cefpodoxime proxetil

For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, Streptococcus canis (group G, ß hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Simplicef®

For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius, S. aureus, Streptococcus canis (group G, beta-hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

Cefpodoxime Proxetil Tablets

Cefpodoxime Proxetil Tablets are indicated for the treatment of skin infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, Streptococcus canis (group G, ß hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

Cefpodoxime Proxetil Tablets For Oral Use In Dogs Only

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 (CIB) 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 pseudintermedius 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 * Veterinary specific interpretive criteria have not been established for the above listed canine pathogens by the NCCLS at this time. † No Range, all isolates yielded the same value. 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* 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† *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).

Cefpodoxime Proxetil Tablets For Oral Use In Dogs Only

CONTRAINDICATIONS: Cefpodoxime proxetil is contraindicated in dogs with known allergy to cefpodoxime or to the ß-lactam (penicillins and cephalosporins) group of antibiotics.

Cefpoderm® (cefpodoxime proxetil tablets)

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.

Cefpoderm® (cefpodoxime proxetil tablets)

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Cefpoderm® (cefpodoxime proxetil tablets)

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 StudyDogs may have experienced more than one of the observations during the study. Clinical Observation Cefpodoxime Proxetil (n=118) Active Control (n=98) Vomiting 2 4 Diarrhea 1 1 Increased water drinking 0 2 Decreased appetite 1 1 To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS) contact Dechra at [866] 933-2472. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae

Cefpoderm® (cefpodoxime proxetil tablets)

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 StudyDogs 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.

SIMPLICEF®

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 cefpodoxime proxetil tablets (n=118) Active Control (n=98) Vomiting 2 4 Diarrhea 1 1 Increased water drinking 0 2 Decreased appetite 1 1 *Dogs may have experienced more than one of the observations during the study.

Cefpodoxime Proxetil Tablets For Oral Use In Dogs Only

5 to 10 milligram per kilogram (2.3 to 4.5 milligram per pound) body weight daily for 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a maximum of 28 days.

Oral

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Simplicef®

Dose range The dose range of 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 Tablets at 5 mg/kg (Table 1) and 10 mg/kg (Table 2). Table 1. Dose Table for Cefpodoxime Proxetil 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 Cefpodoxime Proxetil 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

ORAL

Cefpodoxime Proxetil Tablets For Oral Use In Dogs Only

5-10 mg/kg (2.3-4.5 mg/lb) body weight once a day for 5-7 days or 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

Oral

Federal law restricts this drug to use by or on the order of a licensed veterinarian

Cefpodoxime Proxetil Tablets

DOSAGE AND ADMINISTRATION:

ORAL

Cefpoderm® (cefpodoxime proxetil tablets)