New Sinus and Allergy Guidelines Recommend Omnicef as First-Line Treatment Option for Acute Bacterial Sinusitis

ABBOTT PARK, Ill. -- New treatment

guidelines published last week by the Sinus and Allergy Health Partnership

have identified Abbott Laboratories' Omnicef (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, MD, FACS, clinical professor at the 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.

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.

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).

Abbott Laboratories is a global, broad-based healthcare

company devoted to the discovery, development, manufacture and marketing of

pharmaceuticals, nutritionals and medical products, including devices and

diagnostics. The company employs more than 70,000 people and markets its

products in more than 130 countries.

Source: Abbott Laboratories