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- Cefpodoxime Proxetil
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Oral:
Generic: 50 mg/5 mL (50 mL, 100 mL); 100 mg/5 mL (50 mL, 100 mL)
Generic: 100 mg, 200 mg
- Antibiotic, Cephalosporin (Third Generation)
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Rapid and well absorbed (50%); tablet AUC increased 21% to 33% with food
Good tissue penetration, including lung and tonsils; penetrates into pleural fluid
De-esterified in GI tract to active metabolite, cefpodoxime
Urine (~29% to 33% as unchanged drug) in 12 hours
Time to Peak
Tablets: Within 2 to 3 hours; Oral suspension: Slower in presence of food, 48% increase in Tmax
~2 to 3 hours; prolonged with renal impairment (~10 hours for CrCl <30 mL/minute)
Serum: 22% to 33%; Plasma: 21% to 29%
Special Populations: Renal Function Impairment
Elimination is reduced in those with CrCl less than 50 mL/minute.
Special Populations: Elderly
The half-life is increased to about 4.2 hours.
Use: Labeled Indications
Chronic bronchitis, acute bacterial exacerbation: Treatment of acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (non-beta-lactamase-producing strains only), or Moraxella catarrhalis.
Cystitis, acute uncomplicated: Treatment of acute uncomplicated cystitis caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.
Acute, uncomplicated anorectal infections in women: Treatment of acute, uncomplicated anorectal infections in women due to N. gonorrhoeae (including penicillinase-producing strains). Note: Due to issues of resistance, cefpodoxime is no longer recommended for the treatment of acute, uncomplicated anorectal infections in women.
Acute, uncomplicated urethral and cervical: Treatment of acute, uncomplicated urethral and cervical gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains). Note: Due to issues of resistance, cefpodoxime is no longer recommended for the treatment of acute, uncomplicated urethral and cervical gonorrhea.
Otitis media, acute: Treatment of acute otitis media caused by S. pneumoniae, (excluding penicillin-resistant strains), Streptococcus pyogenes, H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase producing strains).
Pharyngitis or tonsillitis: Treatment of pharyngitis or tonsillitis caused by S. pyogenes.
Pneumonia, community-acquired: Treatment of community-acquired pneumonia caused by S. pneumoniae or H. influenzae (including beta-lactamase-producing strains).
Sinusitis, acute maxillary: Treatment of acute maxillary sinusitis caused by H. influenzae (including beta-lactamase producing strains), S. pneumoniae, and M. catarrhalis. Note: According to the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis, cefpodoxime is no longer recommended as monotherapy for initial empiric treatment.
Skin and skin structure infections, uncomplicated: Treatment of uncomplicated skin and skin structure infections caused by S. aureus (including penicillinase-producing strains) or S. pyogenes.
Hypersensitivity to cefpodoxime, any component of the formulation, or other cephalosporins
Bronchitis (chronic), bacterial exacerbation: Oral: 200 mg every 12 hours for 10 days
Cystitis, acute uncomplicated (alternative agent): Oral: 100 mg twice daily for 5 to 7 days (Hooton 2018)
Pharyngitis/tonsillitis: Oral: 100 mg every 12 hours for 5 to 10 days
Pneumonia, community acquired: Oral: 200 mg every 12 hours for 14 days. Note: For outpatient empiric therapy in adults, IDSA guidelines recommend use in combination with a macrolide (preferred) or doxycycline and a shortened duration of treatment (ie, minimum of 5 days [patient should be afebrile for ≥48 hours and clinically stable before discontinuation of therapy]) (Mandell 2007).
Rhinosinusitis, acute maxillary: Oral: 200 mg every 12 hours for 10 days
Skin and skin structure: Oral: 400 mg every 12 hours for 7 to 14 days
Refer to adult dosing.
Usual dosage range:
Infants ≥2 months of age and Children <12 years of age: Oral: 10 mg/kg/day divided every 12 hours (maximum: 200 mg/dose).
Children ≥12 years of age and Adolescents: Oral: 100 to 400 mg every 12 hours.
Bronchitis (chronic), bacterial exacerbation: Children ≥12 years of age and Adolescents: Oral: Refer to adult dosing.
Cystitis, acute uncomplicated: Children ≥12 years of age and Adolescents: Oral: Refer to adult dosing.
