CEFPODERM- cefpodoxime proxetil tablet

Cefpoderm by

Drug Labeling and Warnings

Cefpoderm by is a Animal medication manufactured, distributed, or labeled by Dechra Veterinary Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For Oral Use in Dogs Only

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

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.

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:

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

Table 1. Dose Table for Cefpoderm 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 Cefpoderm 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

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 and pets. 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*

Clinical Observation	Cefpodoxime Proxetil (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 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 http://www.fda.gov/AnimalVeterinary/SafetyHealth

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 displays the mean (+ 1SD) plasma cefpodoxime concentrations and Table 4 lists the mean (SD) pharmacokinetic parameters following administration of cefpodoxime proxetil tablets to fasting Beagles.

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 Clinical Laboratory Standards Institute (CLSI). 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
* Veterinary specific interpretive criteria have not been established for the above listed canine pathogens by the CLSI at this time. † No Range, all isolates yielded the same value.
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 mirabalis	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*
Staphylococcus pneumoniae 49619	10 mcg	28-34 mm†	0.03-0.12 mcg/mL†

EFFECTIVENESS:

The clinical effectiveness of 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 cefpodoxime proxetil (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, 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.

SPL UNCLASSIFIED SECTION

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 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 are 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 with PV on one side, 18 on the other side)

• Bottles of 100: NDC: 17033-432-10

SPL UNCLASSIFIED SECTION

ANADA 200-543, Approved by FDA

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

Made in Austria.

Rev. March 2018

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label

100 mg

Cefpoderm™
(cefpodoxime proxetil) Tablets
Antimicrobial For Oral Use
100 mg

Use in dogs only

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

ANADA 200-543, Approved by FDA

100 tablets
Dechra

PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label

200 mg

Cefpoderm™
(cefpodoxime proxetil) Tablets
Antimicrobial For Oral Use
200 mg

Use in dogs only

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

ANADA 200-543, Approved by FDA

100 tablets
Dechra

INGREDIENTS AND APPEARANCE

CEFPODERM 
cefpodoxime proxetil tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 17033-431
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	YELLOW	Score	2 pieces
Shape	OVAL	Size	11mm
Flavor		Imprint Code	PV17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17033-431-10	100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200543	12/19/2018

CEFPODERM 
cefpodoxime proxetil tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 17033-432
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	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	PV18
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17033-432-10	100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200543	12/19/2018

Labeler - Dechra Veterinary Products LLC (362142734)