(amoxicillin trihydrate/clavulanate potassium) (amoxicillin trihydrate/clavulanate potassium) Drops Veterinary Tablets For veterinary oral suspension For use in dogs and cats For use in dogs and cats CAUTION: Federal law restricts this drug to use by or Periodontal infections due to susceptible strains of CAUTION: Federal law restricts this drug to use by INDICATIONS AND USAGE: Clavamox Drops are on the order of a licensed veterinarian. both aerobic and anaerobic bacteria. Clavamox has or on the order of a licensed veterinarian. indicated in the treatment of: been shown to be clinically effective for treating cases DESCRIPTION: Clavamox (amoxicillin trihydrate/ DESCRIPTION: Clavamox (amoxicillin trihydrate/ Dogs: Skin and soft tissue infections such as of canine periodontal disease. clavulanate potassium) is an orally administered clavulanate potassium) is an orally administered wounds, abscesses, cellulitis, superficial/juvenile Cats: Skin and soft tissue infections such as wounds, formulation comprised of the broadspectrum antibiotic formulation comprised of the broad-spectrum and deep pyoderma due to susceptible strains of abscesses, and cellulitis/dermatitis due to susceptible Amoxi® (amoxicillin trihydrate) and the β- lactamase antibiotic Amoxi® (amoxicillin trihydrate) and the the following organisms: β-lactamase-producing strains of the following organisms: β-lactamase- Staphylococcus aureus, non- -lactamase-producing inhibitor, clavulanate potassium (the potassium salt of β-lactamase inhibitor, clavulanate potassium (the β producing Staphylococcus aureus, non- -lactamase- clavulanic acid). β potassium salt of clavulanic acid). Staphylococcus aureus, Staphylococcus spp., producing Staphylococcus aureus, Staphylococcus Streptococcus spp., and E. coli. Amoxicillin trihydrate is a semisynthetic antibiotic spp., Streptococcus spp., E. coli, and Pasteurella spp. Amoxicillin trihydrate is a semisynthetic antibiotic Peridontal infections due to susceptible strains of with a broad spectrum of bactericidal activity against Urinary tract infections (cystitis) due to susceptible with a broad spectrum of bactericidal activity both aerobic and anaerobic bacteria. Clavamox has many gram-positive and gram-negative, aerobic strains of E. coli. against many gram-positive and gram-negative, and anaerobic microorganisms. It does not resist aerobic and anaerobic microorganisms. It does been shown to be clinically effective for treating Therapy may be initiated with Clavamox prior to cases of canine periodontal disease. destruction by β-lactamases; therefore, it is not not resist destruction by β-lactamases; therefore, effective against β-lactamase-producing bacteria. obtaining results from bacteriological and susceptibility studies. A culture should be obtained prior to treatment it is not effective against β-lactamase-producing Cats: Skin and soft tissue infections such as Chemically, it is D(-)-a- amino-p-hydroxybenzyl bacteria. Chemically, it is D(-)-α-amino-p- wounds, abscesses, and cellulitis/dermatitis due penicillin trihydrate. to determine susceptibility of the organisms to Clavamox. Following determination of susceptibility hydroxybenzyl penicillin trihydrate. to susceptible strains of the following organisms: Clavulanic acid, an inhibitor of β-lactamase -lactamase-producing Staphylococcus aureus, results and clinical response to medication, therapy Clavulanic acid, an inhibitor of β-lactamase β enzymes, is produced by the fermentation of may be reevaluated. enzymes, is produced by the fermentation of non- β-lactamase-producing Staphylococcus Streptomyces clavuligerus. Clavulanic acid by itself Streptomyces clavuligerus. Clavulanic acid by itself aureus, Staphylococcus spp., Streptococcus spp., has only weak antibacterial activity. Chemically, CONTRAINDICATIONS: The use of this drug is has only weak antibacterial activity. Chemically, E. coli, Pasteurella multocida, and Pasteurella spp. clavulanate potassium is potassium z-(3R,5R)-2-β- contraindicated in animals with a history of an allergic clavulanate potassium