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| |  Ceftin (Cefuroxime Axetil) First-Line Treatment For Acute Bacterial Rhinosinusitis RESEARCH TRIANGLE PARK, NC -- July 28, 2000 -- A coalition of physicians are urging that doctors use extra care in treating bacterial sinus infections that strike 20 million people every year in the US, saying that more judicious use of antibiotics will help stem the incidence of patients developing resistance to the drugs. According to National Ambulatory Medical Care Survey (NAMCS) data, sinusitis is the fifth most common diagnosis for which an antibiotic is prescribed. Sinusitis accounted for 7 percent - 12 percent of all antibiotic prescriptions written from 1985 to 1992. In 1996, the primary diagnosis of sinusitis led to expenditures of approximately US$3.39 billion in the United States. The guidelines, issued by the Sinus and Allergy Health Partnership were published in the July issue of Otolaryngology-Head and Neck Surgery were part of a national effort coordinated by the Centers for Disease Control and Prevention (CDC) to emphasize the importance of accurate diagnosis to prevent the use of antibiotics for non-bacterial infections. The overuse of antibiotics may be associated with the development and spread of bacteria that are increasingly resistant to treatment. Ceftin and amoxicillin-clavulanate are in a structural class of antibiotics called beta-lactams. These beta-lactams have been recommended because of their effective coverage of the major pathogens associated with sinusitis, Streptococcus pneumoniae and Haemophilus influenzae. These are the most common pathogens responsible for acute bacterial rhinosinusitis (ABRS) an infection referring to inflammation of the nose and sinuses. "Although the guidelines show that amoxicillin remains the first line of therapy, physicians can use some of the other beta-lactam agents as first line therapy, such as cefuroxime axetil which still has proven efficacy against the leading respiratory pathogens," said James A. Hadley, MD, FACS, Clinical Associate Professor, Otolaryngology, University of Rochester Medical Center To help physicians judiciously prescribe antibiotics in an era of rising drug resistance, the CDC convened several working groups to develop guidelines for the treatment of respiratory infections. The Sinus and Allergy Health Partnership spearheaded the development of guidelines for acute bacterial rhinosinusitis. The recommendations for first-line therapy include beta- lactams such as Ceftin, amoxicillin, amoxicillin-clavulanate, or cefpodoxime proxetil for adults with mild sinusitis or moderate sinusitis who have not received an antibiotic in the previous four to six weeks. Quinolones, another class of antibiotics, should be used in adults with moderate sinusitis who have received antibiotics in the previous four to six weeks or for patients with moderate sinusitis who have allergies or intolerance to beta-lactams. Quinolones include gatifloxacin, moxifloxacin, and levofloxacin. The guidelines also recommend trimethoprim/sulfamethoxazole, doxycycline, azithromycin, clarithromycin, or erythromycin for adults with mild sinusitis (with no prior antibiotics in past 4-6 weeks) who are allergic to beta-lactam antibiotics. Ceftin has been proven effective in clinical trials of adult patients with acute bacterial maxillary sinusitis. Ceftin has a well established safety profile; in U.S.-based clinical trials with Ceftin Tablets 125 to 500 mg b.i.d., the most commonly reported adverse events were diarrhea/loose stools at an incidence of 3.7 percent and nausea/vomiting at 3 percent. After 12 years on the market, Ceftin continues to be an effective agent for the treatment of upper respiratory infections. In the past 18 months, Glaxo Wellcome antibiotics have been included in treatment guidelines by two CDC Working Groups. Last year the CDC Drug-Resistant Streptococcus pneumoniae (DRSP) Working Group recommended Ceftin for the treatment of acute otitis media after amoxicillin failure. Zinacef® (cefuroxime for injection) was recently recommended for first- line therapy in the treatment of moderately ill hospitalized patients with community acquired pneumonia because of its good activity against pneumococci. This report was published in the May 22 issue of Archives of Internal Medicine titled, "Management of Community-Acquired Pneumonia in the Era of Pneumococcal Resistance: A Report from the Drug-Resistant Streptococcus Pneumoniae Therapeutic Working Group." Ceftin Tablets are indicated for the treatment of acute bacterial maxillary sinusitis caused by S pneumoniae or H influenzae (non-beta- lactamase-producing strains only). Ceftin for Oral Suspension is indicated for acute bacterial otitis media caused by S pneumoniae, H influenzae, Moraxella catarrhalis or Streptococcus pyogenes. Zinacef is indicated for lower respiratory infections, including pneumonia, caused by S pneumoniae, H influenzae, Klebsiella spp., Staphylococcus aureus, S pyogenes, and Escherichia coli. Ceftin Tablets, Ceftin for Oral Suspension, and Zinacef are contraindicated in patients with known hypersensitivity to the cephalosporin group of antibiotics. Ceftin Tablets and Ceftin for Oral Suspension are not bioequivalent and are not substitutable on a mg/mg basis. In U.S. clinical trials with Ceftin for Oral Suspension, the most commonly reported adverse events were diarrhea/loose stools (8.6 percent), dislike of taste (5 percent), diaper rash (3.4 percent), and nausea/vomiting (2.6 percent). The most common adverse events with Zinacef have been local reactions following intravenous administration.
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