Label: CEFUROXIME AXETIL tablet

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

Cefuroxime axetil tablets contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration.

 

Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of cefuroxime, is (RS )-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48.

 

Cefuroxime axetil is in the amorphous form and has the following structural formula:

 

Cefuroxime axetil tablets are uncoated and contain the equivalent of 125, 250 or 500 mg of cefuroxime as cefuroxime axetil. Cefuroxime axetil tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, microcrystalline cellulose and sodium lauryl sulfate

.

Absorption and Metabolism:

After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to cefuroxime. Cefuroxime is subsequently distributed throughout the extracellular fluids. The axetil moiety is metabolized to acetaldehyde and acetic acid.

Pharmacokinetics:

Approximately 50%of serum cefuroxime is bound to protein. Serum pharmacokinetic parameters for cefuroxime axetil tablets are shown in Table 1. 

Comparative Pharmacokinetic Properties: Cefuroxime axetil for oral suspension was not bioequiv­alent to cefuroxime axetil tablets when tested in healthy adults. The tablet and powder for oral suspension formulations are NOT substitutable on a milligram-per-milligram basis. 

The area under the curve for the suspension averaged 91%of that for the tablet, and the peak plasma concentration for the suspension averaged 71%of the peak plasma concentration of the tablets. Therefore, the safety and effectiveness of both the tablet and oral suspension formulations had to be established in separate clinical trials.

Food Effect on Pharmacokinetics:

Absorption of the tablet is greater when taken after food (absolute bioavailability of cefuroxime axetil tablets increases from 37%to 52%). Despite this difference in absorption, the clinical and bacteriologic responses of patients were independent of food intake at the time of tablet administration in 2 studies where this was assessed.

 

Renal Excretion:

Cefuroxime is excreted unchanged in the urine; in adults, approximately 50%of the administered dose is recovered in the urine within 12 hours. The pharmacokinetics of cefuroxime in the urine of pediatric patients have not been studied at this time. Until further data are available, the renal pharmacokinetic properties of cefuroxime axetil established in adults should not be extrapolated to pediatric patients.

 

Because cefuroxime is renally excreted, the serum half-life is prolonged in patients with reduced renal function. In a study of 20 elderly patients (mean age = 83.9 years) having a mean creatinine clearance of 34.9 mL/min, the mean serum elimination half-life was 3.5 hours. Despite the lower elimination of cefuroxime in geriatric patients, dosage adjustment based on age is not necessary (see

PRECAUTIONS: Geriatric Use

).

 

Microbiology:

The

in vivo

bactericidal activity of cefuroxime axetil is due to cefuroxime’s binding to essential target proteins and the resultant inhibition of cell-wall synthesis.

 

Cefuroxime has bactericidal activity against a wide range of common pathogens, including many beta-lactamase–producing strains. Cefuroxime is stable to many bacterial beta-lactamases, especially plasmid-mediated enzymes that are commonly found in enterobacteriaceae.

 

Cefuroxime has been demonstrated 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 (see

INDICATIONS AND USAGE 

section).

 

Aerobic Gram-Positive Microorganisms:

 

Staphylococcus aureus

(including beta-lactamase–producing strains)

Streptococcus pneumoniae
Streptococcus pyogenes

 

Aerobic Gram-Negative Microorganisms:

 

Escherichia coli

Haemophilus influenzae

(including beta-lactamase–producing strains)

Haemophilus parainfluenzae

Klebsiella pneumoniae

Moraxella catarrhalis

(including beta-lactamase–producing strains)

Neisseria gonorrhoeae

(including beta-lactamase–producing strains)

 

Spirochetes:

 

Borrelia burgdorferi

 

Cefuroxime has been shown to be active

in vitro

against most strains of the following microorganisms; however, the clinical significance of these findings is unknown.

 

Cefuroxime exhibits

in vitro

minimum inhibitory concentrations (MICs) of 4 mcg/mL or less (systemic susceptible breakpoint) against most (≥90%) strains of the following microorganisms; however, the safety and effectiveness of cefuroxime in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled trials.