is potassium z-(3R,5R)-2-β- Urinary tract infections (cystitis) due to susceptible hydroxyethylidene clavam-3-carboxylate. reaction to any of the penicillins or cephalosporins. hydroxyethylidene clavam-3-carboxylate. strains of E. coli. ACTIONS: Clavamox is stable in the presence of WARNINGS: Safety of use in pregnant or breeding gastric acid and is not significantly influenced by animals has not been determined. Store in a dry, cool CLINICAL PHARMACOLOGY: Clavamox is stable in Therapy may be initiated with Clavamox prior gastric or intestinal contents. The 2 components place at temperatures not above 25°C (77°F). the presence of gastric acid and is not significantly to obtaining results from bacteriological and are rapidly absorbed resulting in amoxicillin and Do not remove from foil strip until ready to use. influenced by gastric or intestinal contents. The susceptibility studies. 2 components are rapidly absorbed resulting in clavulanic acid concentrations in serum, urine, and ADVERSE REACTIONS: Clavamox contains a A culture should be obtained prior to treatment amoxicillin and clavulanic acid concentrations in tissues similar to those produced when each is semisynthetic penicillin (amoxicillin) and has the to determine susceptibility of the organisms to serum, urine, and tissues similar to those produced administered alone. potential for producing allergic reactions. If an allergic Clavamox. Following determination of susceptibility when each is administered alone. Amoxicillin and clavulanic acid diffuse readily into reaction occurs, administer epinephrine and/or results and clinical response to medication, therapy most body tissues and fluids with the exception of steroids. Amoxicillin and clavulanic acid diffuse readily into may be reevaluated. DOSAGE AND ADMINISTRATION: most body tissues and fluids with the exception of brain and spinal fluid, which amoxicillin penetrates CONTRAINDICATIONS: The use of this drug is Dogs: The recommended dosage is 6.25 mg/lb of body brain and spinal fluid, which amoxicillin penetrates adequately when meninges are inflamed. Most of contraindicated in animals with a history of an weight twice a day. adequately when meninges are inflamed. Most of the amoxicillin is excreted unchanged in the urine. allergic reaction to any of the penicillins or Skin and soft tissue infections such as abscesses, the amoxicillin is excreted unchanged in the urine. Clavulanic acid’s penetration into spinal fluid is cephalosporins. unknown at this time. Approximately 15% of the cellulitis, wounds, superficial/juvenile pyoderma, and Clavulanic acid’s penetration into spinal fluid is administered dose of clavulanic acid is excreted in the periodontal infections should be treated for 5–7 days unknown at this time. Approximately 15% of the WARNINGS: Safety of use in pregnant or breeding urine within the first 6 hours. or for 48 hours after all symptoms have subsided. If administered dose of clavulanic acid is excreted in animals has not been determined. For use in dogs the urine within the first 6 hours. and cats only. Clavamox combines the distinctive properties of a no response is seen after 5 days of treatment, therapy should be discontinued and the case reevaluated. broad-spectrum antibiotic and a β-lactamase inhibitor Clavamox combines the distinctive properties of ADVERSE REACTIONS: Clavamox contains a Deep pyoderma may require treatment for 21 days; to effectively extend the antibacterial spectrum of a broad-spectrum antibiotic and a β-lactamase semisynthetic penicillin (amoxicillin) and has the the maximum duration of treatment should not exceed amoxicillin to include β-lactamase producing as well inhibitor to effectively extend the antibacterial potential for producing allergic reactions. 