Simplicef: Product Information

SIMPLICEF- cefpodoxime proxetil tablet
Zoetis Inc.

SIMPLICEF®
(cefpodoxime proxetil tablets)

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)-(Omethyloxime), 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 SIMPLICEF (cefpodoxime proxetil) tablets are expressed in terms of the active cefpodoxime moiety. SIMPLICEF is available as:

100 mg Tablet, each reddish-orange, elliptical, scored tablet contains cefpodoxime proxetil equivalent to 100 mg of cefpodoxime.

200 mg Tablet, each light orange, round rectangle, scored tablet contains cefpodoxime proxetil equivalent to 200 mg of cefpodoxime.

INDICATION

SIMPLICEF tablets are indicated for the treatment of skin infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus canis (group G, β hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

DOSAGE AND ADMINISTRATION

Dose range

The dose range of SIMPLICEF (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

SIMPLICEF 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 SIMPLICEF at 5 mg/kg (Table 1) and 10 mg/kg (Table 2).

Table 1. Dose Table for SIMPLICEF 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 SIMPLICEF 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 β-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 SIMPLICEF(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 a suspected adverse reaction call 1-888-963-8471.

To request a safety data sheet (SDS) for SIMPLICEF tablets, call 1-888-963-8471.

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