SIMPLICEF™ (cefpodoxime proxetil) is the first and only once-daily oral cephalosporin
that’s FDA approved for veterinary use in the treatment of canine skin infections.
It’s designed to be convenient and a good value for your large dog.
For detailed dosing information download the following pdf: dosing_chart.pdf
Animal safety studies: well tolerated at up to 40x normal
daily oral dose.
|Ease of dosing.
||No more multiple capsules multiple times a day.
||Many large dogs can be treated with just one tablet.
||Film-coated tablets for easier administration.
||Doses can be given with or without food.
||100 mg scored tablets for greater flexibility.
||200 mg tablets.
||Available in bottles of 100.
In animal safety studies, SIMPLICEF™ (cefpodoxime proxetil) was well tolerated at
up to 40x the normal daily oral dose for 13 weeks in adult dogs and 28 days in puppies
(18-23 days of age).
Safety has been demonstrated in dogs for up to six months of daily therapy.
Contraindications and warnings are similar to other cephalosporins.1
118 dogs of various breeds and all ages were included in this
field study safety analysis.
SIMPLICEF™ (cefpodoxime proxetil) should not be used in dogs that are hypersensitive
or cephalosporin. Safety in pregnant and lactating animals or breeding male dogs
1Proprietary data on file. SIMPLICEF is a trademark of Pharmacia & Upjohn. ©2004 Pfizer Inc. All rights reserved
For Oral Use In Dogs Only
CAUTION: Federal (USA) law restricts this drug to use by or on the
order of a licensed veterinarian.
Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic
cephalosporin antibiotic. The chemical name is: (+/-)-1-Hydroxyethyl(+)-(6R,7R)-7-[2-(2-
2-ene-2-carboxylate, 72-(Z)-(O-methyloxime), isopropyl carbonate (ester)
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, elliptical tablet contains cefpodoxime
proxetil equivalent to 200 mg of cefpodoxime.
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, ß 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).
Cefpodoxime proxetil is contraindicated in dogs
with known allergy to cefpodoxime or to the ß-lactam (penicillins and cephalosporins)
group of antibiotics.
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.
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.
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.
Dogs may have experienced more than one of the observations during
To report a suspected adverse reaction call 1-800-366-5288.
To request a material safety data sheet (MSDS) for SIMPLICEF tablets, call 1-800-733-5500.
Pharmacokinetics/Pharmacodynamics: Cefpodoxime proxetil is a prodrug that is absorbed
from and de-esterified in the gastrointestinal tract to its active metabolite, cefpodoxime.
Following oral administration to fasting Beagles, oral bioavailability was 63.1
Cefpodoxime is distributed in the body with an apparent volume of distribution of
151 ± 27 mL/kg. Like other ß-lactam antibiotics, cefpodoxime is eliminated from
the body primarily in the urine, with an apparent elimination half-life of approximately
5-6 hours after oral administration. This is similar to the 4.7 hour apparent elimination
half-life observed after intravenous dosing. Following intravenous administration
of 10 mg/kg, the average total body clearance (ClB) was 22.7 ± 4.19 mL/hr/kg.
Microbiology: Like other ß-lactam antibiotics, cefpodoxime exerts its inhibitory
effect by interfering with bacterial cell wall synthesis. This interference is primarily
due to its covalently binding to the penicillin-binding proteins (PBPs) (i.e. transpeptidase
and/or carboxypeptidase), which are essential for synthesis of the
bacterial cell wall. Therefore, cefpodoxime is bactericidal. Cefpodoxime is stable
in the presence of many common ß-lactamase enzymes. As a result, many organisms
resistant to other ß-lactam antibiotics (penicillins and some cephalosporins) due
to the production of ß-lactamases may be susceptible to cefpodoxime.
Cefpodoxime has a broad spectrum of clinically useful antibacterial activity that
includes staphylococci, streptococci, and Gram-negative species (including Pasteurella,
, and Proteus
). The compound is not active against
most obligate anaerobes, Pseudomonas
spp., or enterococci. The minimum
concentrations (MICs) for cefpodoxime against Gram-positive and Gram-negative pathogens
isolated from canine skin infections (wounds and abscesses) in a 2002 U.S. field
study are presented in Table 5. All MICs were determined in accordance with the
National Committee for Clinical Laboratory Standards (NCCLS). Appropriate quality
control (QC) ranges for in vitro
susceptibility testing are presented in
† No Range, all isolates yielded the same value.
* Veterinary specific interpretive criteria have not been established for the above
listed canine pathogens by the NCCLS at this time.
a These ranges are for quality control strains used to monitor accuracy
of minimum inhibitory concentrations (MICs) of non-fastidious organisms using cation-adjusted
Mueller-Hinton agar or broth medium. The dilution range should encompass the QC
ranges of these strains in the broth micro-dilution method.
b These ranges are for quality control strains used to monitor accuracy
of minimum inhibitory concentrations (MICs) of fastidious organisms. When susceptibility
testing is performed for Streptococcus canis (group G, ß hemolytic), Streptococcus
pneumoniae ATCC 49619 should be included as a QC strain in the presence
of 5% lysed sheep blood (KB disk diffusion method) or 2.5% lysed horse blood (broth
The clinical effectiveness of SIMPLICEF (cefpodoxime proxetil) was established in
a multi-location (23 site) field study. In this study, 216 dogs with infected wounds
or abscesses were treated with either SIMPLICEF (n=118) once daily at 5 mg/kg (2.3
mg/lb) body weight or with an active control antibiotic (n=98) administered twice
daily for 5-7 days. In this study, SIMPLICEF was considered noninferior to the active
control (88.7% versus 88.4% respectfully) in the treatment of canine skin infections
(wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius,
Staphylococcus aureus, Streptococcus canis
(group G, ß hemolytic), Escherichia
coli, Pasteurella multocida
, and Proteus mirabilis
In target animal safety studies, cefpodoxime was well tolerated at exaggerated daily
oral doses of 100 mg/kg/day (10 times the maximum label dose) for 13 weeks in adult
dogs and for 28 days in puppies (18-23 days of age). Therefore, once daily administration
of cefpodoxime oral tablets at the maximum labeled dose of 10 mg/kg for up to 28
days was shown to be safe in adult dogs and puppies.
Blood dyscrasia including neutropenias, may be seen following high doses of cephalosporins.
Cephalosporin administration should be discontinued in such cases.
Store tablets at controlled room temperature 20° to 25°C (68° to 77°F). Replace
cap securely after each opening.
SIMPLICEF tablets are available in the following strengths (cefpodoxime equivalent),
colors, and sizes: 100 mg (reddish-orange, elliptical, scored, debossed with 5228)
Bottles of 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . NDC 0009-5228-01
200 mg (light orange, elliptical, debossed with 5229)
Bottles of 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . NDC 0009-5229-01
NADA# 141-232, Approved by FDA
819 826 000