SIMPLICEF TABLETS
Antimicrobial For Oral Use In Dogs Only
Pfizer Simplicef (Cefpodoxime proxetil) and is
offered in 100 mg and 200 mg tablets.
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, B 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: 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 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
SIMPLICEF is contraindicated in dogs with known
allergy to cefpodoxime or to the b-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
Vomiting, diarrhea, increased water drinking and
decreased appetite can occur.
CLINICAL PHARMACOLOGY
Microbiology: Like other b-lactam
antibiotics, cefpodoxime exerts its inhibitory effect by interfering with
bacterial cell wall synthesis. This interference is primarily due to its
covelently 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 b-lactamese enzymes. As
a result, many organisms resistant to other b-lactam antibiotics (penicillins
and some cephalosporins) due to the production of b-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, Escherichia, and
Proteus). The compound is not active against most obligate anaerobes,
Pseudomonas spp., or enterococci.
EFFECTIVENESS
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 a
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, R hemolytic), Escherichia coli, Pasteurella multocida, and
Proteus mirabilis.
ANIMAL SAFETY
In target animal safety studies, SIMPLICEF 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 SIMPLICEX 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.
STORAGE
Store tablets at controlled room temperature 20° to
25°C (68° to 77°F). Replace cap securely after each opening.