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Cefpodoxime

Medically reviewed by Drugs.com. Last updated on Sep 14, 2020.

Pronunciation

(sef pode OKS eem)

Index Terms

  • Cefpodoxime Proxetil
  • Vantin

Dosage Forms

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)

Tablet, Oral:

Generic: 100 mg, 200 mg

Pharmacologic Category

  • Antibiotic, Cephalosporin (Third Generation)

Pharmacology

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.

Absorption

Rapid and well absorbed (50%); tablet AUC increased 21% to 33% with food

Distribution

Good tissue penetration, including lung and tonsils; penetrates into pleural fluid

Metabolism

De-esterified in GI tract to active metabolite, cefpodoxime

Excretion

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

Half-Life Elimination

~2 to 3 hours; prolonged with renal impairment (~10 hours for CrCl <30 mL/minute)

Protein Binding

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.

Special Populations Note

Anti-infective considerations:

Parameters associated with efficacy:

Time-dependent; associated with time free drug concentration (fT) > minimum inhibitory concentration (MIC):

Enterobacterales: Goal: 30% to 40% fT > MIC (bacteriostatic), 60% to 70% fT > MIC (bactericidal) (Craig 1998; Turnidge 1998).

Streptococcus spp. and H. influenzae: Goal: >40% fT > MIC (Craig 1998; Turnidge 1998).

Expected drug concentration in normal renal function:

Infants >8 months of age and children ≤12 years of age, Cmax (peak):

5 mg/kg, oral suspension, single dose: 2.1 mg/L.

Adults, Cmax (peak):

100 mg, oral suspension, single dose: 1.5 mg/L (range: 1.1 to 2.1 mg/L).

100 mg, oral tablet, steady state: 1.19 ± 0.41 mg/L (Borin 1991).

200 mg, oral tablet, steady state: 2.3 ± 0.71 mg/L (Borin 1991).

400 mg, oral tablet, steady state: 3.62 ± 0.62 mg/L (Borin 1991).

Postantibiotic effect: Generally <1 hour; varies based on organism (Craig 1991; Craig 1998).

Use: Labeled Indications

Chronic obstructive pulmonary disease, acute exacerbation: Treatment of acute bacterial exacerbation of chronic obstructive pulmonary disease 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.

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).

Pneumonia, community-acquired: Treatment of community-acquired pneumonia caused by S. pneumoniae or H. influenzae (including beta-lactamase-producing strains).

Rhinosinusitis, acute bacterial: Treatment of acute bacterial rhinosinusitis caused by H. influenzae (including beta-lactamase-producing strains), S. pneumoniae, and M. catarrhalis. Note: According to the Infectious Diseases Society of America guidelines for acute bacterial rhinosinusitis, cefpodoxime is recommended in combination with clindamycin due to concern for pneumococcal resistance (IDSA [Chow 2012]).

Skin and soft tissue infection: Treatment of uncomplicated skin and soft tissue infection caused by Staphylococcus aureus (including penicillinase-producing strains) or S. pyogenes.

Streptococcal pharyngitis (group A): Treatment of pharyngitis or tonsillitis caused by S. pyogenes.

Off Label Uses

Urinary tract infection, complicated (including pyelonephritis)

Clinical experience suggests the utility of cefpodoxime as an alternative agent in the treatment of acute complicated urinary tract infection (including pyelonephritis) after administration of an appropriate parenteral agent [Hooton 2020a], [Johnson 2018].

Contraindications

Hypersensitivity to cefpodoxime, any component of the formulation, or other cephalosporins.

Documentation of allergenic cross-reactivity for beta-lactams (eg, penicillins and cephalosporins) is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Chronic obstructive pulmonary disease, acute exacerbation: Note: Avoid use in patients with risk factors for Pseudomonas infection or poor outcomes (eg, ≥65 years of age with major comorbidities, FEV1 <50% predicted, frequent exacerbations) (Sethi 2020).

Oral: 200 mg twice daily for 3 to 7 days (GOLD 2019; Phillips 1993; Sethi 2020).

Otitis media, acute (alternative agent for patients with penicillin allergy that does not preclude cephalosporin use): Oral: 200 mg twice daily. Duration is 5 to 7 days for mild to moderate infection and 10 days for severe infection (Limb 2020).

Pneumonia, community-acquired, outpatient empiric therapy (alternative agent): Oral: 200 mg twice daily as part of an appropriate combination regimen. Duration of therapy is for a minimum of 5 days; patients should be clinically stable with normal vital signs before therapy is discontinued (ATS/IDSA [Metlay 2019]).

