Cefpodoxime

Pharmacologic Category

Antibiotic, Cephalosporin (Third Generation)

Dosing: Adult

Chronic obstructive pulmonary disease, acute exacerbation: Oral: 200 mg twice daily for 3 to 7 days (GOLD 2019; Phillips 1993; Sethi 2020). Note: Some experts reserve cefpodoxime for patients without risk factors for poor outcomes (eg, age <65 years of age without major comorbidities, FEV₁ >50% predicted, infrequent exacerbations) (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-HNS [Rosenfeld 2015]; 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) (ESMID/IDSA [Gupta 2011]; Hooton 2020b).

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

Acute pyelonephritis or other complicated urinary tract infection (off-label use): Oral: 200 mg twice daily for 10 to 14 days (ESMID/IDSA [Gupta 2011]; Hooton 2020a, 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 (ESMID/IDSA [Gupta 2011]; Hooton 2020a).

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

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: Adult

Cirrhosis (with or without ascites): No dosage adjustment necessary.

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

Dosing: Renal Impairment: Pediatric

Infants ≥2 months, Children, and Adolescents:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: Administer every 24 hours.

Hemodialysis: Approximately 23% removed during a 3-hour dialysis session. Administer dose 3 times weekly after hemodialysis.

Dosing: Hepatic Impairment: Pediatric

Infants ≥ 2 months, Children, and Adolescents: No dosage adjustment necessary in patients with cirrhosis.

Calculations

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 (nonbeta-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.

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.

* See Uses in AHFS Essentials for additional information.

Use: Off-Label: Adult

Urinary tract infection, complicated (including pyelonephritis)Level of Evidence [C]

Clinical experience suggests the utility of cefpodoxime as an alternative agent in treatment of acute complicated urinary tract infection (including pyelonephritis) after administration of an appropriate parenteral agent ^Ref.

Level of Evidence Definitions

Level of Evidence Scale

Use: Unsupported: Adult

Gonorrhea

Based on Centers for Disease Control guidelines, cefpodoxime is no longer a recommended oral therapy for treatment of gonococcal infection based on inferior efficacy and less favorable pharmacodynamics compared to other treatment options (CDC [Workowski 2015]).

Class and Related Monographs

Cephalosporins

Clinical Practice Guidelines

Pneumonia, Community-Acquired

ATS/IDSA, "Diagnosis and Treatment of Adults With Community-Acquired Pneumonia," October 2019

IDSA/PIDS, "The Management of Community-Acquired Pneumonia in Infants and Children Older Than 3 Months of Age," 2011

Rhinosinusitis:

IDSA, “Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children and Adults,” 2012

Urinary Tract Infections:

IDSA, “International Clinical Practice Guidelines for the Treatment of Acute Uncomplicated Cystitis and Pyelonephritis in Women,” March 2011

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.

Administration: Pediatric

Oral:

Tablet: Administer with food

Suspension: May administer with or without food; shake suspension well before use

Dietary Considerations

Take tablets with food.

Storage/Stability

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.

Preparation for Administration: Adult

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

Preparation for Administration: Pediatric

Oral suspension: Reconstitute powder for oral suspension with appropriate amount of water as specified on the bottle. Shake vigorously until suspended.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat bacterial infections.

Frequently reported side effects of this drug

• Diarrhea

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Seizures

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

• Signs of a significant reaction like 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. 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 brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

Contraindications

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

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.

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.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

Considered one of the drugs of choice for outpatient treatment of community-acquired pneumonia in the elderly. Adjust dosage with renal function.

Pregnancy Risk Factor

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Breast-Feeding Considerations

Cefpodoxime is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends a decision be made to discontinue breastfeeding or to discontinue the drug, taking into account the importance of treatment to the mother.

In general, antibiotics that are present in breast milk may cause non-dose-related modification of bowel flora (WHO 2002).

Lexicomp Pregnancy & Lactation, In-Depth

Cefpodoxime

Briggs' Drugs in Pregnancy & Lactation

Cefpodoxime

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

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

Cephalosporin Allergy

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Aminoglycosides: Cephalosporins (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy

Antacids: May decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: 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. Risk X: Avoid combination

Histamine H2 Receptor Antagonists: May decrease the absorption of Cefpodoxime. Separate oral doses by at least 2 hours. Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy

Proton Pump Inhibitors: May decrease the serum concentration of Cefpodoxime. Risk C: 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. Risk D: 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. Risk D: Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Food Interactions

Food increases extent of absorption and peak concentration of tablets. Management: Take tablets with food.

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

Monitoring Parameters

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

Advanced Practitioners Physical Assessment/Monitoring

Assess results of culture/sensitivity tests and patient's allergy history prior to therapy. Assess prothrombin time. Monitor for hemolytic anemia, hypoprothrombinemia, and bleeding. Teach patient to report nephrotoxicity, opportunistic infection, and hypersensitivity reaction.

Nursing Physical Assessment/Monitoring

Results of culture/sensitivity tests and patient's allergy history should be assessed prior to therapy. Monitor prothrombin time. Monitor for hemolytic anemia, hypoprothrombinemia, and bleeding. Teach patient to report nephrotoxicity, opportunistic infection, and hypersensitivity reaction.

Dosage Forms: US

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

Anatomic Therapeutic Chemical (ATC) Classification

J01DD13

Generic Available (US)

Yes

Pricing: US

Suspension (reconstituted) (Cefpodoxime Proxetil Oral)

50 mg/5 mL (per mL): $0.86 - $0.91

100 mg/5 mL (per mL): $1.72

Tablets (Cefpodoxime Proxetil Oral)

100 mg (per each): $6.74

200 mg (per each): $8.46

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

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.

Pharmacodynamics/Kinetics

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

Protein binding: Serum: 22% to 33%; Plasma: 21% to 29%

Metabolism: De-esterified in GI tract to active metabolite, cefpodoxime

Bioavailability: Oral: 50%

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

Time to peak: Tablets: Within 2 to 3 hours; Oral suspension: Slower in presence of food, 48% increase in T_max

Excretion: Urine (~29% to 33% as unchanged drug) in 12 hours

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: Elimination is reduced in those with CrCl less than 50 mL/minute.

Geriatric: The half-life is increased to about 4.2 hours.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Cefpodoxime Proxetil; Vantin

FDA Approval Date

August 07, 1992

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Brand Names: International

Auropodox (TZ); Banadoz (ID); Banan (CN, HK, JP, KR, TH); Banan Dry Syrup (KR); Biocef (AT); Cefadox (PH); Cefdox (BD); Cefdoxime (KR); Cefirax (EC, PE, PY); Cefodox (AE, BH, CY, IL, IQ, IR, IT, JO, KW, LB, LU, LY, OM, QA, SA, SY, UA, YE); Cefpotek (UA); Ceodox (VN); Cepodem (IN, UA, ZA, ZW); Cepox (BD); Daedox (VN); Doxcef (EG); Forexo (CZ, RO, SK); Froxtil (KR); Leprox (BD); Leprox DS (BD); Maxispect (EG); Monocrin (LK); Necpod (VN); Nifin Kids (VN); Orelox (BB, BH, BM, BS, BZ, CH, CR, DE, DO, FI, FR, GR, GT, GY, HN, IT, JM, KW, LB, LU, MT, MX, NI, NO, PA, PK, PL, PT, QA, SR, SV, TT, VN); Otreon (AT, IT); Podacef (EG); Podomexef (CH, DE); Rexocef (HR); Swich (PH); Thirgecef (EG); Trefpod (HR); Trizef (PH); Zudem (PH)

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