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White Paper on Nimesulide Pharmacologic Category

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White Paper on Nimesulide Pharmacologic Category 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. .
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  • Nimesulide: Patients Still Exposed to a Risk of Severe Hepatitis
    Translated from Rev Prescrire January 2011; 31 (327): 22-23 Nimesulide: patients still exposed to a risk of severe hepatitis Abstract imesulide, a nonsteroidal anti- Severe liver damage at standard N inflammatory drug (NSAID), has doses, especially in young women. In Nimesulide, a nonsteroidal anti- been on the French market since 2007, the Italian Medicines Agency inflammatory drug (NSAID) that has 1998 (1). It is neither more effective nor released Italian pharmacovigilance data been marketed in France since 1998, is better tolerated than many other showing that hepatic adverse effects rep- neither more effective nor better tol- NSAIDs, and has been shown to cause resented 13.8% of reports implicating erated than other NSAIDs. potentially life-threatening liver da- nimesulide, compared to only 1.4% for mage (1-5). ibuprofen and 2.8% for diclofenac (3). Many reports and reviews published What is known concerning the hepatic The CHMP report published in 2008 by drug regulatory agencies in Spain, adverse effects of nimesulide in early included similar findings. Among the Ireland and Italy have warned of the 2011? 574 reports implicating nimesulide record- hepatic adverse effects of nimesulide. ed in the European EudraVigilance phar- In early 2008, 17 cases of nimesulide- An increasing number of reports of macovigilance database, the proportion of induced liver damage requiring trans- liver damage. Soon after it was first mar- hepatic disorders (cholestasis, jaundice, plantation had been reported in Ire- keted, cases of hepatitis were attributed liver failure, and hepatitis) was higher land, Italy, Spain, Finland and France. to nimesulide, including a case of fulmi- than with cox-2 inhibitors.
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