Label: CEFPROZIL tablet, film coated

  • NDC Code(s): 0093-1077-01, 0093-1078-01, 0093-1078-53
  • Packager: Teva Pharmaceuticals USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 9, 2018

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  • SPL UNCLASSIFIED SECTION

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil tablets and other antibacterial drugs, cefprozil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

  • DESCRIPTION

    Cefprozil, USP is a semi-synthetic broad-spectrum cephalosporin antibiotic.

    Cefprozil, USP is a cis and trans isomeric mixture (≥ 90% cis). The chemical name for the monohydrate is (6R,7R)-7-[(R)-2-amino-2-(p-hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, and the structural formula is:

    Structural formula for cefprozil.

    C18H19N3O5S•H2O M.W. 407.45

    Cefprozil, USP is a white to yellowish powder.

    Cefprozil Tablets USP are intended for oral administration.

    Cefprozil Tablets USP contain cefprozil, USP equivalent to 250 mg or 500 mg of anhydrous cefprozil. In addition, each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 250 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake.

  • CLINICAL PHARMACOLOGY

    The pharmacokinetic data were derived from the capsule formulation; however, bioequivalence has been demonstrated for the oral solution, capsule, tablet, and suspension formulations under fasting conditions.

    Following oral administration of cefprozil to fasting subjects, approximately 95% of the dose was absorbed. The average plasma half-life in normal subjects was 1.3 hours, while the steady-state volume of distribution was estimated to be 0.23 L/kg. The total body clearance and renal clearance rates were approximately 3 mL/min/kg and 2.3 mL/min/kg, respectively.

    Average peak plasma concentrations after administration of 250 mg, 500 mg, or 1 g doses of cefprozil to fasting subjects were approximately 6.1, 10.5, and 18.3 mcg/mL, respectively, and were obtained within 1.5 hours after dosing. Urinary recovery accounted for approximately 60% of the administered dose. (See Table.)

    *
    Data represent mean values of 12 healthy volunteers.

    Dosage (mg)

    Mean Plasma Cefprozil Concentrations (mcg/mL)*

    8 hour Urinary Excretion (%)

    Peak appx. 1.5 h

    4 h

    8 h

    250 mg

    6.1

    1.7

    0.2

    60%

    500 mg

    10.5

    3.2

    0.4

    62%

    1000 mg

    18.3

    8.4

    1.0

    54%

    During the first 4 hour period after drug administration, the average urine concentrations following 250 mg, 500 mg, and 1 g doses were approximately 700 mcg/mL, 1000 mcg/mL, and 2900 mcg/mL, respectively.

    Administration of cefprozil with food did not affect the extent of absorption (AUC) or the peak plasma concentration (Cmax) of cefprozil. However, there was an increase of 0.25 to 0.75 hours in the time to maximum plasma concentration of cefprozil (Tmax).

    The bioavailability of the capsule formulation of cefprozil was not affected when administered 5 minutes following an antacid.

    Plasma protein binding is approximately 36% and is independent of concentration in the range of 2 mcg/mL to 20 mcg/mL.

    There was no evidence of accumulation of cefprozil in the plasma in individuals with normal renal function following multiple oral doses of up to 1000 mg every 8 hours for 10 days.

    In patients with reduced renal function, the plasma half-life may be prolonged up to 5.2 hours depending on the degree of the renal dysfunction. In patients with complete absence of renal function, the plasma half-life of cefprozil has been shown to be as long as 5.9 hours. The half-life is shortened during hemodialysis. Excretion pathways in patients with markedly impaired renal function have not been determined (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).

    In patients with impaired hepatic function, the half-life increases to approximately 2 hours. The magnitude of the changes does not warrant a dosage adjustment for patients with impaired hepatic function.