Otitis media, acute: Infants ≥2 months of age and Children <12 years of age: Oral: 5 mg/kg/dose (maximum: 200 mg/dose) every 12 hours for 5 days. Note: AAP guidelines recommend duration based on patient age: If <2 years of age or severe symptoms (any age): 10-day course; if 2 to 5 years of age with mild to moderate symptoms: 7-day course; if ≥6 years of age with mild to moderate symptoms: 5- to 7-day course (AAP [Lieberthal 2013]).
Infants ≥2 months and Children <12 years of age: Oral: 5mg/kg/dose every 12 hours (maximum: 100 mg/dose) for 5 to 10 days.
Children ≥12 years of age and Adolescents: Oral: Refer to adult dosing.
Pneumonia, community acquired: Children ≥12 years of age and Adolescents: Oral: Refer to adult dosing.
Rhinosinusitis, acute maxillary:
Infants ≥2 months of age and Children <12 years of age: Oral: 5 mg/kg/dose (maximum: 200 mg/dose) every 12 hours for 10 days. Note: IDSA recommends use in combination with clindamycin for 10 to 14 days in patients with non-type 1 penicillin allergy, after failure of initial therapy or in patients at risk for antibiotic resistance (eg, daycare attendance, age <2 years, recent hospitalization, antibiotic use within the past month) (Chow 2012).
Children ≥12 years of age and Adolescents: Oral: Refer to adult dosing.
Skin and skin structure: Children ≥12 years of age and Adolescents: Oral: Refer to adult dosing.
Dosing: Renal Impairment
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: Administer every 24 hours.
Hemodialysis: Dose 3 times/week following dialysis.
Dosing: Hepatic Impairment
Cirrhosis (with or without ascites): No dosage adjustment necessary.
Suspension: Refer to manufacturer’s product labeling for reconstitution instructions.
Oral: Administer around-the-clock to promote less variation in peak and trough serum levels. Administer tablets with food; suspension may be administered without regard to food. Shake suspension well before using.
Take tablets with food.
Suspension: Store at 20°C to 25°C (68°F to 77°F); after reconstitution, suspension may be stored in refrigerator for 14 days.
Tablet: Store at 20°C to 25°C (68°F to 77°F); protect from light.
Aminoglycosides: Cephalosporins (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Antacids: May decrease the serum concentration of Cefpodoxime. Monitor therapy
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination
Histamine H2 Receptor Antagonists: May decrease the absorption of Cefpodoxime. Separate oral doses by at least 2 hours. Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy
Probenecid: May increase the serum concentration of Cephalosporins. Monitor therapy
Proton Pump Inhibitors: May decrease the serum concentration of Cefpodoxime. Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy
Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction
Dermatologic: Diaper rash (12%)
Gastrointestinal: Diarrhea (infants and toddlers 15%)
1% to 10%:
Central nervous system: Headache (1%)
Dermatologic: Skin rash (1%)
Gastrointestinal: Diarrhea (7%), nausea (4%), abdominal pain (2%), vomiting (1% to 2%)
Genitourinary: Vaginal infection (3%)
<1%: Anaphylaxis, anxiety, chest pain, cough, decreased appetite, dizziness, dysgeusia, epistaxis, eye pruritus, fatigue, fever, flatulence, flushing, fungal skin infection, hypotension, insomnia, malaise, nightmares, pruritus, pseudomembranous colitis, purpuric nephritis, tinnitus, vulvovaginal candidiasis, weakness, xerostomia
Concerns related to adverse effects:
• Beta-lactam allergy: Use with caution in patients with a history of beta-lactam allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.
Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.
Pregnancy Risk Factor
Teratogenic events were not observed in animal reproduction studies. An increase in most types of birth defects was not found following first trimester exposure to cephalosporins.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience diarrhea. Have patient report immediately to prescriber bruising, bleeding, severe loss of strength and energy, urinary retention, change in amount of urine passed, chills, pharyngitis, seizures, vaginitis, or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
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- Drug class: third generation cephalosporins
- Cefpodoxime Proxetil (AHFS Monograph)
- Cefpodoxime Proxetil (FDA)
- Cefpodoxime Proxetil Suspension (FDA)
Other brands: Vantin