Rhinosinusitis, acute bacterial (alternative agent for patients with penicillin allergy that does not preclude cephalosporin use): Note: In uncomplicated acute bacterial rhinosinusitis, initial observation and symptom management without antibiotic therapy is appropriate in most patients (AAO-HNSF [Rosenfeld 2015]; ACP/CDC [Harris 2016]).

Oral: 200 mg twice daily (von Sydow 1995) for 5 to 7 days; some experts add clindamycin when there is concern for pneumococcal resistance (eg, high-prevalence area, multiple comorbidities, treatment failure) (IDSA [Chow 2012]; Patel 2020).

Skin and soft tissue infection (alternative agent): Oral: 400 mg every 12 hours (Stevens 1993) for 7 to 14 days (IDSA [Stevens 2014]; Stevens 1993).

Streptococcal pharyngitis (group A) (alternative agent for patients with penicillin allergy that does not preclude cephalosporin use): Oral: 100 mg every 12 hours for 5 to 10 days (Pichichero 2007; Pichichero 2020).

Urinary tract infection (alternative agent): Note: Uncomplicated urinary tract infection (UTI) has traditionally been defined as infection in an otherwise healthy nonpregnant female with a normal urinary tract; UTI in other patient populations has been considered complicated. Some experts instead categorize UTI as either acute simple cystitis (mild infection limited to the bladder with no signs/symptoms of upper tract or systemic infection in a nonpregnant adult) or complicated UTI (pyelonephritis or cystitis symptoms with other signs/symptoms of systemic infection) (Hooton 2020b; Hooton 2020c). Use only when first-line agents cannot be used (due to limited evidence of decreased efficacy of oral beta-lactams) (Hooton 2020b; IDSA/ESMID [Gupta 2011]).

Acute uncomplicated or simple cystitis: Oral: 100 mg twice daily (Hooton 2012; Kavatha 2003) for 5 to 7 days (Hooton 2020b; Hooton 2020c; IDSA/ESMID [Gupta 2011]).

Acute pyelonephritis or other complicated urinary tract infection (off-label use): Oral: 200 mg twice daily for 10 to 14 days (Hooton 2020a; IDSA/ESMID [Gupta 2011]; Johnson 2018). Note: Give after appropriate parenteral therapy; patients should be monitored closely. For outpatient treatment of mild infection, a single dose of a long-acting parenteral agent is acceptable before transitioning to oral therapy (Hooton 2020a; IDSA/ESMID [Gupta 2011]).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

General dosing, susceptible infection: Mild to moderate infections: Infants, Children, and Adolescents: Oral: 5 mg/kg/dose every 12 hours; usual maximum dose: 200 mg/dose; however, in patients ≥12 years, higher doses (ie, 400 mg/dose) may be required for some types of infection (Bradley 2015; Red Book [AAP 2015])

Bronchitis, bacterial exacerbation of chronic: Children ≥12 years and Adolescents: Oral: 200 mg every 12 hours for 10 days

Otitis media, acute: Infants and Children 2 months to 12 years: Oral: 5 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose. Variable duration of therapy; the manufacturer suggests 5-day course in all patients; however, 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]).

Pharyngitis/tonsillitis:

Infants ≥2 months and Children <12 years: Oral: 5 mg/kg/dose every 12 hours for 5 to 10 days; maximum dose: 100 mg/dose

Children ≥12 years and Adolescents: Oral: 100 mg every 12 hours for 5 to 10 days

Pneumonia, acute community-acquired:

Infants >3 months and Children <12 years: Limited data available: Oral: 5 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose (Bradley 2015; IDSA [Bradley 2011])

Children ≥12 years and Adolescents: Oral: 200 mg every 12 hours for 14 days

Rhinosinusitis, acute maxillary:

Infants ≥2 months and Children <12 years: Oral: 5 mg/kg/dose every 12 hours for 10 days; maximum dose: 200 mg/dose; Note: IDSA recommends use in combination with clindamycin for 10 to 14 days in patients with nontype 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 and Adolescents: Oral: 200 mg every 12 hours for 10 days

Skin and skin structure: Children ≥12 years and Adolescents: Oral: 400 mg every 12 hours for 7 to 14 days

Urinary tract infection, uncomplicated: Children ≥12 years and Adolescents: Oral: 100 mg every 12 hours for 7 days

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Reconstitution

Suspension: Refer to manufacturer’s product labeling for reconstitution instructions.

Administration

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.

Dietary Considerations

Take tablets with food.

Storage

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.

Drug Interactions

Aminoglycosides: Cephalosporins may enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration 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. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. 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

Test Interactions

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

Adverse Reactions

>10%:

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

Warnings/Precautions

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.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.

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.

Monitoring Parameters

Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Patient Education

What is this drug used for?

• It is used to treat bacterial infections.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Diarrhea

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Seizures

Clostridioides (formerly Clostridium) difficile-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools.

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.