Amoxicillin And Clavulanate Potassium Tablets

WARNINGS: Safety of use in pregnant or breeding animals has not been determined. Store at controlled room temperature, 68-77°F (20-25°C).

Do not remove from foil strip until ready to use.

Keep Amoxicillin and Clavulanate Potassium Tablets in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

INDICATIONS: Amoxicillin and Clavulanate Potassium Tablets are indicated in 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 organisms: β-lactamase-producing Staphylococcus aureus, non-β-lactamase-producing Staphylococcus  aureus, Staphylococcus spp., Streptococcus spp., and E. coli.

Periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria. Amoxicillin and clavulanate potassium tablets have been shown to be clinically effective for treating cases of canine periodontal disease.

Cats: Skin and soft tissue infections such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: 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 Amoxicillin and Clavulanate Potassium Tablets prior to obtaining results from bacteriological and susceptibility studies. A culture should be obtained prior to treatment to determine susceptibility of the organisms to Amoxicillin and Clavulanate Potassium Tablets. Following determination of susceptibility results and clinical response to medication, therapy may be reevaluated.

HOW SUPPLIED: Amoxicillin and Clavulanate Potassium Tablets in the following strengths are supplied in strip packs. Each strip contains 14 tablets. Cartons with 5 strips (70 tablets per carton) and 15 strips (210 tablets per carton) are available.

Each 62.5-mg tablet contains amoxicillin trihydrate equivalent to 50 mg of amoxicillin activity and 12.5 mg of clavulanic acid as the potassium salt.

For use in dogs and cats.

Each 125-mg tablet contains amoxicillin trihydrate equivalent to 100 mg of amoxicillin activity and 25 mg of clavulanic acid as the potassium salt.

For use in dogs only.

Each 250-mg tablet contains amoxicillin trihydrate equivalent to 200 mg of amoxicillin activity and 50 mg of clavulanic acid as the potassium salt.

For use in dogs only.

Each 375-mg tablet contains amoxicillin trihydrate equivalent to 300 mg of amoxicillin activity and 75 mg of clavulanic acid as the potassium salt.

For use in dogs only.

Dispense according to recommendations outlined in Dosage and Administration section.

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

DESCRIPTION: Amoxicillin and Clavulanate Potassium Tablets are 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).

Amoxicillin trihydrate is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative, aerobic and anaerobic microorganisms. It does not resist destruction by β-lactamases; therefore, it is not effective against β-lactamase-producing

bacteria. Chemically, it is D(-)-α-amino-p-hydroxybenzyl penicillin trihydrate.

Clavulanic acid, an inhibitor of β-lactamase enzymes, is produced by the fermentation of Streptomyces clavuligerus. Clavulanic acid by itself has only weak antibacterial activity. Chemically, clavulanate potassium is potassium z-(3R,5R)-2-β-hydroxyethylidene clavam-3-carboxylate.

ADVERSE REACTIONS: Amoxicillin and Clavulanate Potassium Tablets contain a semisynthetic penicillin (amoxicillin) and has the potential for

producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids.

Post-Approval Experience (July, 2017):

The following adverse events are based on the post-approval adverse drug experience reporting. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a casual relationship to product exposure using these data.

The following adverse events reported for dogs and cats are listed in decreasing order of reporting frequency for amoxicillin and clavulanate potassium tablets: Anorexia, lethargy, vomiting and diarrhea.

To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Cronus Pharma LLC at 1-844-227- 6687 (1-844-2-CRONUS). For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For use in dogs and cats

MICROBIOLOGY: Amoxicillin is bactericidal in action and acts through the inhibition of biosynthesis of cell wall mucopeptide of susceptible organisms. The action of clavulanic acid extends the antimicrobial spectrum of amoxicillin to include organisms resistant to amoxicillin and other β-lactam antibiotics. Amoxicillin/clavulanate has been shown to have a wide range of activity which includes β-lactamaseproducing strains of both gram-positive and gram-negative aerobes, facultative anaerobes, and obligate anaerobes. Many strains of the following organisms, 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 organisms in animals.