 

Aerobic Gram-Positive Microorganisms:

 

Staphylococcus epidermidis

Staphylococcus saprophyticus

Streptococcus agalactiae

 

NOTE:

Listeria monocytogenes

and certain strains of enterococci, e.g.,

Enterococcus faecalis

(formerly

Streptococcus faecalis

), are resistant to cefuroxime. Methicillin-resistant staphylococci are resistant to cefuroxime.

 

Aerobic Gram-Negative Microorganisms:

 

Morganella morganii

Proteus inconstans

Proteus mirabilis

Providencia rettgeri

 

NOTE:

Pseudomonas

spp.,

Campylobacter

spp.,

Acinetobacter calcoaceticus

,

Legionella

spp., and most strains of

Serratia

spp. and

Proteus vulgaris

are resistant to most first- and second-generation cephalosporins. Some strains of

Morganella morganii

,

Enterobacter cloacae

, and

Citrobacter

spp. have been shown by

in vitro

tests to be resistant to cefuroxime and other cephalosporins.

 

Anaerobic Microorganisms:

 

Peptococcus niger

 

NOTE: Most strains of

Clostridium difficile

and

Bacteroides fragilis

are resistant to cefuroxime.

 

Susceptibility Tests: Dilution Techniques:

Quantitative methods that are used to determine MICs provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure uses a standardized dilution method

1

(broth, agar, or microdilution) or equivalent with cefuroxime powder. The MIC values obtained should be interpreted according to the following criteria:

A report of “Susceptible” indicates that the pathogen, if in the blood, is likely to be inhibited by usually achievable concentrations of the antimicrobial compound in blood. A report of “Intermediate” indicates that inhibitory concentrations of the antibiotic may be achieved if high dosage is used or if the infection is confined to tissues or fluids in which high antibiotic concentrations are attained. This category also provides a buffer zone that prevents small, uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that usually achievable concentrations of the antimicrobial compound in the blood are unlikely to be inhibitory and that other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms. Standard cefuroxime powder should give the following MIC values: 

Diffusion Techniques:

Quantitative methods that require measurement of zone diameters provide estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure

2

that has been recommended (for use with disks) to test the susceptibility of microorganisms to cefuroxime uses the 30 mcg cefuroxime disk. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for cefuroxime.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30 mcg cefuroxime disk should be interpreted according to the following criteria: 

Interpretation should be as stated above for results using dilution techniques.

As with standard dilution techniques, diffusion methods require the use of laboratory control microorganisms. The 30 mcg cefuroxime disk provides the following zone diameters in these laboratory test quality control strains:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil and other antibacterial drugs, cefuroxime axetil 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.

 

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIO­EQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).

 

Cefuroxime Axetil Tablets:

Cefuroxime axetil 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:

 

1.   

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. Cefuroxime axetil tablets are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of

Streptococcus pyogenes.

 

2.    

Acute Bacterial Otitis Media

caused by

Streptococcus pneumoniae

,

Haemophilus influenzae

(including beta-lactamase–producing strains),

Moraxella catarrhalis

(including beta-lactamase–producing strains), or

Streptococcus pyogenes.

 

3.   

Acute Bacterial Maxillary Sinusitis

caused by

Streptococcus pneumoniae

or

Haemophilus influenzae

(non-beta-lactamase–producing strains only). (See

CLINICAL STUDIES

section.)

 

NOTE:

In view of the insufficient numbers of isolates of beta-lactamase–producing strains of

Haemophilus influenzae

and

Moraxella catarrhalis

that were obtained from clinical trials with cefuroxime axetil tablets for patients with acute bacterial maxillary sinusitis, it was not possible to adequately evaluate the effectiveness of cefuroxime axetil tablets for sinus infections known, suspected, or considered potentially to be caused by beta-lactamase–producing

Haemophilus influenzae

or

Moraxella catarrhalis

.

 

4.    

Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis

caused by

Streptococcus pneumoniae

,

Haemophilus influenzae

(beta-lactamase negative strains), or

Haemophilus parainfluenzae

(beta-lactamase negative strains). (See

DOSAGE AND ADMINISTRATION

section and

CLINICAL STUDIES

section.)