    Healthy geriatric volunteers (≥ 65 years old) who received a single 1 g dose of cefprozil had 35% to 60% higher AUC and 40% lower renal clearance values compared with healthy adult volunteers 20 to 40 years of age. The average AUC in young and elderly female subjects was approximately 15% to 20% higher than in young and elderly male subjects. The magnitude of these age- and gender-related changes in the pharmacokinetics of cefprozil is not sufficient to necessitate dosage adjustments.

    Adequate data on CSF levels of cefprozil are not available.

    Comparable pharmacokinetic parameters of cefprozil are observed between pediatric patients (6 months to 12 years) and adults following oral administration of selected matched doses. The maximum concentrations are achieved at 1 to 2 hours after dosing.

    The plasma elimination half-life is approximately 1.5 hours. In general, the observed plasma concentrations of cefprozil in pediatric patients at the 7.5, 15, and 30 mg/kg doses are similar to those observed within the same time frame in normal adult subjects at the 250, 500 and 1000 mg doses, respectively. The comparative plasma concentrations of cefprozil in pediatric patients and adult subjects at the equivalent dose level are presented in the table below.

    *
    n = 11
    n = 5
    n = 9
    §
    n = 11

    Mean (SD) Plasma Cefprozil Concentrations (mcg/mL)

    Population

    Dose

    1 h

    2 h

    4 h

    6 h

    T½ (h)

    children (n = 18)

    7.5 mg/kg

    4.70 (1.57)

    3.99 (1.24)

    0.91 (0.30)

    0.23* (0.13)

    0.94 (0.32)

    adults (n = 12)

    250 mg

    4.82 (2.13)

    4.92 (1.13)

    1.70 (0.53)

    0.53 (0.17)

    1.28 (0.34)

    children (n = 19)

    15 mg/kg

    10.86 (2.55)

    8.47 (2.03)

    2.75 (1.07)

    0.61 (0.27)

    1.24 (0.43)

    adults (n = 12)

    500 mg

    8.39 (1.95)

    9.42 (0.98)

    3.18§ (0.76)

    1.00§(0.24)

    1.29 (0.14)

    children (n = 10)

    30 mg/kg

    16.69 (4.26)

    17.61 (6.39)

    8.66 (2.70)

    --

    2.06 (0.21)

    adults (n = 12)

    1000 mg

    11.99 (4.67)

    16.95 (4.07)

    8.36 (4.13)

    2.79 (1.77)

    1.27 (0.12)

    Microbiology

    Cefprozil has in vitro activity against a broad range of gram-positive and gram-negative bacteria. The bactericidal action of cefprozil results from inhibition of cell-wall synthesis. Cefprozil has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

    Aerobic gram-positive microorganisms:

    Aerobic gram-negative microorganisms:

    Staphylococcus aureus (including β-lactamase-producing strains)

    Haemophilus influenzae (including β-lactamase-producing strains)

    NOTE: Cefprozil is inactive against methicillin-resistant staphylococci.

    Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains)

    Streptococcus pneumoniae

     

    Streptococcus pyogenes


    The following in vitro data are available; however, their clinical significance is unknown. Cefprozil exhibits in vitro minimum inhibitory concentrations (MICs) of 8 mcg/mL or less against most (≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of cefprozil in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.

    Aerobic gram-positive microorganisms:

    Enterococcus durans

    Staphylococcus warneri

    Enterococcus faecalis

    Streptococcus agalactiae

    Listeria monocytogenes

    Streptococci (Groups C, D, F, and G)

    Staphylococcus epidermidis

    viridans group Streptococci

    Staphylococcus saprophyticus

    NOTE: Cefprozil is inactive against Enterococcus faecium.  

    Aerobic gram-negative microorganisms:

    Citrobacter diversus

    Proteus mirabilis

    Escherichia coli

    Salmonella spp.

    Klebsiella pneumoniae

    Shigella spp.

    Neisseria gonorrhoeae (including β-lactamase-producing strains)

    Vibrio spp.

    NOTE: Cefprozil is inactive against most strains of Acinetobacter, Enterobacter, Morganella morganii, Proteus vulgaris, Providencia, Pseudomonas, and Serratia.

