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Cefadroxil

Pronunciation

Class: First Generation Cephalosporins
CAS Number: 66592-87-8
Brands: Duricef

Introduction

Antibacterial; β-lactam antibiotic; first generation cephalosporin.a

Uses for Cefadroxil

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci).100 120 121 Generally effective in eradicating S. pyogenes from nasopharynx; efficacy in prevention of subsequent rheumatic fever not established to date.100 120 121

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;111 116 117 119 other anti-infectives (e.g., oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.116 117 119

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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).116 117 119

Skin and Skin Structure Infections

Treatment of mild to moderate skin and skin structure infections caused by susceptible staphylococci or streptococci.100 120 121

Urinary Tract Infections (UTIs)

Treatment of mild to moderate UTIs, including acute prostatitis, caused by susceptible Escherichia coli, Klebsiella, or Proteus mirabilis.100 120 121

Prevention of Bacterial Endocarditis

Alternative for prevention of α-hemolytic (viridans group) streptococcal endocarditis in penicillin-allergic individuals undergoing certain dental or upper respiratory tract procedures who have cardiac conditions that put them at highest risk.115 119 Should not be used in those with immediate-type penicillin hypersensitivity (see Cross-hypersensitivity under Cautions).115 119

When selecting anti-infectives for prophylaxis of bacterial endocarditis, consult most recent AHA recommendations for specific information on which cardiac conditions are associated with highest risk of endocarditis and which procedures require prophylaxis.115

Cefadroxil Dosage and Administration

Administration

Oral Administration

Administer orally.100 120 121

May be given without regard to meals;100 120 121 administration with food may minimize adverse GI effects.100 120 121

Reconstitution

Reconstitute oral suspension at time of dispensing by adding the amount of water specified on the container in 2 equal portions; shake well after each addition.121

Reconstituted suspensions contain 125, 250, or 500 mg of cefadroxil/5 mL.121

Shake oral suspension well prior to administration of each dose.121

Dosage

Available as the monohydrate; dosage expressed as cefadroxil.100 121

Pediatric Patients

General Pediatric Dosage
Oral

Children beyond the neonatal period: AAP recommends 30 mg/kg daily in 2 equally divided doses for treatment of mild or moderate infections.119 AAP states the drug is inappropriate for treatment of severe infections.119

Pharyngitis and Tonsillitis
Oral

30 mg/kg daily given as a single dose or in 2 equally divided doses for 10 days.100 120 121

Skin and Skin Structure Infections
Impetigo
Oral

30 mg/kg daily given as a single dose or in 2 equally divided doses.100 120 121

Other Skin and Skin Structure Infections
Oral

30 mg/kg daily given in 2 equally divided doses.100 120 121

Urinary Tract Infections (UTIs)
Oral

30 mg/kg daily given in 2 equally divided doses.100 120 121

Adults

Pharyngitis and Tonsillitis
Oral

1 g daily given as a single dose or in 2 divided doses for 10 days.100 120 121

Skin and Skin Structure Infections
Oral

1 g daily given as a single dose or in 2 divided doses.100 120 121

Urinary Tract Infections (UTIs)
Uncomplicated Lower UTIs (e.g., Cystitis)
Oral

1 or 2 g daily given as a single dose or in 2 divided doses.100 120 121

Other UTIs
Oral

2 g daily given in 2 divided doses.100 120 121

Special Populations

Renal Impairment

Dosage adjustments required if Clcr ≤50 mL/minute per 1.73 m2.100 120 121 Use an initial 1-g dose followed by 500-mg maintenance doses given at intervals based on the degree of renal impairment.100 120 121 (See Table.)

Adult Dosage in Renal Impairment100120121

Clcr (mL/min per 1.73 m2)

Initial Dose

Maintenance Dosage

25–50

1 g

500 mg every 12 hours

10–25

1 g

500 mg every 24 hours

0–10

1 g

500 mg every 36 hours

Geriatric Patients

Cautious dosage selection because of age-related decreases in renal function.121 (See Renal Impairment under Dosage and Administration.)

Cautions for Cefadroxil

Contraindications

  • Known hypersensitivity to cefadroxil or other cephalosporins.100 120 121

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi with prolonged use.100 120 121 Close observation of the patient is essential.100 120 121 Institute appropriate therapy if superinfection occurs.100 120 121

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.100 120 121 142 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 cefadroxil, and may range in severity from mild diarrhea to fatal colitis.100 142 C. difficile produces toxins A and B which contribute to development of CDAD;100 142 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.100

Consider CDAD if diarrhea develops and manage accordingly.100 120 121 142 Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.100 142

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.100 142 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.100 120 121 142

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reactions (e.g., urticaria, pruritus, rash, 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, anaphylaxis).100 120 121 a

If a hypersensitivity reaction occurs, discontinue cefadroxil immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).100 120 121 a

