Cefpodoxime Proxetil

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Side Effects & Adverse Reactions

BEFORE THERAPY WITH CEFPODOXIME PROXETIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFPODOXIME, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFPODOXIME IS TO BE ADMINISTERED TO PENICILLIN SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFPODOXIME PROXETIL OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINE, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefpodoxime proxetil, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

A concerted effort to monitor for C. difficile in cefpodoxime-treated patients with diarrhea was undertaken because of an increased incidence of diarrhea associated with C. difficile in early trials in normal subjects. C. difficile organisms or toxin was reported in 10% of the cefpodoxime-treated adult patients with diarrhea; however, no specific diagnosis of pseudomembranous colitis was made in these patients.

In post-marketing experience outside the United States, reports of pseudomembranous colitis associated with the use of cefpodoxime proxetil have been received.

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute otitis media caused by Streptococcus pneumoniae, (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilus influenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase producing strains).

Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes.

NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefpodoxime proxetil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefpodoxime proxetil for the prophylaxis of subsequent rheumatic fever are not available.

Community-acquired pneumonia caused by S. pneumoniae or H. Influenzae (including beta-lactamase-producing strains).

Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis. Data are insufficient at this time to establish efficacy in patients with acute bacterial exacerbations of chronic bronchitis caused by beta-lactamase-producing strains of H. influenzae.

Acute, uncomplicated urethral and cervical gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).

Acute, uncomplicated ano-rectal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).

NOTE: The efficacy of cefpodoxime in treating male patients with rectal infections caused by N. gonorrhoeae has not been established. Data do not support the use of cefpodoxime proxetil in the treatment of pharyngeal infections due to N. gonorrhoeae in men or women.

Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) or Streptococcus pyogenes. Abscesses should be surgically drained as clinically indicated.

NOTE: In clinical trials, successful treatment of uncomplicated skin and skin structure infections was dose-related. The effective therapeutic dose for skin infections was higher than those used in other recommended indications. (See DOSAGE AND ADMINISTRATION.)

Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae, and Moraxella catarrhalis.

Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.

NOTE: In considering the use of cefpodoxime proxetil in the treatment of cystitis, cefpodoxime proxetil’s lower bacterial eradication rates should be weighed against the increased eradication rates and different safety profiles of some other classes of approved agents. (See CLINICAL STUDIES section.)

Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime. Therapy may be instituted while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.

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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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History

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Other Information

Cefpodoxime proxetil 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 molecular formula is C 21H 27N 5O 9S 2 and its structural formula is represented below:

The molecular weight of cefpodoxime proxetil is 557.6.

Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of cefpodoxime proxetil in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied as film-coated tablets.

Cefpodoxime proxetil tablets contain cefpodoxime proxetil equivalent to 100 mg or 200 mg of cefpodoxime activity and the following inactive ingredients: carboxy methyl cellulose calcium, lactose monohydrate, hydroxy propyl cellulose, sodium lauryl sulfate, crospovidone, corn starch, magnesium stearate, hypromellose, titanium dioxide, propylene glycol and FD&C yellow #6 aluminum lake. In addition, the 100 mg film-coated tablets contain iron oxide yellow and the 200 mg film-coated tablets contain FD&C red #40 aluminum lake.

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Cefpodoxime Proxetil Manufacturers

Pd-rx Pharmaceuticals, Inc.

Cefpodoxime Proxetil | Pd-rx Pharmaceuticals, Inc.

(See INDICATIONS AND USAGE for indicated pathogens.) FILM-COATED TABLETS
Cefpodoxime proxetil tablets 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) Type of Infection Total Daily
Dose Dose Frequency Duration    Pharyngitis and/or tonsillitis
200 mg
100 mg Q 12 hours
5 to 10 days
   Acute community-acquired pneumonia
400 mg
200 mg Q 12 hours
14 days
   Acute bacterial exacerbations of chronic bronchitis
400 mg
200 mg Q 12 hours
10 days
   Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)
200 mg
single dose
   Skin and skin structure
800 mg
400 mg Q 12 hours
7 to 14 days
   Acute maxillary sinusitis
400 mg
200 mg Q 12 hours
10 days
   Uncomplicated urinary tract infection
200 mg
100 mg Q 12 hours
7 days
GRANULES FOR ORAL SUSPENSION
Cefpodoxime proxetil oral suspension may be given without regard to food. The recommended dosages, durations of treatment, and applicable patient populations are as described in the following chart:

