Simplicef (cefpodoxime proxetil)

Client Information Sheet For Cefpodoxime Proxetil (Rx) General Description: An oral cephalosporin antibiotic used to treat many common bacterial infections in dogs and cats (ex. ear, bladder and skin infections). Typically, you only need to…

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Cefpodoxime Proxetil (Rx)

General Description: An oral cephalosporin antibiotic used to treat many common bacterial infections in dogs and cats (ex. ear, bladder and skin infections). Typically, you only need to give cefpodoxime once daily. Cefprodoxime is available as 100 mg and 200 mg tablets or as an oral suspension.

What is this drug?

3^rd generation cephalosporin; an antibiotic
Given by mouth

Reasons for prescribing:

Useful broad spectrum antibiotic most often prescribed for common and uncomplicated infections
Especially useful against many skin infections

What dogs/cats should not take this medication?

Use with caution in pets with kidney failure or a history of seizures
Use with caution in breeding, pregnant or nursing animals
Pets whom have had previous allergic reactions to penicillin, other cephalosporins or antibiotics

Directions:

Give medication as directed by your veterinarian. It is usually given once a day.

Missed doses reduce the effectiveness of therapy.

Read and follow the label carefully.

Give the exact amount prescribed and only as often as directed.

Give this medication for as long as your veterinarian directs. Call ahead for refills.

For liquids, shake well before accurately measuring the dose.

May be given on a full or empty stomach.

Ideally, give the medication at the same time daily.

What if a dose is missed?

If a dose is missed, give it as soon as you can. If it is time already for the next dose, skip the missed dose and go back to the normal schedule. Do not give two doses at the same time.

What to tell/ask veterinarian before giving medication?

Talk to your veterinarian about:

When will your pet need to be rechecked
What tests may need to be performed prior to and during treatment with this drug
Risks and benefits of using this drug

Tell your veterinarian about:

If your pet has experienced side-effects on other drugs/products
If your pet has experienced digestive upset now or ever
If your pet has experienced kidney disease now or ever
If your pet has experienced any other medical problems or allergies now or ever
All medicines and supplements that you are giving your pet or plan to give your pet, including those you can get without a prescription. Your veterinarian may want to check that all of your pet’s medicines can be given together.
If your pet is pregnant or nursing or if you plan to breed your pet

Storage and Warnings:

Store tablets and powder in a tight, light resistant, childproof container in a cool, dry place at room temperature away from heat and direct sunlight.

Once reconstituted, the oral suspension is stable for two weeks (refrigeration is recommended). Shake well before using.

Keep this and all medication out of reach of children and pets.

Call your physician immediately if you accidentally take this product.

Pet owners who are allergic to penicillin and/or other antibiotics should avoid handling this drug.

Potential side effects:

This medication is usually well tolerated by dogs and cats and is commonly used for several weeks
Vomiting, diarrhea and loss of appetite may be experienced
If you notice anything unusual, contact your veterinarian

Can this drug be given with other drugs?

These drugs may interact with cefpodoxime: H₂ antagonists (ranitidine, cimetidine), omeprazole and antacids.

Overdosing?

Contact your veterinarian if pet eats more than the prescribed amount.

What else should I know?

As with all prescribed medicines, cefpodoxime should only be given to the dog/cat for which it was prescribed. It should be given only for the condition for which it was prescribed.

Notify your veterinarian if your animal’s condition does not improve or worsens despite this treatment.

This is just a summary of information about cefpodoxime. If you have any questions or concerns about cefpodoxime or the condition it was prescribed for, contact your veterinarian.

Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

SIMPLICEF™ TABLETS

Pharmacia & Upjohn

(cefpodoxime proxetil)

Antimicrobial For Oral Use In Dogs Only

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)-(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 SIMPLICEF (cefpodoxime proxetil) tablets are expressed in terms of the active cefpodoxime moiety. Simplicef is available as:

100 mg Tablet, each reddish-orange, ellipital, scored tablet contains cefpodoxime proxetil equivalent of 100 mg of cefpodoxime.

200 mg Tablet, each light orange, elliptical tablet contains cefpodoxime proxetil equivalant 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, B hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

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

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 Study¹

Clinical Observation	SIMPLICEF (n=118)	Active Control (n=98)
Vomiting	2	4
Diarrhea	1	1
Increased water drinking	0	2
Decreased appetite	1	1

¹ Dogs may have experienced more than one of the observations during the study.

To report a suspected adverse reaction call 1-800-366-5288.

To request a material safety data sheet (MSDS) for SIMPLICEF tablets, call 1-800-733-5500.

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 (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 ISD)
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(l.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 covelently 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-lactamese 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

† No Range, all isolates yielded the same value.

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

Table 6. Acceptable Quality Control Ranges for Cefpodoxime

QC ATCC strain	KB Disk Diffusion Method		Broth Micro-dilution Method
QC ATCC strain	Drug concentration	Zone diameter	MIC
Escherichia coli 25922	10 mcg	23-28 mm^a	0.25-1 mcg/mL^a
Staphylococcus aureus 25923	10 mcg	19-25 mm^a
Staphylococcus aureus 29213			1-8 mcg/mL^a
Streptococcus pneumoniae 49619	10 mcg	28-34 mm^b	0.03-0.12 mcg/mL^b

^a 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 (IC ranges of these strains in the broth micro-dilution method.

^bThese 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).

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, R 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). 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	NDC 0009-5228-01
200 mg (light orange, elliptical, debossed with 5229)
Bottles of 100	NDC 0009-5229-01