Cefpoderm: Product Information

CEFPODERM- cefpodoxime proxetil tablet
Dechra Veterinary Products LLC

For Oral Use in Dogs Only

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

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, 72 -(Z)-(0-methyloxime), isopropyl carbonate (ester) [87239-81-4].

Cefpodoxime Proxetil Chemical Structure:

Chemical Structure
(click image for full-size original)

Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of Cefpoderm (cefpodoxime proxetil) tablets are expressed in terms of the active cefpodoxime moiety. Cefpoderm is available as:

100 mg Tablet , each yellow, elliptical, scored tablet contains cefpodoxime proxetil equivalent to 100 mg of cefpodoxime.

200 mg Tablet , each orange, oblong, tablet contains cefpodoxime proxetil equivalent to 200 mg of cefpodoxime.

INDICATION:

Cefpoderm is 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 Cefpoderm (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: Cefpoderm 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 Cefpoderm at 5 mg/kg (Table 1) and 10 mg/kg (Table 2).

Table 1. Dose Table for Cefpoderm 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 Cefpoderm 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 and pets. 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 (n=118) Active Control (n=98)
*
Dogs may have experienced more than one of the observations during the study.
Vomiting 2 4
Diarrhea 1 1
Increased water drinking 0 2
Decreased appetite 1 1

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

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