Nimesulide is a non-steroidal anti-inflammatory drug (NSAID)
with analgesic and antipyretic properties and a specific
mode of action.
Nimesulide
is indicated for the treatment of acute pain, the
symptomatic treatment of painful osteoarthritis and primary
dysmenorrhoea.
The recommended oral dose of
Nimesulide
for adults and adolescents above 12 years is 100 mg twice
daily, to be used for the shortest time needed to treat
symptoms.
The warnings and contraindications are in line with those of
the other drugs of the class. The drug is contraindicated in
children below 12 years.
Nimesulide efficacy & safety
have been evaluated in over 200 clinical studies in a wide
range of conditions characterized by acute pain. In these
studies,
Nimesulide
was found to be at least effective, or superior, to placebo
and other NSAIDs, with a particular fast onset of analgesic
action.
Nimesulide
safety profile is in line with that of the whole NSAID
class.
Nimesulide
shows a superior gastrointestinal safety profile in
comparison to other NSAIDs and a low propensity for renal,
cardiovascular, skin and hepatic side effects.
Nimesulide
post–marketing data and the results of a recent
retrospective cohort study showed that the occurrence of
hepatic reactions after administration of
Nimesulide
is a rare event with an incidence comparable to that of all
the other NSAIDs.
Nimesulide overall positive benefit/risk profile is
supported by
about 500 million patients treated worldwide
since its first introduction on the market in Italy in 1985
(data as of December 2006).
The therapeutic effects of Nimesulide are the result of its
specific mode of action which targets a number of key mediators of the
inflammatory process such as: COX-2 mediated prostaglandins,
free radicals, proteolytic enzymes and histamine.
Nimesulide has been developed and licensed out by Helsinn
Healthcare SA, Switzerland, which acquired the exclusive world-wide
rights for the drug in 1976. Only Helsinn's official
partners market the original product, granting the highest
quality thanks to first-rate and controlled manufacturing
processes under GMP rules.
Nimesulide is currently marketed in around 50 countries
world-wide
under different brand names, and it is among the most
prescribed NSAIDs. It is available as tablets, granules,
suppositories and in some countries also as oral drops and
oral suspension.
Nimesulide
is also now on the market
as
topical gel.
The Original Nimesulide registered trademarks in the world
are:
Aulin®, Ainex®, Donulide®, Eskaflam®, Mesulid®, Nexen®,
Nimed®, Nisulid®, Scaflam®, Scaflan®.
The prescription and use in compliance with the approved
Summary of Product Characteristics are fundamental to
guarantee the safety of all drugs, including
Nimesulide.
For any question or doubt, please refer to your physician.