Cefpodoxime

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This page reprints a manufacturer label. Everything below in quotation marks is copied from Cefpodoxime Proxetil Tablets For Oral Use In Dogs Only, 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 Cefpodoxime Proxetil Tablets For Oral Use In Dogs Only by BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA, a cefpodoxime product labelled for dogs. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed. 4 other stored labels carry the same active ingredient and are listed at the end.

The label

Product: Cefpodoxime Proxetil Tablets For Oral Use In Dogs Only. Manufacturer: BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA. FDA Structured Product Label set id 427a35b9-445b-432d-a100-ca4c86b97e18. Label effective 2025-08-11. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

Cefpodoxime Proxetil Tablets are indicated for the treatment of skin infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus pseudintermedius , Staphylococcus aureus , Streptococcus canis (group G, ß hemolytic), Escherichia coli , Pasteurella multocida , and Proteus mirabilis .

Dosage and Administration

Dose range The dose range of Cefpodoxime Proxetil Tablets is 5-10 mg/kg (2.3-4.5 mg/lb) body weight, administered orally, once a day. The dose may be given with or without food. The determination of dosage for any particular patient must take into consideration such factors as the severity and nature of the infection, the susceptibility of the causative organisms, and the integrity of the patient's host-defense mechanisms. Obtain a sample of the pathogenic organism for culture and sensitivity testing prior to beginning antimicrobial therapy. Once results become available, continue with appropriate therapy. Duration Cefpodoxime Proxetil Tablets should be administered once daily for 5-7 days or for 2-3 days beyond the cessation of clinical signs, up to a maximum of 28 days. Treatment of acute infections should not be continued for more than 3-4 days if no response to therapy is seen. Dosing Charts For daily oral administration of Cefpodoxime Proxetil Tablets at 5 mg/kg (Table 1) and 10 mg/kg (Table 2). Table 1. Dose Table for Cefpodoxime Proxetil Tablets at 5 mg/kg Total Daily Dosage Weight of Dog (lbs) Daily Dose 22 44 66 88 132 No. of 100 mg tablets 0.5 1 1.5 1 No. of 200 mg tablets 1 1 Weight of Dog (kgs) Daily Dose 10 20 30 40 60 No. of 100 mg tablets 0.5 1 1.5 1 No. of 200 mg tablets 1 1 Table 2. Dose Table for Cefpodoxime Proxetil Tablets at 10 mg/kg Total Daily Dosage Weight of Dog (lbs) Daily Dose 11 22 44 66 88 132 No. of 100 mg tablets 0.5 1 1 No. of 200 mg tablets 1 1 2 3 Weight of Dog (kgs) Daily Dose 5 10 20 30 40 60 No. of 100 mg tablets 0.5 1 1 No. of 200 mg tablets 1 1 2 3

Contraindications

Cefpodoxime proxetil is contraindicated in dogs with known allergy to cefpodoxime or to the ß-lactam (penicillins and cephalosporins) group of antibiotics.

Warnings

Not for human use. Keep this and all drugs out of reach of children. Antimicrobial drugs, including penicillins and cephalosporins, can cause allergic reactions in sensitized individuals. To minimize the possibility of allergic reactions, those handling such antimicrobials, including cefpodoxime, are advised to avoid direct contact of the product with the skin and mucous membranes.

Precautions

The safety of cefpodoxime proxetil in dogs used for breeding, pregnant dogs, or lactating bitches has not been demonstrated. As with other cephalosporins, cefpodoxime proxetil may occasionally induce a positive direct Coombs' test.

Adverse Reactions

A total of 216 dogs of various breeds and ages ranging from 2 months to 15 years were included in the field study safety analysis. The following table shows the number of dogs displaying each clinical observation. Table 3. Abnormal Health Findings in the U.S. Field Study* Clinical Observation cefpodoxime proxetil tablets (n=118) Active Control (n=98) Vomiting 2 4 Diarrhea 1 1 Increased water drinking 0 2 Decreased appetite 1 1 *Dogs may have experienced more than one of the observations during the study.

Description

Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic cephalosporin antibiotic. The chemical name is: (+/-)-1-Hydroxyethyl(+)-(6R,7R)-7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 7 2 -(Z)- (O-methyloxime), isopropyl carbonate (ester) [87239-81-4]. Cefpodoxime proxetil Chemical Structure: Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of Cefpodoxime Proxetil Tablets are expressed in terms of the active cefpodoxime moiety. Cefpodoxime Proxetil Tablets are available as: 100 mg Tablet, each red-colored, oval-shaped, film-coated, scored tablet contains cefpodoxime proxetil equivalent to 100 mg of cefpodoxime. 200 mg Tablet, each orange-colored, oblong-shaped, film-coated, scored tablet contains cefpodoxime proxetil equivalent to 200 mg of cefpodoxime. structure

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (between 59° and 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container. Replace cap securely after each opening.

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 cefpodoxime 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: 3,982 reports

Reactions most often coded in dogs, 3,982 reports
VeDDRA reaction termReports
Vomiting703
Lethargy (see also Central nervous system depression in 'Neurological')444
Anorexia371
Diarrhoea314
Lack of efficacy - NOS307
Other abnormal test result NOS257
Emesis252
Elevated alanine aminotransferase (ALT)248
Death by euthanasia228
Seizure NOS214
Elevated serum alkaline phosphatase (SAP)196
Death177
Pruritus173
Polydipsia168
Depression166

Outcome as recorded by the reporter: Ongoing 1,460; Recovered/Normal 881; Outcome Unknown 606; Died 241; Euthanized 177; Recovered with Sequela 44.

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

Sources

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