Naprelan (naproxen sodium)
Company: Elan, Wyeth-Ayerst Laboratories
Approval Status: Approved January 1996
Treatment for: osteoarthritis, rheumatoid arthritis
Areas: Endocrinology; Musculoskeletal; Rheumatology
| General Information | Side Effects | Literature References | Additional Information |
General Information
Naprelan (naproxen sodium) is the once-a-day formulation of the arthritis medication Naprosyn (naproxen). Naprelan, a sodium salt formulation of Naprosyn, provides for more rapid absorption.
Naprelan tablets use a proprietary delivery system, IPDAS (Intestinal Protective Drug Absorption System), a matrix of naproxen sodium with immediate and controlled release components. Upon ingestion, and after rapid disintegration of the tablet matrix, an initial fraction (approximately 30%) of the medication is released for rapid systemic absorption achieving onset of analgesic action within 30 minutes. In addition, a sustained-release component of microparticles provide an extended absorption phase that both minimizes local gastrointestinal concentrations and prolongs therapeutic systemic levels of the drug, enabling 24-hour duration of action and once-a-day dosing (2-4).
Side Effects
The most frequent complaints relate to the gastrointestinal tract. In subjects treated chronically with Naprelan, a non-steroidal anti-inflammatory drug, serious gastrointestinal toxicity such as perforation, ulceration, and bleeding can occur.
Literature References
Cooper, SA, Gaston, G, Devane J. A double-blind, randomized, parallel, group study of the acute analgesic efficacy of Naprelan in patients following oral surgery. February 1994. Data on file, Wyeth-Ayerst Laboratories.
A double-blind, randomized, parallel, group study of the acute analgesic efficacy of Naprelan. December 1994. Data on file, Wyeth-Ayerst Laboratories.
Caldwell, J. Keller M. A Comparison of Naprelan versus Naprosyn in the treatment of rheumatoid arthritis. December 1994. Data on file, Wyeth-Ayerst Laboratories.
Serge E. Long term experience with naproxen: Open label cohort survey of nearly 900 rheumatoid arthritis and osteoarthritis patients. Current Ther. Res 1980; 28:47-60.
Additional Information
Naproxen or naproxen sodium-based products account for approximately one in every five prescriptions written for non-steroidal anti-inflammatory drugs in the United States.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
