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Pronunciation:

(sef a DROKS il)

U.S. Brand Names:

Duricef®

Synonyms:

Cefadroxil Monohydrate

Generic Available:

Yes: Capsule, tablet

Canadian Brand Names:

Apo-Cefadroxil®; Duricef®; Novo-Cefadroxil

Use:

Treatment of susceptible bacterial infections, including those caused by group A beta-hemolytic Streptococcus; prophylaxis against bacterial endocarditis in patients who are allergic to penicillin and undergoing surgical or dental procedures

Use - Dental:

Alternative antibiotic for prevention of bacterial endocarditis. Individuals allergic to amoxicillin (penicillins) may receive cefadroxil provided they have not had an immediate, local, or systemic IgE-mediated anaphylactic allergic reaction to penicillin.

Pregnancy Risk Factor:

Lactation:

Enters breast milk (small amounts)/use caution (AAP rates "compatible")

Contraindications:

Hypersensitivity to cefadroxil, other cephalosporins, or any component of the formulation

Warnings/Precautions:

Modify dosage in patients with severe renal impairment; prolonged use may result in superinfection; use with caution in patients with a history of penicillin allergy especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria). May cause antibiotic-associated colitis or colitis secondary to C. difficile.

Adverse Reactions:

1% to 10%: Gastrointestinal: Diarrhea

<1%: Anaphylaxis, rash (maculopapular and erythematous), erythema multiforme, Stevens-Johnson syndrome, serum sickness, arthralgia, urticaria, pruritus, angioedema, pseudomembranous colitis, abdominal pain, dyspepsia, nausea, vomiting, cholestasis, vaginitis, neutropenia, agranulocytosis, thrombocytopenia, transaminases increased, fever

Reactions reported with other cephalosporins include toxic epidermal necrolysis, abdominal pain, superinfection. renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, increased BUN, increased creatinine, eosinophilia, pancytopenia, seizure

Overdosage/Toxicology:

Symptoms of overdose include neuromuscular hypersensitivity and convulsions. Many beta-lactam containing antibiotics have the potential to cause neuromuscular hyperirritability or convulsive seizures. Hemodialysis may be helpful to aid in removal of the drug from blood; otherwise, treatment is supportive or symptom-directed.

Drug Interactions:

Increased effect: Probenecid may decrease cephalosporin elimination

Increased toxicity: Furosemide, aminoglycosides may be a possible additive to nephrotoxicity

Ethanol/Nutrition/Herb Interactions:

Food: Concomitant administration with food, infant formula, or cow's milk does not significantly affect absorption.

Stability:

Refrigerate suspension after reconstitution; discard after 14 days

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

Distribution: Widely throughout the body and reaches therapeutic concentrations in most tissues and body fluids, including synovial, pericardial, pleural, and peritoneal fluids; bile, sputum, and urine; bone, myocardium, gallbladder, skin and soft tissue; crosses placenta; enters breast milk

Protein binding: 20%

Half-life elimination: 1-2 hours; Renal failure: 20-24 hours

Time to peak, serum: 70-90 minutes

Excretion: Urine (>90% as unchanged drug)

Dosage:

Oral:

Children: 30 mg/kg/day divided twice daily up to a maximum of 2 g/day

Adults: 1-2 g/day in 2 divided doses

Prophylaxis against bacterial endocarditis:

Children: 50 mg/kg 1 hour prior to the procedure

Adults: 2 g 1 hour prior to the procedure

Dosing interval in renal impairment:

Clcr 10-25 mL/minute: Administer every 24 hours

Clcr<10 mL/minute: Administer every 36 hours

Administration:

Administer around-the-clock to promote less variation in peak and trough serum levels.

Monitoring Parameters:

Observe for signs and symptoms of anaphylaxis during first dose

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

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Take as directed, at regular intervals around-the-clock (with or without food). Chilling oral suspension improves flavor (do not freeze). Do not chew or crush extended release tablets. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Complete full course of medication, even if you feel better. May cause false test results with Clinitest®; use of another type of glucose testing is preferable. May cause diarrhea (yogurt, boiled milk, or buttermilk may help). Report changes in urinary pattern or pain on urination; opportunistic infection (eg, vaginal itching or drainage; sores in mouth; blood in urine or stool; unusual fever or chills); or nausea, vomiting, or abdominal pain. Breast-feeding precaution: Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause nervousness; case reports of euphoria, delusion, illusions, and depersonalization with cephalosporins

Mental Health: Effects on Psychiatric Treatment:

