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Ranbaxy announces nationwide availability of DisperMox in time for the respiratory season

PRINCETON, N.J., November 4, 2003 -- Ranbaxy Pharmaceuticals has launched DisperMox (Amoxicillin Tablets for Oral Suspension, 200 mg and 400 mg). This is the first dispersible tablet form of amoxicillin, designed for use as an alternative to oral suspensions, and offering dosing convenience and accuracy. The DisperMox tablet immediately disperses when mixed in water and is administered in suspension form.

DisperMox embodies a new dosage form of amoxicillin designed to build on the strong efficacy, safety, and tolerability features of Amoxil* (amoxicillin powder for oral suspension). Available in a pleasant strawberry flavor, DisperMox provides dosing accuracy and is administered as a convenient, twice-a-day dosage regimen. Since DisperMox is a tablet, it does not require refrigeration.

The launch of suspensions or liquids was the biggest advancement in increasing compliance in the pediatric population in recent times, especially for children under 5 years of age (and older children who are ill) who are unable and/or unwilling to swallow a tablet or capsule. Parents of small children are familiar with the challenges of giving medicine to their uncooperative kids -- and many of them have had experience with refrigerated older delivery forms of amoxicillin for bacterial infections. As a convenient alternative, DisperMox tablets for Oral Suspension are mixed with water for consumption, forming a great-tasting liquid.

The Office of Generic Drugs (OGD) has determined that the Ranbaxy formulation can be expected to have the same therapeutic effect as Amoxil (amoxicillin for Oral Suspension), which the agency referred to as the basis of safety and effectiveness.

Ranbaxy says this new dosage form of amoxicillin will be especially beneficial in pediatric patients with bacterial infections due to susceptible (only beta - lactamase negative) strains of streptococcus spp. alpha and beta hemolytic strains only), streptococcus pneumoniae, staphylococcus spp., or H. influenzae including acute otitis media (bacterial ear infection). Acute otitis media (AOM) is the most common cause of pediatric office visits (exceeding 35 million in 2001) in the United States and represents the most frequent bacterial infection in children. It represents a considerable burden to the U.S. healthcare system, annually adding more than $5 billion in costs.

To re-examine the best approach to antibacterial drug treatment of AOM, the Centers for Disease Control and Prevention (CDC) convened the Drug-Resistant Streptococcus Pneumoniae Therapeutic Working Group in 1996. Based on published literature, surveillance data, and expert clinical experience, the panel recommended amoxicillin as first-line treatment for AOM. Coupled with amoxicillin's long history of efficacy, safety, limited adverse effects and relatively low cost, the CDC group concluded that oral amoxicillin remains the best first-line choice for empiric treatment of AOM in children.

*Amoxil is a registered trademark of GlaxoSmithKline.

Source: Ranbaxy Pharmaceuticals

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Posted: November 2003