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Cefadroxil


General


Pronunciation

(sef a DROKS il)


Indications


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.


Contraindications


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


Dosing and Administration


Dosing: Adult

Pharyngitis: Oral:

Manufacturer 's labeling: 1 g/day in a single or 2 divided doses for 10 days

Alternate dosing: 30 mg/kg/dose once daily (maximum: 1 g daily) for 10 days (Shulman 2012). Note: Recommended as an alternative agent in penicillin-allergic patients; however, avoid in patients with immediate type hypersensitivity to penicillin.

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

Tonsillitis: Oral: 1 g daily in a single or 2 divided doses for 10 days

Urinary tract infections: Oral: 1 g twice daily. For uncomplicated cystitis: 1 or 2 g daily in a single or 2 divided doses


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

Pharyngitis: Children and Adolescents: Oral:

Manufacturer 's labeling: 30 mg/kg/day in a single dose or divided every 12 hours

Alternate dosing: Refer to adult dosing

Skin and skin structure infections: Children and Adolescents: Oral: 30 mg/kg/day in divided doses every 12 hours. For impetigo: 30 mg/kg/day in a single dose or divided every 12 hours.

Tonsillitis: Children and Adolescents: Oral: 30 mg/kg/day in a single dose or divided every 12 hours

Urinary tract infections: Children and Adolescents: Oral: 30 mg/kg/day in divided doses every 12 hours


Dosing: Renal Impairment

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

There are no dosage adjustments provided in the manufacturer 's labeling.


Reconstitution

Powder for suspension: Refer to manufacturer 's product labeling for reconstitution instructions. Shake vigorously until suspended.


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.


Storage

Store capsules, tablets and unreconstituted oral suspension at 20 � �C to 25 � �C (68 � �F to 77F); 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).


Dosage Forms/Strengths


Dosage Forms

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 (100 mL); 500 mg/5 mL (75 mL, 100 mL)

Tablet, Oral:

Generic: 1 g


Drug Interactions

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Probenecid: May increase the serum concentration of Cephalosporins. 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. 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. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy


Monitoring Parameters

Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.


Lab Test Interferences


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 Jaffe reaction


Adverse Reactions


1% to 10%: Gastrointestinal: Diarrhea

<1% (Limited to important or life-threatening): Agranulocytosis, anaphylaxis, angioedema, cholestasis, Clostridium difficile associated diarrhea, dyspepsia, erythema multiforme, erythematous rash, genital candidiasis, hepatic failure, increased serum transaminases, maculopapular rash, neutropenia, pseudomembranous colitis, serum sickness, Stevens-Johnson syndrome, thrombocytopenia, vaginitis


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.


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.


Actions


Pharmacology

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.


Absorption

Rapid and well absorbed from GI tract


Distribution

Vd: 0.31 L/kg


Excretion

Urine (>90% as unchanged drug within 24 hours)


Time to Peak

Serum: Within 70 to 90 minutes


Half-Life Elimination

1 to 2 hours; 20 to 24 hours in renal failure


Protein Binding

20%


Patient and Family Education


Patient Education

- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Patient may experience diarrhea. Have patient report immediately to prescriber signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), chills, pharyngitis, severe loss of strength and energy, seizures, urinary retention, change in amount of urine passed, vaginitis, or signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools) (HCAHPS).

- Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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