Aerobic bacteria, including Staphylococcus aureus¹ , β-lactamase producing Staphylococcus aureus¹ (penicillin resistant), Staphylococcus species¹ , Staphylococcus epidermidis, Staphylococcus intermedius, Streptococcus faecalis, Streptococcus species¹ , Corynebacterium pyogenes, Corynebacterium species, Erysipelothrix rhusiopathiae, Bordetella bronchiseptica, Escherichia coli¹ , Proteus mirabilis, Proteus species, Enterobacter species, Klebsiella pneumoniae, Salmonella dublin, Salmonella typhimurium, Pasteurella multocida, Pasteurella haemolytica, Pasteurella species¹

¹The susceptibility of these 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 peridontal 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® (AMC) discs for estimating the susceptibility of bacteria to amoxicillin and clavulanate potassium tablets.

Dogs: The recommended dosage is 6.25 mg/lb of body weight twice a day.

Skin and soft tissue infections such as abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and periodontal infections should be treated for 5-7 days or for 48 hours after all symptoms 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; the maximum duration of treatment should not exceed 30 days.

Cats: The recommended dosage is 62.5 mg twice a day Skin and soft tissue infections such as abscesses and cellulitis/dermatitis should be treated for 5-7 days or for 48 hours after all symptoms have subsided, not to exceed 30 days. 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 10-14 days or longer. The maximum duration of treatment should not exceed 30 days.

NDC 69043-020-21

Amoxicillin and Clavulanate Potassium Tablets

62.5 mg

Veterinary Tablets

For use in dogs and cats

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Each film-coated tablet contains amoxicillin trihydrate equivalent to 50 mg of amoxicillin USP activity and 12.5 mg of clavulanic acid USP as the potassium salt

Approved by FDA under ANADA # 200-702

15 strips 14 tablets each

210 tablets

INDICATIONS: Amoxicillin and Clavulanate Potassium Tablets are indicated in 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 organisms: β-lactamase-producing Staphylococcus aureus, non-β-lactamase-producing Staphylococcus  aureus, Staphylococcus spp., Streptococcus spp., and E. coli.

Periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria. Amoxicillin and clavulanate potassium tablets have been shown to be clinically effective for treating cases of canine periodontal disease.

Cats: Skin and soft tissue infections such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: 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 Amoxicillin and Clavulanate Potassium Tablets prior to obtaining results from bacteriological and susceptibility studies. A culture should be obtained prior to treatment to determine susceptibility of the organisms to Amoxicillin and Clavulanate Potassium Tablets. Following determination of susceptibility results and clinical response to medication, therapy may be reevaluated.

HOW SUPPLIED: Amoxicillin and Clavulanate Potassium Tablets in the following strengths are supplied in strip packs. Each strip contains 14 tablets. Cartons with 5 strips (70 tablets per carton) and 15 strips (210 tablets per carton) are available.

Each 62.5-mg tablet contains amoxicillin trihydrate equivalent to 50 mg of amoxicillin activity and 12.5 mg of clavulanic acid as the potassium salt.

For use in dogs and cats.

Each 125-mg tablet contains amoxicillin trihydrate equivalent to 100 mg of amoxicillin activity and 25 mg of clavulanic acid as the potassium salt.

For use in dogs only.

Each 250-mg tablet contains amoxicillin trihydrate equivalent to 200 mg of amoxicillin activity and 50 mg of clavulanic acid as the potassium salt.

For use in dogs only.

Each 375-mg tablet contains amoxicillin trihydrate equivalent to 300 mg of amoxicillin activity and 75 mg of clavulanic acid as the potassium salt.

For use in dogs only.

Dispense according to recommendations outlined in Dosage and Administration section.

