Treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci). Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established to date.
CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice; oral cephalosporins and oral macrolides considered alternatives. Amoxicillin sometimes used instead of penicillin V, especially for young children.
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, include 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† 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.
Dosage and Administration
Administration
Oral Administration
Administer orally.
May be given without regard to meals; administration with food may minimize adverse GI effects.
Dosage
Available as the monohydrate; dosage expressed as cefadroxil.
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. 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.
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.†
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.
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.†
Special Populations
Renal Impairment
Dosage adjustments required if Clcr ≤50 mL/minute per 1.73 m2. Use an initial 1-g induction dose followed by 500-mg maintenance doses given at intervals based on the degree of renal impairment. (See Table.)
Adult Dosage in Renal Impairment
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. Cautious dosage selection because of age-related decreases in renal function. (See Renal Impairment under Dosage and Administration.)
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 may permit overgrowth of Clostridium difficile. 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.
Consider CDAD if diarrhea develops and manage accordingly. 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.
If CDAD is suspected or confirmed, the anti-infective may need to be discontinued. Some mild cases may respond to discontinuance alone. 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.
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 transfusioncross-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 assess renal function periodically because of age-related decreases in renal function. (See Renal Impairment under Dosage and Administration.)
Renal Impairment
Decreased clearance and increased half-life.
Use with caution in those with markedly impaired renal function. Monitor closely and assess renal function prior to and during therapy.
Reduce dosage in those with Clcr ≤50 mL/minute. (See Renal Impairment under Dosage and Administration.)
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 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.
Stability
Storage
Oral
Capsules and Tablets
15–30°C in tight container.
For Suspension
15–30°C. After reconstitution, refrigerate in a tight container and discard after 14 days.
Actions
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. Oxacillin-resistant staphylococci (methicillin-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.
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.
* 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 09/2009. 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.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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