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Cefuroxime Axetil

H.J. Harkins Company, Inc.
Aurobindo Pharma Limited

Cefuroxime Axetil Tablets, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION


CEFUROXIME AXETIL DESCRIPTION




RS RR2ZO2022410


Cefuroxime Axetil

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.

CLINICAL PHARMACOLOGY

Absorption and Metabolism


Pharmacokinetics



Table 1. Postprandial Pharmacokinetics of Cefuroxime Administered as Cefuroxime Axetil Tablets to Adults*
*Mean values of 12 healthy adult volunteers.
† Drug administered immediately after a meal.
Dose†
(Cefuroxime
Equivalent)
 Peak Plasma
Concentration
(mcg/mL)
 Time of Peak
Plasma
Concentration (hr)
 Mean
Elimination
Half-Life (hr)
 AUC
(mcg-hr mL)
   125 mg
2.1
 2.2
 1.2
 6.7
   250 mg
4.1
 2.5
 1.2
 12.9
   500 mg
7
 3
 1.2
 27.4
   1,000 mg
13.6
 2.5
 1.3
 50
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.

Food Effect on Pharmacokinetics


Renal Excretion




PRECAUTIONS: Geriatric Use

Microbiology


in vivo



in vitro INDICATIONS AND USAGE

Aerobic Gram-Positive Microorganisms


Staphylococcus aureus
Streptococcus pneumoniae
Streptococcus pyogenes

Aerobic Gram-Negative Microorganisms


Escherichia coli
Haemophilus influenzae
Haemophilus parainfluenzae
Klebsiella pneumoniae
Moraxella catarrhalis
Neisseria gonorrhoeae

Spirochetes


Borrelia burgdorferi

in vitro

in vitro

Aerobic Gram-Positive Microorganisms


Staphylococcus epidermidis
Staphylococcus saprophyticus
Streptococcus agalactiae

Listeria monocytogenes Enterococcus faecalis Streptococcus faecalis

Aerobic Gram-Negative Microorganisms


Morganella morganii
Proteus inconstans
Proteus mirabilis
Providencia rettgeri

Pseudomonas Campylobacter Acinetobacter calcoaceticusLegionella Serratia Proteus vulgaris Morganella morganiiEnterobacter cloacaeCitrobacter in vitro

Anaerobic Microorganisms


Peptococcus niger

Clostridium difficile Bacteroides fragilis

Susceptibility Tests

Dilution Techniques


1
MIC (mcg/mL)
Interpretation
≤4
 (S) Susceptible
8-16
 (I) Intermediate
≥32
 (R) Resistant




Microorganism
MIC (mcg/mL)
Escherichia coli ATCC 25922
 2-8
Staphylococcus aureus ATCC 29213
 0.5-2

Diffusion Techniques


2


Zone Diameter (mm)
Interpretation
≥23
 (S) Susceptible
15-22
 (I) Intermediate
≤14
 (R) Resistant



Microorganism
Zone Diameter (mm)
Escherichia coli ATCC 25922
 20-26
Staphylococcus aureus ATCC 25923
 27-35

CEFUROXIME AXETIL INDICATIONS AND USAGE




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

 

  • 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.  
  • 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.  
  • 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.  
  • 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.)  
  • Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including beta-lactamase–producing strains) or Streptococcus pyogenes.  
  • Uncomplicated Urinary Tract Infections caused by Escherichia coli or Klebsiella pneumoniae.  
  • 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.  
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.

CEFUROXIME AXETIL CONTRAINDICATIONS


WARNINGS


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 C. difficile

C. difficile C. difficile

C. difficileC. difficile

PRECAUTIONS

General












Information for Patients/Caregivers (Pediatric)

  • During clinical trials, the tablet was tolerated by pediatric patients old enough to swallow the cefuroxime axetil tablet whole. The crushed tablet has a strong, persistent, bitter taste and should not be administered to pediatric patients in this manner. Pediatric patients who cannot swallow the tablet whole should receive the oral suspension.  
  • Patients should be counseled that antibacterial drugs, including cefuroxime axetil, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefuroxime axetil is 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 cefuroxime axetil or other antibacterial drugs in the future.