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.100 120 121 a

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.100 120 121 a Cautious use recommended in patients with a history of hypersensitivity to penicillins:100 120 121 avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction104 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 cefadroxil and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.121

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.121 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.121

History of GI Disease

Use cephalosporins with caution in patients with a history of GI disease, particularly colitis.100 120 121 a (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

Coombs’ Test Results

Positive direct Coombs’ test results reported with cephalosporins.100 120 121 a This may interfere with certain hematologic studies or transfusion cross-matching procedures.100 120 121 a May also cause positive Coombs’ tests in neonates whose mothers received a cephalosporin prior to delivery.100 120 121 a

Specific Populations

Pregnancy

Category B.100 120 121

Lactation

Cephalosporins generally distributed into milk.a Use with caution.100 120 121

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.100 121

Substantially eliminated by kidneys and dosage adjustments are necessary in patients with impaired renal function.100 120 121 Select dosage with caution and consider renal function monitoring since geriatric patients are more likely to have renal impairment.100 120 121 (See Renal Impairment under Dosage and Administration.)

Renal Impairment

Decreased clearance and increased half-life.105 114

Monitor closely and assess renal function prior to and during therapy.100 120 121 Use with caution in those with markedly impaired renal function.100 120 121

Reduce dosage in those with Clcr ≤50 mL/minute.100 120 121 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Dyspepsia, nausea, vomiting.100 120 121

Cefadroxil Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed from GI tract.100 101 102 103 104 105 106 121 Peak serum concentrations attained within 1–2 hours.101 102 103 104 105 106 107 108 109 110 112 113

Food

Food does not affect absorption.100 102 107 108 109 121

Distribution

Extent

Cephalosporins widely distributed into tissues and fluids.a

Plasma Protein Binding

20%.a

Elimination

Metabolism

Not appreciably metabolized.100 121

Elimination Route

≥70% of a dose excreted unchanged in urine.100 101 102 103 104 105 106 107 110 112 113 121

Half-life

1.1–2 hours in adults with normal renal function.103 105 107 108 110 112

Special Populations

Clearance is decreased and half-life increased in patients with renal impairment.105 114

Half-life is 2.5–8.5 hours in those with Clcr 20–50 mL/minute per 1.73 m2 and 13.3–25.5 hours in those with Clcr < 20 mL/minute per 1.73 m2.114

Stability

Storage

Oral

Capsules and Tablets

20–25°C in tight container.100

For Suspension

20–25°C.121 After reconstitution, refrigerate in a tight container; discard after 14 days.121

Actions and Spectrum

  • First generation cephalosporin with a limited spectrum of activity compared with second and third generation cephalosporins.a

  • Usually bactericidal.100 121 a

  • Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.100 121 a

  • In vitro spectrum of activity includes some gram-positive aerobic bacteria and some gram-negative aerobic bacteria.100 121 a Inactive against anaerobic bacteria, fungi, and viruses.a

  • Gram-positive aerobes: active in vitro and in clinical infections against staphylococci (including penicillinase-producing strains), Streptococcus pyogenes (group A β-hemolytic streptococci), and S. pneumoniae.100 121 a Methicillin-resistant staphylococci (oxacillin-resistant staphylococci) and most enterococci are resistant.100 121 a

  • Gram-negative aerobes: active in vitro and in clinical infections against Moraxella catarrhalis, Escherichia coli, Klebsiella, and Proteus mirabilis.100 121 a Inactive against Acinetobacter, Enterobacter, Morganella morganii, P. vulgaris, and Pseudomonas.100 121 a

Advice to Patients

  • Advise patients that antibacterials (including cefadroxil) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).100 121

  • Importance of completing full course of therapy, even if feeling better after a few days.100 121

  • 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 cefadroxil or other antibacterials in the future.100 121

  • Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.100 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.100

  • Importance of discontinuing therapy and informing clinician if an allergic reaction occurs.100 120 121

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs as well as any concomitant illnesses.100 120 121

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.100 120 121

  • Importance of informing patients of other important precautionary information.100 120 121 (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

Cefadroxil

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

500 mg*

Cefadroxil Capsules

For suspension

125 mg/5mL*

Cefadroxil for Suspension

250 mg/5 mL*

Cefadroxil for Suspension

500 mg/5 mL*

Cefadroxil for Suspension

Tablets

1 g*

Cefadroxil 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.

Cefadroxil 1GM Tablets (TEVA PHARMACEUTICALS USA): 30/$139.99 or 60/$279.98

Cefadroxil 500MG Capsules (LUPIN PHARMACEUTICALS): 30/$35.99 or 60/$71.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 8, 2013. 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.

References

Only references cited for selected revisions after 1984 are available electronically.

100. West-ward Pharmaceutical Corp. Cefadroxil tablets, film coated and cefadroxil capsules prescribing information. Eatontown, NJ; 2011 Feb.

