Source: FDA, National Drug Code (US) Revision Year: 2019
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.
(See INDICATIONS AND USAGE for indicated pathogens.)
Cefpodoxime proxetil for 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 |
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) / 72 x serum creatinine (mg/100 mL)
(mL/min)
Females: 0.85 x above value
(mL/min)
Cefpodoxime pharmacokinetics in cirrhotic patients (with or without ascites) are similar to those in healthy subjects. Dose adjustment is not necessary in this population.
Before reconstitution, remove the desiccant capsule by pulling out two small rings, then discard.
Preparation of Suspension:
| Constitution Directions For Oral Suspension | ||
|---|---|---|
| Constituted Volume | Final Concentration | Directions |
| 50 mL | 50 mg per 5 mL | Suspend in a total of 31 mL of distilled water. Method: First, shake the bottle to loosen granules. Then add the water in two approximately equal portions, shaking vigorously after each aliquot of water. |
| 75 mL | 50 mg per 5 mL | Suspend in a total of 44 mL of distilled water. Method: First, shake the bottle to loosen granules. Then add the water in two approximately equal portions, shaking vigorously after each aliquot of water. |
| 100 mL | 50 mg per 5 mL | Suspend in a total of 57 mL of distilled water. Method: First, shake the bottle to loosen granules. Then add the water in two approximately equal portions, shaking vigorously after each aliquot of water. |
| 50 mL | 100 mg per 5 mL | Suspend in a total of 30 mL of distilled water. Method: First, shake the bottle to loosen granules. Then add the water in two approximately equal portions, shaking vigorously after each aliquot of water. |
| 75 mL | 100 mg per 5 mL | Suspend in a total of 43 mL of distilled water. Method: First, shake the bottle to loosen granules. Then add the water in two approximately equal portions, shaking vigorously after each aliquot of water. |
| 100 mL | 100 mg per 5 mL | Suspend in a total of 57 mL of distilled water. Method: First, shake the bottle to loosen granules. Then add the water in two approximately equal portions, shaking vigorously after each aliquot of water. |
After mixing, the suspension should be stored in a refrigerator, 2° to 8°C (36° to 46°F). Shake well before using. Keep container tightly closed. The mixture may be used for 14 days. Discard unused portion after 14 days.
In acute rodent toxicity studies, a single 5 g/kg oral dose produced no adverse effects.
In the event of serious toxic reaction from overdosage, hemodialysis or peritoneal dialysis may aid in the removal of cefpodoxime from the body, particularly if renal function is compromised.
The toxic symptoms following an overdose of beta-lactam antibiotics may include nausea, vomiting, epigastric distress, and diarrhea.
Store unsuspended granules at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Directions for mixing are included on the label. After mixing, suspension should be stored in a refrigerator, 2° to 8°C (36° to 46°F). Shake well before using. Keep container tightly closed. The mixture may be used for 14 days. Discard unused portion after 14 days.
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