Product Description

Cefpodoxime Proxetil Description

Cefpodoxime Proxetil USP is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl(+)-(6R,7R)-7-[2-(2-amino-4-thiazolyl)-2-{(Z)methoxyimino}acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylate. Its empirical formula is C21H27N5O9S2 and its structural formula is represented below:

The molecular weight of Cefpodoxime Proxetil USP is 557.6.

Cefpodoxime Proxetil USP is a prodrug; its active metabolite is cefpodoxime. All doses of Cefpodoxime Proxetil USP in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied as film-coated tablets. Cefpodoxime Proxetil tablets USP 100 mg contain FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6 as color additives. Cefpodoxime Proxetil tablets USP 200 mg contain color additives including FD&C Yellow No. 6.

Cefpodoxime Proxetil tablets USP contain Cefpodoxime Proxetil USP equivalent to 100 mg or 200 mg of cefpodoxime activity and the following inactive ingredients: carboxymethylcellulose calcium, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and opadry orange. The constituents of opadry orange 03H53614 (used in 100 mg strength) are hypromellose, titanium dioxide, propylene glycol, FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6. The constituents of opadry orange 03H53615 (used in 200 mg strength) are hypromellose, titanium dioxide, propylene glycol, FD&C Yellow No. 6 and FD&C Red No. 40.