1 INDICATIONS AND USAGE
Cefuroxime axetil is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1)
Pharyngitis/tonsillitis
(adults and pediatric patients) (1.1)
Acute
bacterial otitis media (pediatric patients) (1.2)
Acute
bacterial maxillary sinusitis (adults and pediatric patients)
(1.3)
Acute
bacterial exacerbations of chronic bronchitis (adults and pediatric
patients 13 years and older) (1.4)
Uncomplicated
skin and skin-structure infections (adults and pediatric patients 13 years
and older) (1.5)
Uncomplicated
urinary tract infections (adults and pediatric patients 13 years and
older) (1.6)
Uncomplicated
gonorrhea (adults and pediatric patients 13 years and older)
(1.7
))
Early Lyme
disease (adults and pediatric patients 13 years and older)
(1.8)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil tablets and other antibacterial drugs, cefuroxime axetil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
1.1 Pharyngitis/Tonsillitis
Cefuroxime axetil tablets, USP are indicated for the treatment of adult patients and pediatric patients (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes.
Limitations of Use
The
efficacy of cefuroxime axetil
tablets, USP in the prevention of rheumatic fever
was not established in clinical trials.
The
efficacy of cefuroxime axetil
tablets, USP in the treatment of
penicillin-resistant strains of Streptococcus pyogenes
has not been
demonstrated in clinical trials.
1.2 Acute Bacterial Otitis Media
Cefuroxime axetil tablets, USP are indicated for the treatment of pediatric patients (who can swallow tablets whole) with acute bacterial otitis media caused by susceptible strains of Streptococcuspneumoniae, Haemophilus influenzae (including -lactamase-producing strains), Moraxella catarrhalis (including -lactamase-producing strains), or Streptococcus pyogenes.
1.3 Acute Bacterial Maxillary Sinusitis
Cefuroxime axetil tablets, USP are indicated for the treatment of adult and pediatric patients (13 years and older) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non--lactamase-producing strains only).
Limitations of Use
The effectiveness of cefuroxime axetil tablets, USP for sinus infections caused by -lactamase-producing Haemophilus influenzae or Moraxella catarrhalis in patients with acute bacterial maxillary sinusitis was not established due to insufficient numbers of these isolates in the clinical trials [see Clinical Studies (14.1)].
1.4 Acute Bacterial Exacerbations of Chronic Bronchitis
Cefuroxime axetil tablets, USP are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with mild-to-moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (-lactamase-negative strains), or Haemophilus parainfluenzae (-lactamase-negative strains).
1.5 Uncomplicated Skin and Skin-Structure Infections
Cefuroxime axetil tablets, USP are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated skin and skin-structure infections caused by susceptible strains of Staphylococcus aureus (including -lactamase-producing strains) or Streptococcus pyogenes.
1.6 Uncomplicated Urinary Tract Infections
Cefuroxime axetil tablets, USP are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated urinary tract infections caused by susceptible strains of Escherichia coli or Klebsiella pneumoniae.
1.7 Uncomplicated Gonorrhea
Cefuroxime axetil tablets, USP are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated gonorrhea, urethral and endocervical, caused by penicillinase-producing and non-penicillinaseproducing susceptible strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinaseproducing susceptible strains of Neisseria gonorrhoeae.
1.8 Early Lyme Disease (erythema migrans)
Cefuroxime axetil tablets, USP are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with early Lyme disease (erythema migrans) caused by susceptible strains of Borrelia burgdorferi.
1.10 Usage
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.