 

5.   

Uncomplicated Skin and Skin-Structure Infections

caused by

Staphylococcus aureus

(including beta-lactamase–producing strains) or

Streptococcus pyogenes.

 

6.    

Uncomplicated Urinary Tract Infections

caused by

Escherichia coli

or

Klebsiella pneumoniae

.

 

7.    

Uncomplicated Gonorrhea,

urethral and endocervical, caused by penicillinase-producing and non-penicillinase–producing strains of

Neisseria gonorrhoeae

and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase–producing strains of

Neisseria gonorrhoeae

.

 

8.   Early Lyme Disease (erythema migrans)

caused by

Borrelia burgdorferi.

Cefuroxime axetil products are contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE THEREFORE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).

 

BEFORE THERAPY WITH CEFUROXIME AXETIL PRODUCTS IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFUROXIME AXETIL PRODUCTS, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10%OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF A CLINICALLY SIGNIFICANT ALLERGIC REACTION TO CEFUROXIME AXETIL PRODUCTS OCCURS, DISCONTINUE THE DRUG AND INSTITUTE APPROPRIATE THERAPY. 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 cefuroxime, 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.

CEFUROXIME AXETIL TABLETS IN CLINICAL TRIALS: Multiple-Dose Dosing Regimens: 7 to 10 Days Dosing:

Using multiple doses of cefuroxime axetil tablets, 912 patients were treated with cefuroxime axetil (125 to 500 mg twice daily). There were no deaths or permanent disabilities thought related to drug toxicity. Twenty (2.2%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. Seventeen (85%) of the 20 patients who discontinued therapy did so because of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain. The percentage of cefuroxime axetil tablet-treated patients who discontinued study drug because of adverse events was very similar at daily doses of 1,000, 500, and 250 mg (2.3%, 2.1%, and 2.2%, respectively). However, the incidence of gastrointestinal adverse events increased with the higher recommended doses.

 

The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil tablets in multiple-dose clinical trials (n = 912 cefuroxime axetil-treated patients).

5-Day Experience (see CLINICAL STUDIES section):

In clinical trials using cefuroxime axetil in a dose of 250 mg twice daily in the treatment of secondary bacterial infections of acute bronchitis, 399 patients were treated for 5 days and 402 patients were treated for 10 days. No difference in the occurrence of adverse events was found between the 2 regimens.

In Clinical Trials for Early Lyme Disease With 20 Days Dosing:

Two multicenter trials assessed cefuroxime axetil tablets 500 mg twice a day for 20 days. The most common drug-related adverse experiences were diarrhea (10.6%of patients), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%). Other adverse experiences occurred with frequencies comparable to those reported with 7 to 10 days dosing.

 

Single-Dose Regimen for Uncomplicated Gonorrhea:

In clinical trials using a single dose of cefuroxime axetil tablets, 1,061 patients were treated with the recommended dosage of cefuroxime axetil (1,000 mg) for the treatment of uncomplicated gonorrhea. There were no deaths or permanent disabilities thought related to drug toxicity in these studies.

 

The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil in 1,000 mg single-dose clinical trials of cefuroxime axetil tablets in the treatment of uncomplicated gonorrhea conducted in the United States.  

POSTMARKETING EXPERIENCE WITH CEFUROXIME AXETIL PRODUCTS
 

In addition to adverse events reported during clinical trials, the following events have been identified during clinical practice in patients treated with cefuroxime axetil tablets or with cefuroxime axetil for oral suspension and were reported spontaneously. Data are generally insufficient to allow an estimate of incidence or to establish causation.

General:

The following hypersensitivity reactions have been reported: anaphylaxis, angioedema, pruritus, rash, serum sickness-like reaction, urticaria.

Gastrointestinal:

Pseudomembranous colitis (see

WARNINGS

).

 

Hematologic:

Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, and increased prothrombin time.

 

Hepatic:

Hepatic impairment including hepatitis and cholestasis, jaundice.

 

Neurologic:

Seizure.

 

Skin:

Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

 

Urologic:

Renal dysfunction.

