Generic Name: Cefadroxil
Class: First Generation Cephalosporins
CAS Number: 66592-87-8
Introduction
Antibacterial; β-lactam antibiotic; first generation cephalosporin.a
Uses for Duricef
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 the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established to date.100 120 121
CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;116 117 118 119 oral cephalosporins and oral macrolides considered alternatives.116 117 118 119 Amoxicillin sometimes used instead of penicillin V, especially for young children.116 119
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, include 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.115 116 Should not be used in those with immediate-type penicillin hypersensitivity (see Cross-hypersensitivity under Cautions).115
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
Duricef 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
Dosage
Available as the monohydrate; dosage expressed as cefadroxil.100
Pediatric Patients
General Pediatric Dosage
Oral
AAP recommends 30 mg/kg daily in 2 equally divided doses for treatment of mild or moderately severe infections in children ≥1 month of age.116 AAP states the drug is inappropriate for treatment of severe infections.116
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
Prevention of Bacterial Endocarditis†
Patients Undergoing Certain Dental or Upper Respiratory Tract Procedures†
Oral
50 mg/kg (up to 2 g) as a single dose given 1 hour prior to the procedure.116
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
Prevention of Bacterial Endocarditis†
Patients Undergoing Certain Dental or Upper Respiratory Tract Procedures†
Oral
2 g as a single dose given 1 hour prior to the procedure.116
Special Populations
Renal Impairment
Dosage adjustments required if Clcr ≤50 mL/minute per 1.73 m2.100 120 121 Use an initial 1-g induction 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)
|
Induction 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
No dosage adjustments except those related to renal impairment.a Cautious dosage selection because of age-related decreases in renal function.a (See Renal Impairment under Dosage and Administration.)
Cautions for Duricef
Contraindications
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 may permit overgrowth of Clostridium difficile.100 120 121 Clostridium 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 cefadroxil, and may range in severity from mild diarrhea to fatal colitis.100
Consider CDAD if diarrhea develops and manage accordingly.100 120 121 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.100
If CDAD is suspected or confirmed, the anti-infective may need to be discontinued.100 Some mild cases may respond to discontinuance alone.100 120 121 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.100 120 121 a
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.100
When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.100 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.100
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 assess renal function periodically because of age-related decreases in renal function.100 120 121 (See Renal Impairment under Dosage and Administration.)
Renal Impairment
Decreased clearance and increased half-life.100 120
Use with caution in those with markedly impaired renal function.100 120 121 Monitor closely and assess renal function prior to and during therapy.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
Duricef Pharmacokinetics
Absorption
Bioavailability
Rapidly and almost completely absorbed from GI tract.100 101 102 103 104 105 106 Peak serum concentrations attained within 1–2 hours.101 102 103 104 105 106 107 108 109 110 111 112 113
Food
Food does not affect absorption.100 102 107 108 109
Distribution
Extent
Cephalosporins widely distributed into tissues and fluids.a
Plasma Protein Binding
20%.a
Elimination
Metabolism
Not appreciably metabolized.100
Elimination Route
≥70% of a dose excreted unchanged in urine.100 101 102 103 104 105 106 107 110 111 112 113
Half-life
1.1–2 hours in adults with normal renal function.103 105 107 108 110 111 112
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
15–30°C in tight container.100 120
For Suspension
15–30°C.100 After reconstitution, refrigerate in a tight container and discard after 14 days.100 121
Actions and SpectrumActions
First generation cephalosporin with a limited spectrum of activity compared with second and third generation cephalosporins.a
Usually bactericidal.100 a
Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.100 a
In vitro spectrum of activity includes some gram-positive aerobic bacteria and some gram-negative aerobic bacteria.100 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 a Oxacillin-resistant staphylococci (methicillin-resistant staphylococci) and most enterococci are resistant.100 a
Gram-negative aerobes: active in vitro and in clinical infections against Moraxella catarrhalis, Escherichia coli, Klebsiella, and Proteus mirabilis.100 a Inactive against Acinetobacter, Enterobacter, Morganella morganii, P. vulgaris, and Pseudomonas.100 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
Importance of completing full course of therapy, even if feeling better after a few days.100
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
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
|
Ranbaxy, Sandoz, Teva
|
|
For suspension
|
250 mg/5 mL*
|
Cefadroxil for Suspension
|
Ranbaxy
|
|
|
|
Duricef
|
Warner-Chilcott
|
|
|
500 mg/5 mL*
|
Cefadroxil for Suspension
|
Ranbaxy
|
|
|
|
Duricef
|
Warner-Chilcott
|
|
Tablets
|
1 g*
|
Cefadroxil Tablets
|
Ranbaxy, Teva
|
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.
Cefadroxil 1GM Tablets (TEVA PHARMACEUTICALS USA): 30/$139.99 or 60/$279.98
Cefadroxil 500MG Capsules (TEVA PHARMACEUTICALS USA): 30/$34.99 or 60/$69.98
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 March 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.
References
Only references cited for selected revisions after 1984 are available electronically.
100. Warner Chilcott. Duricef (cefadroxil monohydrate) prescribing information. Rockaway, NJ. 2007 Apr.
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. Simon VC. Zur Pharmakokinetik von Cefadroxil, einem neuen Oral-Cephalosporin. (German; with English abstract.) Arzneim-Forsch. 1980; 30:502-4.
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. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006:754,834.
117. Dajani A, Taubert K, Ferrieri P et al and the American Heart Association Committee on Rheumatic Fever et al. Treatment of acute streptococcal pharyngitis and prevention of rheumatic fever: a statement for health professionals. Pediatrics. 1995; 96:758-64. [IDIS 355409] [PubMed 7567345]
118. Cooper RJ, Hoffman JR, Bartlett JG et al. Principles of appropriate antibiotic use for acute pharyngitis in adults: background. Ann Intern Med. 2001; 134:509-17. [IDIS 460578] [PubMed 11255530]
119. Bisno AL, Gerber MA, Gwaltney JM et al et al. Diagnosis and management of group A streptococcal pharyngitis: a practice guideline. Clin Infect Dis. 1997; 25:574-83. [PubMed 9314443]
120. Ranbaxy. Cefadroxil tablets and capsules USP prescribing information. Princeton, NJ. 2002 May.
121. Ranbaxy. Cefadroxil for oral suspension, USP prescribing information. Princeton, NJ. 2003 Nov.
a. AHFS Drug Information 2003. McEvoy GK, ed. Cephalosporins General Statement. American Society of Health-System Pharmacists; 2003:125-39.
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Compare Duricef with other medications
- Bacterial Endocarditis Prevention
- Impetigo
- Kidney Infections
- Skin and Structure Infection
- Skin Infection
- Tonsillitis/Pharyngitis
- Upper Respiratory Tract Infection
- Urinary Tract Infection