Cefpodoxime Proxetil

Class: Third Generation Cephalosporins
CAS Number: 87239-81-4
Brands: Vantin

Introduction

Antibacterial; β-lactam antibiotic; aminothiazolyl third generation cephalosporin.^{1 2 3 14}

Uses for Cefpodoxime Proxetil

Acute Otitis Media (AOM)

Treatment of AOM caused by S. pneumoniae (penicillin-susceptible strains only), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains).^{1 28 29 30 31 61}

Not a drug of first choice; considered a preferred alternative to amoxicillin or amoxicillin and clavulanate when these drugs are ineffective or cannot be used (e.g., in patients with a history of non-type 1 hypersensitivity reactions to penicillin).^{12 61}

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by susceptible S. pyogenes (group A β-hemolytic streptococci).^{1 10 11 12 14 23 26 27 38 40} Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established to date.¹

CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;^{10 11 12 16 59} oral cephalosporins and oral macrolides considered alternatives.^{11 12 16 59} Amoxicillin sometimes used instead of penicillin V, especially for young children.^{12 11}

Respiratory Tract Infections

Treatment of acute maxillary sinusitis caused by susceptible Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), or Moraxella catarrhalis.^{1 14 23 39 40}

Treatment of acute exacerbations of chronic bronchitis caused by susceptible S. pneumoniae, H. influenzae (non-β-lactamase-producing strains only), or M. catarrhalis.^{1 14 21 37}

Treatment of mild to moderate community-acquired pneumonia (CAP) caused by susceptible S. pneumoniae or H. influenzae (including β-lactamase-producing strains).^{1 14 22} Recommended by ATS and IDSA as an alternative for treatment of CAP caused by penicillin-susceptible S. pneumoniae.⁵⁸ Also recommended as an alternative in certain combination regimens used for empiric treatment of CAP.⁵⁸ Select regimen for empiric treatment of CAP based on most likely pathogens and local susceptibility patterns; after pathogen is identified, modify to provide more specific therapy (pathogen-directed therapy).⁵⁸

For empiric outpatient treatment of CAP when risk factors for drug-resistant S. pneumoniae are present (e.g., comorbidities such as chronic heart, lung, liver, or renal disease, diabetes, alcoholism, malignancies, asplenia, immunosuppression, use of anti-infectives within the last 3 months), ATS and IDSA recommend monotherapy with a fluoroquinolone active against S. pneumoniae (moxifloxacin, gemifloxacin, levofloxacin) or, alternatively, a combination regimen that includes a β-lactam active against S. pneumoniae (high-dose amoxicillin or fixed combination of amoxicillin and clavulanic acid or, alternatively, ceftriaxone, cefpodoxime, or cefuroxime) given in conjunction with a macrolide (azithromycin, clarithromycin, erythromycin) or doxycycline.⁵⁸ Cefpodoxime and cefuroxime may be less active against S. pneumoniae than amoxicillin or ceftriaxone.⁵⁸

If an oral cephalosporin is used as an alternative to penicillin G or amoxicillin for treatment of CAP caused by penicillin-susceptible S. pneumoniae, ATS and IDSA recommend cefpodoxime, cefprozil, cefuroxime, cefdinir, or cefditoren.⁵¹

Gonorrhea and Associated Infections

Treatment of acute, uncomplicated, urethral or cervical gonorrhea caused by susceptible Neisseria gonorrhoeae (including penicillinase-producing strains [PPNG]).^{1 12 13 15 63 64}

Treatment of uncomplicated anorectal gonorrhea in women;¹ efficacy for treatment of anorectal infections in men has not been established.¹

Data do not support use for treatment of pharyngeal gonococcal infections in men or women.¹

For treatment of uncomplicated cervical, urethral, or rectal gonorrhea in adults and adolescents, CDC, AAP, and others recommend IM ceftriaxone or oral cefixime;^{12 13 15 64} IM ceftriaxone is the drug of choice for pharyngeal infections.⁶⁴ CDC states that some evidence suggests that oral cefpodoxime may be an alternative for uncomplicated urogenital gonorrhea.^{13 64}

Follow-up treatment of disseminated gonococcal infections† after an initial parenteral regimen (ceftriaxone or, alternatively, cefotaxime, ceftizoxime, or spectinomycin [not currently commercially available in the US]).⁶⁴

Skin and Skin Structure Infections

Treatment of mild to moderate uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase- and non-penicillinase-producing strains) or S. pyogenes.^{1 14 24}

