Clavaseptin Chewable Tablets (250 mg) (Canada)

Manufacturer: Vétoquinol

Pr CLAVASEPTIN 50 mg	DIN 02316900
Amoxicillin/clavulanic Acid Chewable Tablets
Active Ingredients	(per tablet)
Amoxicillin (as amoxicillin trihydrate)	40 mg
Clavulanic acid (as clavulanate potassium)	10 mg
Pr CLAVASEPTIN 250 mg	DIN 02316919
Amoxicillin/clavulanic Acid Chewable Tablets
Active Ingredients	(per tablet)
Amoxicillin (as amoxicillin trihydrate)	200 mg
Clavulanic acid (as clavulanate potassium)	50 mg
Pr CLAVASEPTIN 500 mg	DIN 02316927
Amoxicillin/clavulanic Acid Chewable Tablets
Active Ingredients	(per tablet)
Amoxicillin (as amoxicillin trihydrate)	400 mg
Clavulanic acid (as clavulanate potassium)	100 mg

For Veterinary Use Only

Dosage Form

Divisible tablets.

Clavaseptin Chewable Tablets (250 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: It is recommended to obtain samples for in vitro culture and susceptibility testing prior to treatment.

Clavaseptin Chewable Tablets (250 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.

Periodontal infections in dogs and skin and soft tissue infections in cats should be treated for 7 days. The clinical status of cats should be re-evaluated after 7 days. If necessary, clinically improved animals may be treated 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/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 (250 mg) Cautions

The safety of Clavaseptin 50 mg /250 mg/500 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.

To limit the development of antimicrobial resistance:

Clavaseptin 50 Mg /250 Mg/500 Mg Should Not Be Used In Food-producing Animals.

the Extra-label Drug Use Of clavaseptin 50 Mg /250 Mg/500 Mg Is Not Recommended.

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

Antibiotic

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 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 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.

Presentation

Cats: Clavaseptin 50 Mg

strip aluminum/aluminum with 10 tablets/strip as 10 strips within a cardboard carton.

Dogs: Clavaseptin 50 Mg

strip aluminum/aluminum with 10 tablets/strip as 10 strips within a cardboard carton.

Clavaseptin 250 Mg

strip aluminum/aluminum with 10 tablets/strip as 10 strips within a cardboard carton.

Clavaseptin 500 Mg

strip aluminum/aluminum with 10 tablets/strip as 10 strips within a cardboard carton.

Vétoquinol N.-A. Inc., 2000, ch. Georges, Lavaltrie, Qc, Canada J5T 3S5

430304 0312 B

	Net	Code
50 mg	100 tablets	992018	410639 0908D
250 mg	100 tablets	992019	410847 0908C
500 mg	100 tablets	992020	410854 0908C

Nac No.

12342944