INDICATIONS AND USAGE
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-lactamaseproducing
strains), Moraxella catarrhalis (including
beta-lactamaseproducing strains), or Streptococcus
pyogenes.
3.
Acute
Bacterial Maxillary Sinusitis caused by Streptococcus
pneumoniae or Haemophilus influenzae
(non-beta-lactamaseproducing strains only). (See
CLINICAL STUDIES
section.)
NOTE: In view of the insufficient numbers of isolates of
beta-lactamaseproducing 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-lactamaseproducing
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-lactamaseproducing 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-penicillinaseproducing strains of Neisseria gonorrhoeae
and uncomplicated gonorrhea, rectal, in females, caused by
non-penicillinaseproducing strains of Neisseria
gonorrhoeae.
8.Early Lyme Disease (erythema
migrans) caused by Borrelia burgdorferi.