Urinary Tract Infections (UTIs)

Treatment of uncomplicated UTIs (cystitis) caused by susceptible Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or S. saprophyticus.^{1 14 25}

Cefpodoxime Proxetil Dosage and Administration

Administration

Oral Administration

Administer orally.¹

Administer tablets with food.¹

Administer oral suspension without regard to meals.¹

Reconstitution

Reconstitute oral suspension at time of dispensing by adding the amount of water specified on the container in two portions; invert bottle and shake after each addition.¹

Reconstituted solution contains 50 or 100 mg of cefpodoxime/5 mL.¹

Shake suspension well prior to administration of each dose.¹

Dosage

Available as cefpodoxime proxetil; dosage expressed in terms of cefpodoxime.¹

Pediatric Patients

Acute Otitis Media (AOM)

Oral

Children 2 months through 12 years of age: 5 mg/kg every 12 hours for 5 days.¹

Pharyngitis and Tonsillitis

Oral

Children 2 months through 12 years of age: 5 mg/kg every 12 hours for 5–10 days.¹

Children ≥12 years of age: 100 mg every 12 hours for 5–10 days.¹

Respiratory Tract Infections

Acute Sinusitis

Oral

Children 2 months through 12 years of age: 5 mg/kg every 12 hours for 10 days.¹

Children ≥12 years of age: 200 mg every 12 hours for 10 days.¹

Acute Exacerbations of Chronic Bronchitis

Oral

Children ≥12 years of age: 200 mg every 12 hours for 10 days.¹

Community-acquired Pneumonia

Oral

Children ≥12 years of age: 200 mg every 12 hours for 14 days.¹

Gonorrhea and Associated Infections

Uncomplicated Urethral or Cervical Gonorrhea in Adolescents

Oral

Children ≥12 years of age: Manufacturer recommends 200 mg as a single dose.¹

Adolescents: CDC recommends 400 mg as a single dose.^{15 64}

Uncomplicated Anorectal Gonorrhea in Adolescent Girls

Oral

Adolescent girls ≥12 years of age: Manufacturer recommends 200 mg as a single dose.¹

Disseminated Gonococcal Infections in Adolescents†

Oral

400 mg twice daily recommended by CDC; given to complete ≥1 week of treatment after an initial parenteral regimen of ceftriaxone, cefotaxime, ceftizoxime, or spectinomycin (not currently commercially available in the US).⁶⁴

Skin and Skin Structure Infections

Oral

Children ≥12 years of age: 400 mg every 12 hours for 7–14 days.¹

Urinary Tract Infections (UTIs)

Oral

Children ≥12 years of age: 100 mg every 12 hours for 7 days.¹

Adults

Pharyngitis and Tonsillitis

Oral

100 mg every 12 hours for 5–10 days.¹

Respiratory Tract Infections

Acute Maxillary Sinusitis

Oral

200 mg every 12 hours for 10 days.¹

Acute Exacerbations of Chronic Bronchitis

Oral

200 mg every 12 hours for 10 days.¹

Community-acquired Pneumonia

Oral

200 mg every 12 hours for 14 days.¹

Gonorrhea and Associated Infections

Uncomplicated Urethral or Cervical Gonorrhea in Men or Women

Oral

Manufacturer recommends 200 mg as a single dose.¹

CDC recommends 400 mg as a single dose.⁶⁴

Uncomplicated Anorectal Gonorrhea in Women

Oral

Manufacturer recommends 200 mg as a single dose.¹

Disseminated Gonococcal Infections in Adults†

Oral

400 mg twice daily recommended by CDC; given to complete ≥1 week of treatment after an initial parenteral regimen of ceftriaxone, cefotaxime, ceftizoxime, or spectinomycin (not currently commercially available in the US).⁶⁴

Skin and Skin Structure Infections

Oral

400 mg every 12 hours for 7–14 days.¹

Urinary Tract Infections (UTIs)

Oral

100 mg every 12 hours for 7 days.¹

Prescribing Limits

Pediatric Patients

Acute Otitis Media (AOM)

Oral

Maximum 200 mg every 12 hours for children 2 months to 12 years of age.¹

Pharyngitis and Tonsillitis

Oral

Maximum 100 mg every 12 hours for children 2 months to 12 years of age.¹

Acute Maxillary Sinusitis

Oral

Maximum 200 mg every 12 hours for children 2 months to 12 years of age.¹

Special Populations

Hepatic Impairment

No dosage adjustments required in patients with cirrhosis (with or without ascites).¹