    Anaerobic microorganisms:

    Prevotella (Bacteroides) melaninogenicus

    Fusobacterium spp.

    Clostridium difficile

    Peptostreptococcus spp.

    Clostridium perfringens

    Propionibacterium acnes

    NOTE: Most strains of the Bacteroides fragilis group are resistant to cefprozil.  

    Susceptibility Testing

    For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

  • INDICATIONS AND USAGE

    Cefprozil tablets are 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 β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-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 β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-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 cefprozil tablets and other antibacterial drugs, cefprozil tablets 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.

  • CONTRAINDICATIONS

    Cefprozil is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

  • WARNINGS

    BEFORE THERAPY WITH CEFPROZIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFPROZIL, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFPROZIL OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefprozil tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

    C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

    If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

  • PRECAUTIONS

    General

    Prescribing cefprozil tablets in the absence of a 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 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.

    Information for Patients

    Patients should be counseled that antibacterial drugs including cefprozil tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefprozil tablets 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 tablets 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® tablets1), 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.

    1Clinitest® and Clinistix® are registered trademarks of Bayer Healthcare LLC.

    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/m2.

    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.

    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/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.

    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 mcg/mL. Caution should be exercised when cefprozil 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 cefprozil 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 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.

    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 (see CLINICAL PHARMACOLOGY).

    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. See DOSAGE AND ADMINISTRATION for dosing recommendations for patients with impaired renal function.

  • 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 cefprozil, have been rarely reported during postmarketing surveillance: anaphylaxis, angioedema, colitis (including pseudomembranous colitis), erythema multiforme, fever, serum-sickness 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.

  • OVERDOSAGE

    Single 5000 mg/kg oral doses of cefprozil caused no mortality or signs of toxicity in adult, weanling, or neonatal rats, or adult mice. A single oral dose of 3000 mg/kg caused diarrhea and loss of appetite in cynomolgus monkeys, but no mortality.

    Cefprozil is eliminated primarily by the kidneys. In case of severe overdosage, especially in patients with compromised renal function, hemodialysis will aid in the removal of cefprozil from the body.

  • DOSAGE AND ADMINISTRATION

    Cefprozil tablets are administered orally.

    *
    In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days.
    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*

    Acute Sinusitis
    (For moderate to severe infections, the higher dose should be used)

    250 q12h or
    500 q12h

    10

    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 to 12 years)

    UPPER RESPIRATORY TRACT

    Pharyngitis/Tonsillitis

    7.5 mg/kg q12h

    10*

    SKIN AND SKIN STRUCTURE

    Uncomplicated Skin and Skin Structure Infections

    20 mg/kg q24h

    10

    INFANTS & CHILDREN (6 months to 12 years)

    UPPER RESPIRATORY TRACT

    Otitis Media (See INDICATIONS AND USAGE and CLINICAL STUDIES)

    15 mg/kg q12h

    10

    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 to 120

    standard

    standard

    0 to 29*

    50% of standard

    standard

    Hepatic Impairment

    No dosage adjustment is necessary for patients with impaired hepatic function.

  • HOW SUPPLIED

    Cefprozil Tablets USP are available as follows:

    250 mg: Round-shaped, light orange, film-coated, unscored tablets, debossed with “93” and “1077” on one side and plain on the other side, in bottles of 100 (NDC 0093-1077-01).

    500 mg: Capsule-shaped, white, film-coated, unscored tablets, debossed with “1078” on one side and “93” on the other, in bottles of 50 (NDC 0093-1078-53).

