Label: SIMPLICEF- cefpodoxime proxetil tablet
- NDC Code(s): 54771-5228-1, 54771-5228-2, 54771-5229-1, 54771-5229-2
- Packager: Zoetis Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated September 14, 2022
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- SPL UNCLASSIFIED SECTION
- CAUTION
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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
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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
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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
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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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CLINICAL PHARMACOLOGY
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* # 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† 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 - *
- 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.
- †
- 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).
Escherichia coli 25922 10 mcg 23-28 mm* 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† 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.
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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
- HOW SUPPLIED
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- 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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INGREDIENTS AND APPEARANCE
SIMPLICEF
cefpodoxime proxetil tabletProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-5228 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFPODOXIME PROXETIL (UNII: 2TB00A1Z7N) (CEFPODOXIME - UNII:7R4F94TVGY) CEFPODOXIME 100 mg Product Characteristics Color orange (reddish-orange) Score 2 pieces Shape OVAL (elliptical) Size 11mm Flavor Imprint Code 5228 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-5228-1 100 in 1 BOTTLE 2 NDC:54771-5228-2 250 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141232 07/22/2004 SIMPLICEF
cefpodoxime proxetil tabletProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-5229 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFPODOXIME PROXETIL (UNII: 2TB00A1Z7N) (CEFPODOXIME - UNII:7R4F94TVGY) CEFPODOXIME 200 mg Product Characteristics Color orange (reddish-orange) Score 2 pieces Shape OVAL (elliptical) Size 15mm Flavor Imprint Code 5228 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-5229-1 100 in 1 BOTTLE 2 NDC:54771-5229-2 250 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141232 07/22/2004 Labeler - Zoetis Inc. (828851555)
