Animal NDC 17033-432-10 Cefpoderm

Cefpodoxime Proxetil

Animal Product Information

Field Name	Field Value
Animal NDC Code	17033-432-10
Proprietary Name	Cefpoderm 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	Dechra Veterinary Products Llc
Product Type	Prescription Animal Drug
Usage Information	INDICATION:Cefpoderm is 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.
Active Ingredient(s)	Cefpodoxime Proxetil
Marketing Category	ANADA - ABBREVIATED 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	ANADA200543 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.

Cefpoderm Images

Cefpoderm 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.

Other
Safe Handling Warning
Description
Veterinary Indications
Dosage & Administration
Contraindications
Warnings
Precautions
Adverse Reactions
Pharmacokinetics
Microbiology
Summary Of Safety And Effectiveness
Storage And Handling
How Supplied
Principal Display Panel - 100 Mg Tablet Bottle Label
Principal Display Panel - 200 Mg Tablet Bottle Label

Other

For Oral Use in Dogs Only

Cefpodoxime Proxetil Chemical Structure:

Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of Cefpoderm (cefpodoxime proxetil tablets) are expressed in terms of the active cefpodoxime moiety. Cefpoderm is available as:

100 mg Tablet, each yellow, elliptical, scored tablet contains cefpodoxime proxetil equivalent to 100 mg of cefpodoxime.

200 mg Tablet, each orange, oblong, tablet contains cefpodoxime proxetil equivalent to 200 mg of cefpodoxime.

Dose range: The dose range of Cefpoderm 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: Cefpoderm 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 Cefpoderm at 5 mg/kg (Table 1) and 10 mg/kg (Table 2).

Table 1. Dose Table for Cefpoderm 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 Cefpoderm 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

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.

Approved by FDA under ANADA
# 200-543

Manufactured for:
Dechra Veterinary Products
7015 College Boulevard, Suite 525
Overland Park, KS 66211 USA

Cefpoderm is a registered trademark of Dechra Veterinary Products, LLC.

Rev. January 2023

Safe Handling Warning

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

Description

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)-(O-methyloxime), isopropyl carbonate (ester) [87239-81-4].

Veterinary Indications

INDICATION:

Cefpoderm is 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.

Dosage & Administration

DOSAGE AND ADMINISTRATION:

Contraindications

CONTRAINDICATIONS:

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

Warnings

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

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

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	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

Pharmacokinetics

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 (Cl_B) 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)
AUC_0-∞	mcg∙hr/mL	145 (77.6)
AUC_0-LOQ	mcg∙hr/mL	142 (77.5)
Maximum concentration (C_max)	mcg/mL	16.4 (11.8)
Terminal plasma elimination half-life (t_1/2,z)	hr	5.61 (1.15)
Time of maximum concentration (t_max)	hr	2.21 (0.542)
Mean residence time (MRT_0-∞)	hr	9.21 (1.97)

Microbiology

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 pseudintermedius	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
Staphylococcus 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

Summary Of Safety And Effectiveness

EFFECTIVENESS:

The clinical effectiveness of cefpodoxime proxetil tablets was established in a multi-location (23 site) field study. In this study, 216 dogs with infected wounds or abscesses were treated with either cefpodoxime proxetil (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, cefpodoxime proxetil was considered noninferior to the active control (88.7% versus 88.4% respectively) in the treatment of canine skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, Streptococcus canis (group G, β hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

Storage And Handling

STORAGE INFORMATION:

Store at controlled room temperature 68-77°F (20-25°C). Replace cap securely after each opening.

How Supplied

HOW SUPPLIED:

Cefpoderm (cefpodoxime proxetil tablets) is available in the following strengths (cefpodoxime equivalent), colors, and sizes:

100 mg (yellow, scored, elliptical, debossed with PV on one side, 17 on the other side)
Bottles of 100
NDC 17033-431-10

200 mg (orange, oblong, debossed with PV on one side, 18 on the other side)
Bottles of 100
NDC 17033-432-10

Principal Display Panel - 100 Mg Tablet Bottle Label

Cefpoderm^® 100 mg
(cefpodoxime proxetil tablets)

Antimicrobial for Oral Use in Dogs only
Approved by FDA under ANADA # 200-543
Case Qty.: 40 bottles; 100 Tablets per bottle
Keep tightly closed. Store at controlled room temperature, 68-77°F (20-25°C).
Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Manufactured for: Dechra Veterinary Products, 7015 College Boulevard
Suite 525, Overland Park, KS 66211 USA
Product of China
Made in Austria
Rev. January 2023

Principal Display Panel - 200 Mg Tablet Bottle Label

Cefpoderm^® 200 mg
(cefpodoxime proxetil tablets)