Cefuroxime Axetil

Cefuroxime Axetil

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Questions & Answers

Side Effects & Adverse Reactions

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 axetil, 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 2 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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil tablets USP and other antibacterial drugs, cefuroxime axetil tablets USP 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 USP AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIO‑EQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).

Cefuroxime Axetil Tablets USP:Cefuroxime axetil tablets USP 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 USP 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 STUDIESsection.)

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 USP for patients with acute bacterial maxillary sinusitis, it was not possible to adequately evaluate the effectiveness of cefuroxime axetil tablets USP 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 ADMINISTRATIONand CLINICAL STUDIES).

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.

History

There is currently no drug history available for this drug.

Other Information

Cefuroxime axetil tablets USP 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:

Chemical Structure

Cefuroxime axetil tablets USP are film-coated and contain the equivalent of 250 mg or 500 mg of cefuroxime as cefuroxime axetil USP. Cefuroxime axetil tablets USP contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide.

Cefuroxime Axetil Manufacturers


  • Preferred Pharmaceuticali Inc.
    Cefuroxime Axetil Tablet, Film Coated [Preferred Pharmaceuticali Inc.]
  • Direct Rx
    Cefuroxime Axetil Tablet [Direct Rx]
  • Ranbaxy Pharmaceuticals Inc.
    Cefuroxime Axetil Tablet [Ranbaxy Pharmaceuticals Inc.]
  • Rebel Distributors Corp
    Cefuroxime Axetil Tablet [Rebel Distributors Corp]
  • Ascend Laboratories, Llc
    Cefuroxime Axetil Tablet, Film Coated [Ascend Laboratories, Llc]
  • Physicians Total Care, Inc.
    Cefuroxime Axetil Tablet [Physicians Total Care, Inc.]
  • H.j. Harkins Company, Inc.
    Cefuroxime Axetil Tablet, Film Coated [H.j. Harkins Company, Inc.]
  • H.j. Harkins Company, Inc.
    Cefuroxime Axetil Tablet [H.j. Harkins Company, Inc.]
  • Wockhardt Limited
    Cefuroxime Axetil Tablet, Film Coated [Wockhardt Limited]
  • Wockhardt Usa Llc.
    Cefuroxime Axetil Tablet, Film Coated [Wockhardt Usa Llc.]
  • Pd-rx Pharmaceuticals, Inc.
    Cefuroxime Axetil Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Cefuroxime Axetil Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Cefuroxime Axetil Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Medvantx, Inc.
    Cefuroxime Axetil Tablet, Film Coated [Medvantx, Inc.]
  • Stat Rx Usa Llc
    Cefuroxime Axetil Tablet, Film Coated [Stat Rx Usa Llc]
  • Apotex Corp.
    Cefuroxime Axetil Tablet, Film Coated [Apotex Corp.]
  • A-s Medication Solutions Llc
    Cefuroxime Axetil Tablet, Film Coated [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cefuroxime Axetil Tablet, Film Coated [A-s Medication Solutions Llc]
  • Lupin Pharmaceuticals, Inc.
    Cefuroxime Axetil Tablet [Lupin Pharmaceuticals, Inc.]
  • Citron Pharma Llc
    Cefuroxime Axetil Tablet, Film Coated [Citron Pharma Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Cefuroxime Axetil Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Northstar Rx Llc
    Cefuroxime Axetil Tablet [Northstar Rx Llc]
  • Clinical Solutions Wholesale
    Cefuroxime Axetil Tablet, Film Coated [Clinical Solutions Wholesale]
  • Aurobindo Pharma Limited
    Cefuroxime Axetil Tablet [Aurobindo Pharma Limited]
  • Aurobindo Pharma Limited
    Cefuroxime Axetil Tablet [Aurobindo Pharma Limited]
  • Gen-source Rx
    Cefuroxime Axetil Tablet [Gen-source Rx]
  • Unit Dose Services
    Cefuroxime Axetil Tablet, Film Coated [Unit Dose Services]
  • Gen-source Rx
    Cefuroxime Axetil Tablet, Film Coated [Gen-source Rx]
  • Direct Rx
    Cefuroxime Axetil Tablet [Direct Rx]
  • Preferred Pharmaceuticals, Inc.
    Cefuroxime Axetil Tablet [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Cefuroxime Axetil Tablet [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Cefuroxime Axetil Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]

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