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E-Drug : Nimesulide
1. Nimesulide is not yet marketed in India by Schering Plough USA. However,
a lot of Indian companies are marketing Nimesulide in tablet, ointment, kid
dispersible tablets, and paed. suspension form.
3. It is approved in India for paediatric use, however, we, as citizens, or
pharmacists, or doctors have no simple means to know for what indications
exactly the drug is approved by the FDA, because there is no official
publication/bulletin of the FDA.
2. Most of the information that the doctors get is through the pharmac
companies itself. The drug literature of different pharma companies state
the following indications for children
Company 1 - : fever & inflammatory symptoms associated with upper
respiratory tract infections (viral or bacterial origin) and in reducing
pain of various origins in children like post-operative pain, pain due to
musculoskeletal injury, pain due to soft tissue injury, etc.
Company 2 - Clinical studies have established the analgesic,
anti-inflammatory and antipyretic effectiveness of orally (5mg/kg)
administered Nimesulide in the treatment of a variety of painful
inflammatory conditions, including those associated with fractures, soft
tissue injury, post operative trauma, sport injuries, ear, nose and throat
disorders, dental surgey, thrombophlebitis, upper airways inflammations.
Nimesulide therapy is characterised by a rapid onset of analgesia and
symptomatic relief in studies where a significant difference in clinical
efficacy between active treatment was observed. Nimesulide is as effective
as mefenamic acid or paracetamol at reducing fever and inflammatory
symptoms associated with upper respiratory tract infection and at reducing
pain of various origins in children. Compared with other NSAIDs and
paracetamol, Nimesulide generally showed a significant faster reduction of
fever and other sign and symptoms (dyspnoea, cough, asthenia, hyperemia,
oedema and pharyngeal pain) of respiratory tract inflammation.
Company 3 - & Company 4 - almost ditto as company 2 above.
Company 4 - Usage and Dosage in children: Nimesulide is as effective as
mefenamic acid or paracetamol in reducing fever and inflammatory
symptoms associated with URTI and reducing pain of various origin in
children.
Compared with other NSAIDS nimesulide generally showed faster reduction of
fever and other symptoms ( dyspnoea, cough, oedema and pharyngeal pain).
In paediatric trials the dosage administered is 5mg /K g / Day in 2or 3
divided doses.
I could not get any more drug literatures right now, but have asked for
more.
Indian companies can spin fairy tells better than Alice in Wonderland as
you will notice !
The dosage recommended in children is 5mg/kg, divided into 2 or 3 divided
doses or as directed by the physician (this is uniform with all companies).
say that Nimesulide suspension is slowly taking over sales of paracetamol,
ibuprofen & mefenamic acid suspensions. Doctors have found something new
and are prescribing nimesulide suspension left right & centre regardless of
side effects - which is simple - the companies do not report any side
effects, hence in their eyes itis a safe drug with better effects than the
rest ! Now, parents have become so used to nimesulide that thy have begun
to ask for it without a prescription - they have an answer ready - doctor
told me (last time, or over the phone !)to give my child for fever !
Raj Vaidya, M.Pharm.
Raj Vaidya, M.Pharm,
Community Pharmacist,
Hindu Phamacy,
Panaji - Goa - India.
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