Pharmacologic Category
Antibiotic, Cephalosporin (First Generation)
Dosing: Adult
Prosthetic joint infection, staphylococci (oxacillin-susceptible), chronic oral antimicrobial suppression (off-label use): 500 mg every 12 hours (Osmon 2013)
Skin and skin structure infections: Oral: 1 g daily in a single or 2 divided doses
Streptococcal pharyngitis (group A) (alternative agent for mild [non-anaphylactic] penicillin allergy): Oral: 1 g once daily for 10 days (IDSA [Shulman 2012]; Pichichero 2018; manufacturer’s labeling)
Manufacturer’s labeling: Dosing in the prescribing information may not reflect current clinical practice. 500 mg twice daily
Urinary tract infection (UTI) (alternative agent):
Note: Use with caution and only when recommended agents cannot be used (due to decreased efficacy of oral beta-lactams compared to other agents) (Hooton 2018a; ESMID/IDSA [Gupta 2011]; Greenberg 1986; Sandberg 1990).
Cystitis, acute uncomplicated: Oral: 500 mg twice daily (Greenberg 1986; Hooton 1995) for 5 to 7 days (Greenberg 1986; Hooton 2018a)
UTI, complicated (including pyelonephritis): Oral: 1 g twice daily (Sandberg 1990) for 10 to 14 days (Hooton 2018b; Sandberg 1990). Note: Oral therapy should follow appropriate parenteral therapy. For outpatient treatment of mild infection, a single dose of a long-acting parenteral agent is acceptable; for outpatients who are more ill or are at risk for more severe illness, consider continuing parenteral therapy until culture and susceptibility results are available (ESMID/IDSA [Gupta 2011]; Hooton 2018b).
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
Initial: 1 g as a single dose.
Maintenance:
CrCl >50 mL/minute: No dosage adjustment necessary.
CrCl 25 to 50 mL/minute: 500 mg every 12 hours.
CrCl 10 to 25 mL/minute: 500 mg every 24 hours.
CrCl <10 mL/minute: 500 mg every 36 hours.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer’s labeling.
Dosing: Pediatric
General dosing, susceptible infection: Mild to moderate infection: Infants, Children, and Adolescents: Oral: 15 mg/kg/dose twice daily; maximum daily dose: 2,000 mg/day (Red Book [AAP 2015])
Impetigo: Children and Adolescents: Oral: 30 mg/kg/day in a single dose or divided every 12 hours; maximum daily dose: 1,000 mg/day
Pharyngitis/tonsillitis: Children and Adolescents: Oral: 30 mg/kg/day in a single dose or divided every 12 hours for 10 days; maximum daily dose: 1,000 mg/day
Skin and skin structure infections: Children and Adolescents: Oral: 15 mg/kg/dose every 12 hours; maximum daily dose: 1,000 mg/day
Urinary tract infections: Children and Adolescents: Oral: 15 mg/kg/dose every 12 hours; maximum daily dose: 2,000 mg/day
Dosing: Renal Impairment: Pediatric
Infants, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling for this age group; however, the following have been used by some clinicians (Aronoff 2007): Dosing based on a usual dose of 30 mg/kg/day in divided doses every 12 hours:
CrCl ≥30 mL/minute/1.73 m2: No dosage adjustment necessary
CrCl 10 to 29 mL/minute/1.73 m2: 15 mg/kg/dose every 24 hours
CrCl <10 mL/minute/1.73 m2: 15 mg/kg/dose every 36 hours
Hemodialysis, intermittent: 15 mg/kg/dose every 24 hours
Peritoneal dialysis: 15 mg/kg/dose every 36 hours
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling.
Calculations
Use: Labeled Indications
Pharyngitis and/or tonsillitis: Treatment of pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (group A beta-hemolytic streptococci).
Skin and skin structure infections: Treatment of skin and skin structure infections caused by staphylococci and/or streptococci.
Urinary tract infection: Treatment of urinary tract infections caused by Escherichia coli, Proteus mirabilis, and Klebsiella species.
* See Uses in AHFS Essentials for additional information.
