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Clavacillin (Amoxicillin/Clavulanate Potassium) Veterinary Tablets

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Description

Clavacillin (amoxicillin trihydrate/clavulanate potassium) is an orally administered formulation comprised of the broad-spectrum antibiotic amoxicillin trihydrate and the ß-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 ß-lactamases; therefore, it is not effective against ß-lactamase-producing bacteria. Chemically, it is D(-)-?-amino-p-hydroxybenzyl penicillin trihydrate.

Clavulanic acid, an inhibitor of ?-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-ß-hydroxyethylidene clavam-3-carboxylate.

Key Benefits

  • Broad-spectrum antibiotic that treats a wide array of bacterial infections
  • Treats soft tissue infections such as wounds, abscesses, cellulitis, and superficial and deep pyoderma
  • Also used to treat canine periodontal disease

How it works

Clavacillin Trihydrate and Clavulanate Potassium Tablets work by inhibiting the formation of bacterial cell walls. It treats a wide array of bacterial infections, including soft tissue infections such as wounds, abscesses, cellulitis, and superficial and deep pyoderma. It may also be used in the treatment of periodontal disease in dogs.

Indications:

Clavacillin 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: ß-lactamase-producing Staphylococcus aureus, non-ß-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and E. coli.

Periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria. Amoxicillin trihydrate/clavulanate potassium has 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: ß-lactamase-producing Staphylococcus aureus, non-ß-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcusspp., E. coli, and Pasteurella spp. Urinary tract infections (cystitis) due to susceptible strains of E. coli.

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

Ingredients

Clavacillin Trihydrate and Clavulanate Potassium 62.5 mg Tablet
Active Ingredient Amount
Amoxicillin Trihydrate equivalent of amoxicillin activity 50 mg
Clavulanic Acid as the potassium salt 12.5 mg
Clavacillin Trihydrate and Clavulanate Potassium 125 mg Tablet
Active Ingredient Amount
Amoxicillin Trihydrate equivalent of amoxicillin activity 100 mg
Clavulanic Acid as the potassium salt 25 mg
Clavacillin Trihydrate and Clavulanate Potassium 250 mg Tablet
Active Ingredient Amount
Amoxicillin Trihydrate equivalent of amoxicillin activity 200 mg
Clavulanic Acid as the potassium salt 50 mg
Clavacillin Trihydrate and Clavulanate Potassium 375 mg Tablet
Active Ingredient Amount
Amoxicillin Trihydrate equivalent of amoxicillin activity 300 mg
Clavulanic Acid as the potassium salt 75 mg

Directions

View Clavacillin product label.

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.

Caution:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Actions:

Clavacillin is stable in the presence of gastric acid and is not significantly influenced by gastric or intestinal contents. The 2 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 6 hours.

Clavacillin combines the distinctive properties of a broad-spectrum antibiotic and a ß-lactamase inhibitor to effectively extend the antibacterial spectrum of amoxicillin to include ß-lactamase-producing as well as non-ß-lactamase-producing aerobic and anaerobic organisms.

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 ß-lactam antibiotics. Amoxicillin/clavulanate has been shown to have a wide range of activity which includes ß-lactamase-producing strains of both gram-positive and gram-negative aerobes, facultative anaerobes, and obligate anaerobes. Many strains of the following organisms, including ß-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, ß-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.

1 The 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 periodontal disease. Both gram-positive and gram-negative aerobic and anaerobic subgingival isolates indicate sensitivity to amoxicillin/clavulanic acid during antimicrobial susceptibility testing.

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.

Adverse Reactions:

Clavacillin contains a semisynthetic penicillin (amoxicillin) and has the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids. To report suspected adverse events, for technical assistance or to obtain a copy of the safety data sheet (SDS), contact Dechra at (866) 933-2472.For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or http://www.fda.gov/AnimalVeterinary/SafetyHealth

FAQ

Clavacillin Trihydrate and Clavulanate Potassium Tablets is a penicillin-like antibiotic that fights bacteria in the body. Clavacillin Trihydrate and Clavulanate Potassium Tablets can be used to treat infections such as ear infections, urinary tract infections, and skin infections. Clavacillin Trihydrate and Clavulanate Potassium Tablets may also be used for purposes other than those listed.

Clavacillin Trihydrate and Clavulanate Potassium Tablets is a prescription medication available as 62.5 mg tablets, 125 mg tablets, 250 mg tablets, and 375 mg tablets. The usual dose of Clavacillin Trihydrate and Clavulanate Potassium Tablets is 6.25 mg/lb of body weight twice a day for dogs, 62.5 mg twice a day for cats.

For dogs, 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 re-evaluated. Deep pyoderma may require treatment for 21 days; the maximum duration of treatment should not exceed 30 days.

For cats, 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 10-13 days or longer.

Tell your veterinarian if your pet has ever had an allergic reaction to another penicillin or to a cephalosporin. Also tell your veterinarian if your pet has any other allergies and if your pet has kidney, stomach or intestinal disease.
Give this medication exactly as directed by your veterinarian.
Clavacillin Trihydrate and Clavulanate Potassium Tablets contains a semisynthetic penicillin (amoxicillin) and has the potential for producing allergic reactions. If an allergic reaction occurs, contact your veterinarian immediately. The use of this drug is contraindicated in animals with a history of an allergic reaction to any of the penicillins or cephalosporins.
Consult your veterinarian.
Seek emergency veterinary medical treatment if an overdose is suspected. Symptoms of overdose may include muscle spasms or weakness, pain or twitching, seizures, confusion, coma, or agitation.
There are no restrictions on food or activity during treatment with Clavacillin Trihydrate and Clavulanate Potassium Tablets unless otherwise directed by your veterinarian.
Before giving Clavacillin Trihydrate and Clavulanate Potassium Tablets, tell your veterinarian if your pet is being given another antibiotic (for the same or a different infection), allopurinol, or probenecid. You may not be able to give Clavacillin Trihydrate and Clavulanate Potassium Tablets or you may need to have the dosage adjusted. Drugs other than those listed here may also interact with Clavacillin Trihydrate and Clavulanate Potassium Tablets. Talk to your veterinarian or pharmacist before giving any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

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