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.