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Cefprozil (Systemic)

Introductory Information

Antibacterial; β-lactam antibiotic; second generation cephalosporin.1, a

Class: 8:12.06.08 Second Generation Cephalosporins

Brands*: Cefzil®

*also available generically

Generic Name: Cefprozil

CAS Number: 92665-29-7
Chemical Name: (6R, 7R)-7-[(R)-2-amino-2-(p-hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-
azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate

Uses

Acute Otitis Media (AOM)

Treatment of AOM caused by S. pneumoniae, H. influenzae (including β-lactamase-producing strains), or

M. catarrhalis (including β-lactamase-producing strains).1, 3, 4, 12, 21, 30, 36, 37, 43, 44, 45, 62, 80, 81

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci).1

Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in prevention of
subsequent rheumatic fever has not been established to date.1, 80, 81

CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as
treatments of choice;48, 49, 50, 59, 76 oral cephalosporins and oral macrolides considered alternatives.48,
49, 50, 59, 76 Amoxicillin sometimes used instead of penicillin V, especially for young children.48, 50

Respiratory Tract Infections

Treatment of acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-

lactamase-producing strains), or Moraxella catarrhalis (including β-lactamase-producing strains).1, 34, 65,
80, 81

Treatment of secondary bacterial infections of acute bronchitis caused by susceptible S. pneumoniae, H.

influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing
strains).1, 16, 38, 80, 81

Treatment of acute bacterial exacerbation of chronic bronchitis caused by susceptible S. pneumoniae, H.

influenzae (including β-lactamase producing strains), or M. catarrhalis (including β-lactamase producing
strains).1, 16, 38, 80, 81

Treatment of mild to moderate community-acquired pneumonia (CAP).20 If an oral cephalosporin is

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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.20

Skin and Skin Structure Infections

Treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus
(including penicillinase-producing strains) or S. pyogenes.1, 10, 35, 63, 80, 81

Also has been used for treatment of uncomplicated skin and skin structure infections caused by S.
epidermidis , S. saprophyticus , group B or G streptococci , E. coli , or K. pneumoniae .10, 35

Dosage and Administration

Administration

Oral Administration
Administer orally without regard to meals.1, 80, 81

Dosage

Available as cefprozil monohydrate; dosage expressed as anhydrous cefprozil.1, 80, 81

Pediatric Patients
Acute Otitis Media (AOM)
Oral: Children 6 months to 12 years of age: 15 mg/kg every 12 hours for 10 days.1, 80, 81

Pharyngitis or Tonsillitis
Oral: Children 2-12 years of age: 7.5 mg/kg every 12 hours for 10 days.1, 80, 81
Children ≥13 years of age: 500 mg once daily for 10 days.1, 80, 81

Respiratory Tract Infections

>Acute Sinusitis
Oral: Children 6 months to 12 years of age: 7.5 mg/kg every 12 hours for 10 days.1, 80, 81 For moderate
to severe infections, 15 mg/kg every 12 hours for 10 days.1, 80, 81
Children ≥13 years of age: 250 mg every 12 hours for 10 days.1, 80, 81 For moderate to severe infections,
500 mg every 12 hours for 10 days.1, 80, 81

>Secondary Bacterial Infections of Acute Bronchitis

Oral: Children ≥13 years of age: 500 mg every 12 hours for 10 days.1, 80, 81

>Acute Exacerbations of Chronic Bronchitis

Oral: Children ≥13 years of age: 500 mg every 12 hours for 10 days.1, 80, 81

Skin and Skin Structure Infections

Oral: Children 2-12 years of age: 20 mg/kg once every 24 hours for 10 days.1, 80, 81
Children ≥13 years of age: 250 or 500 mg every 12 hours for 10 days or 500 mg once daily for 10 days.1,
80, 81

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Adults
Pharyngitis or Tonsillitis
Oral: 500 mg once daily for 10 days.1, 80, 81

Respiratory Tract Infections

>Acute Sinusitis
Oral: 250 mg every 12 hours for 10 days.1, 80, 81 For moderate to severe infections, 500 mg every 12
hours for 10 days.1, 80, 81

>Secondary Bacterial Infections of Acute Bronchitis

Oral: 500 mg every 12 hours for 10 days.1, 80, 81

>Acute Exacerbations of Chronic Bronchitis

Oral: 500 mg every 12 hours for 10 days.1, 80, 81

Skin and Skin Structure Infections

Oral: 250 or 500 mg every 12 hours for 10 days or 500 mg once daily for 10 days.1, 80, 81