 

CEPHALOSPORIN-CLASS ADVERSE REACTIONS

 

In addition to the adverse reactions listed above that have been observed in patients treated with cefuroxime axetil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: toxic nephropathy, aplastic anemia, hemorrhage, increased BUN, increased creatinine, false-positive test for urinary glucose, increased alkaline phosphatase, neutropenia, elevated bilirubin, and 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 of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.

NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).

 

Patients With Renal Failure:

The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established. Since cefuroxime is renally eliminated, its half-life will be prolonged in patients with renal failure.

Cefuroxime Axetil Tablets, USP 250 mg

of cefuroxime (as cefuroxime axetil), are  white to off-white, uncoated, capsule-shaped tablets with “A33” debossed on one side and plain on the other side.

 

               10 Tablets/Bottle                           NDC 21695-370-10

               20 Tablets/Bottle                           NDC 21695-370-20

 

Cefuroxime Axetil Tablets, USP 500 mg

of cefuroxime (as cefuroxime axetil), are  white to off-white, uncoated, capsule-shaped tablets with “A34” debossed on one side and plain on the other side.

 

               20 Tablets/Bottle                           NDC 21695-150-20

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.

Cefuroxime Axetil Tablets: Acute Bacterial Maxillary Sinusitis:

One adequate and well-controlled study was performed in patients with acute bacterial maxillary sinusitis. In this study each patient had a maxillary sinus aspirate collected by sinus puncture before treatment was initiated for presumptive acute bacterial sinusitis. All patients had to have radiographic and clinical evidence of acute maxillary sinusitis. As shown in the following summary of the study, the general clinical effectiveness of cefuroxime axetil tablets was comparable to an oral antimicrobial agent that contained a specific betalactamase inhibitor in treating acute maxillary sinusitis. However, sufficient microbiology data were obtained to demonstrate the effectiveness of cefuroxime axetil tablets in treating acute bacterial maxillary sinusitis due only to

Streptococcus pneumoniae

or non-beta-lactamase–producing

Haemophilus influenzae.

An insufficient number of beta-lactamase–producing

Haemophilus influenzae

and

Moraxella catarrhalis

isolates were obtained in this trial to adequately evaluate the effectiveness of cefuroxime axetil tablets in the treatment of acute bacterial maxillary sinusitis due to these 2 organisms.

 

This study enrolled 317 adult patients, 132 patients in the United States and 185 patients in South America. Patients were randomized in a 1:1 ratio to cefuroxime axetil 250 mg twice daily or an oral antimicrobial agent that contained a specific beta-lactamase inhibitor. An intent-to-treat analysis of the submitted clinical data yielded the following results:

 

In this trial and in a supporting maxillary puncture trial, 15 evaluable patients had non-beta-lactamase–producing

Haemophilus influenzae

as the identified pathogen. Ten (10) of these 15 patients (67%) had their pathogen (non-beta-lactamase-producing

Haemophilus influenzae

) eradicated. Eighteen (18) evaluable patients had

Streptococcus pneumoniae

as the identified pathogen. Fifteen (15) of these 18 patients (83%) had their pathogen (

Streptococcus pneumoniae

) eradicated.

 

Safety:

The incidence of drug-related gastrointestinal adverse events was statistically significantly higher in the control arm (an oral antimicrobial agent that contained a specific beta-lactamase inhibitor) versus the cefuroxime axetil arm (12%versus 1%, respectively;

P

<.001), particularly drug-related diarrhea (8%versus 1%, respectively; 

P

= .001).

 

Early Lyme Disease:

Two adequate and well-controlled studies were performed in patients with early Lyme disease. In these studies all patients had to present with physician-documented erythema migrans, with or without systemic manifestations of infection. Patients were randomized in a 1:1 ratio to a 20-day course of treatment with cefuroxime axetil 500 mg twice daily or doxycycline 100 mg 3 times daily. Patients were assessed at 1 month posttreatment for success in treating early Lyme disease (Part I) and at 1 year posttreatment for success in preventing the progression to the sequelae of late Lyme disease (Part II).