30 days. as non-β-lactamase-producing aerobic and anaerobic spectrum of amoxicillin to include β-lactamase- If an allergic reaction occurs, administer organisms. Cats: The recommended dosage is 62.5 mg twice a day. producing as well as non-β-lactamase-producing Skin and soft tissue infections such as abscesses and epinephrine and/or steroids. MICROBIOLOGY: Amoxicillin is bactericidal in action aerobic and anaerobic organisms. cellulitis/ dermatitis should be treated for 5–7 days or and acts through the inhibition of biosynthesis of DOSAGE AND ADMINISTRATION: for 48 hours after all symptoms have subsided, not to Microbiology: Amoxicillin is bactericidal in action cell wall mucopeptide of susceptible organisms. The Dogs: The recommended dosage is 6.25 mg/lb exceed 30 days. If no response is seen after 3 days and acts through the inhibition of biosynthesis of action of clavulanic acid extends the antimicrobial (1 mL/10 lb) of body weight twice a day. Skin of treatment, therapy should be discontinued and the cell wall mucopeptide of susceptible organisms. spectrum of amoxicillin to include organisms and soft tissue infections such as abscesses, case reevaluated. The action of clavulanic acid extends the resistant to amoxicillin and other β-lactam antibiotics. cellulitis, wounds, superficial/juvenile pyoderma, Urinary tract infections may require treatment for antimicrobial spectrum of amoxicillin to include Amoxicillin/ clavulanate has been shown to have a and periodontal infections should be treated for 10–14 days or longer. The maximum duration of organisms resistant to amoxicillin and other wide range of activity which includes β-lactamase- 5–7 days or for 48 hours after all symptoms have treatment should not exceed 30 days. β-lactam antibiotics. producing strains of both gram positive and gram- subsided. If no response is seen after 5 days of negative aerobes, facultative anaerobes, and obligate HOW SUPPLIED: Clavamox Tablets in the following Amoxicillin/clavulanate has been shown to have a treatment, therapy should be discontinued and anaerobes. Many strains of the following organisms, strengths are supplied in strip packs. Each carton wide range of activity which includes β-lactamase the case reevaluated. Deep pyoderma may require including β-lactamase-producing strains, isolated holds 15 strips with 14 tablets per strip (210 tablets producing strains of both gram-positive and treatment for 21 days; the maximum duration of from veterinary sources, were found to be susceptible per carton). gram-negative aerobes, facultative anaerobes, and treatment should not exceed 30 days. obligate anaerobes. Many strains of the following to amoxicillin/clavulanate in vitro but the clinical Each 62.5-mg tablet contains amoxicillin trihydrate Cats: The recommended dosage is 62.5 mg (1 mL) organisms, including β-lactamase-producing significance of this activity has not been demonstrated equivalent to 50 mg of amoxicillin activity and 12.5 mg twice a day. Skin and soft tissue infections such strains, isolated from veterinary sources, were for some of these organisms in animals. of clavulanic acid as the potassium salt. For use in as abscesses and cellulitis/dermatitis should be dogs and cats. found to be susceptible to amoxicillin/clavulanate Aerobic bacteria, including Staphylococcus treated for 5–7 days or 48 hours after all symptoms Each 125-mg tablet contains amoxicillin trihydrate in vitro but the clinical significance of this activity aureus*, β-lactamase- producing Staphylococcus have subsided, not to exceed 30 days. If no equivalent to 100 mg of amoxicillin activity and 25 mg has not been demonstrated for some of these aureus* (penicillin resistant), Staphylococcus response is seen after 3 days of treatment, therapy of clavulanic acid as the potassium salt. For use in organisms in animals. Aerobic bacteria, including species*, Staphylococcus epidermidis, should be discontinued and the case reevaluated. dogs only. Staphylococcus aureus*, β-lactamase-producing Staphylococcus intermedius, Streptococcus Each 250-mg tablet contains amoxicillin trihydrate Staphylococcus aureus* (penicillin resistant), Urinary tract infections may require treatment for faecalis, Streptococcus species*, Corynebacterium equivalent to 200 mg of amoxicillin activity and 50 mg Staphylococcus species*, Staphylococcus 10–14 days or longer. The maximum