Use: Off-Label: Adult
Prosthetic joint infection with Staphylococci (oxacillin-susceptible)Level of Evidence [G]
Based on the Infectious Diseases Society of America (IDSA) guidelines for the management of prosthetic joint infection, cefadroxil is an effective and recommended agent for chronic oral antimicrobial suppression of prosthetic joint infection with Staphylococci (oxacillin-susceptible) after completion of parenteral therapy.
Level of Evidence Definitions
Level of Evidence Scale
Class and Related Monographs
Clinical Practice Guidelines
Pharyngitis, Group A Streptococci:
IDSA, “Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis,” September 2012
Prosthetic Joint Infection:
IDSA, “Diagnosis and Management of Prosthetic Joint Infection: Clinical Practice Guideline,” January 2013
Administration: Oral
Administer around-the-clock to promote less variation in peak and trough serum levels. Administer without regards to meals; administration with food may diminish GI complaints.
Administration: Pediatric
Oral: May be administered without regard to food; administration with food may decrease nausea or vomiting; shake suspension well before use.
Storage/Stability
Store capsules, tablets and unreconstituted oral suspension at 20°C to 25°C (68°F to 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F). After reconstitution, oral suspension may be stored for 14 days under refrigeration (4°C).
Preparation for Administration: Adult
Powder for suspension: Refer to manufacturer’s product labeling for reconstitution instructions. Shake vigorously until suspended.
Preparation for Administration: Pediatric
Oral: Reconstitute powder for oral suspension with appropriate amount of water as specified on the bottle. Shake vigorously until suspended.
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used to treat bacterial infections.
Frequently reported side effects of this drug
• Diarrhea
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.
• Chills
• Sore throat
• Seizures
• Vaginal pain, itching, and discharge
• Clostridioides (formerly Clostridium) difficile-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools.
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Medication Safety Issues
Sound-alike/look-alike issues:
Contraindications
Hypersensitivity to cefadroxil, any component of the formulation, or other cephalosporins
Warnings/Precautions
Concerns related to adverse effects:
• Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, may occur. If an allergic reaction occurs, discontinue treatment and institute appropriate supportive measures.
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Colitis: Use with caution in patients with a history of gastrointestinal disease, particularly colitis.
• Renal impairment: Use with caution in patients with renal impairment (CrCl <50 mL/minute/1.73 m2); dosage adjustment may be needed.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer’s labeling
• Suspension: May contain sulfur dioxide (sulfite); hypersensitivity reactions, including anaphylaxis and/or asthmatic exacerbations, may occur (may be life threatening).
Other warnings/precautions:
• Appropriate use: Only IM penicillin has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil is generally effective in the eradication of streptococci from the oropharynx; efficacy data for cefadroxil in the prophylaxis of subsequent rheumatic fever episodes are not available.
* See Cautions in AHFS Essentials for additional information.
Geriatric Considerations
Adjust dose for renal function.
Warnings: Additional Pediatric Considerations
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Pregnancy Risk Factor
B
Pregnancy Considerations
Adverse events have not been observed in animal reproduction studies. Cefadroxil crosses the placenta. Limited data is available concerning the use of cefadroxil in pregnancy; however, adverse fetal effects were not noted in a small clinical trial.
Breast-Feeding Considerations
Very small amounts of cefadroxil are excreted in breast milk. The manufacturer recommends that caution be exercised when administering cefadroxil to nursing women. Nondose-related effects could include modification of bowel flora.
Lexicomp Pregnancy & Lactation, In-Depth
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
1% to 10%: Gastrointestinal: Diarrhea
<1%: postmarketing, and/or case reports: Abdominal pain, agranulocytosis, anaphylaxis, angioedema, arthralgia, cholestasis, Clostridioides (formerly Clostridium) difficile-associated diarrhea, dyspepsia, erythema multiforme, erythematous rash, fever, genital candidiasis, hepatic failure, increased serum transaminases, maculopapular rash, nausea, neutropenia, pruritus, pseudomembranous colitis, serum sickness, Stevens-Johnson syndrome, thrombocytopenia, urticaria, vaginitis, vomiting
* See Cautions in AHFS Essentials for additional information.
Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Test Interactions
Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction
Monitoring Parameters
Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.
Advanced Practitioners Physical Assessment/Monitoring
Assess results of culture/sensitivity tests and patient's allergy history prior to therapy. Assess anticoagulants patient may be taking for potential interactions. Hypersensitivity can occur several days after therapy is started. Advise patients with diabetes about use of Clinitest®. Teach patient to report hypersensitivity, opportunistic infection, renal dysfunction, and anemia.
Nursing Physical Assessment/Monitoring
Results of culture/sensitivity tests and patient's allergy history should be assessed prior to therapy. Hypersensitivity can occur several days after therapy is started. Advise patients with diabetes about use of Clinitest®. Teach patient to report hypersensitivity, opportunistic infection, renal dysfunction, and anemia.
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Generic: 500 mg
Suspension Reconstituted, Oral:
Generic: 250 mg/5 mL (50 mL, 100 mL); 500 mg/5 mL (75 mL, 100 mL)
Tablet, Oral:
Generic: 1 g
Dosage Forms: Canada
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Generic: 500 mg
Anatomic Therapeutic Chemical (ATC) Classification
Generic Available (US)
Yes
Pricing: US
Capsules (Cefadroxil Oral)
500 mg (per each): $3.72
Suspension (reconstituted) (Cefadroxil Oral)
250 mg/5 mL (per mL): $0.61
500 mg/5 mL (per mL): $0.84
Tablets (Cefadroxil Oral)
1 g (per each): $7.00 - $7.14
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Mechanism of Action
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Pharmacodynamics/Kinetics
Absorption: Rapid and well absorbed from GI tract
Distribution: Vd: 0.31 L/kg
Protein binding: 20%
Half-life elimination: 1 to 2 hours; 20 to 24 hours in renal failure
Time to peak serum concentration: Within 70 to 90 minutes
Excretion: Urine (>90% as unchanged drug within 24 hours)
Dental Use
Alternative antibiotic for treatment of orofacial infections in patients allergic to penicillins; susceptible bacteria including aerobic gram-positive bacteria and anaerobes
* See Uses in AHFS Essentials for additional information.
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
No significant effects or complications reported
Effects on Bleeding
No information available to require special precautions
Dental Usual Dosing
Orofacial infections: Oral: Adults: Dosage range: 250-500 mg every 8 hours
Index Terms
Cefadroxil Monohydrate; Duricef
FDA Approval Date
February 17, 1978
References
American Academy of Pediatrics (AAP). In: Kimberlin DW, Brady MT, Jackson MA, Long SA, eds. Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015.
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Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]
Aronoff GR, Bennett WM, Berns JS, et al, Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children, 5th ed. Philadelphia, PA: American College of Physicians; 2007.
Cefadroxil capsules [prescribing information]. North Wales, PA: Teva Pharmaceuticals; June 2014.
Cefadroxil suspension [prescribing information]. Jacksonville, FL: Ranbaxy Pharmaceuticals Inc.; August 2012.
Cefadroxil tablets [prescribing information]. North Wales, PA: Teva Pharmaceuticals; June 2014.
Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]
Cronberg S, Banke S, Bruno AM, et al. Ampicillin plus mecillinam vs. cefotaxime/cefadroxil treatment of patients with severe pneumonia or pyelonephritis: a double-blind multicentre study evaluated by intention-to-treat analysis. Scand J Infect Dis. 1995;27(5):463-468.[PubMed 8588136]
Cutler RE, Blair AD, Kelly MR. Cefadroxil kinetics in patients with renal insufficiency. Clin Pharmacol Ther. 1979;25(5, pt 1):514-521.[PubMed 436355]
Donowitz GR, Mandell GL. Drug therapy. Beta-lactam antibiotics (2). N Engl J Med. 1988;318(8):490-500. doi: 10.1056/NEJM198802253180806.[PubMed 3277054]
Donowitz GR, Mandell GL. Beta-Lactam antibiotics (1). N Engl J Med. 1988;318(7):419-426. doi: 10.1056/NEJM198802183180706.[PubMed 3277053 ]
Greenberg RN, Reilly PM, Luppen KL, Weinandt WJ, Ellington LL, Bollinger MR. Randomized study of single-dose, three-day, and seven-day treatment of cystitis in women. J Infect Dis. 1986;153(2):277-282.[PubMed 3484773]
Gupta K, Hooton TM, Naber KG, et al; Infectious Diseases Society of America; European Society for Microbiology and Infectious Diseases. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011;52(5):e103-120. doi: 10.1093/cid/ciq257.[PubMed 21292654]
Gustaferro CA, Steckelberg JM. Cephalosporin antimicrobial agents and related compounds. Mayo Clin Proc. 1991;66(10):1064-1073.[PubMed 1921490 ]
Hooton T, Kalpana G. Acute uncomplicated cystitis in women. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 22, 2018a.
