Animal NDC 54771-5228-1 Simplicef
Cefpodoxime Proxetil

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-5228-1
Proprietary Name Simplicef What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Cefpodoxime Proxetil What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zoetis Inc.
Product Type Prescription Animal Drug
Usage Information
    Cefpodoxime proxetil is contraindicated in dogs with known allergy to cefpodoxime or to the β-lactam (penicillins and cephalosporins) group of antibiotics.
Active Ingredient(s)
  • Cefpodoxime Proxetil
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA141232 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

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Simplicef Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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:

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.


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

Dogs may have experienced more than one of the observations during the study.

Clinical Observation SIMPLICEF
(n=118)		 Active Control (n=98)
 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.


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 ± 5.3%.

Figure 1. Canine Plasma Concentration of Cefpodoxime After a Single Oral Dose of 10 mg/kg Cefpodoxime Proxetil Tablets

Cefpodoxime is distributed in the body with an apparent volume of distribution of 151 ± 27 mL/kg. Like other β-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.

Table 4. Summary of Pharmacokinetic Parameters Obtained after a Single Oral Dose of 10 mg Cefpodoxime/kg BW, Administered as a Tablet
PK Parameter Unit Tablet (SD)
 AUC0-∞ mcg∙hr/mL 145 (77.6)
 AUC0-LOQ mcg∙hr/mL 142 (77.5)
 Maximum concentration (Cmax) mcg/mL 16.4 (11.8)
 Terminal plasma elimination half-life (t1/2,z) hr 5.61 (1.15)
 Time of maximum concentration (tmax) hr 2.21 (0.542)
 Mean residence time (MRT0-∞) hr 9.21 (1.97)

Microbiology



Like other β-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 β-lactamase enzymes. As a result, many organisms resistant to other β-lactam antibiotics (penicillins and some cephalosporins) due to the production of β-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. The minimum inhibitory 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 Table 6.

Table 5. Cefpodoxime Minimum Inhibitory Concentration Values (mcg/mL) from a 2002 Field Study Evaluating Skin Infections (wounds and abscesses) of Canines in the United States.
Organism

Veterinary specific interpretive criteria have not been established for the above listed canine pathogens by the NCCLS at this time.

 # of Isolates MIC50 MIC90 Range
 Staphylococcus intermedius 118 0.12 0.50 0.12->32.0
 Streptococcus canis (group G, β hemolytic) 33 ≤0.03 ≤0.03 ≤0.03

No Range, all isolates yielded the same value.

 Escherichia coli 41 0.25 0.50 0.12->32.0
 Pasteurella multocida 32 ≤0.03 ≤0.03 ≤0.03-0.12
 Proteus mirabilis 14 ≤0.03 0.06 ≤0.03-0.06
 Staphylococcus aureus 19 2.0 2.0 0.12-2.0
Table 6. Acceptable Quality Control Ranges for Cefpodoxime
QC ATCC strain KB Disk Diffusion Method Broth Micro-dilution Method
Drug concentration Zone diameter MIC
 Escherichia coli 25922 10 mcg 23-28 mm

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.

 0.25-1 mcg/mL
 Staphylococcus aureus 25923 10 mcg 19-25 mm 
 Staphylococcus aureus 29213   1-8 mcg/mL
 Streptococcus pneumoniae 49619 10 mcg 28-34 mm

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, β 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 micro-dilution method).

 0.03-0.12 mcg/mL

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, β hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.


Animal Safety



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.


Storage Information



Store tablets at controlled room temperature 20° to 25°C (68° to 77°F). Dispense in tight, light-resistant container. Replace cap securely after each opening.


How Supplied



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
Bottles of 250

200 mg (light orange, round rectangle, scored, debossed with 5229)
Bottles of 100
Bottles of 250


Principal Display Panel - 100 Mg 100 Tabs Tablet Bottle Label





Principal Display Panel - 100 Mg 250 Tabs Tablet Bottle Label





Principal Display Panel - 200 Mg 100 Tabs Tablet Bottle Label





Principal Display Panel - 200 Mg 250 Tabs Tablet Bottle Label





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