Renal Impairment

Patients with Cl_cr <30 mL/minute: Give usual dose once every 24 hours.¹

Patients maintained on hemodialysis: Give usual dose 3 times weekly after dialysis.¹

Geriatric Patients

No dosage adjustments except those related to renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Cautions for Cefpodoxime Proxetil

Contraindications

• 
  

  Known hypersensitivity to cefpodoxime or other cephalosporins.¹

  
  

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible organisms, including Enterobacter, Pseudomonas, enterococci, or Candida, with prolonged use.¹ Careful observation of the patient is essential.¹ Institute appropriate therapy if superinfection occurs.¹

Treatment with anti-infectives may permit overgrowth of Clostridium difficile.¹ C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including cefpodoxime, and may range in severity from mild diarrhea to fatal colitis.¹

Consider CDAD if diarrhea develops and manage accordingly.¹ Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.¹

Some mild cases of CDAD may respond to discontinuance alone.^{1 a} Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.^{1 a}

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reactions such as urticaria, pruritus, rash (maculopapular, erythematous, morbilliform), fever and chills, eosinophilia, joint pain or inflammation, edema, erythema, genital and anal pruritus, angioedema, shock, hypotension, vasodilatation, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis, and anaphylaxis reported with cephalosporins.^a

If a hypersensitivity reaction occurs, discontinue cefpodoxime and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).¹

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.^{1 50}

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.¹ Cautious use recommended in patients with a history of hypersensitivity to penicillins:¹ avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction^{1 50 51} and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.^a

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of cefpodoxime and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.¹

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.^a In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹

Specific Populations

Pregnancy

Category B.¹

Lactation

Distributed into milk.¹ Discontinue nursing or cefpodoxime.¹

Pediatric Use

Safety and efficacy not established in children <2 months of age.¹

Adverse effects in pediatric patients similar to those in adults.^{1 14 22 26 29 30 31}

Geriatric Use

Safety and efficacy in those ≥65 years of age similar to that in younger adults.¹

Plasma half-life may be slightly increased, however other pharmacokinetic parameters are unaffected.^{1 32 33}

Consider age-related decreases in renal function when selecting dosage and adjust dosage if necessary.^{1 32 33} (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Pharmacokinetics not altered⁶ ; no dosage adjustments required.¹

Renal Impairment

Decreased clearance in patients with moderate to severe renal impairment (Cl_cr <50 mL/minute);¹ reduce dosage if Cl_cr <30 mL/minute.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Diarrhea, loose stools, nausea, vomiting.^{1 2 14 40}

Interactions for Cefpodoxime Proxetil

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Antacids (sodium bicarbonate or aluminum-containing)	Decreased absorption of cefpodoxime1
Diuretics		Caution if used concomitantly with potent diuretics1
Histamine H2-receptor antagonists	Decreased absorption of cefpodoxime1
Nephrotoxic drugs	Potential for increased risk of nephrotoxicitya	Closely monitor renal function when used concomitantly with nephrotoxic drugs1
Probenecid	Decreased clearance and increased cefpodoxime plasma concentrations1
Tests for glucose	Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solutiona	Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)a

Cefpodoxime Proxetil Pharmacokinetics

Absorption

Bioavailability

Cefpodoxime proxetil is a prodrug that is absorbed from the GI tract and de-esterified to the active metabolite, cefpodoxime.¹

About 50% of a dose is absorbed from the GI tract;^{1 6 14} peak plasma concentrations of cefpodoxime attained within 2–3 hours.¹

Food

Food increases bioavailability of cefpodoxime proxetil tablets but does not affect bioavailability of the oral suspension.^{1 6 57}

Distribution

Extent

Distributed into blister fluid,^{1 6} interstitial fluid,¹⁴ middle ear fluid,¹⁹ tonsils,^{1 6 14 36} maxillary sinus mucosa,⁶ bronchial mucosa,¹⁴ pleural fluid,^{6 14 35} lung tissue,^{1 6 20 34} epithelial lining fluid,²⁰ myometrium,^{6 14} seminal fluid,^{6 14} prostatic adenoma tissue,^{6 14} and bile.⁶

Cefpodoxime is distributed into milk.^{1 14}

Plasma Protein Binding

21–29%.¹

Elimination

Metabolism

Cefpodoxime proxetil is a prodrug and is inactive until hydrolyzed in vivo to cefpodoxime by nonspecific esterases within the intestinal lumen.^{1 2 6 14}