Special Populations

Hepatic Impairment
No dosage adjustments required.1, 80, 81

Renal Impairment
No dosage adjustments required in patients with Clcr ≥30 mL/minute.1, 7, 80, 81

Patients with Clcr <30 mL/minute: administer 50% of the usual dose using the usual dosing intervals.1, 80,
81

Hemodialysis patients: administer cefprozil doses after dialysis sessions.1, 80, 81

Geriatric Patients
No dosage adjustments required except those related to renal impairment.1, 80, 81 Cautious dosage
selection because of age-related decreases in renal function.1, 80, 81 See Renal Impairment under Dosage
and Administration.

Cautions

Contraindications

• Known allergy to cefprozil or other cephalosporins.1, 80, 81

Warnings/Precautions

Warnings
Superinfection/Clostridium difficile-associated Diarrhea and Colitis
Possible emergence and overgrowth of nonsusceptible bacteria or fungi with prolonged use.1, 80, 81

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Careful observation of the patient is essential.1, 80, 81 Institute appropriate therapy if superinfection
occurs.1, 80, 81

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium
difficile.1, 80, 81 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 cefprozil, and may range in severity from mild diarrhea to fatal colitis.1 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

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1, 80, 81 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

If CDAD is suspected or confirmed, the anti-infective may need to be discontinued.1 Some mild cases
may respond to discontinuance alone.1, 69, 70, 71, 72, 73 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, 69, 70, 71, 72

Sensitivity Reactions
Hypersensitivity Reactions
Hypersensitivity reactions (anaphylaxis,1 serum-sickness-like reactions,1, 14 erythema,9, 12 Stevens-
Johnson syndrome1, 14) have been reported.1

If a hypersensitivity reaction occurs, discontinue cefprozil immediately 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

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 a 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 cefprozil and other
antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be
caused by susceptible bacteria.1, 80, 81

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility
testing.1, 80, 81 In the absence of such data, consider local epidemiology and susceptibility patterns when
selecting anti-infectives for empiric therapy.1, 80, 81

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Phenylketonuria
Oral suspensions containing 125 or 250 mg of cefprozil/5 mL contain aspartame (NutraSweet®), which is
metabolized in the GI tract to provide 28 mg of phenylalanine/5 mL.1, 3, 81

Other commercially available preparations do not contain aspartame;1 these other preparations should be
used in individuals with phenylketonuria (i.e., homozygous genetic deficiency of phenylalanine
hydroxylase) and other individuals who must restrict their intake of phenylalanine.1

History of GI Disease
Cephalosporins should be used with caution in patients with a history of GI disease, particularly colitis.1,
80, 81 (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

Coombs' Test Results

Positive direct Coombs' test results reported with some cephalosporins.1, a This may interfere with certain
hematologic studies or transfusion cross-matching procedures.a May also cause positive Coombs' tests in
neonates whose mothers received a cephalosporin prior to delivery.a

Specific Populations
Pregnancy
Category B.1, 80, 81

Lactation
Distributed into milk; use with caution.1, 80, 81

Pediatric Use
Safety and efficacy not established in infants <6 months of age for the treatment of AOM or acute
sinusitis.1, 80, 81

Safety and efficacy not established in children <2 years of age for the treatment of pharyngitis or
tonsillitis or for uncomplicated skin and skin structure infections.1, 80, 81

Geriatric Use
Safety and efficacy in those ≥65 years of age similar to that in younger adults, but possibility exists of
greater sensitivity to the drug in some geriatric patients.1, 80, 81

Cefprozil is substantially eliminated by kidneys and risk of toxicity may be greater in patients with
impaired renal function.1, 80, 81 Assess renal function periodically since geriatric patients are more likely
to have renal impairment.1, 80, 81

Hepatic Impairment
Half-life only slightly prolonged.1 No dosage adjustments required.1

Renal Impairment
Decreased clearance.1, 80, 81

Use with caution in those with known or suspected renal impairment.1, 80, 81 Monitor closely and assess
renal function prior to and during therapy.1, 80, 81

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Reduce dosage in those with Clcr <30 mL/minute.1, 80, 81 See Renal Impairment under Dosage and
Administration.

