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E-DRUG Nemisulide Nepalese DRA's reason for giving tempora
Sender: owner-e-drug@usa.healthnet.org
Precedence: bulk
Errors-To: owner-e-drug@usa.healthnet.org
[Moderators Comment: I thought that we were finished with this drug but the
following comment seems to be such a well balances assessment that it should
be circulated. Richard Laing Co-Moderator]
Considering comparative advantages-quick antipyretic effect,less
ADR(gastritis), the need for less frequent dosing plus the favourable
clinical outcomes experienced by paediaatrician in Kathmandu, the
drug regulatory authority in Nepal has granted a TEMPORARY
REGISTRATION of tablet and paediatric suspension of Nemisulide. The
regulatory authority (DDA) has decided to go cautiously taking
advantages of experiences of the countries of the region. Should
drug regulatory authorities come across any serious complication, the
registration is subject to withdrawal quickly. The discourses taking
place in E-drug forum should be helpful for us in taking appropriate
decision in future. Currently three companies from India and thre
from Nepal are marketing a ranges of products including paediatric
forms in Nepalese market.
In some children, a prolonged hypothermic effect has been noted. The
regulatory has advised concern physician that they should take care
in adjusting the dose not only on the basis of body weight but also
taking into account the age of child under treatment.
While considering the alternatives, aspirin is not suitable for
children and analgin in all forms including injectable forms is
banned. Having found Nimesulide as a relatively safer and effective
alternative over existing NSAIDs, the drug was registered for
paediatric population as well.
Dr.Asfaq Sheak
Chief Drug Administrator
Dept.of Drug Administration
Ministry of Health,
Bijulibazar,Kathmandu, Nepal
Note: This is an article published in "Drugs 1993;43(suppl.I):215-218
A.G.Ugazio,S.Guarnaccia,m.Berardi and I.Renzetti.
Summary:
In a randomised nonblind clinical investigation,100 hospitalised
children with acute upper respiratory tract infections and fever
reeceived nimesulide oral suspension (5mg/kg/day) or
paracetamol(26mg/kg/day) for 3 to 9 days. The antipyretic and
anti-inflammatory effects of nimesulide were superior to those
observed with paracetamol (p,0.01) and both drugs were well
tolerated.
100 hospitalised children (of either sex and aged 3 to 6 years) with
acute upper respiratory tract infections and fever (body temperature>
38.5 degree C) due to bacterial or viral infection were recruited to
this nonblind parallel clinical study.
Conclusion: Nimesulide was more effective than paracetamol in terms
of anti-inflammatory and anti-pyretic efficacy in the treatment of
children with upper respiratory tract infection and fever.
Furthermore, both nimesulide and paracetamol were well tolerated.
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