BARETTO ( Cefpodoxime Proxetil Tablets IP )

Cefpodoxime Proxetil

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefpodoxime Proxetil and other antibacterial drugs, Cefpodoxime Proxetil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Description

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefpodoxime Proxetil and other antibacterial drugs, Cefpodoxime Proxetil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

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.

Cefpodoxime Proxetil is a prodrug that is absorbed from the gastrointestinal tract and de-esterified to its active metabolite, cefpodoxime. Following oral administration of 100 mg of Cefpodoxime Proxetil to fasting subjects, approximately 50% of the administered cefpodoxime dose was absorbed systemically. Over the recommended dosing range (100 to 400 mg), approximately 29 to 33% of the administered cefpodoxime dose was excreted unchanged in the urine in 12 hours. There is minimal metabolism of cefpodoxime in vivo.

The extent of absorption (mean AUC) and the mean peak plasma concentration increased when film-coated tablets were administered with food. Following a 200 mg tablet dose taken with food, the AUC was 21 to 33% higher than under fasting conditions, and the peak plasma concentration averaged 3.1 mcg/mL in fed subjects versus 2.6 mcg/mL in fasted subjects. Time to peak concentration was not significantly different between fed and fasted subjects.