Common Adverse Effects

Diarrhea, nausea, vomiting, rash, genital pruritus or vaginitis, dizziness.1, 9

Interactions

Specific Drugs and Laboratory Tests

Drug or Test Interaction Comments

Nephrotoxicity has been reported when
Aminoglycosides aminoglycosides used concomitantly with
some cephalosporins1
Study using capsules (not commercially
Antacids available) indicate bioavailability not affected
when given 5 minutes after an antacid1
Caution if used concomitantly with
Diuretics potent diuretics since such drugs may
adversely affect renal function1
Probenecid Increased cefprozil AUC1
Possible false-positive reactions in urine
glucose tests using Clinitest®, Benedict's Use glucose tests based on enzymatic
Tests for glucose solution, or Fehling's solution1 glucose oxidase reactions (e.g.,
False-negative reaction possible in blood Clinistix®, Tes-Tape®)1
glucose tests using ferricyanide

Pharmacokinetics

Absorption

Bioavailability
Rapidly and almost completely absorbed from GI tract.1 Bioavailability is 90-95% in fasting adults;1, 21,
24 peak plasma concentrations attained within 1.5 hours.1, 61

Tablets and oral suspension are bioequivalent under fasting conditions.1

Food
Food does not affect absorption or peak plasma concentrations, but time to peak plasma concentrations
may be prolonged by 15-45 minutes.1 Not considered clinically important.1

Distribution

Extent
Distributed into various body tissues and fluids including blister fluid,21, 22 middle ear fluid,26 and

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tonsillar and adenoidal tissue.21, 27

Distributed into milk in low concentrations.1, 5

Plasma Protein Binding

35-45%.1, 23

Elimination

Metabolism
Not appreciably metabolized.21, 22, 23, 24, 28

Elimination Route
Eliminated principally in urine by glomerular filtration and tubular secretion.21, 22, 23, 24, 28

54-70% of a single dose eliminated unchanged in urine within 24 hours.1, 21, 22, 23, 24, 28

Half-life
Adults with normal renal function: 1-1.4 hours.1, 21, 22, 23, 28

Children 6 months to 12 years of age: 0.94-2.1 hours.1, 13, 21

Special Populations
In geriatric patients, clearance decreased and AUC increased.1

Plasma half-life increased slightly in patients with hepatic impairment (about 2 hours).1, 21

Prolonged plasma half-life (up to 5.2-5.9 hours) in patients with renal impairment.1, 7

Stability

Storage

Oral
Tablets
15-30°C.1, 80

For Suspension
15-25°C.1, 81 After reconstitution, store in a refrigerator and discard after 14 days.1, 81

Actions and Spectrum

• Second generation cephalosporin active against some aerobic gram-negative bacteria that generally are
resistant to first generation cephalosporins, but has a narrower spectrum of activity than third
generation cephalosporins.1, 3, 11
• Usually bactericidal.1, a
• Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall
synthesis.1, a

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• In vitro spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic
bacteria, and some anaerobic bacteria.1 Inactive against fungi and viruses.a
• Gram-positive aerobes: active in vitro and in clinical infections against Staphylococcus aureus
(including β-lactamase-producing strains), Streptococcus pneumoniae, and S. pyogenes (group A β-
hemolytic streptococci).1 Also active in vitro against Enterococcus durans, E. faecalis, Listeria
monocytogenes, Staphylococcus epidermidis, S. saprophyticus, S. warneri, Streptococcus agalactiae
(group B streptococci), and groups C, D, F, and G streptococci.1 E. faecium and oxacillin-resistant
(methicillin-resistant) staphylococci are resistant.1
• Gram-negative aerobes: active in vitro and in clinical infections against Haemophilus influenzae
(including β-lactamase producing strains) and Moraxella catarrhalis (including β-lactamase-producing
strains).1, 21, a Also active in vitro against Citrobacter diversus, Escherichia coli, Klebsiella
pneumonia, Neisseria gonorrhoeae, (including β-lactamase-producing strains), Proteus mirabilis,
Salmonella, Shigella, and Vibrio.1 Inactive against most strains of Acinetobacter, Enterobacter,
Morganella morganii, P. vulgaris, Providencia, Pseudomonas, and Serratia.1
• Anaerobes: active in vitro against Prevotella melaninogenicus, Clostridium difficile, C. perfringens,
Fusobacterium, Peptostreptococcus, and Propionibacterium acnes.1 Most strains of Bacteroides
fragilis are resistant.1
• Strains of staphylococci resistant to penicillinase-resistant penicillins (oxacillin-resistant staphylococci)
should be considered resistant to cefprozil, although results of in vitro susceptibility tests may indicate
that the organisms are susceptible to the drug.19 In addition, β-lactamase-negative, ampicillin-resistant
(BLNAR) strains of H. influenzae should be considered resistant to cefprozil despite the fact that
results of in vitro susceptibility tests may indicate that the organisms are susceptible to the drug.19

