Cefprozil

Pharmacologic Category

Antibiotic, Cephalosporin (Second Generation)

Dosing: Adult

Acute bacterial exacerbation of chronic bronchitis: Oral: 500 mg every 12 hours for 10 days

Pharyngitis/tonsillitis: Oral: 500 mg every 24 hours for 10 days (administer for ≥10 days if due to S. pyogenes)

Skin and skin-structure infections, uncomplicated: Oral: 250 to 500 mg every 12 hours, or 500 mg every 24 hours for 10 days

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

Manufacturer's labeling: Oral:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: Reduce dose by 50%.

End-stage renal disease (ESRD) on hemodialysis: Give dose after dialysis on dialysis days.

Alternative recommendations (Aronoff, 2007):

Oral:

CrCl >50 mL/minute: No dosage adjustment necessary

CrCl <50 mL/minute: Administer 50% of usual dose every 12 hours

Intermittent hemodialysis (IHD): Supplement with 250 mg after dialysis on dialysis days

Peritoneal dialysis: Administer 50% of usual dose every 12 hours

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary.

Dosing: Pediatric

General dosing, susceptible infection (Red Book [AAP 2018]): Infants, Children, and Adolescents: Oral: Mild to moderate infection: 7.5 to 15 mg/kg/dose twice daily; maximum single dose: 500 mg/dose.

Bronchitis, acute bacterial exacerbation of chronic bronchitis: Adolescents: Oral: 500 mg every 12 hours for 10 days.

Otitis media, acute: Infants ≥6 months and Children: Oral: 15 mg/kg/dose every 12 hours for 10 days; maximum single dose: 500 mg/dose. Note: Cefprozil is not routinely recommended as a treatment option in the acute otitis media guidelines (AAP [Lieberthal 2013]).

Pharyngitis/tonsillitis:

Children ≥2 years: Oral: 7.5 mg/kg/dose every 12 hours for 10 days; maximum single dose: 500 mg/dose.

Adolescents: Oral: 500 mg every 24 hours for 10 days.

Rhinosinusitis: Note: Not recommended for the empiric monotherapy of acute sinusitis due to risk of resistance (IDSA [Chow 2012]):

Infants ≥6 months and Children: Oral: 7.5 to 15 mg/kg/dose every 12 hours for 10 days; maximum single dose: 500 mg/dose.

Adolescents: Oral: 250 to 500 mg every 12 hours for 10 days.

Skin and skin structure infection, uncomplicated: Oral:

Children ≥2 years: 20 mg/kg/dose once daily for 10 days; maximum single dose: 500 mg/dose.

Adolescents: 250 mg every 12 hours or 500 mg every 12 to 24 hours for 10 days.

Urinary tract infection: Oral: Infants ≥2 months and Children ≤2 years: 15 mg/kg/dose twice daily for 7 to 14 days (AAP 2011).

Dosing: Renal Impairment: Pediatric

Manufacturer's labeling: Infants ≥6 months, Children, and Adolescents: Oral:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: Reduce usual recommended dose by 50%.

End-stage renal disease on hemodialysis: Give dose after dialysis on dialysis days.

Alternative recommendations: The following recommendations have been used by some clinicians (Aronoff 2007): Note: Renally adjusted dose recommendations are based on a usual dose of 30 mg/kg/day divided every 12 hours.

Infants, Children, and Adolescents: Oral:

GFR ≥30 mL/minute/1.73 m²: No dosage adjustment necessary.

GFR <30 mL/minute/1.73 m²: 7.5 mg/kg/dose every 12 hours.

Intermittent hemodialysis: ~55% is removed by hemodialysis; 7.5 mg/kg/dose every 12 hours; administer an additional 5 mg/kg/dose after dialysis session.

Peritoneal dialysis: 7.5 mg/kg/dose every 12 hours.

