SPECTRACEF SUMMARY
SPECTRACEF tablets contain cefditoren pivoxil, a semi-synthetic cephalosporin antibiotic for oral administration. It is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active cefditoren.
SPECTRACEF® (cefditoren pivoxil) is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below.
Acute Bacterial Exacerbation of Chronic Bronchitis caused by
Haemophilus influenzae
(including (beta)-lactamase-producing strains), Haemophilus parainfluenzae
(including (beta)-lactamase-producing strains), Streptococcus pneumoniae
(penicillin-susceptible strains only), or
Moraxella catarrhalis
(including (beta)-lactamase-producing strains).
Community-Acquired Pneumonia caused by
Haemophilus influenzae
(including (beta)-lactamase-producing strains), Haemophilus parainfluenzae
(including (beta)-lactamase-producing strains), Streptococcus pneumoniae
(penicillin-susceptible strains only), or
Moraxella catarrhalis
(including (beta)-lactamase-producing strains).
Pharyngitis/Tonsillitis caused by
Streptococcus pyogenes. NOTE: SPECTRACEF is effective in the eradication of
Streptococcus pyogenes
from the oropharynx. SPECTRACEF has not been studied for the prevention of rheumatic fever following
Streptococcus pyogenes
pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin-Structure Infections caused by
Staphylococcus aureus
(including (beta)-lactamase-producing strains) or
Streptococcus pyogenes.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of SPECTRACEF and other antibacterial drugs, SPECTRACEF should be used only to treat 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.
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