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Three-Day Antibiotic For Children, Zithromax (Azithromycin Dihydrate), Now Available In Canada

MONTREAL, QC -- December 19, 2002 -- Pfizer Canada Inc. today announced Health Canada's approval of a new three-day pediatric oral dosing regimen for its antibiotic Zithromax (azithromycin dihydrate) in the treatment of acute otitis media (AOM) - middle ear infections - in children age six months and older. The liquid antibiotic, administered once a day for three days, offers parents a more convenient way to treat AOM.

"An antibiotic that can be prescribed for three days is a tremendous benefit to physicians and parents alike," says Dr. Mickey Lester, Associate Professor of Pediatrics, University of Toronto, and consultant pediatrician, Hospital for Sick Children and Trillium Health Centre. "Administering medicine to kids can be challenging. Surveys show more than half of kids stop taking their medication by the third day of treatment and up to 82 percent by the ninth day. Being able to prescribe an antibiotic that can be taken safely and effectively for three days may help improve compliance."

Compliance benefits children and their parents but also helps address a serious public health concern, Dr. Lester added. "When patients don't take their full course of antibiotics, they may not only experience a recurrence of their infection but may also contribute to the emergence of antibiotic-resistant bacteria."

In a study conducted in children age 6 months to 12 years, the Zithromax 3-day dosing regimen resulted in an overall clinical success rate of 83 percent in treating the signs and symptoms of AOM. The type and incidence of side effects seen with the 3-day dosing were comparable to those seen with the traditional 5-day regimen of Zithromax.

In a separate study of children age 4 to 12 years, a large majority preferred the cherry taste of Zithromax to the taste of Cefzil™, another common antibiotic. Interviews with parents of children with middle ear infections also found their kids liked the taste of Zithromax and did not have to be persuaded to take their medication.

"We've come a long way in finding more convenient ways to improve the health of our children, from digital thermometers to five-in-one vaccines. And with shorter course antibiotic therapies, like Zithromax, parents now have advantages that were not available just a decade ago," says Dr. Lester.

Zithromax works by getting into the infected tissue where it is released slowly over time and continues to fight bacterial infection for many days after the last dose is taken. For this reason, children may continue to experience symptoms of their illness after their three-day treatment is completed.

Zithromax three-day therapy is well-tolerated, does not need to be refrigerated, and can be taken with or without meals. In clinical trials, the most common side effects reported included diarrhea, abdominal pain, vomiting, nausea and rash. These were considered mild to moderate and disappeared after treatment was stopped or completed.

Pfizer has a long history in antimicrobials, dating back to the Second World War when they developed the first process to mass-produce penicillin. Pfizer Canada is committed to promoting appropriate antibiotic use. In 1996, the company created the National Information Program on Antibiotics, a coalition of eight medical, pharmacist and patient organizations whose mandate is to help educate Canadians about the appropriate use of antibiotics. Pfizer Canada continues to underwrite the operating costs of NIPA's annual campaign, including Antibiotic Awareness Week.

Pfizer Canada Inc. is the Canadian operation of Pfizer Inc, the world's leading pharmaceutical company. Pfizer discovers, develops, manufactures and markets leading prescription medicines for both humans and animals, as well as many of the world's best-known over-the-counter healthcare products. Pfizer Canada is one of Canada's top investors in research and development, investing more than $132 million in 2001. Canadian headquarters of the Pfizer Pharmaceuticals Group are in Kirkland, Quebec. Global headquarters are located in New York City, where the company was founded in 1849.

SOURCE: PFIZER CANADA INC

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