duration of pyogenes, Corynebacterium species, Erysipelothrix of clavulanic acid as the potassium salt. For use in epidermidis, Staphylococcus intermedius, treatment should not exceed 30 days. rhusiopathiae, Bordetella bronchiseptica, Escherichia Streptococcus faecalis, Streptococcus species*, dogs only. Reconstitution instructions - Oral Suspension: coli*, Proteus mirabilis, Proteus species, Enterobacter Corynebacterium pyogenes, Corynebacterium Each 375-mg tablet contains amoxicillin trihydrate Add 14 mL of water to the 15-mL bottle and shake species, Klebsiella pneumoniae, Salmonella dublin, species, Erysipelothrix rhusiopathiae, Bordetella equivalent to 300 mg of amoxicillin activity and 75 mg vigorously. Each mL of suspension will contain Salmonella typhimurium, Pasteurella multocida, bronchiseptica, Escherichia coli*, Proteus mirabilis, of clavulanic acid as the potassium salt. For use in 50 mg of amoxicillin activity as the trihydrate and Pasteurella haemolytica, Pasteurella species*. Proteus species, Enterobacter species, Klebsiella dogs only. 12.5 mg of clavulanic acid activity as the potassium * The susceptibility of these organisms has also been pneumoniae, Salmonella dublin, Salmonella Dispense according to recommendations outlined in salt. demonstrated in in vivo studies. Dosage and Administration section. typhimurium, Pasteurella multocida*, Pasteurella Studies have demonstrated that both aerobic and haemolytica, Pasteurella species*. Note: Any unused portion of the reconstituted NADA #55-099, Approved by FDA suspension must be discarded after 10 days. anaerobic flora are isolated from gingival cultures * The susceptibility of these organisms has also of dogs with clinical evidence of peridontal disease. Clavamox is a trademark owned by and used under license Refrigeration of the reconstituted suspension is from GlaxoSmithKline. been demonstrated in in vivo studies. Both gram-positive and gram-negative aerobic and required. Augmentin is a trademark owned by GlaxoSmithKline. Studies have demonstrated that both aerobic and anaerobic subgingival isolates indicate sensitivity HOW SUPPLIED: Clavamox Drops aresupplied in anaerobic flora are isolated from gingival cultures to amoxicillin/ clavulanic acid during antimicrobial 15-mL bottles containing 50 mg of amoxicillin/12.5 mg of dogs with clinical evidence of periodontal susceptibility testing. of clavulanic acid per mL. SUSCEPTIBILITY TEST: The recommended quantitative disease. Both gram-positive and gram-negative disc susceptibility method (FEDERAL REGISTER aerobic and anaerobic subgingival isolates indicate NADA #55-101, Approved by FDA sensitivity to amoxicillin/clavulanic acid during 37:20527–29; Bauer AW, Kirby WMM, Sherris JC, et al: Distributed by: Clavamox is a trademark owned by and used under license antimicrobial susceptibility testing. from GlaxoSmithKline. Antibiotic susceptibility testing by standardized single Zoetis Inc. disc method. Am J Clin Path 45:493, 1966) utilized Kalamazoo, MI 49007 Susceptibility test: The recommended quantitative Augmentin is a trademark owned by GlaxoSmithKline. 30 mcg Augmentin® (AMC) discs for estimating the disc susceptibility method (FEDERAL REGISTER susceptibility of bacteria to Clavamox Tablets. 37:20527–29; Bauer AW, Kirby WMM, Sherris MADE IN INDIA INDICATIONS: Clavamox Tablets are indicated in the JC, et al: Antibiotic susceptibility testing by Distributed by: treatment of: Dogs: Skin and soft tissue infections standardized single disc method. Am J Clin Path Zoetis Inc. such as wounds, abscesses, cellulitis, superficial/ 45:493, 1966) utilized 30 mcg Augmentin® (AMC) Kalamazoo, MI 49007 juvenile and deep pyoderma due to susceptible strains discs for estimating the susceptibility of bacteria to F000007869PI1 F000007875PI1 of the following organisms: -lactamase-producing Clavamox Tablets and Drops. β Revised: April 2013 Revised:January 2013 Staphylococcus aureus, non- -lactamase-producing β MADE IN INDIA MADE IN INDIA Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and E. coli. P1506890A&P P1506643A&P