Drug/Laboratory Test Interactions


®®

Drug/Drug Interactions






Carcinogenesis, Mutagenesis, Impairment of Fertility


in vitroin vivo2

Pregnancy

Teratogenic Effects


22

Labor and Delivery


Nursing Mothers


Pediatric Use


CLINICAL PHARMACOLOGY INDICATIONS AND USAGE ADVERSE REACTIONS DOSAGE AND ADMINISTRATION CLINICAL STUDIES

Geriatric Use


CEFUROXIME AXETIL ADVERSE REACTIONS

CEFUROXIME AXETIL TABLETS IN CLINICAL TRIALS

Multiple-Dose Dosing Regimens

7 to 10 Days Dosing




Table 2. Adverse Reactions— Cefuroxime Axetil Tablets Multiple-Dose Dosing Regimens—Clinical Trials
   Incidence ≥1%
   Diarrhea/loose stools                                        3.7%
   Nausea/vomiting                                               3%
   Transient elevation in AST                                2%
   Transient elevation in ALT                               1.6%
   Eosinophilia                                                     1.1%
   Transient elevation in LDH                                1%
   Incidence
      <1% but >0.1%
    Abdominal pain
   Abdominal cramps
   Flatulence
   Indigestion
   Headache
   Vaginitis
   Vulvar itch
   Rash
   Hives
   Itch
   Dysuria
   Chills
   Chest pain
   Shortness of breath
   Mouth ulcers
   Swollen tongue
   Sleepiness
   Thirst
   Anorexia
   Positive Coombs test
5-Day Experience (see CLINICAL STUDIES section)

In Clinical Trials for Early Lyme Disease With 20 Days Dosing

Single-Dose Regimen for Uncomplicated Gonorrhea





Table 3. Adverse Reactions— Cefuroxime Axetil Tablets 1-g Single-Dose Regimen for Uncomplicated Gonorrhea—Clinical Trials
   Incidence ≥1%
   Nausea/vomiting                            6.8%
   Diarrhea                                        4.2%
   Incidence
      <1% but >0.1%
    Abdominal pain
   Dyspepsia
   Erythema
   Rash
   Pruritus
   Vaginal candidiasis
   Vaginal itch
   Vaginal discharge
   Headache
   Dizziness
   Somnolence
   Muscle cramps
   Muscle stiffness
   Muscle spasm of neck
   Tightness/pain in chest
   Bleeding/pain in urethra
   Kidney pain
   Tachycardia
   Lockjaw-type reaction

POSTMARKETING EXPERIENCE WITH CEFUROXIME AXETIL PRODUCTS




General:

Gastrointestinal: WARNINGS

Hematologic:

Hepatic:

Neurologic:

Skin:

Urologic:

CEPHALOSPORIN-CLASS ADVERSE REACTIONS




DOSAGE AND ADMINISTRATION OVERDOSAGE

OVERDOSAGE


CEFUROXIME AXETIL DOSAGE AND ADMINISTRATION


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).
Table 4. Cefuroxime Axetil Tablets (May be administered without regard to meals.)
*The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

Population/Infection		 Dosage
 Duration
(days)
   Adolescents and Adults (13 years and older)
      Pharyngitis/tonsillitis
250 mg b.i.d.
 10
      Acute bacterial maxillary sinusitis
250 mg b.i.d.
 10
      Acute bacterial exacerbations of chronic bronchitis
250 or 500 mg b.i.d.
 10*
      Secondary bacterial infections of acute bronchitis
250 or 500 mg b.i.d.
 5-10
      Uncomplicated skin and skin­-structure infections
250 or 500 mg b.i.d.
 10
      Uncomplicated urinary tract infections
250 mg b.i.d.
 7-10
      Uncomplicated gonorrhea
1,000 mg once
 single dose
      Early Lyme disease
500 mg b.i.d.
 20
   Pediatric Patients (who can swallow tablets whole)
      Acute otitis media
250 mg b.i.d.
 10
      Acute bacterial maxillary sinusitis
250 mg b.i.d.
 10

Patients With Renal Failure


HOW SUPPLIED


Cefuroxime Axetil Tablets, USP 500 mg




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.

