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Cefpodoxime Proxetil

Pronunciation

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

Introduction

Antibacterial; β-lactam antibiotic; aminothiazolyl third generation cephalosporin.1 2 3 14 66

Uses for Cefpodoxime Proxetil

Acute Otitis Media (AOM)

Treatment of AOM caused by Streptococcus pneumoniae (penicillin-susceptible strains only), Haemophilus influenzae (including β-lactamase-producing strains), or Moraxella catarrhalis (including β-lactamase-producing strains).1 28 29 30 31 37 66

When anti-infectives indicated, AAP recommends high-dose amoxicillin or amoxicillin and clavulanate as drugs of choice for initial treatment of AOM; certain cephalosporins (cefdinir, cefpodoxime, cefuroxime, ceftriaxone) recommended as alternatives for initial treatment in penicillin-allergic patients without a history of severe and/or recent penicillin-allergic reactions.37

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by susceptible S. pyogenes (group A β-hemolytic streptococci).1 10 11 14 23 26 27 38 40 66 Generally effective in eradicating S. pyogenes from nasopharynx; efficacy in prevention of subsequent rheumatic fever not established to date.1 66

AAP, IDSA, AHA, and others recommend a penicillin regimen (10 days of oral penicillin V or oral amoxicillin or single dose of IM penicillin G benzathine) as treatment of choice for S. pyogenes pharyngitis and tonsillitis;10 11 16 17 other anti-infectives (oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.10 11 16 17

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If an oral cephalosporin used, 10-day regimen of first generation cephalosporin (cefadroxil, cephalexin) preferred instead of other cephalosporins with broader spectrums of activity (e.g., cefaclor, cefdinir, cefixime, cefpodoxime, cefuroxime).10 16 17

Respiratory Tract Infections

Treatment of acute maxillary sinusitis caused by susceptible S. pneumoniae, H. influenzae (including β-lactamase-producing strains), or M. catarrhalis.1 14 23 39 40 66 Because of variable activity against S. pneumoniae and H. influenzae, IDSA no longer recommends second or third generation oral cephalosporins for empiric monotherapy of acute bacterial sinusitis.43 Oral amoxicillin or amoxicillin and clavulanate usually recommended for empiric treatment.43 44 If an oral cephalosporin used as an alternative in children (e.g., in penicillin-allergic individuals), combination regimen that includes a third generation cephalosporin (cefixime or cefpodoxime) and clindamycin (or linezolid) recommended.43 44

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 61 66

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 66 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 cefdinir, cefditoren, cefpodoxime, cefprozil, or cefuroxime.51

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 66

Urinary Tract Infections (UTIs)

Treatment of uncomplicated UTIs (cystitis) caused by susceptible Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or S. saprophyticus.1 14 25 66

Some clinicians suggest that certain oral third generation cephalosporins (cefdinir, cefpodoxime, ceftibuten) are one of several alternatives for outpatient treatment of recurrent UTIs or UTIs that occur in patients who have indwelling urinary catheters or acquired the infections in hospitals or nursing homes; these infections likely to be caused by multidrug-resistant gram-negative bacilli.11

Gonorrhea and Associated Infections

Has been used for treatment of acute, uncomplicated, urethral or cervical gonorrhea caused by susceptible Neisseria gonorrhoeae (including penicillinase-producing strains [PPNG]).1 10 13 15 63 66 Has been used for treatment of uncomplicated anorectal gonorrhea in women.1 66

Efficacy for treatment of anorectal infections in men or pharyngeal gonococcal infections in men or women not established.1 66

Because of concerns related to recent reports of N. gonorrhoeae with reduced susceptibility to cephalosporins, CDC states that oral cephalosporins no longer recommended as first-line treatment for uncomplicated gonorrhea.68 For treatment of uncomplicated urogenital, anorectal, or pharyngeal gonorrhea, CDC recommends a combination regimen that includes a single dose of IM ceftriaxone and either a single dose of oral azithromycin or 7-day regimen of oral doxycycline.68

Cefpodoxime Proxetil Dosage and Administration

Administration

Oral Administration

Administer orally.1 66

Administer tablets with food.1 (See Food under Pharmacokinetics.)

