Data from FDA - Curated by EPG Health - Last updated 01 January 2017

Indication(s)

INDICATIONS AND USAGE CEFZIL is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: UPPER RESPIRATORY TRACT Pharyngitis/tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present. Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including βlactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including βlactamase-producing strains). (See CLINICAL STUDIES. ) NOTE: In the treatment of otitis media due to β-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific β-lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing β-lactamase inhibitors. Acute Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenza (including βlactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including βlactamase-producing strains). LOWER RESPIRATORY TRACT Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFZIL and other antibacterial drugs, CEFZIL should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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Advisory information

contraindications
CONTRAINDICATIONS CEFZIL (cefprozil) is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
Special warnings and precautions
PRECAUTIONS General Prescribing CEFZIL in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. In patients with known or suspected renal impairment (see DOSAGE AND ADMINISTRATION ), careful clinical observation and appropriate laboratory studies should be done prior to and during therapy. The total daily dose of CEFZIL (cefprozil) should be reduced in these patients because high and/or prolonged plasma antibiotic concentrations can occur in such individuals from usual doses. Cephalosporins, including CEFZIL, should be given with caution to patients receiving concurrent treatment with potent diuretics since these agents are suspected of adversely affecting renal function. Prolonged use of CEFZIL may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. Cefprozil should be prescribed with caution in individuals with a history of gastrointestinal disease particularly colitis. Positive direct Coombs' tests have been reported during treatment with cephalosporin antibiotics. Information for Patients Phenylketonurics: CEFZIL for oral suspension contains phenylalanine 28 mg per 5 mL (1 teaspoonful) constituted suspension for both the 125 mg/5 mL and 250 mg/5 mL dosage forms. Patients should be counseled that antibacterial drugs including CEFZIL should only be used to treat bacterial infections. They do not treat viral infections (eg, the common cold). When CEFZIL is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by CEFZIL or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Drug Interactions Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporin antibiotics. Concomitant administration of probenecid doubled the AUC for cefprozil. The bioavailability of the capsule formulation of cefprozil was not affected when administered 5 minutes following an antacid. Drug/laboratory Test Interactions Cephalosporin antibiotics may produce a false positive reaction for glucose in the urine with copper reduction tests (Benedict's or Fehling's solution or with Clinitest ® tablets Clinitest ® and Clinistix ® are registered trademarks of Bayer Healthcare LLC. ), but not with enzyme-based tests for glycosuria (eg, Clinistix ®). A false negative reaction may occur in the ferricyanide test for blood glucose. The presence of cefprozil in the blood does not interfere with the assay of plasma or urine creatinine by the alkaline picrate method. Carcinogenesis, Mutagenesis, Impairment of Fertility Long term in vivo studies have not been performed to evaluate the carcinogenic potential of cefprozil. Cefprozil was not found to be mutagenic in either the Ames Salmonella or E. coli WP2 urvA reversion assays or the Chinese hamster ovary cell HGPRT forward gene mutation assay and it did not induce chromosomal abnormalities in Chinese hamster ovary cells or unscheduled DNA synthesis in rat hepatocytes in vitro. Chromosomal aberrations were not observed in bone marrow cells from rats dosed orally with over 30 times the highest recommended human dose based upon mg/m 2. Impairment of fertility was not observed in male or female rats given oral doses of cefprozil up to 18.5 times the highest recommended human dose based upon mg/m 2. Pregnancy Teratogenic Effects: Pregnancy Category B Reproduction studies have been performed in rabbits, mice, and rats using oral doses of cefprozil of 0.8, 8.5, and 18.5 times the maximum daily human dose (1000 mg) based upon mg/m 2, and have revealed no harm to the fetus. There are, however, no adequate and wellcontrolled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Labor and Delivery Cefprozil has not been studied for use during labor and delivery. Treatment should only be given if clearly needed. Nursing Mothers Small amounts of cefprozil (<0.3% of dose) have been detected in human milk following administration of a single 1 gram dose to lactating women. The average levels over 24 hours ranged from 0.25 to 3.3 μg/mL. Caution should be exercised when CEFZIL is administered to a nursing woman, since the effect of cefprozil on nursing infants is unknown. Pediatric Use (See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION .) The safety and effectiveness of cefprozil in the treatment of otitis media have been established in the age groups 6 months to 12 years. Use of CEFZIL for the treatment of otitis media is supported by evidence from adequate and well-controlled studies of cefprozil in pediatric patients. (See CLINICAL STUDIES. ) The safety and effectiveness of cefprozil in the treatment of pharyngitis/tonsillitis or uncomplicated skin and skin-structure infections have been established in the age groups 2 to 12 years. Use of CEFZIL for the treatment of these infections is