CLINICAL STUDIES

Cefuroxime Axetil Tablets

Acute Bacterial Maxillary Sinusitis


Streptococcus pneumoniae Haemophilus influenzae. Haemophilus influenzae Moraxella catarrhalis




Table 5. Clinical Effectiveness of Cefuroxime Axetil Tablets Compared to Beta-Lactamase Inhibitor-Containing Control Drug in the Treatment of Acute Bacterial Maxillary Sinusitis
*95% Confidence interval around the success difference [-0.08, +0.32].
†95% Confidence interval around the success difference [-0.1, +0.16].
 
 U.S. Patients*
 South American Patients†
Cefuroxime Axetil
(n = 49)
 Control
(n = 43)
 Cefuroxime Axetil
(n = 87)
 Control
(n = 89)
   Clinical success
   (cure + improvement)
65%
 53%
 77%
 74%
   Clinical cure
53%
 44%
 72%
 64%
   Clinical improvement
12%
 9%
 5%
 10%

Haemophilus influenzae Haemophilus influenzaeStreptococcus pneumoniae Streptococcus pneumoniae

Safety


PP

Early Lyme Disease




Borrelia burgdorferi




Table 6. Clinical Effectiveness of Cefuroxime Axetil Tablets Compared to Doxycycline in the Treatment of Early Lyme Disease
* 95% confidence interval around the satisfactory difference for Part I (-0.08, +0.05).
† 95% confidence interval around the satisfactory difference for Part II (-0.13, +0.07).
‡ n’s include patients assessed as unsatisfactory clinical outcomes (failure + recurrence) in Part I (cefuroxime axetil tablets - 11 [5 failure, 6 recurrence]; doxycycline - 8 [6 failure, 2 recurrence]).
§ Satisfactory clinical outcome includes cure + improvement (Part I) and success + improvement (Part II).
Part I
(1 Month Posttreatment)*
 Part II
(1 Year Posttreatment)†
Cefuroxime Axetil
(n = 125)
 Doxycycline
(n = 108)
 Cefuroxime Axetil
(n = 105‡)
 Doxycycline
(n = 83‡)
   Satisfactory
   clinical outcome§
91%
 93%
 84%
 87%
   Clinical cure/success
72%
 73%
 73%
 73%
   Clinical improvement
19%
 19%
 10%
 13%

Safety


P PP

Secondary Bacterial Infections of Acute Bronchitis


®®


Table 7. Clinical Effectiveness of Cefuroxime Axetil Tablets 250 mg Twice Daily in Secondary Bacterial Infections of Acute Bronchitis: Comparison of 5 Versus 10 Days’ Treatment Duration
*95% Confidence interval around the success difference [-0.164, +0.029].
† 95% Confidence interval around the success difference [-0.061, +0.103].
CAE-516 and CAE-517*
 CAEA4001 and CAEA4002†
5 day
(n = 127)
 10 day
(n = 139)
 5 day
(n = 173)
 10 day
(n = 192)
   Clinical success
   (cure + improvement)
 80%
 87%
 84%
 82%
   Clinical cure
61%
 70%
 73%
 72%
   Clinical improvement
19%
 17%
 11%
 10%

Safety


REFERENCES

  • 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.
  • 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.   

®®



Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited





PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (60 Tablet Bottle)


NDC 65862-035-60
Cefuroxime Axetil Tablets, USP
500 mg*
Rx only                      60 Tablets
AUROBINDO
Cefuroxime Axetil

Cefuroxime Axetil

Cefuroxime Axetil TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52959-939(NDC:65862-035)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CEFUROXIME AXETIL CEFUROXIME 500 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROGENATED COTTONSEED OIL
cellulose, microcrystalline
SODIUM LAURYL SULFATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off-white) 20 mm A34 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52959-939-20 20 in 1 BOTTLE
2 NDC:52959-939-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065308 2006-03-29


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