Administer oral suspension without regard to meals.66

Reconstitution

Reconstitute oral suspension at time of dispensing by adding amount of water specified on the container in 2 portions; invert bottle and shake after each addition.66

Reconstituted suspension contains 50 or 100 mg of cefpodoxime/5 mL.66

Shake suspension well prior to administration of each dose.66

Dosage

Available as cefpodoxime proxetil; dosage expressed in terms of cefpodoxime.1 66

Pediatric Patients

General Pediatric Dosage
Oral

Children beyond neonatal period: AAP recommends 10 mg/kg daily in 2 equally divided doses for treatment of mild or moderate infections.10 AAP states the drug is inappropriate for treatment of severe infections.10

Acute Otitis Media (AOM)
Oral

Children 2 months through 12 years of age: 5 mg/kg every 12 hours for 5 days.66

AAP does not recommend oral anti-infective regimens of <10 days’ duration in children <2 years of age or in patients with severe symptoms.37

Pharyngitis and Tonsillitis
Oral

Children 2 months through 12 years of age: 5 mg/kg every 12 hours for 5–10 days.66

Children ≥12 years of age: 100 mg every 12 hours for 5–10 days.1 66

IDSA and AHA do not recommend cephalosporin regimens of ≤5 days’ duration.16 17

Respiratory Tract Infections
Acute Sinusitis
Oral

Children 2 months through 12 years of age: 5 mg/kg every 12 hours for 10 days.66

Children ≥12 years of age: 200 mg every 12 hours for 10 days.1 66

Acute Exacerbations of Chronic Bronchitis
Oral

Children ≥12 years of age: 200 mg every 12 hours for 10 days.1 66

Community-acquired Pneumonia
Oral

Children ≥12 years of age: 200 mg every 12 hours for 14 days.1 66

Skin and Skin Structure Infections
Oral

Children ≥12 years of age: 400 mg every 12 hours for 7–14 days.1 66

Urinary Tract Infections (UTIs)
Oral

Children ≥12 years of age: 100 mg every 12 hours for 7 days.1 66

Gonorrhea and Associated Infections
Uncomplicated Gonorrhea in Adolescents
Oral

Uncomplicated urethral or cervical gonorrhea in adolescents ≥12 years of age: Manufacturer recommends 200 mg as a single dose.1 66

Uncomplicated anorectal gonorrhea in adolescent girls ≥12 years of age: Manufacturer recommends 200 mg as a single dose.1 66

Not recommended by CDC as first-line treatment.68 (See Gonorrhea and Associated Infections under Uses.)

Adults

Pharyngitis and Tonsillitis
Oral

100 mg every 12 hours for 5–10 days.1 66

IDSA and AHA do not recommend cephalosporin regimens of ≤5 days’ duration.16 17

Respiratory Tract Infections
Acute Maxillary Sinusitis
Oral

200 mg every 12 hours for 10 days.1 66

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 66

Skin and Skin Structure Infections
Oral

400 mg every 12 hours for 7–14 days.1 66

Urinary Tract Infections (UTIs)
Oral

100 mg every 12 hours for 7 days.1 66

Gonorrhea and Associated Infections
Uncomplicated Gonorrhea
Oral

Uncomplicated urethral or cervical gonorrhea: Manufacturer recommends 200 mg as a single dose.1 66

Uncomplicated anorectal gonorrhea in women: Manufacturer recommends 200 mg as a single dose.1 66

Not recommended by CDC as first-line treatment.68 (See Gonorrhea and Associated Infections under Uses.)

Prescribing Limits

Pediatric Patients

Acute Otitis Media (AOM)
Oral

Maximum 200 mg every 12 hours for children 2 months to 12 years of age.66

Pharyngitis and Tonsillitis
Oral

Maximum 100 mg every 12 hours for children 2 months to 12 years of age.66

Acute Maxillary Sinusitis
Oral

Maximum 200 mg every 12 hours for children 2 months to 12 years of age.66

Special Populations

Hepatic Impairment

Dosage adjustments not required in patients with cirrhosis (with or without ascites).1 66

Renal Impairment

Patients with Clcr <30 mL/minute: Give usual dose once every 24 hours.1 66

Patients maintained on hemodialysis: Give usual dose 3 times weekly after dialysis.1 66

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 66

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 66 Careful observation of the patient is essential.1 Institute appropriate therapy if superinfection occurs.1 66

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 42 66 C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including cefpodoxime, and may range in severity from mild diarrhea to fatal colitis.1 42 66 C. difficile produces toxins A and B which contribute to development of CDAD;1 40 42 hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.1 40

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 42 66 Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.1 42 66

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.1 42 66 Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.1 42 66

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 66

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.1 50 66

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.1 66 Cautious use recommended in patients with a history of hypersensitivity to penicillins:1 66 avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction1 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 66

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 66 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1 66

Phenylketonuria

Depending on the manufacturer, oral suspension may contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 17 mg of phenylalanine per 5 mL.66 101 102 103 104 105

Specific Populations

Pregnancy

Category B.1 66

Lactation

Distributed into milk.1 66 Discontinue nursing or cefpodoxime.1 66

Pediatric Use

Safety and efficacy not established in neonates or infants <2 months of age.1 66

Adverse effects in pediatric patients similar to those in adults.1 14 22 26 29 30 31 66

