White paper on Nimesulide

Pharmacologic Category : Analgesic, Nonsteroidal Anti-inflammatory Drug; Nonsteroidal Anti-inflammatory Drug (NSAID) Indications: Fever, Pain & Inflammation Duration: Can be safely prescribed upto 15 days. Adults: Oral: 100 mg twice daily. Children below 12 years: Not to be used.

Product Availability: Product available in various countries; not currently available in the U.S. Dosage Forms: Tablet: 100 mg

1. Nimesulide has preferential selectivity for COX-2 over COX-1 in vivo at full therapeutic doses and induces less gastrointestinal damage than that seen with naproxen in the short term. [ Uptodate: Gut. 2001;48(3):339.] 2. Atopy is a risk factor for non-steroidal anti-inflammatory drug sensitivity. The prevalence of atopy is increased in challenge-proven NSAID-intolerant patients. The atopic condition may represent an important risk factor for developing reactions to these drugs. Paracetamol and nimesulide are relatively safe alternative choices in those patients. [ Uptodate: Ann Allergy Asthma Immunol. 2000;84(1):101.] 3. Topical NSAIDs that are effective for chronic musculoskeletal pain in adults include diclofenac, ketoprofen (level 1 [likely reliable] evidence), ibuprofen, felbinac, and nimesulide (level 2 [mid-level] evidence) [DynaMed] 4. nimesulide may be associated with better efficacy than diclofenac for acute gout (level 2 [mid-level] evidence) [Ter Arkh 2007;79(5):35 ] 5. Nimesulide is safe in Crohn's disease [DynaMed: Clin Gastroenterol Hepatol 2006 Feb;4(2):196] 6. It is safe in ulcerative colitis { DynaMed Clin Gastroenterol Hepatol 2006 Feb;4(2):196, commentary can be found in Clin Gastroenterol Hepatol 2006 Feb;4(2):157] 7. Many PUBMED studies are available about its efficacy in primary dysmennhorea, acute dental pain, respiratory inflammatory conditions etc. 8. International Brands: Available in 54 countries worldwide. 9. MNCs marketing nimesulide: Merck Heugan; Sanofi-Aventis Nimed; Novartis Mesulid; Abbott Sintalgin; GSK Eskaflam and Teva Octrapin

10. International Brands: Names: Agudol (PY); Ainex (CO); Aldoron (AR); Algimesil (IT); Algolider (IT); AllDone (BG); Antalgo (IT); Antiflogil (BR); Antifloxil (ES); Apolide (MX); Aponil (TR); Arflex Retard (BR); Arslide (PK); Aulin (AR, BG, CH, CZ, GR, HR, IE, IT, PL, PT, RO, VE); Auronim (IN, RU); BangNi (CN); Biosal (IT); Blunid (PK); Coxtral (PL, RU); Defam (MX); Deflogen (BR); Delfos (IT); Doloc (CL); Doloctaprin (AR); Dolonime (CO); Domes (IT); Donulide (PT); Drexel (VE); Efridol (IT); Elinap (TR); Emdon (TH); Enetra (BG); Eskaflam (MX); Fansidol (IT); Fasulide (BR); Flamide (MX); Flogovital N.F. (AR); Flolid (IT); Gravx (PK); Guaxan (ES); Inflalid (BR); Isodol (IT); Jabasulide (PT); Laidor (IT); Ledoren (IT); Li Nuo Ke (CN); Manaslu (KP); Mesid (IT); Mesulid (BE, CZ, GR, HK, HU, IL, IN, IT, LU, MX, PY); Metaflex (AR); MF/110 (IT); Molden (KP); Nerelid (IT); Nexen (FR); Nide (IT); Nidol (HK, HU, PK, TH); Nidolid (PH); Nimax (KP); Nimed (BG, CZ, ID, PT); Nimel (IN); Nimelid (VE); Nimepast (CL); Nimesil (IT, PL); Nimesol (PY); Nimesulene (IT); Nimesulide Dorom (IT); Nimesulide GNR (IT); Nimesulide UCB (IT); Nimind (IN); Nimm (HK, TR); Nimotop (PT); Nims (IT); Nimulid (IN); Nisal (IT); Nise (PE); Nisulid (BR, CH); Nisural (CL); Noalgos (IT); Nodo (UY); Noxalide (IT); Octaprin (AR); Pacisulide (HK); Penalgin (CO); Precoxi (MY); Prolid (RU); Pu Wei (CN); Quimoral Plus (PE); Redaflam (MX); Remov (IT); Resulin (IT); RuiLi (CN); Scaflam (BR, CO, VE); Scalid (BR); Severin (MX); Sharonim (HK); Sintalgin (BR); Solving (IT); Sulidamor (IT); Sulide (IT); Sulidene[vet.] (FR); Sulidin (PH); Sulidor (PT); Sulimed (ES); Tenesmin (UY); Teonim (IT); Veedol (TH); Ventor (GR); Virobron (AR); Xilox (HU); Ximede (ID)

Note:  Central government prohibits the use of Nimesulide in children below 12 years of age.  DCGI approved Nimesulide on 13th January 1995 for painful & inflammatory conditions as well as fever.  The European Medicines Agency has completed a review of the safety and effectiveness of systemic medicines containing nimesulide (capsules, tablets, suppositories and powder or granules for oral suspension). The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of nimesulide used systemically continue to outweigh its risks but that its use should be restricted to the treatment of acute pain and primary dysmenorrhoea. The Committee noted that the studies looking into the effectiveness of nimesulide in acute pain relief have shown that it is as effective as other NSAID pain killers such as diclofenac, ibuprofen and naproxen. In terms of safety, the Committee noted that nimesulide has the same risk of causing stomach and gut problems as other NSAIDs. To current recommendation is use of lowest effective doses for the shortest possible duration, and a maximum duration of treatment for acute pain. Its approved for use upto 15 days.  In US the drug is not available as being an European drug the permission was never applied.  Even aspirin is not safe in children. Aspirin has been linked with Reye's syndrome. Children and teenagers recovering from chickenpox or flu-like symptoms should never take aspirin.  Even Paracetamol is not safe. around 82,000-90,000 patients present with toxcity per annum in UK alone with 150 –250 deaths. [Bateman N et al (2014) Br J Clin Pharmacol 78:610]. Concerns with paracetamol in USA and EU; new dosage restrictions (325mg) in USA has been set.