Simplicef: Product Information (Page 3 of 3)

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, β 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). Dispense in tight, light-resistant container. 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
Bottles of 250
200 mg (light orange, round rectangle, scored, debossed with 5229)
Bottles of 100
Bottles of 250

Approved by FDA under NADA # 141-232
zoetis
Manufactured by:
Sandoz
Kundl, Austria
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007
Revised: October 202046272333

PRINCIPAL DISPLAY PANEL — 100 mg 100 tabs Tablet Bottle Label

PRINCIPAL DISPLAY PANEL — 100 mg 250 tabs Tablet Bottle Label

PRINCIPAL DISPLAY PANEL — 200 mg 100 tabs Tablet Bottle Label

PRINCIPAL DISPLAY PANEL — 200 mg 250 tabs Tablet Bottle Label

SIMPLICEF cefpodoxime proxetil tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-5228 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFPODOXIME PROXETIL (CEFPODOXIME) CEFPODOXIME 100 mg

Product Characteristics Color orange (reddish-orange) Score 2 pieces Shape OVAL (elliptical) Size 11mm Flavor Imprint Code 5228 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54771-5228-1 100 TABLET in 1 BOTTLE None 2 NDC:54771-5228-2 250 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141232 07/22/2004

SIMPLICEF cefpodoxime proxetil tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-5229 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFPODOXIME PROXETIL (CEFPODOXIME) CEFPODOXIME 200 mg

Product Characteristics Color orange (reddish-orange) Score 2 pieces Shape OVAL (elliptical) Size 15mm Flavor Imprint Code 5228 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54771-5229-1 100 TABLET in 1 BOTTLE None 2 NDC:54771-5229-2 250 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141232 07/22/2004

Labeler — Zoetis Inc. (828851555)

Revised: 09/2022 Zoetis Inc.