Dosing: Hepatic Impairment: Pediatric

Infants, Children and Adolescents: No dosage adjustment necessary

Calculations

• Creatinine Clearance by Cockcroft-Gault
• Creatinine Clearance by Cockcroft-Gault (SI units)
• Creatinine Clearance by Cockcroft-Gault with IBW
• Creatinine Clearance by Cockcroft-Gault with IBW (SI units)
• Glomerular Filtration Rate by Abbreviated MDRD
• Glomerular Filtration Rate by Abbreviated MDRD (SI units)
• Glomerular Filtration Rate by MDRD
• Glomerular Filtration Rate by MDRD (IDMS-Traceable SCr)
• Glomerular Filtration Rate by MDRD (SI units)
• Glomerular Filtration Rate by Schwartz
• Glomerular Filtration Rate Estimate in African Americans by AASK Equation

Use: Labeled Indications

Acute bacterial exacerbation of chronic bronchitis: Treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis caused by S. pneumoniae, H. influenzae (including beta-lactamase–producing strains), and M. catarrhalis (including beta-lactamase–producing strains).

Otitis media: Treatment of mild to moderate otitis media caused by S. pneumoniae, Haemophilus influenzae (including beta-lactamase–producing strains), and Moraxella (Branhamella) catarrhalis (including beta-lactamase–producing strains).

Pharyngitis/tonsillitis: Treatment of mild to moderate pharyngitis/tonsillitis caused by Streptococcus pyogenes.

Limitations of use: Cefprozil is generally effective in the eradication of S. pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present.

Skin and skin-structure infections, uncomplicated: Treatment of mild to moderate uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) and S. pyogenes.

* See Uses in AHFS Essentials for additional information.

Use: Unsupported: Adult

Acute sinusitis

Although included as an FDA-approved use in the manufacturer’s prescribing information for the treatment of acute sinusitis, clinical practice guidelines do not recommend cefprozil as initial empiric treatment of acute bacterial rhinosinusitis due to variable rates of resistance among Streptococcus pneumoniae (Chow 2012).

Class and Related Monographs

Cephalosporins

Clinical Practice Guidelines

ATS/IDSA, "Diagnosis and Treatment of Adults With Community-Acquired Pneumonia," 2019. Note: Information contained within this monograph is pending revision based on these more recent guidelines.

IDSA/PIDS, "The Management of Community-Acquired Pneumonia in Infants and Children Older Than 3 Months of Age," 2011

AAP, “Clinical Practice Guideline for the Diagnosis and Management of the Initial UTI in Febrile Infants 2 to 24 months,” 2011

Administration: Oral

Administer without regard to meals. Administer around the clock to promote less variation in peak and trough serum levels.

Administration: Pediatric

Oral: Administer without regard to meals. Shake suspension well before each use.

Dietary Considerations

Some products may contain phenylalanine.

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Refrigerate suspension after reconstitution; discard after 14 days.

Preparation for Administration: Adult

Oral suspension: Refer to manufacturer's product labeling for reconstitution instructions. Shake well.

Preparation for Administration: Pediatric

Oral suspension: Reconstitute powder for oral suspension with appropriate amount of water as specified on the bottle; add water in 2 divided portions for ease of preparation. 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

• Nausea

• Diarrhea

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Seizures

• Vaginal pain, itching, or 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 cefprozil, any component of the formulation, or other cephalosporins

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: If a serious hypersensitivity reaction occurs, discontinue and institute emergency supportive measures, including airway management and treatment (eg, epinephrine, antihistamines and/or corticosteroids).

• 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:

• Gastrointestinal disease: Use with caution in patients with a history of gastrointestinal disease, particularly colitis.

• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.

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.

• Phenylalanine: Some products may contain phenylalanine.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer's labeling.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

Has not been studied exclusively in the elderly. Adjust dose for renal function.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Breast-Feeding Considerations

Small amounts of cefprozil are excreted in breast milk. The manufacturer recommends that caution be exercised when administering cefprozil to nursing women. Nondose-related effects could include modification of bowel flora.

Lexicomp Pregnancy & Lactation, In-Depth

• Cefprozil

Briggs' Drugs in Pregnancy & Lactation

• Cefprozil

Adverse Reactions

Frequency not always defined.

1% to 10%:

Central nervous system: Dizziness (1%)

Dermatologic: Diaper rash (2%), genital pruritus (2%)

Gastrointestinal: Nausea (4%), diarrhea (3%), abdominal pain (1%), vomiting (1%)

Genitourinary: Vaginitis

Hepatic: Increased serum transaminases (2%)

Infection: Superinfection

<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, arthralgia, cholestatic jaundice, confusion, drowsiness, eosinophilia, erythema multiforme, fever, headache, hyperactivity, increased blood urea nitrogen, increased serum creatinine, insomnia, leukopenia, pseudomembranous colitis, serum sickness, skin rash, Stevens-Johnson syndrome, thrombocytopenia, urticaria

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

• Cephalosporin Allergy

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Aminoglycosides: Cephalosporins (2nd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy

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

Food Interactions

Food delays cefprozil absorption. Management: May administer with food.

