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Cefprozil (Tablet, Film Coated)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2457

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Cefprozil (Tablet, Film Coated)
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Cefprozil is administered orally.<br/>Renal Impairment: Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.<br/>Hepatic Impairment: No dosage adjustment is necessary for patients with impaired hepatic function.
dailymed-instance:descripti...
Cefprozil is a semi-synthetic broad-spectrum cephalosporin antibiotic. Cefprozil 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: Cefprozil is a white to yellowish powder with a molecular formula for the monohydrate of CHNOS���HO and a molecular weight of 407.44. Each cefprozil tablet intended for oral administration contains cefprozil equivalent to 250 mg or 500 mg of anhydrous cefprozil. In addition each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, sodium starch glycolate and titanium dioxide. The 500 mg tablets also contain ferric oxide.
dailymed-instance:clinicalP...
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.) 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 tablet formulation with food did not affect the extent of absorption (AUC) or the peak plasma concentration (C) of cefprozil. However, there was an increase of 0.25 to 0.75 hours in the time to maximum plasma concentration of cefprozil (T). 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. 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%���60% higher AUC and 40% lower renal clearance values compared with healthy adult volunteers 20���40 years of age. The average AUC in young and elderly female subjects was approximately 15���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-12 years) and adults following oral administration of selected matched doses. The maximum concentrations are achieved at 1-2 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.<br/>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: Staphylococcus aureus(including��-lactamase-producing strains) Streptococcus pneumoniaeStreptococcus pyogenes Aerobic gram-negative microorganisms: Haemophilus influenzae(including��-lactamase-producing strains) Moraxella (Branhamella) catarrhalis(including��-lactamase-producing strains) 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 duransEnterococcus faecalisListeria monocytogenesStaphylococcus epidermidisStaphylococcus saprophyticusStaphylococcus warneriStreptococcus agalactiaeStreptococci (Groups C, D, F, and G)viridans group Streptococci Aerobic gram-negative microorganisms: Citrobacter diversusEscherichia coliKlebsiella pneumoniaeNeisseria gonorrhoeae(including��-lactamase-producing strains)Proteus mirabilisSalmonella spp.Shigella spp.Vibrio spp. Anaerobic microorganisms: Prevotella (Bacteroides) melaninogenicusClostridium difficileClostridium perfringensFusobacterium spp.Peptostreptococcus spp.Propionibacterium acnes<br/>Susceptibility Tests:
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Cefprozil is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
dailymed-instance:supply
Cefprozil Tablets USP, 250 mg are oval-shaped, white to cream tinged, unscored, film-coated tablets, debossed 347 on one side and 250 on the reverse side and are supplied as follows: NDC 0781-5043-01 in bottles of 100 tablets Ceprozil Tablets USP, 500 mg are oval-shaped, beige, unscored, filmcoated tablets, debossed 348 on one side and 500 on the reverse side and are supplied as follows: NDC 0781-5044-50 in bottles of 50 tabletsNDC 0781-5044-01 in bottles of 100 tablets Store at 20��-25��C (68��-77��F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
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dailymed-instance:overdosag...
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.
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Cefprozil
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Cefprozil (Tablet, Film Coated)
dailymed-instance:adverseRe...
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.<br/>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. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
dailymed-instance:warning
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��-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. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefprozil, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibioticassociated" colitis. After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.
dailymed-instance:indicatio...
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil 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. 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:<br/>UPPER RESPIRATORY TRACT: Pharyngitis/tonsillitis caused by Streptococcus pyogenes. Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including��-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including��-lactamase-producing strains). Acute Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including��-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including��-lactamase-producing strains).<br/>LOWER RESPIRATORY TRACT: Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenza (including��-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including��-lactamase-producing strains).<br/>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
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Cefprozil