May rarely cause neutropenia; use caution with clozapine and carbamazepine

Dosage Forms:

Capsule, as monohydrate: 500 mg

Powder for oral suspension, as monohydrate: 250 mg/5 mL (50 mL, 100 mL); 500 mg/5 mL (75 mL, 100 mL) [contains sodium benzoate; orange-pineapple flavor]

Tablet, as monohydrate: 1 g

International Brand Names:

Adroxef® (CL); Alxil® (ID); Ancefa® (ID); Apidroxil® (RO); Apo-Cefadroxil® (CA); Baxan® (GB); Becedril® (CY); Bidicef® (ID); Biodroxil® (AT, CO, CR, CZ, DO, GT, HU, ID, IL, PA, PL, RO, RU, SV); Biofaxil® (PT); Cedrox® (CZ, DE, EG, JO, KW, LB, RO, SY); Cedroxil® (BR); Cedroxim® (CR, DO, GT, HN, PA, SV); Cefacar® (AR); Cefacile® (PT); Cefacilina® (AR); Cefa® (DO); Cefadril® (IT, TH); Cefadrox® (AR, CZ); Cefadroxil AZU® (DE); Cefadroxil beta® (DE); Cefadroxil Biochemie® (SE); Cefadroxil Generics® (FI); Cefadroxil Hexpharm® (ID); Cefadroxil Indo Farma® (ID); Cefadroxil Lindo® (DE); Cefadroxil Merck® (PT); Cefadroxil NM Pharma® (SE); Cefadroxilo Clariana Pico® (ES); Cefadroxilo® (CL, EC); Cefadroxilo Genfar® (EC); Cefadroxilo MK® (CR, DO, GT, HN, PA, SV); Cefadroxilo Sabater® (ES); Cefadroxil® (RO); Cefadroxil Sandoz® (DE); Cefamox® (BR, CL, MX, SE); Cefasin® (AR); Cefatenk® (AR); Cefat® (ID); Ceforal® (PT); Cefradur® (TR); Ceoxil® (IT); Cephos® (IT); Cexyl® (RO); Cipadur® (ZA); Dacef® (ZA); Dazel® (GT, HN, SV); Dexacef® (ID); Drocef® (BR); Drofex® (PL); Droxef® (PL); Droxil® (JO, RO); Droxyl® (RO); Duracef® (AT, BE, BG, CN, CO, CR, CZ, EC, ES, FI, GT, HN, HR, HU, IL, LU, MX, PA, PL, RO, RU, SV, YU, ZA); Duricef™ (CA); Duricef® (ID, SG, TR); Fadrox® (CO); Foxil® (IT); Galadrox® (YU); Grüncef® (DE); Kandicin® (AR); Kelfex® (ID); Lapicef® (ID); Librocef® (ID); Longcef® (ID); Lydroxil® (IN); Moxacef® (BE, LU); Nor-Dacef® (DO, GT, HN, SV); Novo-Cefadroxil (CA); Odoxil® (IN, RO); Omnidrox® (SI); Opicef® (ID); Oracéfal® [à dissoudre] (FR); Oradroxil® (IT); Osadrox® (ID); Pyricef® (ID); Q-cef® (ID); Qidrox® (ID); Rafemox® (CL); Renasistin® (ID); Sedrofen® (ID); Sofidrox® (SG); Staforin® (ID); Tadroxil® (PL); Tisacef® (ID); Tridocylon® (CL); Ultracef® (IE); Vepan® (IN); Versatic® (AR)

References

"Advisory Statement. Antibiotic Prophylaxis for Dental Patients With Total Joint Replacements. American Dental Association; American Academy of Orthopedic Surgeons,"J Am Dent Assoc, 1997, 128(7):1004-8.

Cutler RE, Blair AD, and Kelly MR, "Cefadroxil Kinetics in Patients With Renal Insufficiency,"Clin Pharmacol Ther, 1979, 25(5 Pt 1):514-21.

Dajani AS, Taubert KA, Wilson W, et al, "Prevention of Bacterial Endocarditis Recommendations by the American Heart Association,"JAMA, 1997, 277(22):1794-801.

Donowitz GR and Mandell GL, "Beta-Lactam Antibiotics,"N Engl J Med, 1988, 318(7):419-26 and 318(8):490-500.

Marshall WF and Blair JE, "The Cephalosporins,"Mayo Clin Proc, 1999, 74(2):187-95.

Smith GH, "Oral Cephalosporins in Perspective,"DICP, 1990, 24(1):45-51.

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