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New Guidelines Recommend Cefdinir as First-Line Treatment for Acute Bacterial Sinusitis

ABBOTT PARK, Ill., Feb. 26 /PRNewswire-FirstCall/ -- New treatment guidelines published last week by the Sinus and Allergy Health Partnership have identified Abbott Laboratories' Omnicef(R) (cefdinir) as one of the primary treatment options for acute bacterial sinusitis. Omnicef is the only extended-spectrum cephalosporin included in the guidelines, which were developed as an educational tool for health care providers involved in managing adult and pediatric patients with acute bacterial rhinosinusitis (ABRS).

"The guidelines have been updated to provide physicians with the most current information on appropriate diagnosis and treatment, antibiotic resistance patterns and new antibiotic options for bacterial sinusitis," said Jack Anon, M.D., FACS, Clinical Professor, University of Pittsburgh School of Medicine and one of the lead authors of the guidelines. "We included Omnicef as one of the primary treatment options for acute bacterial sinusitis because of its efficacy and tolerability in treating the infection in both adults and children."

This is the first update for the guidelines, which were originally established in 1999 by the Sinus and Allergy Health Partnership, a not-for-profit organization created through the joint efforts of the American Academy of Otolaryngic Allergy, the American Academy of Otolaryngology-Head and Neck Surgery, and the American Rhinologic Society.

An estimated 20 million cases of ABRS are diagnosed per year, making it the leading respiratory illness in the United States. ABRS may be diagnosed in adults or children with a viral upper respiratory infection (known as the "common cold") that has not been resolved after 10 days or worsened after five to seven days. Symptoms may include nasal drainage or congestion, facial pressure/pain, post-nasal drainage, lessened or inability to smell, fever, cough, fatigue, maxillary dental pain and ear pressure/fullness.

Guidelines Highlight Treatment Options
The guidelines recommend Omnicef as one of the initial treatment options for adults and children with mild acute bacterial sinusitis who have not received antibiotics in the previous four to six weeks. Omnicef is also recommended as one of the initial therapies in children with mild illness who have not received antibiotics in the previous four to six weeks, and as an initial option for penicillin-allergic children who have received antibiotics in the previous four to six weeks or who have moderate symptoms. In addition to the benefit of efficacy and tolerability, the guidelines note that in the pediatric case, Omnicef is a preferred cephalosporin therapy because of high patient acceptance. Studies have shown that the taste and smell of Omnicef oral suspension is well received in children four to eight years old. According to data published in the Pediatric Infectious Disease Journal, nine out of 10 children aged four to eight preferred the strawberry taste and smell of Omnicef to other leading oral suspension antibiotics.

Contributors to the updated guidelines also addressed the important issue of antibiotic resistance. The diagnosis of bacterial "sinusitis" is often made too frequently and, as a result, patients are sometimes prescribed an antibiotic that is not only ineffective but also risks leading to increased resistance among respiratory tract pathogens. The guidelines divide patients with ABRS into two treatment categories: (1) those with mild symptoms who have not received antibiotics within the past four to six weeks, and (2) those with mild disease who have received antibiotics within the past four to six weeks or those with moderate disease regardless of recent antibiotic exposure.

"We're pleased to see that Omnicef has been included for the first time in these important sinusitis guidelines and follows the lead of other highly respected treatment guidelines for acute bacterial sinusitis and middle ear infections," said Mary Szela, vice president, primary care operations, Abbott Laboratories. "Omnicef is an effective and well-tolerated therapy for adults and children suffering from sinusitis. It's also offered in a taste that children prefer, which may enhance compliance for the youngest patients."

In 1999, the Sinus and Allergy Health Partnership originally published the treatment guidelines for ABRS to provide recommendations for diagnosing and treating ABRS; to explain the differences between viral and bacterial rhinosinusitis; to reduce the misuse of antibiotic therapy; and to describe pharmacokinetics and pharmacodynamics, and how they relate to the effectiveness of antimicrobial therapy.

About Omnicef
Omnicef is indicated for adult, adolescent and pediatric patients (ages six months to 12 years) for the treatment of mild to moderate infections, including acute bacterial otitis media (pediatric) and acute maxillary sinusitis (adolescents and adults) due to Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae (penicillin- susceptible strains only) and Moraxella catarrhalis (including beta-lactamase- producing strains); and pharyngitis/tonsillitis due to Streptococcus pyogenes. Cefdinir is effective in the eradication of Streptococcus pyogenes from the orapharynx. Cefdinir has not, however, 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.

Omnicef is indicated for the treatment of uncomplicated skin and skin structure infections (adults, adolescents and pediatrics) due to Streptococcus aureus (including beta-lactamase producing strains) and Streptococcus pyogenes. It is also indicated to treat acute exacerbations of chronic bronchitis and community-acquired pneumonia (adults and adolescents) due to Haemophilus influenzae (including beta-lactamase producing strains), Haemophilus parainfluenzae (including beta-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including beta-lactamase producing strains).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Omnicef and other antibacterial drugs, Omnicef should be used only to treat or prevent infections that are strongly suspected to be caused by bacteria.

Omnicef is contraindicated in patients with known allergy to the cephalosporin class of antibiotics. Patients with previous hypersensitivity to penicillins should be closely monitored when taking Omnicef. If allergic reaction to Omnicef occurs, the drug should be discontinued. The safety and efficacy of Omnicef in neonates and infants less than six months of age have not been established. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Omnicef and other antibacterial drugs, Omnicef should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

In clinical studies, Omnicef was well tolerated. In pediatric trials, the most common adverse events were: diarrhea (8 percent), rash (3 percent) and vomiting (1 percent). In adult and adolescent trials, the most common adverse effects were: diarrhea (15 percent), vaginal moniliasis (4 percent of women), nausea (3 percent), headache (2 percent), abdominal pain (1 percent) and vaginitis (1 percent of women).

For complete details, please see full prescribing information.

Source: Abbott Laboratories

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