PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67877-878-20
Cefpodoxime Proxetil
Tablets, USP 100 mg*
Rx only
20 Tablets

NDC 67877-879-20
Cefpodoxime Proxetil
Tablets, USP 200 mg*
Rx only
20 Tablets

DOSAGE AND ADMINISTRATION

(See INDICATIONS AND USAGE for indicated pathogens.)
** Film-coated Tablets**
****Cefpodoxime Proxetil Tablets, USP should be administered orally with food to enhance absorption. (See CLINICAL PHARMACOLOGY.)
The recommended dosages, durations of treatment, and applicable patient population are as described in the following chart:

Adults and Adolescents (age 12 years and older)

Patients with Renal Dysfunction
For patients with severe renal impairment (<30 mL/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. In patients maintained on hemodialysis, the dose frequency should be 3 times/week after hemodialysis.
When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to estimate creatinine clearance (mL/min). For this estimate to be valid, the serum creatinine level should represent a steady state of renal function.

Males: Weight (kg) × (140 - age)

(mL/min) 72 × serum creatinine (mg/100 mL)

Females: 0.85 × above value

(mL/min)

Patients with Cirrhosis
Cefpodoxime pharmacokinetics in cirrhotic patients (with or without ascites) are similar to those in healthy subjects. Dose adjustment is not necessary in this population.

CLINICAL TRIALS

Cystitis
****In two double-blind, 2:1 randomized, comparative trials performed in adults in the United States, cefpodoxime proxetil was compared to other beta- lactam antibiotics. In these studies, the following bacterial eradication rates were obtained at 5 to 9 days after therapy:

In these studies, clinical cure rates and bacterial eradication rates for cefpodoxime proxetil were comparable to the comparator agents; however, the clinical cure rates and bacteriologic eradication rates were lower than those observed with some other classes of approved agents for cystitis.

Acute Otitis Media Studies
****In controlled studies of acute otitis media performed in the United States, where significant rates of beta-lactamase-producing organisms were found, cefpodoxime proxetil was compared to cefixime. In these studies, using very strict evaluability criteria and microbiologic and clinical response criteria at the 4 to 21 day post-therapy follow-up, the following presumptive bacterial eradication/clinical success outcomes (cured and improved) were obtained.

Manufactured by:
****Alkem Laboratories Ltd.,

INDIA.

Distributed by:
****Ascend Laboratories, LLC
Parsippany, NJ 07054

Revised: October, 2022

PT3652