Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Stirling Anglian Pharmaceuticals Ltd., Hillington Park Innovation Centre, 1 Ainslie Road, Hillington Park, Glasgow G52 4RU, United Kingdom
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, propionic acid derivatives
ATC code: M01AE02
Naproxen is a non-steroidal anti-inflammatory analgesic agent.
Antipyretic properties have been demonstrated in classical animal test systems.
Naproxen exhibits its anti-inflammatory effect even in adrenalectomised animals, indicating that its action is not mediated through the pituitary-adrenal axis. Like other NSAIDs, naproxen inhibits prostaglandin synthetase. However, the exact mechanism of its anti-inflammatory action is not known.
Naproxen is completely absorbed from the gastro-intestinal tract, and peak plasma levels are reached in 2 to 4 hours. Naproxen is present in the blood mainly as unchanged drug, extensively bound to plasma proteins. The plasma half-life is between 12 and 15 hours, enabling a steady state to be achieved within 3 days of initiation of therapy on a twice daily dose regimen. The degree of absorption is not significantly affected by either foods or most antacids. Excretion is almost entirely via the urine, mainly as conjugated naproxen, with some unchanged drug. Metabolism in children is similar to that in adults. Chronic alcoholic liver disease reduces the total plasma concentration of naproxen but the concentration of unbound naproxen increases. In the elderly, the unbound plasma concentration of naproxen is increased although total plasma concentration is unchanged.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