Test Interactions

Positive direct Coombs, false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest, Fehling's solution), but not with enzyme-based tests for glycosuria (eg, Clinistix). A false-negative reaction may occur in the ferricyanide test for blood glucose.

Monitoring Parameters

Monitor renal function at baseline and as clinically indicated. Monitor for signs of anaphylaxis during first dose.

Advanced Practitioners Physical Assessment/Monitoring

Assess results of culture/sensitivity tests and patient's allergy history prior to therapy. Monitor for interstitial nephritis, hemolytic anemia, and hemorrhage. Advise patients with diabetes about use of Clinitest® (may cause false-positive test). Teach patient to report opportunistic infection and hypersensitivity reactions.

Nursing Physical Assessment/Monitoring

Results of culture/sensitivity tests and patient's allergy history should be assessed prior to therapy. Monitor prothrombin time. Advise patients with diabetes about use of Clinitest® (may cause false-positive test). Teach patient to report opportunistic infection and hypersensitivity reaction.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension Reconstituted, Oral:

Generic: 125 mg/5 mL (50 mL, 75 mL, 100 mL); 250 mg/5 mL (50 mL, 75 mL, 100 mL)

Tablet, Oral:

Generic: 250 mg, 500 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension Reconstituted, Oral:

Cefzil: 125 mg/5 mL ([DSC]); 250 mg/5 mL ([DSC])

Generic: 125 mg/5 mL (50 mL, 75 mL, 100 mL); 250 mg/5 mL (75 mL, 100 mL)

Tablet, Oral:

Cefzil: 250 mg [DSC], 500 mg [DSC]

Generic: 250 mg, 500 mg

Anatomic Therapeutic Chemical (ATC) Classification

• J01DC10

Generic Available (US)

Yes

Pricing: US

Suspension (reconstituted) (Cefprozil Oral)

125 mg/5 mL (per mL): $0.42

250 mg/5 mL (per mL): $0.77

Tablets (Cefprozil Oral)

250 mg (per each): $4.38

500 mg (per each): $9.04

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: Well absorbed (95%).

Distribution: V_d: 0.23 L/kg.

Protein binding: ~36%.

Bioavailability: 95%.

Half-life elimination:

Infants ≥6 months and Children: 1.5 hours.

Adults:

Normal: 1.3 hours.

Kidney impairment: Up to 5.2 hours (dependent upon degree of kidney impairment).

Kidney failure: Up to 5.9 hours.

Hepatic impairment: ~2 hours.

Time to peak, serum:

Infants ≥6 months and Children: 1 to 2 hours.

Adult: Fasting: 1.5 hours.

Excretion: Urine (~60% as unchanged drug).

Pharmacodynamics/Kinetics: Additional Considerations

Geriatric: AUC is about 35% to 60% higher.

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

Index Terms

Cefzil

FDA Approval Date

December 23, 1991

References

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American Academy of Pediatrics. Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants 2 to 24 months. Pediatrics. 2011;128(3):595-610. http://pediatrics.aappublications.org/content/128/3/595.full.[PubMed 21873693]

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Brand Names: International

Aprozil (BD); Aurozil (ET); Cefacura (EG); Cefavil (EG); Cefproz (AE, BH, LB, SA); Cefrozil (KR); Cefzil (AE, BB, BD, BG, BH, BM, BS, BZ, CN, CZ, EE, EG, GB, GR, GY, HN, JM, JO, KR, LB, LT, NL, PL, SA, SI, SK, SR, TT); Cerofazil (KR); Cesilpro (KR); Cronocef (IT); Lemcocef (EG); Lizor (ID); Orprozil (IN); Pathozil (BD); Procef (AR, AT, CH, CO, EC, HK, MX, MY, PH, PT, SG, TH, TR, VE); Prozef (ZA); Quzil (JO); Zilapro (BD); Zilospore (EG); Zilpro (PK); Zilroz (VN)

Last Updated 3/11/20