Geriatric Use

Safety and efficacy in those ≥65 years of age similar to that in younger adults.1 66

Plasma half-life may be slightly increased, however other pharmacokinetic parameters are unaffected.1 32 33 66

Consider age-related decreases in renal function when selecting dosage and adjust dosage if necessary.1 32 33 66 (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Pharmacokinetics not altered6 ; dosage adjustments not required.1 66

Renal Impairment

Decreased clearance in patients with moderate to severe renal impairment (Clcr <50 mL/minute);1 reduce dosage if Clcr <30 mL/minute.1 66 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Diarrhea, loose stools, nausea, vomiting.1 2 14 40 66

Interactions for Cefpodoxime Proxetil

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Antacids (sodium bicarbonate or aluminum-containing)

Decreased absorption of cefpodoxime1 66

Diuretics

Caution if used concomitantly with potent diuretics1 66

Histamine H2-receptor antagonists

Decreased absorption of cefpodoxime1 66

Nephrotoxic drugs

Potential for increased risk of nephrotoxicitya

Closely monitor renal function when used concomitantly with nephrotoxic drugs1 66

Probenecid

Decreased clearance and increased cefpodoxime plasma concentrations1 66

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 66

About 50% of a dose is absorbed from the GI tract;1 6 14 66 peak plasma concentrations of cefpodoxime attained within 2–3 hours.1 66

Food

Food increases bioavailability of cefpodoxime proxetil tablets but does not affect bioavailability of the oral suspension.1 6 57 66

Distribution

Extent

Distributed into blister fluid,1 6 66 interstitial fluid,14 middle ear fluid,19 tonsils,1 6 14 36 66 maxillary sinus mucosa,6 bronchial mucosa,14 pleural fluid,6 14 35 lung tissue,1 6 20 34 66 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 66

Plasma Protein Binding

21–29%.1 66

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 66

Cefpodoxime is not appreciably metabolized.1 66

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 66

Special Populations

Cirrhosis does not affect the half-life or renal clearance of the drug.1 66 Ascites does not appear to affect values in cirrhotic patients.1 66

Clearance decreased in patients with moderate to severe renal impairment (Clcr <50 mL/minute).1 66 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 66

In geriatric patients, plasma half-life averages 4.2 hours;1 66 other pharmacokinetic values are similar to those in younger adults.1 66

Stability

Storage

Oral

Tablets

20–25°C in tight container.1

For Suspension

20–25°C.66 After reconstitution, refrigerate suspension in tight container at 2–8°C;66 discard after 14 days.66

Actions and Spectrum

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

  • Cefpodoxime proxetil is a prodrug that is inactive until hydrolyzed in vivo to cefpodoxime.1 5 6 14 66

  • Usually bactericidal.1 66

  • Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.1 66 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 66 Also active in vitro against S. agalactiae (group B streptococci) and groups C, F, and G streptococci.1 66 Enterococci (e.g., Enterococcus faecalis) and methicillin-resistant (oxacillin-resistant) staphylococci are resistant.1 66

  • 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 66 Also active in vitro against Citrobacter diversus, K. oxytoca, P. vulgaris, Providencia rettgeri, H. parainfluenzae.1 66 Inactive against Pseudomonas and Enterobacter.1 14 66

  • Stable in the presence of a variety of β-lactamases produced by gram-positive and gram-negative bacteria.1 2 14 66

  • Strains of staphylococci resistant to penicillinase-resistant penicillins (methicillin-resistant [oxacillin-resistant] staphylococci) should be considered resistant to cefixime, although results of in vitro susceptibility tests may indicate susceptibility.65

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 66

  • Importance of completing full course of therapy, even if feeling better after a few days.1 66

  • 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 66

  • Importance of administering tablets with food.1 Oral suspension may be administered without regard to meals.66

  • Importance of informing patients with phenylketonuria that cefpodoxime oral suspension may contain aspartame, depending on the manufacturer.66

  • Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.1 66 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 66

  • Importance of discontinuing cefpodoxime and informing clinician if an allergic reaction occurs.1 66

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 66

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, or concomitant illnesses.1 66

  • Importance of informing patients of other important precautionary information.1 66 (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*

Cefpodoxime Proxetil for Suspension

100 mg (of cefpodoxime) per 5 mL*

Cefpodoxime Proxetil for Suspension

Tablets, film-coated

100 mg (of cefpodoxime)*

Cefpodoxime Proxetil Film-coated Tablets

200 mg (of cefpodoxime)*

Cefpodoxime Proxetil Film-coated Tablets

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. 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 (SANDOZ): 20/$127.00 or 60/$355.96

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

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 9, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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