Amoxicillin and clavulanic acid

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This page reprints a manufacturer label. Everything below in quotation marks is copied from Clavacillin ® (amoxicillin and clavulanate potassium for oral suspension), USP, published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.

This page reprints the FDA label for Clavacillin ® (amoxicillin and clavulanate potassium for oral suspension), USP by Dechra Veterinary Products, LLC, a amoxicillin and clavulanic acid product labelled for dogs and cats. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed. 8 other stored labels carry the same active ingredient and are listed at the end.

The label

Product: Clavacillin ® (amoxicillin and clavulanate potassium for oral suspension), USP. Manufacturer: Dechra Veterinary Products, LLC. FDA Structured Product Label set id 013fccfc-463c-423f-be2a-cb259dae7e76. Label effective 2026-04-03. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

Clavacillin Drops 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. Clavacillin ® 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: β-lactamase-producing Staphylococcus aureus , non-β-lactamase-producing Staphylococcus aureus , Staphylococcus spp., Streptococcus spp., E. coli , Pasteurella multocida , 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.

Dosage and Administration

Dogs: The recommended dosage is 6.25 mg/lb (1 mL/10 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 (1 mL) twice a day. Skin and soft tissue infections such as abscesses and cellulitis/dermatitis should be treated for 5-7 days or 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. Reconstitution Instructions - Oral Suspension: Add 14 mL of water to the 15-mL bottle and shake vigorously. To dose, push the plastic adapter into the neck of the bottle, insert the dosing syringe into the adapter, invert the bottle then slowly pull back the plunger to prescribed dose. The bottle cap fits over the plastic adapter for storage. Each mL of suspension will contain 50 mg of amoxicillin activity as the trihydrate and 12.5 mg of clavulanic acid activity as the potassium salt. Note: Any unused portion of the reconstituted suspension must be discarded after 10 days. Refrigeration of the reconstituted suspension is required. Shake well before use. Store dry powder at controlled room temperature, 68-77°F (20-25°C).

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. For use in dogs and cats only.

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 drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet, contact Dechra Veterinary Products 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/reportanimalae

Description

Clavacillin (amoxicillin and clavulanate potassium for oral suspension), USP 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). 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.

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming amoxicillin and clavulanic acid as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.

Dogs: 629 reports

Reactions most often coded in dogs, 629 reports
VeDDRA reaction termReports
Vomiting133
Other abnormal test result NOS98
Lethargy (see also Central nervous system depression in 'Neurological')71
Diarrhoea69
Lethargy (see also Central nervous system depression in Neurological)69
Death by euthanasia67
Decreased appetite65
Elevated alanine aminotransferase (ALT)65
Anorexia62
Leucocytosis NOS58
Not eating54
Fever53
Urinary tract infection51
Neutrophilia49
Behavioural disorder NOS48

Outcome as recorded by the reporter: Ongoing 202; Outcome Unknown 199; Recovered/Normal 119; Euthanized 65; Died 40; Recovered with Sequela 5.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Cats: 272 reports

Reactions most often coded in cats, 272 reports
VeDDRA reaction termReports
Vomiting38
Anorexia35
Death by euthanasia34
Diarrhoea34
Weight loss33
Behavioural disorder NOS31
Not eating31
Hyperglycaemia28
Ketosis27
Other abnormal test result NOS27
Lethargy (see also Central nervous system depression in Neurological)26
Lethargy (see also Central nervous system depression in 'Neurological')24
Decreased appetite23
Dehydration20
Elevated blood urea nitrogen (BUN)20

Outcome as recorded by the reporter: Outcome Unknown 94; Ongoing 82; Recovered/Normal 50; Euthanized 31; Died 15; Recovered with Sequela 1.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Sources

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