Cefuroxime axetil indications and usage
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
NOTE: CEFTIN TABLETS AND CEFTIN FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY). CEFTIN Tablets
CEFTIN 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 byStreptococcus 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. CEFTIN 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, Haemophilusinfluenzae(including beta-lactamase−producing strains),Moraxellacatarrhalis (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 STUDIES).
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 CEFTIN Tablets for patients with acute bacterial maxillary sinusitis, it was not possible to adequately evaluate the effectiveness of CEFTIN Tablets for sinus infections known, suspected, or considered potentially to be caused by beta-lactamase−producingHaemophilusinfluenzae or Moraxellacatarrhalis.
4.Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis caused by Streptococcus pneumoniae, Haemophilusinfluenzae(beta-lactamase negative strains), or Haemophilusparainfluenzae (beta‑lactamase negative strains) (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES).
5.Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including beta-lactamase−producing strains) orStreptococcus pyogenes.
6.Uncomplicated Urinary Tract Infections caused by Escherichia coli or Klebsiellapneumoniae.
7.Uncomplicated Gonorrhea, urethral and endocervical, caused by penicillinase-producing and non-penicillinase−producing strains ofNeisseriagonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase−producing strains of Neisseriagonorrhoeae.
8.Early Lyme Disease (erythemamigrans) caused by Borreliaburgdorferi.
CEFTIN for Oral Suspension
CEFTIN for Oral Suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. The safety and effectiveness of CEFTIN for Oral Suspension in the treatment of infections other than those specifically listed below have not been established either by adequate and well‑controlled trials or by pharmacokinetic data with which to determine an effective and safe dosing regimen.
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. CEFTIN for Oral Suspension is 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.Impetigo 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 CEFTIN and other antibacterial drugs, CEFTIN 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.
References
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050605s042lbl.pdf