If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  First Single-Dose Treatment for Pediatric Ear Infections Cleared in U.S. NUTLEY, NJ -- January 7, 1998 -- The United States Food and Drug Administration (FDA) has approved Hoffmann-La Roche Inc.'s Rocephin(R) (ceftriaxone sodium) for the treatment of acute otitis media (AOM). Rocephin is the first single-dose, injectable antibiotic for the treatment of AOM, which is the most frequent reason that children under the age of six see a physician. Rocephin received clearance soon after an FDA advisory committee voted unanimously to recommend approval. In one study lower clinical cure rates were observed with a single dose of Rocephin compared to 10 days of oral therapy. However, in a second study comparable cure rates were observed between single dose Rocephin and the comparator. The potentially lower clinical cure rate of Rocephin should be balanced against the potential advantages of one dose injectable therapy. Parental preference for a single-dose injectable therapy was demonstrated in two surveys sponsored by Hoffmann-La Roche of more than 700 parents. Given the choice between single-dose and multi-day, multi-dose oral treatments, more than 67 percent of parents surveyed chose the single-dose therapy. Ninety percent of parents of children treated with Rocephin said they would choose the single-dose AOM treatment over oral therapy in the future. "Rocephin offers parents and children a new alternative in cases where compliance has been a problem, such as those children who cannot take oral medicines or those parents who have difficulties administering oral antibiotics for a 10-day course," said Jerome Klein, M.D., professor of pediatrics and vice chairman for academic affairs in the department of pediatrics at Boston Medical Center, Boston University School of Medicine. "For AOM, single-dose intramuscular Rocephin is a new option when standard multi-day, multi-dose oral therapy is problematic, for example, for children in daycare, or when the family is travelling." Approximately 85 percent of children in the U.S. experience at least one episode of AOM before age three. AOM accounted for an estimated 30 million doctor visits in l997, a 300 percent increase since 1975. During the same time period, the number of children younger than four years increased just 25 percent. "In clinical practice as many as 50 to 60 percent of patients do not comply with the five- to 10-day dosing regimens of oral drugs," said Jeffrey Blumer, Ph.D., M.D., Chief, Division of Pediatric Pharmacology & Critical Care, Rainbow Babies and Childrens Hospitals, University Hospitals of Cleveland. "As a single-dose therapy for AOM, Rocephin is the only drug that gives pediatricians and parents 100 percent guaranteed compliance." Rocephin is generally well tolerated. In clinical trials of children with AOM treated with Rocephin, the most common type of side effects were similar to those of oral antibiotics and included diarrhea, diaper rash and rash. A less frequently reported side effect was injection site reaction (pain, swelling), which occurred in 1.6 percent of patients. In a small bioequivalence study (diluent reduction), conducted on adults, the incidence of injection site reaction (pain, induration and tenderness) was 17 percent. Rocephin, a leading third-generation cephalosporin, has remained the number one injectable antibiotic available in the U.S. for 13 years. It is used to treat infections in hospitals nursing homes, and ambulatory care and home infusion centres.
|