101. Hartstein AI, Patrick KE, Jones SR et al. Comparison of pharmacological and antimicrobial properties of cefadroxil and cephalexin. Antimicrob Agents Chemother. 1977; 12:93-7. [PubMed 883822]

102. Lode VH, Stahlmann R, Dzwillo G et al. Vergleichende Pharmakokinetik oraler Cephalosporine: Cephalexin, Cefaclor und Cefadroxil. (German; with English abstract.) Arzneim-Forsch. 1980; 30:505-9.

103. Marino EL, Dominguez-Gil A. Influence of dose on the pharmacokinetics of cefadroxil. Eur J Clin Pharmacol. 1980; 18:505-9. [IDIS 126977] [PubMed 7461017]

104. Marino EL, Dominguez-Gil A, Muriel C. Influence of dosage form and administration route on the pharmacokinetic parameters of cefadroxil. Int J Clin Pharmacol Ther Toxicol. 1982; 20:73-7. [PubMed 7061182]

105. Humbert G, Leroy A, Fillastre JP et al. Pharmacokinetics of cefadroxil in normal subjects and in patients with renal insufficiency. Infection. 1980; 8(Suppl 5):S598-602.

106. Hampel B, Lode H, Wagner J et al. Pharmacokinetics of cefadroxil and cefaclor during an eight-day dosage period. Antimicrob Agents Chemother. 1982; 22:1061-3. [IDIS 161996] [PubMed 7159069]

107. Pfeffer M, Jackson A, Ximenes J et al. Comparative human oral clinical pharmacology of cefadroxil, cephalexin, and cephradine. Antimicrob Agents Chemother. 1977; 11:331-8. [IDIS 82078] [PubMed 848940]

108. Lode H, Stahlmann R, Koeppe P. Comparative pharmacokinetics of cephalexin, cefaclor, cefadroxil, and CGP 9000. Antimicrob Agents Chemother. 1979; 16:1-6. [PubMed 475366]

109. Ginsburg CM, McCracken GH, Clahsen JC et al. Clinical pharmacology of cefadroxil in infants and children. Antimicrob Agents Chemother. 1978; 13:845-8. [PubMed 666305]

110. La Rosa F, Ripa S, Prenna M et al. Pharmacokinetics of cefadroxil after oral administration in humans. Antimicrob Agents Chemother. 1982; 21:320-2. [IDIS 146663] [PubMed 7073267]

111. Anon. Drugs for bacterial infections. Med Lett Treat Guid. 2010; 8:43-52.

112. Welling PG, Selen A, Pearson JG et al. A pharmacokinetic comparison of cephalexin and cefadroxil using HPLC assay procedures. Biopharm Drug Dispos. 1985; 6:147-57. [IDIS 200635] [PubMed 4005394]

113. Adam D, Gierschik P. Vergleichende Untersuchungen zur Pharmakokinetik von Cefadroxil und Amoxicillin nach oraler Nuchterngabe. (German; with English abstract.) Infection. 1980; 8(Suppl 5):S567-72.

114. Cutler RE, Blair AD, Kelly MR. Cefadroxil kinetics in patients with renal insufficiency. Clin Pharmacol Ther. 1979; 25:514-21. [IDIS 97087] [PubMed 436355]

115. Wilson W, Taubert KA, Gewitz M et al. Prevention of infective endocarditis. Guidelines from the American Heart Association. A guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation. 2007 Apr 19. (Epub ahead of print).

116. Shulman ST, Bisno AL, Clegg HW et al. Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America. Clin Infect Dis. 2012; 55:1279-82. [PubMed 23091044]

117. Gerber MA, Baltimore RS, Eaton CB et al. Prevention of rheumatic fever and diagnosis and treatment of acute Streptococcal pharyngitis: a scientific statement from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young, the Interdisciplinary Council on Functional Genomics and Translational Biology, and the Interdisciplinary Council on Quality of Care and Outcomes Research: endorsed by the American Academy of Pediatrics. Circulation. 2009; 119:1541-51. [PubMed 19246689]

118. Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing: Twenty-first informational supplement. CLSI document M100-S21. Wayne, PA; 2011.

119. American Academy of Pediatrics. Red Book: 2012 Report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012.

120. Ranbaxy. Cefadroxil tablets and capsules USP prescribing information. Princeton, NJ. 2002 May.

121. Ranbaxy Pharmaceuticals Inc. Cefadroxil monohydrate powder for oral suspension prescribing information. Jacksonville, FL; 2007 Mar.

142. Cohen SH, Gerding DN, Johnson S et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010; 31:431-55. [PubMed 20307191]

a. AHFS Drug Information 2003. McEvoy GK, ed. Cephalosporins General Statement. American Society of Health-System Pharmacists; 2003:125-39.

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