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

WARNINGS: Safety of use in pregnant or breeding animals has not been determined. Store at controlled room temperature, 68-77°F (20-25°C).

Do not remove from foil strip until ready to use.

Keep Amoxicillin and Clavulanate Potassium Tablets in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

ADVERSE REACTIONS: Amoxicillin and Clavulanate Potassium Tablets contain a semisynthetic penicillin (amoxicillin) and has the potential for

producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids.

Post-Approval Experience (July, 2017):

The following adverse events are based on the post-approval adverse drug experience reporting. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a casual relationship to product exposure using these data.

The following adverse events reported for dogs and cats are listed in decreasing order of reporting frequency for amoxicillin and clavulanate potassium tablets: Anorexia, lethargy, vomiting and diarrhea.

To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Cronus Pharma LLC at 1-844-227- 6687 (1-844-2-CRONUS). For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

DESCRIPTION: Amoxicillin and Clavulanate Potassium Tablets are 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).

Amoxicillin trihydrate is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative, aerobic and anaerobic microorganisms. It does not resist destruction by β-lactamases; therefore, it is not effective against β-lactamase-producing

bacteria. Chemically, it is D(-)-α-amino-p-hydroxybenzyl penicillin trihydrate.

Clavulanic acid, an inhibitor of β-lactamase enzymes, is produced by the fermentation of Streptomyces clavuligerus. Clavulanic acid by itself has only weak antibacterial activity. Chemically, clavulanate potassium is potassium z-(3R,5R)-2-β-hydroxyethylidene clavam-3-carboxylate.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For use in dogs and cats

MICROBIOLOGY: Amoxicillin is bactericidal in action and acts through the inhibition of biosynthesis of cell wall mucopeptide of susceptible organisms. The action of clavulanic acid extends the antimicrobial spectrum of amoxicillin to include organisms resistant to amoxicillin and other β-lactam antibiotics. Amoxicillin/clavulanate has been shown to have a wide range of activity which includes β-lactamaseproducing strains of both gram-positive and gram-negative aerobes, facultative anaerobes, and obligate anaerobes. Many strains of the following organisms, 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 organisms in animals.

Aerobic bacteria, including Staphylococcus aureus¹ , β-lactamase producing Staphylococcus aureus¹ (penicillin resistant), Staphylococcus species¹ , Staphylococcus epidermidis, Staphylococcus intermedius, Streptococcus faecalis, Streptococcus species¹ , Corynebacterium pyogenes, Corynebacterium species, Erysipelothrix rhusiopathiae, Bordetella bronchiseptica, Escherichia coli¹ , Proteus mirabilis, Proteus species, Enterobacter species, Klebsiella pneumoniae, Salmonella dublin, Salmonella typhimurium, Pasteurella multocida, Pasteurella haemolytica, Pasteurella species¹

¹The susceptibility of these 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 peridontal 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® (AMC) discs for estimating the susceptibility of bacteria to amoxicillin and clavulanate potassium tablets.

Dogs: The recommended dosage is 6.25 mg/lb of body weight twice a day.

Skin and soft tissue infections such as abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and periodontal infections should be treated for 5-7 days or for 48 hours after all symptoms 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; the maximum duration of treatment should not exceed 30 days.

Cats: The recommended dosage is 62.5 mg twice a day Skin and soft tissue infections such as abscesses and cellulitis/dermatitis should be treated for 5-7 days or for 48 hours after all symptoms have subsided, not to exceed 30 days. 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 10-14 days or longer. The maximum duration of treatment should not exceed 30 days.

NDC 69043-020-21

Amoxicillin and Clavulanate Potassium Tablets

62.5 mg

Veterinary Tablets

For use in dogs and cats

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Each film-coated tablet contains amoxicillin trihydrate equivalent to 50 mg of amoxicillin USP activity and 12.5 mg of clavulanic acid USP as the potassium salt

Approved by FDA under ANADA # 200-702

15 strips 14 tablets each

210 tablets