Adults and Adolescents (age 12 years and older) Type of Infection Total Daily Dose Dose Frequency Duration    Pharyngitis and/or tonsillitis
200 mg
100 mg Q 12 hours
5 to 10 days
   Acute community-acquired pneumonia
400 mg
200 mg Q 12 hours
14 days
   Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)
200 mg
single dose
   Skin and skin structure
800 mg
400 mg Q 12 hours
7 to 14 days
   Acute maxillary sinusitis
400 mg
200 mg Q 12 hours
10 days
   Uncomplicated urinary tract infection
200 mg
100 mg Q 12 hours
7 days

Infants and Pediatric Patients (age 2 months through 12 years) Type of Infection Total Daily Dose Dose Frequency Duration    Acute otitis media
10 mg/kg/day
(Max 400 mg/day)
5 mg/kg Q 12 h
(Max 200 mg/dose)
5 days
   Pharyngitis and/or tonsillitis
10 mg/kg/day
(Max 200 mg/day)
5 mg/kg/dose Q 12 h
(Max 100 mg/dose)
5 to 10 days
   Acute maxillary sinusitis
10 mg/kg/day
(Max 400 mg/day)
5 mg/kg Q 12 hours
(Max 200 mg/dose)
10 days
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) x (140 - age)
   (mL/min)                                  72 x serum creatinine (mg/100 mL)

   Females:                                   0.85 x 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.

No Recall
Putney, Inc.

Cefpodoxime Proxetil | Putney, Inc.

DOSAGE AND ADMINISTRATION

Dose Range: The dose range of Cefpodoxime Proxetil Tablets is 5-10 mg/kg (2.3-4.5 mg/lb) body weight, administered orally, once a day. The dose may be given with or without food. The determination of dosage for any particular patient must take into consideration such factors as the severity and nature of the infection, the susceptibility of the causative organisms, and the integrity of the patient's host-defense mechanisms. Obtain a sample of the pathogenic organism for culture and sensitivity testing prior to beginning antimicrobial therapy. Once results become available, continue with appropriate therapy.

Duration: Cefpodoxime Proxetil Tablets should be administered once daily for 5-7 days or for 2-3 days beyond the cessation of clinical signs, up to a maximum of 28 days. Treatment of acute infections shouldnot be continued for more than 3-4 days if no response to therapy is seen.

Dosing Charts: For daily oral administration of Cefpodoxime Proxetil Tablets at 5 mg/kg (Table 1) and 10 mg/kg (Table 2).
Table 1. Dose Table for Cefpodoxime Proxetil Tablets at 5 mg/kg Total Daily Dosage Weight of Dogs (lbs) Daily Dose 22 44 66 88 132 No. 100 mg tablets 0.5 1 1.5 1 No. 200 mg tablets 1 1 Weight of Dogs (kgs) Daily Dose 10 20 30 40 60 No. 100 mg tablets 0.5 1 1.5 1 No. 200 mg tablets 1 1 Table 2. Dose Table for Cefpodoxime Proxetil Tablets at 10 mg/kg Total Daily Dosage Weight of Dogs (lbs) Daily Dose 11 22 44 66 88 132 No. 100 mg tablets 0.5 1 1 No. 200 mg tablets 1 1 2 3 Weight of Dogs (kgs) Daily Dose 5 10 20 30 40 60 No. 100 mg tablets 0.5 1 1 No. 200 mg tablets 1 1 2 3

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Northstar Rx Llc

Cefpodoxime Proxetil | Northstar Rx Llc

(See INDICATIONS AND USAGE for indicated pathogens.)