Cefpodoxime is not appreciably metabolized.¹

Elimination Route

Approximately 53% of a dose eliminated in urine and 43% eliminated in feces as cefpodoxime.⁶

Half-life

2.1–3.3 hours in adults with normal renal function.^{1 6 14}

Special Populations

Cirrhosis does not affect the half-life or renal clearance of the drug.¹ Ascites does not appear to affect values in cirrhotic patients.¹

Clearance decreased in patients with moderate to severe renal impairment (Cl_cr <50 mL/minute).¹ Plasma half-life averages 3.5 hours in those with mild renal impairment and 5.9 or 9.8 hours in those with moderate or severe renal impairment, respectively.¹

In geriatric patients, plasma half-life averages 4.2 hours;¹ other pharmacokinetic values are similar to those in younger adults.¹

Stability

Storage

Oral

Tablets

20–25°C.¹ Protect from excessive moisture.¹

For Suspension

20–25°C.¹ After reconstitution, refrigerate in tight container at 2–8°C;¹ discard after 14 days.¹

Actions and SpectrumActions

• 
  

  Third generation cephalosporin with an expanded spectrum of activity against aerobic gram-negative bacteria compared with first and second generation cephalosporins.^{1 2 3 7 8 9 14}

  
  


• 
  

  Cefpodoxime proxetil is a prodrug that is inactive until hydrolyzed in vivo to cefpodoxime.^{1 5 6 14}

  
  


• 
  

  Usually bactericidal.^{1 a}

  
  


• 
  

  Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.^{1 a}

  
  


• 
  

  Gram-positive aerobes: Active in vitro and in clinical infections against Staphylococcus aureus (including penicillinase-producing strains), S. saprophyticus, Streptococcus pneumoniae (penicillin-susceptible strains only), S. pyogenes (group A β-hemolytic streptococci).¹ Also active in vitro against S. agalactiae (group B streptococci) and groups C, F, and G streptococci.¹ Enterococci (e.g., Enterococcus faecalis) and oxacillin-resistant (methicillin-resistant) staphylococci are resistant.¹

  
  


• 
  

  Strains of staphylococci resistant to penicillinase-resistant penicillins (oxacillin-resistant [methicillin-resistant] staphylococci) should be considered resistant to cefixime, although results of in vitro susceptibility tests may indicate susceptibility.¹⁷

  
  


• 
  

  Gram-negative aerobes: Active in vitro and in clinical infections against Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Haemophilus influenza (including β-lactamase-producing strains), Moraxella catarrhalis, and Neisseria gonorrhoeae.¹ Also active in vitro against Citrobacter diversus, K. oxytoca, P. vulgaris, Providencia rettgeri, H. parainfluenzae.¹ Inactive against Pseudomonas and Enterobacter.^{1 14}

  
  


• 
  

  Stable in the presence of a variety of β-lactamases produced by gram-positive and gram-negative bacteria.^{1 2 14}

  
  

Advice to Patients

• 
  

  Advise patients that antibacterials (including cefpodoxime) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).¹

  
  


• 
  

  Importance of completing full course of therapy, even if feeling better after a few days.¹

  
  


• 
  

  Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefpodoxime or other antibacterials in the future.¹

  
  


• 
  

  Importance of administering tablets with food.¹ Oral suspension may be administered without regard to meals.¹

  
  


• 
  

  Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.¹ Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.¹

  
  


• 
  

  Importance of discontinuing cefpodoxime and informing clinician if an allergic reaction occurs.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, or concomitant illnesses.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cefpodoxime Proxetil

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For suspension	50 mg (of cefpodoxime) per 5 mL	Vantin	Pfizer
		100 mg (of cefpodoxime) per 5 mL	Vantin	Pfizer
	Tablets, film-coated	100 mg (of cefpodoxime)*	Cefpodoxime Proxetil Film-coated Tablets
			Vantin	Pfizer
		200 mg (of cefpodoxime)*	Cefpodoxime Proxetil Film-coated Tablets
			Vantin	Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Cefpodoxime Proxetil 200MG Tablets (RANBAXY PHARMACEUTICALS): 20/$126 or 60/$355.95

Vantin 100MG/5ML Suspension (PFIZER U.S.): 100/$113.99 or 300/$328.97

Vantin 100MG Tablets (PFIZER U.S.): 20/$127.99 or 60/$350.96

Vantin 200MG Tablets (PFIZER U.S.): 20/$194.37 or 60/$534.81

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions December 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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