 

A total of 355 adult patients (181 treated with cefuroxime axetil and 174 treated with doxycycline) were enrolled in the 2 studies. In order to objectively validate the clinical diagnosis of early Lyme disease in these patients, 2 approaches were used:1) blinded expert reading of photographs, when available, of the pretreatment erythema migrans skin lesion; and 2) serologic confirmation (using enzyme-linked immunosorbent assay [ELISA] and immunoblot assay [“Western” blot]) of the presence of antibodies specific to

Borrelia burgdorferi

, the etiologic agent of Lyme disease. By these procedures, it was possible to confirm the physician diagnosis of early Lyme disease in 281 (79%) of the 355 study patients. The efficacy data summarized below are specific to this “validated” patient subset, while the safety data summarized below reflect the entire patient population for the 2 studies.

 

Analysis of the submitted clinical data for evaluable patients in the “validated” patient subset yielded the following results:   

 

Cefuroxime axetil and doxycycline were effective in prevention of the development of sequelae of late Lyme disease.

 

Safety:

Drug-related adverse events affecting the skin were reported significantly more frequently by patients treated with doxycycline than by patients treated with cefuroxime axetil (12%versus 3%, respectively;

P

= .002), primarily reflecting the statistically significantly higher incidence of drug-related photosensitivity reactions in the doxycycline arm versus the cefuroxime axetil arm (9%versus 0%, respectively;

P

<.001). While the incidence of drug-related gastrointestinal adverse events was similar in the 2 treatment groups (cefuroxime axetil - 13%; doxycycline - 11%), the incidence of drug-related diarrhea was statistically significantly higher in the cefuroxime axetil arm versus the doxycycline arm (11%versus 3%, respectively;

P

= .005).

 

Secondary Bacterial Infections of Acute Bronchitis:

Four randomized, controlled clinical studies were performed comparing 5 days versus 10 days of cefuroxime axetil for the treatment of patients with secondary bacterial infections of acute bronchitis. These studies enrolled a total of 1,253 patients (CAE-516 n = 360; CAE-517 n = 177; CAEA4001 n = 362; CAEA4002 n = 354). The protocols for CAE-516 and CAE-517 were identical and compared cefuroxime axetil 250 mg twice daily for 5 days, cefuroxime axetil 250 mg twice daily for 10 days, and AUGMENTIN

®

500 mg 3 times daily for 10 days. These 2 studies were conducted simultaneously. CAEA4001 and CAEA4002 compared cefuroxime axetil 250 mg twice daily for 5 days, cefuroxime axetil 250 mg twice daily for 10 days, and CECLOR

®

250 mg 3 times daily for 10 days. They were otherwise identical to CAE-516 and CAE-517 and were conducted over the following 2 years. Patients were required to have polymorphonuclear cells present on the Gram stain of their screening sputum specimen, but isolation of a bacterial pathogen from the sputum culture was not required for inclusion. The following table demonstrates the results of the clinical outcome analysis of the pooled studies CAE-516/CAE-517 and CAEA4001/CAEA4002, respectively:

 

The response rates for patients who were both clinically and bacteriologically evaluable were consistent with those reported for the clinically evaluable patients.

 

Safety:

In these clinical trials, 399 patients were treated with cefuroxime axetil for 5 days and 402 patients with cefuroxime axetil for 10 days. No difference in the occurrence of adverse events was observed between the 2 regimens.

 

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. 3rd ed. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25. Villanova, Pa: NCCLS; 1993.
2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests. 4th ed. Approved Standard NCCLS Document M2-A4, Vol. 10, No. 7. Villanova, Pa: NCCLS; 1990.  

AUGMENTIN

®

and CECLOR

®

are registered trademarks of GlaxoSmithKline.

CLINITEST and CLINISTIX are registered trademarks of Ames Division, Miles Laboratories, Inc. 

Manufactured for:

Aurobindo Pharma USA, Inc.

2400 Route 130 North

Dayton, NJ 08810 

 

Manufactured by:

Aurobindo Pharma Limited

Chitkul (v)-502 307, A.P., India

Repackaged by:

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