Aventiclav Tablets (250 mg) (Canada)

Company: Aventix

amoxicillin and clavulanate potassium tablets U.S.P.

Veterinary Use Only

broad-spectrum antibiotic

DIN 02394324 (62.5 mg), 02394332 (125 mg), 02394340 (250 mg), 02394359 (375 mg)

Description

AVENTICLAV 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).

DOSAGE FORM: Divisible tablets.

ACTION: Amoxicillin and clavulanic acid are stable in the presence of gastric acid and are 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.

AVENTICLAV 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 aerobic and anaerobic 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 37:20527-29; 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 amoxicillin/clavulanic acid tablets.

™ Trade-mark owned by SmithKline Beecham Corporation.

Aventiclav Tablets (250 mg) Indications

AVENTICLAV 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 AVENTICLAV 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 AVENTICLAV. 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 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.

Warning

Keep out of reach of children. To limit the development of antimicrobial resistance:

● AVENTICLAV should not be used in food-producing animals.

● The extra-label drug use of AVENTICLAV is not recommended.

Aventiclav Tablets (250 mg) Caution

Do not use in animals maintained for breeding purposes as safety has not been established. In case of anaphylaxis, administer epinephrine and/or steroids.

Adverse Reactions

Post-Approval Experience: The most frequent or serious adverse events include vomiting, lethargy, anorexia and hypersensitivity (non-pruritic erythematous ears, lips and perineal area).

Storage

Store in a dry, cool place at temperatures not above 25°C. Do not remove from foil strip until ready to use.

AVAILABILITY: AVENTICLAV Tablets are supplied in four concentrations.

62.5 mg - 50 mg amoxicillin/12.5 mg clavulanic acid - for dogs and cats

125 mg - 100 mg amoxicillin/25 mg clavulanic acid - for dogs

250 mg - 200 mg amoxicillin/50 mg clavulanic acid - for dogs

375 mg - 300 mg amoxicillin/75 mg clavulanic acid - for dogs

Imported & Distributed by: AVENTIX, 4350 Mainway, Burlington, ON. Canada L7L 5R7

905-332-4744

Manufactured by: Norbrook Laboratories Limited, Newry, Northern Ireland, BT35 6PU

108796I02

CPN: 1301045.2