Clavamox Chewable Tablets (62.5 mg) (Canada)

Company: Zoetis

amoxicillin and clavulanate potassium chewable tablets

Veterinary Use Only

DIN 02489473

DIN 02489481

DIN 02489503

DIN 02489511

Description

CLAVAMOX^® (amoxicillin and clavulanate potassium chewable tablets) is an orally administered formulation comprised of the broad-spectrum antibiotic amoxicillin (as amoxicillin trihydrate) and the β-lactamase inhibitor clavulanic acid (as clavulanate potassium).

MEDICINAL INGREDIENTS:

- Each 62.5 mg chewable tablet strength contains 50 mg amoxicillin (as amoxicillin trihydrate) and 12.5 mg clavulanic acid (as clavulanate potassium).

- Each 125 mg chewable tablet strength contains 100 mg amoxicillin (as amoxicillin trihydrate) and 25 mg clavulanic acid (as clavulanate potassium).

- Each 250 mg chewable tablet strength contains 200 mg amoxicillin (as amoxicillin trihydrate) and 50 mg clavulanic acid (as clavulanate potassium).

- Each 375 mg chewable tablet strength contains 300 mg amoxicillin (as amoxicillin trihydrate) and 75 mg clavulanic acid (as clavulanate potassium).

Clavamox Chewable Tablets (62.5 mg) Indications

CLAVAMOX chewable tablets are indicated for the treatment of:

DOGS:

Skin and Soft Tissue Infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following bacteria:

● β-lactamase-producing Staphylococcus aureus,

● non-β-lactamase-producing Staphylococcus aureus,

● Staphylococcus spp., Streptococcus spp., and E. coli.

Urinary Tract Infections (cystitis) due to susceptible strains of E. coli.

Gingivitis associated with periodontal infections due to susceptible strains of aerobic and anaerobic bacteria.

CATS:

Skin and Soft Tissue Infections such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following bacteria:

● β-lactamase-producing Staphylococcus aureus,

● non-β-lactamase-producing Staphylococcus aureus,

● Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella spp.

Urinary Tract Infections (cystitis) due to susceptible strains of E. coli.

Therapy may be initiated with CLAVAMOX chewable tablets prior to obtaining results from bacteriological and susceptibility studies. A culture should be obtained prior to treatment to determine susceptibility of the microorganisms to CLAVAMOX chewable tablets. Following determination of susceptibility results and clinical response to medication, therapy may be reevaluated.

Dosage and Administration

The dose should be prescribed using a combination of whole chewable tablet strengths (62.5 mg, 125 mg, 250 mg, 375 mg). Do not remove from foil strip until ready to use. Even if the chewable tablet is broken, the entire tablet should be consumed.

DOGS: The recommended oral dosage of amoxicillin/clavulanic acid per kg of bodyweight is 12.5 mg twice daily for skin and soft tissue and urinary tract infections, and 13.75 mg twice daily for gingivitis.

Skin and soft tissue infections such as abscesses, cellulitis, wounds, and superficial/juvenile pyoderma should be treated for 5 to 7 days. Gingivitis should be treated for 7 to 10 days. Continue administration for 48 hours after all signs have subsided. If no response is seen after 5 days of treatment, therapy should be discontinued and the case reevaluated. Deep pyoderma may require treatment for 21 days. Urinary tract infections may require treatment for 10 to 14 days or longer. The maximum duration of treatment should not exceed 30 days.

CATS: The recommended oral dosage of amoxicillin/clavulanic acid is 62.5 mg per animal twice daily.

Skin and soft tissue infections such as abscesses and cellulitis/dermatitis should be treated for 5 to 7 days. Continue administration for 48 hours after all signs have subsided. If no response is seen after 3 days of treatment, therapy should be discontinued and the case reevaluated. Urinary tract infections may require treatment for 10 to 14 days or longer. The maximum duration of treatment should not exceed 30 days.

PALATABILITY: The palatability of CLAVAMOX Chewable Tablets was evaluated in dogs in a US multi-location field trial. One hundred twelve (112) client.owned dogs were dosed with CLAVAMOX chewable tablets at 12.5 mg/kg twice daily for 7 days and evaluated for voluntary acceptance/intake of the product. Over the course of the study, a total of 1567 doses were administered. Dogs freely consumed 1293 doses (83%) within 5 minutes of offering from an empty bowl or owner’s hand. Of the 17% of doses unconsumed within 5 minutes, 16% were administered with a treat/food or forced intake and 1% of doses were refused.

