Brand name: Duricef
Drug class: First Generation Cephalosporins
CAS number: 66592-87-8

Medically reviewed by Drugs.com on Sep 28, 2023. Written by ASHP.

Introduction

Antibacterial; β-lactam antibiotic; first generation cephalosporin.

Uses for Cefadroxil

Pharyngitis and Tonsillitis

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

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

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).

Skin and Skin Structure Infections

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

Urinary Tract Infections (UTIs)

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

Prevention of Bacterial Endocarditis

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

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.

Cefadroxil Dosage and Administration

Administration

Oral Administration

Administer orally.

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

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.

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

Shake oral suspension well prior to administration of each dose.

Dosage

Available as the monohydrate; dosage expressed as cefadroxil.

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. AAP states the drug is inappropriate for treatment of severe infections.

Pharyngitis and Tonsillitis

Oral

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

Skin and Skin Structure Infections

Impetigo

Oral

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

Other Skin and Skin Structure Infections

Oral

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

Urinary Tract Infections (UTIs)

Oral

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

Adults

Pharyngitis and Tonsillitis

Oral

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

Skin and Skin Structure Infections

Oral

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

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.

Other UTIs

Oral

2 g daily given in 2 divided doses.

Special Populations

Renal Impairment

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

Geriatric Patients

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

Cautions for Cefadroxil

Contraindications

• Known hypersensitivity to cefadroxil or other cephalosporins.

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

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

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile. 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. C. difficile produces toxins A and B which contribute to development of CDAD; 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.

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

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

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).

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).

Cross-hypersensitivity

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

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

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.

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

History of GI Disease

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

Coombs’ Test Results

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

Specific Populations

Pregnancy

Category B.

Lactation

Cephalosporins generally distributed into milk. Use with caution.

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.

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

Renal Impairment

Decreased clearance and increased half-life.

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

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

Common Adverse Effects

Dyspepsia, nausea, vomiting.

Cefadroxil Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed from GI tract. Peak serum concentrations attained within 1–2 hours.

Food

Food does not affect absorption.

Distribution

Extent

Cephalosporins widely distributed into tissues and fluids.

Plasma Protein Binding

20%.

Elimination

Metabolism

Not appreciably metabolized.

Elimination Route

≥70% of a dose excreted unchanged in urine.

Half-life

1.1–2 hours in adults with normal renal function.

Special Populations

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

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

Stability

Storage

Oral

Capsules and Tablets

20–25°C in tight container.

For Suspension

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

Actions and Spectrum

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

• Usually bactericidal.

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

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

• 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. Methicillin-resistant staphylococci (oxacillin-resistant staphylococci) and most enterococci are resistant.

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

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).

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

• 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.

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

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

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

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

• 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.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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

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Frequently asked questions

• What is the best antibiotic to treat strep throat?

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