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

    Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

  • CLINICAL STUDIES

    Study One:

    In a controlled clinical study of acute otitis media performed in the United States where significant rates of β-lactamase-producing organisms were found, cefprozil was compared to an oral antimicrobial agent that contained a specific β-lactamase inhibitor. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 10 to 16 days post-therapy follow-up, the following presumptive bacterial eradication/clinical cure outcomes (i.e., clinical success) and safety results were obtained:

    U.S. Acute Otitis Media Study
    Cefprozil vs.
    β-lactamase inhibitor-containing control drug

    EFFICACY:

    Pathogen

    % of Cases with Pathogen

    (n = 155)

    Outcome

    S. pneumoniae

    48.4%

    cefprozil success rate 5% better than control

    H. influenzae

    35.5%

    cefprozil success rate 17% less than control

    M. catarrhalis

    13.5%

    cefprozil success rate 12% less than control

    S. pyogenes

    2.6%

    cefprozil equivalent to control

    Overall

    100.0%

    cefprozil success rate 5% less than control


    SAFETY:

    The incidences of adverse events, primarily diarrhea and rash*, were clinically and statistically significantly higher in the control arm versus the cefprozil arm.

    Age Group

    Cefprozil

    Control

    6 months to 2 years

    21%

    41%

    3 to 12 years

    10%

    19%

    *
    The majority of these involved the diaper area in young children.

    Study Two:

    In a controlled clinical study of acute otitis media performed in Europe, cefprozil was compared to an oral antimicrobial agent that contained a specific β-lactamase inhibitor. As expected in a European population, this study population had a lower incidence of β-lactamase-producing organisms than usually seen in U.S. trials. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 10 to 16 days post-therapy follow-up, the following presumptive bacterial eradication/clinical cure outcomes (i.e., clinical success) were obtained:

    European Acute Otitis Media Study
    Cefprozil vs. β-lactamase inhibitor-containing control drug

    EFFICACY:

    Pathogen

    % of Cases with Pathogen
    (n = 47)

    Outcome

    S. pneumoniae

    51.0%

    cefprozil equivalent to control

    H. influenzae

    29.8%

    cefprozil equivalent to control

    M. catarrhalis

    6.4%

    cefprozil equivalent to control

    S. pyogenes

    12.8%

    cefprozil equivalent to control

    Overall

    100.0%

    cefprozil equivalent to control


    SAFETY:

    The incidence of adverse events in the cefprozil arm was comparable to the incidence of adverse events in the control arm (agent that contained a specific β-lactamase inhibitor).

  • SPL UNCLASSIFIED SECTION

    Manufactured By:
    Teva Pharmaceuticals USA, Inc.
    North Wales, PA 19454

    Rev. E 8/2018

  • Package/Label Display Panel

    Cefprozil Tablets USP 250 mg 100 Tablet Label

    Cefprozil Tablets USP 250 mg 100 Tablet Label Text

    NDC 0093-1077-01

    CEFPROZIL

    Tablets USP

    250 mg

    (Film-Coated Tablets)

    Rx only

    100 TABLETS

    TEVA

  • Package/Label Display Panel

    Cefprozil Tablets USP 500 mg 50 Tablet Label

    Cefprozil Tablets USP 500 mg 50 Tablet Label Text

    NDC 0093-1078-53

    CEFPROZIL

    Tablets USP

    500 mg

    (Film-Coated Tablets)

    Rx only

    50 TABLETS

    TEVA

  • INGREDIENTS AND APPEARANCE
    CEFPROZIL 
    cefprozil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0093-1077
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CEFPROZIL (UNII: 4W0459ZA4V) (CEFPROZIL ANHYDROUS - UNII:1M698F4H4E) CEFPROZIL ANHYDROUS250 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorORANGE (light orange) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 93;1077
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0093-1077-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06520812/23/2005
    CEFPROZIL 
    cefprozil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0093-1078
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CEFPROZIL (UNII: 4W0459ZA4V) (CEFPROZIL ANHYDROUS - UNII:1M698F4H4E) CEFPROZIL ANHYDROUS500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVAL (capsule-shaped) Size20mm
    FlavorImprint Code 1078;93
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0093-1078-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/07/200605/31/2008
    2NDC:0093-1078-5350 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06520812/23/2005
    Labeler - Teva Pharmaceuticals USA, Inc. (001627975)