Cefprozil precautions

List of precautions
General Information for patients Drug/lab test interactions Carcinogenesis Mutagenesis Impairment of fertility Pregnancy Labor & delivery Nursing mothers Pediatric use Geriatric use

General
Prescribing Cefprozil 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. Patients with known or suspected renal impairment Prolonged use Patients with a history of gastrointestinal disease Positive direct Coombs' test
 * In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be done prior to and during therapy. The total daily dose of 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 Cefprozil, 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 Cefprozil 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. Return to top

Information for patients
Patients should be counseled that antibacterial drugs including Cefprozil should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefprozil are 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 Cefprozil 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. Return to top

Drug/lab 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), but not with enzyme-based tests for glycosuria (e.g., 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. Return to top

Carcinogenesis
Long term in vivo studies have not been performed to evaluate the carcinogenic potential of Cefprozil. Return to top

Mutagenesis
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/m2. Return to top

Impairment of fertility
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/m2. Return to top

Pregnancy
Teratogenic Effects Nonteratogenic 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/m2, and have revealed no harm to the fetus. There are, however, no adequate and well-controlled 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. Return to top

Labor & delivery
Cefprozil has not been studied for use during labor and delivery. Treatment should only be given if clearly needed. Return to top

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 mcg/mL. Caution should be exercised when Cefprozil tablets are administered to a nursing woman, since the effect of Cefprozil on nursing infants is unknown. Return to top

Pediatric use
Otitis media Pharyngitis/tonsillitis or uncomplicated skin and skin-structure infections Acute sinusitis Patients under 2 years
 * 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 Cefprozil for the treatment of otitis media 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 pharyngitis/tonsillitis or uncomplicated skin and skin-structure infections have been established in the age groups 2 to 12 years. Use of Cefprozil 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 Cefprozil 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. Return to top

Geriatric use
Of the more than 4500 adults treated with Cefprozil 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 Cefprozil cannot be excluded. Cefprozil 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. Return to top