FILM-COATED TABLETS:

Cefpodoxime proxetil tablets 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): Type of Infection Total Daily
Dose Dose Frequency Duration    Pharyngitis and/or tonsillitis
200 mg
100 mg Q 12 hours
5 to 10 days
   Acute community-acquired pneumonia
400 mg
200 mg Q 12 hours
14 days
   Acute bacterial exacerbations of chronic bronchitis
400 mg
200 mg Q 12 hours
10 days
   Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)
200 mg
single dose
   Skin and skin structure
800 mg
400 mg Q 12 hours
7 to 14 days
   Acute maxillary sinusitis
400 mg
200 mg Q 12 hours
10 days
   Uncomplicated urinary tract infection
200 mg
100 mg Q 12 hours
7 days

GRANULES FOR ORAL SUSPENSION:

Cefpodoxime proxetil oral suspension may be given without regard to food. The recommended dosages, durations of treatment, and applicable patient populations are as described in the following chart:

Adults and Adolescents (age 12 years and older): Type of Infection Total Daily Dose Dose Frequency Duration    Pharyngitis and/or tonsillitis
200 mg
100 mg Q 12 hours
5 to 10 days
   Acute community-acquired pneumonia
400 mg
200 mg Q 12 hours
14 days
   Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)
200 mg
single dose
   Skin and skin structure
800 mg
400 mg Q 12 hours
7 to 14 days
   Acute maxillary sinusitis
400 mg
200 mg Q 12 hours
10 days
   Uncomplicated urinary tract infection
200 mg
100 mg Q 12 hours
7 days

Infants and Pediatric Patients (age 2 months through 12 years): Type of Infection Total Daily Dose Dose Frequency Duration    Acute otitis media
10 mg/kg/day
(Max 400 mg/day)
5 mg/kg Q 12 h
(Max 200 mg/dose)
5 days
   Pharyngitis and/or tonsillitis
10 mg/kg/day
(Max 200 mg/day)
5 mg/kg/dose Q 12 h
(Max 100 mg/dose)
5 to 10 days
   Acute maxillary sinusitis
10 mg/kg/day
(Max 400 mg/day)
5 mg/kg Q 12 hours
(Max 200 mg/dose)
10 days

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) x (140 - age)
(mL/min)                                 72 x serum creatinine (mg/100 mL)

Females:                                  0.85 x 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.

No Recall
Aurobindo Pharma Limited

Cefpodoxime Proxetil | Aurobindo Pharma Limited

(See INDICATIONS AND USAGE for indicated pathogens.)

FILM-COATED TABLETS:

Cefpodoxime proxetil tablets 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): Type of Infection Total Daily
Dose Dose Frequency Duration    Pharyngitis and/or tonsillitis
200 mg
100 mg Q 12 hours
5 to 10 days
   Acute community-acquired pneumonia
400 mg
200 mg Q 12 hours
14 days
   Acute bacterial exacerbations of chronic bronchitis
400 mg
200 mg Q 12 hours
10 days
   Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)
200 mg
single dose
   Skin and skin structure
800 mg
400 mg Q 12 hours
7 to 14 days
   Acute maxillary sinusitis
400 mg
200 mg Q 12 hours
10 days
   Uncomplicated urinary tract infection
200 mg
100 mg Q 12 hours
7 days

GRANULES FOR ORAL SUSPENSION:

Cefpodoxime proxetil oral suspension may be given without regard to food. The recommended dosages, durations of treatment, and applicable patient populations are as described in the following chart:

Adults and Adolescents (age 12 years and older): Type of Infection Total Daily Dose Dose Frequency Duration    Pharyngitis and/or tonsillitis
200 mg
100 mg Q 12 hours
5 to 10 days
   Acute community-acquired pneumonia
400 mg
200 mg Q 12 hours
14 days
   Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)
200 mg
single dose
   Skin and skin structure
800 mg
400 mg Q 12 hours
7 to 14 days
   Acute maxillary sinusitis
400 mg
200 mg Q 12 hours
10 days
   Uncomplicated urinary tract infection
200 mg
100 mg Q 12 hours
7 days

Infants and Pediatric Patients (age 2 months through 12 years): Type of Infection Total Daily Dose Dose Frequency Duration    Acute otitis media
10 mg/kg/day
(Max 400 mg/day)
5 mg/kg Q 12 h
(Max 200 mg/dose)
5 days
   Pharyngitis and/or tonsillitis
10 mg/kg/day
(Max 200 mg/day)
5 mg/kg/dose Q 12 h
(Max 100 mg/dose)
5 to 10 days
   Acute maxillary sinusitis
10 mg/kg/day
(Max 400 mg/day)
5 mg/kg Q 12 hours
(Max 200 mg/dose)
10 days

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) x (140 - age)
(mL/min)                                 72 x serum creatinine (mg/100 mL)

Females:                                  0.85 x 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.

