clavulanic acid is an irreversible “suicide” inhibitor of intracellular and extracelluar 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. The amoxicillin/clavulanic acid combination has demonstrated in vitro activity against Pasteurella spp., Staphylococcus spp. and Streptococcus spp. isolated from cats with skin and soft tissue infections and against a wide range of Gram-positive and Gram-negative aerobic and anaerobic bacteria associated with gingivitis in dogs. Isolates of Pseudomonas spp. were generally found to be resistant in vitro to amoxicillin/clavulanic acid.

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 0.9 h. 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 0.75 h.

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.

Pharmacokinetic parameters may be slightly affected (increased or decreased) by the presence of food, but this is not clinically significant.

Storage

Store between 15°C and 25°C. Keep tablets in their original package, as they are sensitive to moisture. 750 mg tablets: Return any part of tablet to the opened blister and use within 48 hours.

PRESENTATION

Cats:

Clavaseptin 50 mg: blister strip with 10 tablets/strip - 100 tablets per carton.

Clavaseptin 62.5 mg: blister strip with 10 tablets/strip - 100 tablets per carton.

Dogs:

Clavaseptin 50 mg: blister strip with 10 tablets/strip - 100 tablets per carton.

Clavaseptin 62.5 mg: blister strip with 10 tablets/strip - 100 tablets per carton.

Clavaseptin 250 mg: blister strip with 10 tablets/strip - 100 tablets per carton.

Clavaseptin 500 mg: blister strip with 10 tablets/strip - 100 tablets per carton.

Clavaseptin 750 mg: blister strip with 10 tablets/strip - 100 tablets per carton.

Vetoquinol N.-A. Inc., 2000, ch. Georges, Lavaltrie, QC, Canada J5T 3S5

Last revision date: December 28, 2022

0223 I

CPN: 1234294.9