Hooton TM, Gupta K. Acute complicated urinary tract infection (including pyelonephritis) in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed March 27, 2018b.
Hooton TM, Winter C, Tiu F, Stamm WE. Randomized comparative trial and cost analysis of 3-day antimicrobial regimens for treatment of acute cystitis in women. JAMA. 1995;273(1):41-45.[PubMed 7654268]
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Brand Names: International
Adroxef (CL); Alkil (ID); Ancefa (ID); Androxyl (MY, SG); Arocef (BD); Baxan (GB); Bidicef (ID); Biodroxil (AE, BG, CY, CZ, IL, IQ, IR, JO, KW, LB, LY, OM, PE, QA, SA, SY, TZ, VN, YE); Biodroxyl (VE); Cedril (BD); Cedrox (AE, CY, IQ, IR, JO, LB, LY, OM, SA, SK, SY, YE); Cedroxil (BR); Cefacar (AR); Cefacell (KR); Cefadril (BH, IT, JO, LB, QA, SA); Cefadrol (IN); Cefadrox (AE, KW, PH, PY, SA); Cefadur (MY); Cefalom (GR); Cefamox (BR, SE); Cefat (ID); Cefco (ID); Cefex (EG); Ceforal (PT); Ceforan (RO); Cexyl (RO); Curisafe (AE, CY, EG, IQ, IR, LB, LY, OM, SA, SY, YE); Cyclomycin-K (GR); Dacef (ZA); Drocef (KR); Drovax (ID); Droxicef (AE, CY, IQ, IR, JO, LB, LY, OM, QA, SA, SY, VN, YE); Droxil (AE, BH, CY, IQ, IR, JO, LB, LY, OM, QA, SA, SY, YE); Droxyl (IN); Drozid (PH); Duracef (AT, BE, BF, BG, BJ, CI, CZ, EC, EE, ES, ET, GH, GM, GN, HU, KE, LR, LT, MA, ML, MR, MU, MW, MX, NE, NG, PE, PL, SC, SD, SL, SN, TN, TZ, UG, ZA, ZM, ZW); Duricef (AE, BH, EG, JO, KR, LB, PK); Erphadrox (ID); Ethicef (ID); Fadrox (CO); Grafacef (ID); Gruncef (DE); Hanacef (KR); Ibidroxil (EG); Justum (PY); Kleotrat (GR); Lapicef (ID); Lesporina (CO); Licef (BD); Likodin (TW); Longicef (EG); Lostacef (ID); Lydroxil (IN); Maxcef (ID); Medicefa (KR); Midroxil (QA); Moxacef (GR); Nefalox (GR); Nor-Dacef (AE, CY, IQ, IR, LB, LY, OM, SA, SY, YE); Odoxil (IN); Opicef (ID); Opicef Forte (ID); Oracefal (FR); Oradroxil (IT); Ouyi (CN); Qualidrox (HK); Roxil (AE, BH, KW, LB, QA, SA); Sofidrox (MY, SG); Twicef (BD); Tytdroxil (VN); Ucefa (TW); Ultracef (IE); Valdocef (SK); Vepan (IN); Versatic (AR); Vidcef (KR); Vocefa (ID); Vocefa Forte (ID); Widrox (ID); Wincef (TW); Wincocef (PH); Zolpra (CO)
Last Updated 3/14/20