Advice to Patients

• Advise patients that antibacterials (including cefprozil) should only be used to treat bacterial infections
and not used to treat viral infections (e.g., the common cold).1, 80, 81
• Importance of completing full course of therapy, even if feeling better after a few days.1, 80, 81
• 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 cefprozil or other antibacterials in the future.1, 80, 81
• 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
• Advise individuals with phenylketonuria and other individuals who must restrict their intake of
phenylalanine that cefprozil oral suspensions contain aspartame (NutraSweet®), which is metabolized
in the GI tract to phenylalanine.1, 81
• Importance of notifying clinician of persistent or worsening symptoms of infection.1, 80, 81
• Importance of informing clinician if history includes allergy or sensitivity to cephalosporins or
penicillins.1, 80, 81, a
• Importance of discontinuing cefprozil and informing clinician if an allergic or hypersensitivity reaction
occurs.1, 80, 81, a
• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-
feed.1, 80, 81, a
• Importance of informing clinician of existing or contemplated concomitant therapy, including
prescription and OTC drugs.a
• Importance of informing patients of other important precautionary information. (See Cautions.)

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Preparations

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

Cefprozil
Routes Dosage Forms Strengths Brand Names Manufacturer
125 mg (of anhydrous cefprozil) Cefprozil for
Oral For suspension
per 5 mL* Suspension
Bristol-Myers
Cefzil® Squibb
250 mg (of anhydrous cefprozil) Cefprozil for
per 5 mL* Suspension
Bristol-Myers
Cefzil® Squibb
Tablets, film- Cefprozil Film-coated
250 mg (of anhydrous cefprozil)*
coated Tablets
Bristol-Myers
Cefzil® Squibb
Cefprozil Film-coated
500 mg (of anhydrous cefprozil)*
Tablets
Bristol-Myers
Cefzil® Squibb
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary)
name

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing
information was updated 03/2011. For the most current and up-to-date pricing information, please visit
www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-
order locations and health insurance copays.

Cefzil 250MG/5ML Suspension (B-M SQUIBB U.S. (PRIMARY CARE)): 100/$73.99 or 300/$212.97

Cefzil 250MG/5ML Suspension (B-M SQUIBB U.S. (PRIMARY CARE)): 50/$45.99 or 150/$115.97

Cefzil 250MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 20/$109.99 or 60/$305.96

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

References

1. Bristol-Myers Squibb. Cefzil (cefprozil) tablets and for oral suspension prescribing information.
Princeton, NJ; 2007 Mar.

2. Bristol-Myers Squibb US Pharmaceutical Division, Princeton, NJ: Personal communication.

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3. Anon. Cefprozil. Med Lett Drugs Ther. 1992; 34:63-4. [PubMed 1608347]

4. Arguedas AG, Zaleska M, Stutman HR et al. Comparative trial of cefprozil vs. amoxicillin
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5. Shyu WC, Shah VR, Campbell DA et al. Excretion of cefprozil into human breast milk. Antimicrob
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6. Barriere SL. Pharmacology and pharmacokinetics of cefprozil. Clin Infect Dis. 1992; 14(Suppl
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7. Shyu WC, Pittman KA, Wilber RB et al. Pharmacokinetics of cefprozil in healthy subjects and
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8. Christenson JC, Swenson E, Gooch WM III et al. Comparative efficacy and safety of cefprozil
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respiratory tract infections: a focus on bronchitis. Infect Med. 1992; (Suppl E):1-9.

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Oct.

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19. Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility
testing; sixteenth informational supplement. CLSI document M100-S16. Wayne, PA; 2006.

20. Mandell LA, Wunderink RG, Anzueto A et al. Infectious Diseases Society of America/American
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27. Shyu WC, Reilly J, Campbell DA et al. Penetration of cefprozil into tonsillar and adenoidal tissues.
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31. Klein JO. Selection of oral antimicrobial agents for otitis media and pharyngitis. Infect Dis Clin
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33. McCarty JM, Renteria A. Treatment of pharyngitis and tonsillitis with cefprozil: review of three

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multicenter trials. Clin Infect Dis. 1992; 14(Suppl 2):S224-30. [IDIS 297200] [PubMed 1617042]

34. van den Wijngaart W, Verbrugh H, Theopold HM et al. A noncomparative study of cefprozil at
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