Clavamox Drops (Canada)

Company: Zoetis

Drops

amoxicillin and clavulanate potassium for oral suspension USP

Veterinary Use Only

DIN 02027879

Description

Clavamox is an orally administered formulation comprised of the broad-spectrum antibiotic amoxicillin trihydrate and the β-lactamase inhibitor clavulanate potassium (the potassium salt of clavulanic acid). Each unreconstituted bottle contains 750 mg of amoxicillin USP and 187.5 mg of clavulanic acid (as clavulanate potassium, diluted Ph.Eur.).

ACTION: Clavamox is stable in the presence of gastric acid and is not significantly influenced by gastric or intestinal contents. The two components are rapidly absorbed resulting in amoxicillin and clavulanic acid concentrations in serum, urine and tissues similar to those produced when each is administered alone.

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 combines 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 bacteria.

MICROBIOLOGY: Amoxicillin is bactericidal in action and acts through the inhibition of biosynthesis of cell wall mucopeptide of susceptible micro-organisms. 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 micro-organisms in animals:

Aerobic bacteria, including Staphylococcus aureus¹, β-lactamase-producing Staphylococcus aureus¹ (penicillin resistant), Staphylococcus spp.¹, Staphylococcus epidermidis, Staphylococcus intermedius, Streptococcus faecalis, Streptococcus spp.¹, Corynebacterium pyogenes, Corynebacterium spp., Erysipelothrix rhusiopathiae, Bordetella bronchiseptica, Escherichia coli¹, Proteus mirabilis, Proteus spp., Enterobacter spp., Klebsiella pneumoniae, Salmonella dublin, Salmonella typhimurium, Pasteurella multocida, Pasteurella haemolytica, Pasteurella spp.¹

¹ The susceptibility of these micro-organisms 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 37:20507-29; 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 µg Augmentin discs for estimating the susceptibility of bacteria to Clavamox Tablets.

Clavamox Drops Indications

Clavamox drops 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 organisms.

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 organisms.

Therapy may be initiated with Clavamox prior to obtaining results from bacteriological and susceptibility studies. A culture should be obtained prior to treatment to determine susceptibility of the micro-organisms to Clavamox. Following determination of susceptibility results and clinical response to medication, therapy may be reevaluated.

Contraindications

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

Dosage and Administration

DOGS: The recommended oral dosage of amoxicillin/clavulanic acid per kg of body weight 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 is 62.5 mg of amoxicillin/clavulanic acid (1 mL) 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.

RECONSTITUTION INSTRUCTIONS: Add 14 mL of water to bottle to make a total volume of 15 mL and shake vigorously. Each mL of reconstituted suspension contains 50 mg of amoxicillin (as amoxicillin trihydrate) and 12.5 mg of clavulanic acid (as clavulanate potassium). Once reconstituted, store suspension at a temperature between 2 and 8°C. Any unused portion must be discarded after 7 days.

Warnings

Keep out of reach of children.

CAUTIONS: Do not use in animals maintained for breeding purposes as safety has not been established. In case of anaphylaxis, administer epinephrine.

Storage

Store unreconstituted product at a temperature between 15 and 25°C.

Zoetis is a trademark and Clavamox is a registered trademark of Zoetis or its licensors, used under license by Zoetis Canada Inc.

Zoetis Canada Inc., Kirkland QC H9H 4M7

8016-11-2

P1517409

CPN: 1198027.7