CEFPROZIL_- cefprozil_tablet, film coated

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. Dosage Mean Plasma Cefprozil 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% *Data represent mean values of 12 healthy volunteers. max max Mean (SD) Plasma Cefprozil Concentrations (mcg/mL) Population Dose 1 h 2 h 4 h 6 h T1/2 (h) children (n=18) 7.5 mg/kg 4.70 (1.57) 3.99 (1.24) 0.91 (0.30) 0.23a (0.13) 0.94 (0.32) adults (n=12) 250 mg 4.82 (2.13) 4.92 (1.13) 1.70b (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) 0.61c (0.27) 1.24 (0.43) adults (n=12) 500 mg 8.39 (1.95) 9.42 (0.98) 3.18d (0.76) 1.00d (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) a b c d Microbiology in vitro INDICATIONS AND USAGE Aerobic gram-positive microorganisms: Aerobic gram-negative microorganisms: Staphylococcus aureus ( Haemophilus influenzae NOTE: Moraxella (Branhamella) catarrhalis 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: Aerobic gram-negative microorganisms: Citrobacter diversus Proteus mirabilis Escherichia coli Salmonella Klebsiella pneumoniae Shigella Neisseria gonorrhoeae Vibrio NOTE: Anaerobic microorganisms: Prevotella (Bacteroides) melaninogenicus Fusobacterium Clostridium difficile Peptostreptococcus Clostridium perfringens Propionibacterium acnes NOTE:

Cefprozil 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: Pharyngitis/tonsillitis Streptococcus pyogenes. Streptococcus pyogenes Otitis Media Streptococcus pneumoniae, Haemophilus influenzae Moraxella (Branhamella) catarrhalis CLINICAL STUDIES Acute Sinusitis Streptococcus pneumoniae, Haemophilus influenza Moraxella (Branhamella) catarrhalis Acute Bacterial Exacerbation of Chronic Bronchitis Streptococcus pneumoniae Haemophilus influenzae Moraxella (Branhamella) catarrhalis Uncomplicated Skin and Skin-Structure Infections Staphylococcus aureus Streptococcus pyogenes

Cefprozil is administered orally. Population/Infection Dosage (mg) Duration (days) a b a b a b Renal Impairment Creatinine Clearance Dosage Dosing Interval *Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.

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. Gastrointestinal Hepatobiliary: Hypersensitivity CNS Hematopoietic Renal Other Cephalosporin class paragraph DOSAGE AND ADMINISTRATION OVERDOSAGE

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

Pregnancy
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
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
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 CLINICAL STUDIES
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 DOSAGE AND ADMINISTRATION

Drug Interactions
Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporin antibiotics. Concomitant administration of probenecid doubled the AUC for cefprozil.
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 registered 1 registered 1 registered registered

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 beta-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 C. difficile C. difficile C. difficile C. difficile C. difficile
Carcinogenesis,Mutagenesis, Impairment Of Fertility
Long term in vivo Salmonella E. coli in vitro 2 2
Labor And Delivery
Cefprozil has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.
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.
CLINICAL STUDIES
Study One: acute otitis Study EFFICACY: Pathogen % of Cases with Pathogen Outcome (n=155) 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. 6% cefprozil equivalent to control Overall 100. 0% cefprozil success rate 5% less than control SAFETY: Age Group Cefprozil Control *The majority of these involved the diaper area in young children. Study Two: European Acute Otitis Media Study Cefprozil vs beta-lactamase inhibitor-containing control drug EFFICACY: Pathogen % of Cases with Pathogen Outcome (n=47) S. pneumoniae H. influenzae M. catarrhalis S. pyogenes SAFETY: Manufactured by: INDIA. Distributed by: cefprozil-company-logo.

Ascend Laboratories, LLC

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