No Recall
Putney Inc

Cefpodoxime Proxetil | Putney Inc

(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) Type of Infection Total Daily Dose Dose Frequency Duration
Pharyngitis and/or tonsillitis

200 mg

100 mg Q 12 hours

5 to 10 days

Acute community-acquired pneumonia

400 mg

200 mg Q 12 hours

14 days

Acute bacterial exacerbations of chronic bronchitis

400 mg

200 mg Q 12 hours

10 days

Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)

200 mg

single dose

Skin and skin structure

800 mg

400 mg Q 12 hours

7 to 14 days

Acute maxillary sinusitis

400 mg

200 mg Q 12 hours

10 days

Uncomplicated urinary tract infection

200 mg

100 mg Q 12 hours

7 days
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:
(mL/min)

Weight (kg) × (140 - age)
72 × serum creatinine (mg/100 mL)

Females:
(mL/min)

0.85 × above value
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.

No Recall
Gen-source Rx

Cefpodoxime Proxetil | Gen-source Rx

(See INDICATIONS AND USAGE for indicated pathogens.)

FILM-COATED TABLETS:

Cefpodoxime proxetil tablets 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): Type of Infection Total Daily
Dose Dose Frequency Duration    Pharyngitis and/or tonsillitis
200 mg
100 mg Q 12 hours
5 to 10 days
   Acute community-acquired pneumonia
400 mg
200 mg Q 12 hours
14 days
   Acute bacterial exacerbations of chronic bronchitis
400 mg
200 mg Q 12 hours
10 days
   Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)
200 mg
single dose
   Skin and skin structure
800 mg
400 mg Q 12 hours
7 to 14 days
   Acute maxillary sinusitis
400 mg
200 mg Q 12 hours
10 days
   Uncomplicated urinary tract infection
200 mg
100 mg Q 12 hours
7 days

GRANULES FOR ORAL SUSPENSION:

Cefpodoxime proxetil oral suspension may be given without regard to food. The recommended dosages, durations of treatment, and applicable patient populations are as described in the following chart:

Adults and Adolescents (age 12 years and older): Type of Infection Total Daily Dose Dose Frequency Duration    Pharyngitis and/or tonsillitis
200 mg
100 mg Q 12 hours
5 to 10 days
   Acute community-acquired pneumonia
400 mg
200 mg Q 12 hours
14 days
   Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)
200 mg
single dose
   Skin and skin structure
800 mg
400 mg Q 12 hours
7 to 14 days
   Acute maxillary sinusitis
400 mg
200 mg Q 12 hours
10 days
   Uncomplicated urinary tract infection
200 mg
100 mg Q 12 hours
7 days

Infants and Pediatric Patients (age 2 months through 12 years): Type of Infection Total Daily Dose Dose Frequency Duration    Acute otitis media
10 mg/kg/day
(Max 400 mg/day)
5 mg/kg Q 12 h
(Max 200 mg/dose)
5 days
   Pharyngitis and/or tonsillitis
10 mg/kg/day
(Max 200 mg/day)
5 mg/kg/dose Q 12 h
(Max 100 mg/dose)
5 to 10 days
   Acute maxillary sinusitis
10 mg/kg/day
(Max 400 mg/day)
5 mg/kg Q 12 hours
(Max 200 mg/dose)
10 days

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) x (140 - age)
(mL/min)                                 72 x serum creatinine (mg/100 mL)

Females:                                  0.85 x 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.

No Recall
Sandoz Inc

Cefpodoxime Proxetil | Sandoz Inc

(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) Type of Infection Total Daily Dose Dose Frequency Duration
Pharyngitis and/or tonsillitis

200 mg

100 mg Q 12 hours

5 to 10 days

Acute community-acquired pneumonia

400 mg

200 mg Q 12 hours

14 days

Acute bacterial exacerbations of chronic bronchitis

400 mg

200 mg Q 12 hours

10 days

Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women)

200 mg

single dose

Skin and skin structure

800 mg

400 mg Q 12 hours

7 to 14 days

Acute maxillary sinusitis

400 mg

200 mg Q 12 hours

10 days

Uncomplicated urinary tract infection

200 mg

100 mg Q 12 hours

7 days
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:
(mL/min)

Weight (kg) × (140 - age)
72 × serum creatinine (mg/100 mL)

Females:
(mL/min)

0.85 × above value
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.

No Recall