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Product Name:  Cefpodoxime 100 mg (Compare to Simplicef), 100 Tablets

Product ID#:  18118
Category:  Ear Care
Prescription Medications & Medical Devices
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Manufacturer:  Putney, Inc.
Price:  $86.51
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Cefpodoxime proxetil

Antimicrobial For Oral Use In Dogs Only

Cefpodoxime proxetil is a generic of Pfizer Simplicef and is offered in 100 mg and 200 mg tablets.

Cefpodoxime proxetil 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 Cefpodoxime proxetil (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 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

CONTRAINDICATIONS

Cefpodoxime proxetil is contraindicated in dogs with known allergy to cefpodoxime or to the b-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

Vomiting, diarrhea, increased water drinking and decreased appetite can occur.

CLINICAL PHARMACOLOGY

Microbiology: Like other b-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 b-lactamese enzymes. As a result, many organisms resistant to other b-lactam antibiotics (penicillins and some cephalosporins) due to the production of b-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.

EFFECTIVENESS

The clinical effectiveness of Cefpodoxime proxetil (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% 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

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