supported by evidence from adequate and well-controlled studies of cefprozil in pediatric patients. The safety and effectiveness of cefprozil in the treatment of acute sinusitis have been established in the age groups 6 months to 12 years. Use of CEFZIL in these age groups is supported by evidence from adequate and well-controlled studies of cefprozil in adults. Safety and effectiveness in pediatric patients below the age of 6 months have not been established for the treatment of otitis media or acute sinusitis, or below the age of 2 years for the treatment of pharyngitis/tonsillitis or uncomplicated skin and skin-structure infections. However, accumulation of other cephalosporin antibiotics in newborn infants (resulting from prolonged drug half-life in this age group) has been reported. Geriatric Use Of the more than 4500 adults treated with CEFZIL in clinical studies, 14% were 65 years and older, while 5% were 75 years and older. When geriatric patients received the usual recommended adult doses, their clinical efficacy and safety were comparable to clinical efficacy and safety in nongeriatric adult patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals to the effects of CEFZIL cannot be excluded (see CLINICAL PHARMACOLOGY ). CEFZIL is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function. See DOSAGE AND ADMINISTRATION for dosing recommendations for patients with impaired renal function.
Adverse reactions
ADVERSE REACTIONS The adverse reactions to cefprozil are similar to those observed with other orally administered cephalosporins. Cefprozil was usually well tolerated in controlled clinical trials. Approximately 2% of patients discontinued cefprozil therapy due to adverse events. The most common adverse effects observed in patients treated with cefprozil are: Gastrointestinal: Diarrhea (2.9%), nausea (3.5%), vomiting (1%), and abdominal pain (1%). Hepatobiliary: Elevations of AST (SGOT) (2%), ALT (SGPT) (2%), alkaline phosphatase (0.2%), and bilirubin values (<0.1%). As with some penicillins and some other cephalosporin antibiotics, cholestatic jaundice has been reported rarely. Hypersensitivity: Rash (0.9%), urticaria (0.1%). Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy. CNS: Dizziness (1%), hyperactivity, headache, nervousness, insomnia, confusion, and somnolence have been reported rarely (<1%). All were reversible. Hematopoietic: Decreased leukocyte count (0.2%), eosinophilia (2.3%). Renal: Elevated BUN (0.1%), serum creatinine (0.1%). Other: Diaper rash and superinfection (1.5%), genital pruritus and vaginitis (1.6%). The following adverse events, regardless of established causal relationship to CEFZIL, have been rarely reported during postmarketing surveillance: anaphylaxis, angioedema, colitis (including pseudomembranous colitis), erythema multiforme, fever, serumsickness like reactions, Stevens-Johnson syndrome, and thrombocytopenia. Cephalosporin class paragraph In addition to the adverse reactions listed above which have been observed in patients treated with cefprozil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Aplastic anemia, hemolytic anemia, hemorrhage, renal dysfunction, toxic epidermal necrolysis, toxic nephropathy, prolonged prothrombin time, positive Coombs' test, elevated LDH, pancytopenia, neutropenia, agranulocytosis. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced. (See DOSAGE AND ADMINISTRATION and OVERDOSAGE .) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION CEFZIL is administered orally. a In the treatment of infections due to Streptococcus pyogenes, CEFZIL should be administered for at least 10 days. b Not to exceed recommended adult doses. Population/Infection Dosage (mg) Duration (days) ADULTS (13 years and older) UPPER RESPIRATORY TRACT Pharyngitis/Tonsillitis 500 q24h 10 a Acute Sinusitis 250 q12h or 10 (For moderate to severe infections, the higher dose should be used) 500 q12h LOWER RESPIRATORY TRACT Acute Bacterial Exacerbation of Chronic Bronchitis 500 q12h 10 SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin Structure Infections 250 q12h or 500 q24h or 500 q12h 10 CHILDREN (2 years–12 years) UPPER RESPIRATORY TRACT b Pharyngitis/Tonsillitis 7.5 mg/kg q12h 10a SKIN AND SKIN STRUCTURE 20 mg/kg q24h Uncomplicated Skin and Skin Structure Infections 10 INFANTS & CHILDREN (6 months–12 years) UPPER RESPIRATORY TRACT b Otitis Media 15 mg/kg q12h 10 (See INDICATIONS AND USAGE and CLINICAL STUDIES ) Acute Sinusitis (For moderate to severe infections, the higher dose should be used) 7.5 mg/kg q12h or 15 mg/kg q12h 10 Renal Impairment Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used. * Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis. Creatinine Clearance (mL/min) Dosage (mg) Dosing Interval 30–120 standard standard 0–29* 50% of standard standard Hepatic Impairment No dosage adjustment is necessary for patients with impaired hepatic function.
Pregnancy and lactation
Nursing Mothers Small amounts of cefprozil (<0.3% of dose) have been detected in human milk following administration of a single 1 gram dose to lactating women. The average levels over 24 hours ranged from 0.25 to 3.3 μg/mL. Caution should be exercised when CEFZIL is administered to a nursing woman, since the effect of cefprozil on nursing infants is unknown.

Interactions

Drug Interactions Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporin antibiotics. Concomitant administration of probenecid doubled the AUC for cefprozil. The bioavailability of the capsule formulation of cefprozil was not affected when administered 5 minutes following an antacid.

More information

Category Value
Authorisation number NDA050664
Agency product number 4W0459ZA4V
Orphan designation No
Product NDC 61126-202,61126-102,61126-101,61126-201
Date Last Revised 06-12-2016
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Corden Pharma Latina S.p.A.