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 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, elliptical, scored tablet contains cefpodoxime proxetil equivalent to 100 mg of cefpodoxime.
200 mg Tablet, each light orange, round rectangle, scored tablet contains cefpodoxime proxetil equivalent 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, β hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.
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.
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
Bottles of 250
200 mg (light orange, round rectangle, scored, debossed with 5229)
Bottles of 100
Bottles of 250
