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
"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
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
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