Good News For Parents: The First and Only 5-Day, Once-Daily Children's Antibiotic Is Available for Common Pediatric Infections

Parents Now Have a Simple, Effective Treatment Choice

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NEW YORK, Sept. 11,1996 Pfizer Inc. [NYSE: PFE] announced today that ZITHROMAX(R) (azithromycin for oral suspension), the first and only antibiotic for children given in 5, once-daily doses is available nationwide for the treatment of common bacterial infections, including acute otitis media caused by Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis. Otitis media, an infection of the middle ear, is one of the most common infections in children, accounting for more than one third of all office visits to pediatricians each year.

In addition to a simplified dosing regimen, other ZITHROMAX benefits that may enhance parent -- and child -- compliance include a low discontinuation rate due to treatment-related side effects and a good cherry taste.

ZITHROMAX, an effective, antibiotic approved for use in children, offers a simpler dosage regimen than other antibiotics. The distinct advantage of ZITHROMAX over existing therapy for acute otitis media is that it can be taken less frequently -- only 5 days, once a day.

"Most antibiotics used in the treatment of otitis media in children require a two- or three-times daily dosing regimen for 10 days," says Michael Pichichero, MD, a pediatrician and professor at the University of Rochester."Given the increasing number of children in either group day care or preschool centers, multi-dose, multi-day dosing regimens may result in missed doses and unfinished courses of therapy which, in turn, can result in treatment failure."

A recently released report from the U.S. Census Bureau shows that a growing number of children of working mothers are cared for in day care or preschool centers. According to the report, Who's Minding Our Preschoolers?, 30% of the 9.9 million U.S. preschoolers with mothers working outside of the home in 1993 were cared for by nonrelatives in day care or preschool centers, an increase from 23% in 1991. Children in group day care settings are at an increased risk of developing acute otitis media due to their repeated exposure to other children's respiratory tract infections, the most common initial event in the pathogenesis of acute otitis media.

Nearly one half of all U.S. children will have otitis media by 1 year of age and more than 70% by age 3 years. Most children have the infection more than once; in fact, 30% of children suffer six or more episodes of acute otitis media before entering school. Acute otitis media is the most common single reason for antimicrobial therapy in children, responsible for upward of 31 million visits to doctors and $3 to $4 billion in treatment costs. Left untreated, acute otitis media may result in hearing loss and related difficulties in language development and learning.

Infants are at risk for acute otitis media largely due to the anatomical positioning of their eustachian tubes. An episode of acute otitis media during the first year of life also increase the risk for recurrence of the condition. Environmental factors can increase the probability of contracting the disease and exacerbate the infection. Children with acute otitis media may exhibit the following signs and symptoms: earache, fever, irritability, sleep disturbances and hearing loss. Vomiting and diarrhea also may be

"Otitis media is an important public health problem, not only in terms of medical treatment and related costs to society, but also in terms of the toll it takes on individual families," says Dr. Pichichero. "The disruption of the family's daily life -- from work schedule and child care arrangements to sleep habits -- combine to cause stress and anxiety as parents cope with a child suffering from a recurrent illness.

Several studies have shown an increase in bacterial resistance to existing therapies for otitis media. While the standard first-line therapy for otitis media is a 10-day course of amoxicillin, recent findings indicate an increasing prevalence of penicillin-resistant S pneumoniae as well as beta- lactamasc-producing strains of H influenzae and M catarrhalis and suggest a need for therapeutic alternatives.

The recommended dose of ZITHROMAX (azithromycin for oral suspension) for the treatment of acute otitis media is 5 once-daily doses: 10 mg/kg on Day 1, Followed by 5 mg/kg on Days 2 to 5. ZITHROMAX should be dosed 1 hour before or 2 hours after a meal. ZITHROMAX is available in a cherry-flavored suspension and does not require refrigeration. ZITHROMAX offers an excellent side-effects profile: the most common side effects observed in children with acute otitis media are diarrhea/loose stools (2%), abdominal pain (2%), vomiting (1%), and nausea (1%). ZITHROMAX is contraindicated in patients with known hypersensitivity to macrolides.

"For the first time, pediatricians can prescribe an antibiotic for middle ear infection that's designed to fit a family's busy schedule -- just once daily for 5 days. The dosage regimen is easy on parents and even easier on their kids," says Joseph M. Feczko, MD, Vice President and Medical Director of Pfizer's U.S. Pharmaceuticals Group. As a leader in anti-infective research, Pfizer views the introduction of ZITHROMAX for children as a major contribution to pediatric medicine."

Five-day, once-daily ZITHROMAX is also available in the U.S. for the treatment of respiratory tract and skin infections in adults. ZITHROMAX also is indicated, in a single 1-gm dose, for the treatment of uncomplicated genital chlamydial infections.

Pfizer Inc is a research based, diversified health care company with global operations. The company reported sales of more than $10 billion for 1995 and expects to spend about $1.7 billion on research and development this year.

ZITHROMAX(R) (azithromycin for oral suspension) full prescribing information available upon request.

CONTACT: Lisa Easley of CDB Healthcare, 212-845-4203