Contraindications

The use of CLAVAMOX chewable tablets is contraindicated in animals with a history of an allergic reaction to any of the penicillins or cephalosporins.

CAUTIONS: The safe use of CLAVAMOX chewable tablets in pregnant or breeding dogs and cats has not been established.

Warnings

Keep out of reach of children.

Adverse Reactions

CLAVAMOX chewable tablets contain a semisynthetic penicillin (amoxicillin) and have the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids.

Although all adverse reactions are not reported, the following information is based on voluntary post-approval drug experience reporting. It is generally recognized that this results in significant under-reporting. The adverse events listed here reflect reporting and not necessarily causality. The following adverse events reported for dogs and cats are listed in decreasing order of reporting frequency: vomiting, diarrhea, lethargy and anorexia.

Clinical Pharmacology

Amoxicillin and clavulanic acid diffuse readily into most body tissues and fluids, with the exception of brain and spinal fluid, which amoxicillin penetrates adequately when meninges are inflamed. Most of the amoxicillin is excreted unchanged in the urine. Clavulanic acid’s penetration into spinal fluid is unknown at this time. Approximately 15% of the administered dose of clavulanic acid is excreted in the urine within the first six hours.

CLAVAMOX chewable tablets combine the distinctive properties of an antibiotic and a β-lactamase inhibitor to effectively extend the antibacterial spectrum of amoxicillin to include β-lactamase as well as non-β-lactamase producing aerobic and anaerobic bacteria.

MICROBIOLOGY: Amoxicillin is bactericidal in action and acts through the inhibition of biosynthesis of cell wall mucopeptide of susceptible microorganisms. The action of clavulanic acid extends the antimicrobial spectrum of amoxicillin to include bacteria resistant to amoxicillin and other β-lactam antibiotics. Amoxicillin/clavulanate has been shown to have a wide range of activity which embraces β-lactamase-producing strains of both gram-positive and gram-negative aerobes, facultative anaerobes, and obligate anaerobes. Many strains of the following bacteria, including β-lactamase-producing strains isolated from veterinary sources, were found to be susceptible to amoxicillin/clavulanate in vitro but the clinical significance of this activity has not been demonstrated for some of these microorganisms in animals:

Aerobic bacteria, including Staphylococcus aureus*, β-lactamase-producing Staphylococcus aureus* (penicillin resistant), Staphylococcus spp.*, Staphylococcus epidermidis, Staphylococcus intermedius, Streptococcus faecalis, Streptococcus spp.*, Corynebacterium pyogenes, Corynebacterium spp., Erysipelothrix rhusiopathiae, Bordetella bronchiseptica, Escherichia coli*, Proteus mirabilis, Proteus spp., Enterobacter spp., Klebsiella pneumoniae, Salmonella dublin, Salmonella typhimurium, Pasteurella multocida, Pasteurella haemolytica, Pasteurella spp.*

* The susceptibility of these microorganisms has also been demonstrated in in vivo studies.

Studies have demonstrated that both aerobic and anaerobic flora are isolated from gingival cultures of dogs with clinical evidence of periodontal disease. Both gram-positive and gram-negative aerobic and anaerobic subgingival isolates indicate sensitivity to amoxicillin/clavulanic acid during antimicrobial susceptibility testing.

Susceptibility Test: The recommended quantitative disc susceptibility method (FEDERAL REGISTER 37:20527-29; Bauer AW, Kirby WMM, Sherris JC, et al: Antibiotic susceptibility testing by standardized single disc method. Am J Clin Path 45:493, 1966) utilized 30 mcg Augmentin discs for estimating the susceptibility of bacteria to CLAVAMOX chewable tablets.

Storage

Store between 15°C to 25°C. Do not remove from foil strip until ready to use.

PRESENTATION: CLAVAMOX chewable tablets are supplied in the following four concentrations:

62.5 mg - for dogs and cats

Available in single strip rolls containing 112 chewable tablets.

125 mg - for dogs

Available in single strip rolls containing 112 chewable tablets.

250 mg - for dogs

Available in single strip rolls containing 112 chewable tablets.

375 mg - for dogs

Available in single strip rolls containing 112 chewable tablets.

Not all pack sizes may be marketed.

Zoetis^® and Clavamox are registered trademarks of Zoetis or its licensors.

Zoetis Canada Inc., Kirkland QC H9H 4M7

10024389-11-0

51746964

CPN: 1198566.2