Nimesulide

Indications
Oral
Acute pain
Adult: 100 mg bid. Use in the European Union (EU) is limited to a max of 15 days.
Oral
Dysmenorrhoea
Adult: 100 mg bid. Use in the European Union (EU) is limited to a max of 15 days.
Oral
Osteoarthritis
Adult: 100 mg bid. Use in the European Union (EU) is limited to a max of 15 days.
Oral
Postoperative pain
Adult: 100 mg bid. Use in the European Union (EU) is limited to a max of 15 days.
Rectal
Acute pain
Adult: 200 mg bid
Rectal
Osteoarthritis
Adult: 200 mg bid
Rectal
Primary dysmenorrhoea
Adult: 200 mg bid
Topical/Cutaneous
Sprains
Adult: 3% gel/cream: Apply thin layer to affected area bid-tid. Duration: 7-15 days.
Topical/Cutaneous
Acute traumatic tendinitis
Adult: 3% gel/cream: Apply thin layer to affected area bid-tid. Duration: 7-15 days.
Contraindications
Hypersensitivity; GI bleeding, active peptic ulcer disease; severe renal and heart failure; hepatic impairment or known liver disease; coagulation disorders; pregnancy; children <12 yr.
Warnings / Precautions
History of GI tract disease, infections, oedema, hypertension, elderly, lactation.
Adverse Reactions
Epigastric discomfort, heartburn or abdominal cramps, nausea, vomiting and diarrhoea; skin rash, pruritus, oedema, headache, dizziness, drowsiness; hypersensitivity reactions (e.g. bronchospasm, rhinitis, angioedema urticaria); GI haemorrhage/perforation; bullous/erosive stomatitis, purpura, thrombocytopenia, toxic epidermal necrolysis, haematuria, oliguria, and renal failure; increases in liver enzymes.
Potentially Fatal: Fatal hepatitis, Stevens Johnson syndrome.
Overdose Reactions
Epigastric pain, nausea, vomiting, drowsiness, lethargy, GI haemorrhage, seizures, hypertension, apnoea, coma, anaphylactic reactions and renal failure. Treatment is supportive.
Drug Interactions
Additive hepatotoxic effects with known hepatotoxins: anti-convulsants (e.g. valproic acid), anti-fungals (e.g. ketoconazole), anti-tuberculous drugs (e.g. isoniazid), tacrine, pemoline, amiodarone, methotrexate, methyldopa, amoxicillin/clavulanic acid. May decrease the oral bioavailability of furosemide and the natriuretic and diuretic response to furosemide. Increased risks of GI and hepatic adverse effects with other NSAIDs, including aspirin. May increase anti-coagulant effect of warfarin. Potentiates the action of phenytoin. May be displaced from binding sites with fenofibrate, salicylic acid, and tolbutamide. Interactions between NSAIDs and lithium, probenecid and ciclosporin, have been documented.
See Below for More nimesulide Drug Interactions
Food Interactions
Alcohol increases the risk of hepatic reactions.
Mechanism of Actions
Nimesulide is a nonsteroidal anti-inflammatory drug (NSAID) with anti-inflammatory, anti-pyretic, and analgesic properties. It inhibits prostaglandin synthetase/cyclooxygenase, which limits prostaglandin production. Its cyclooxygenase inhibiting potency is intermediate, but is relatively selective for the cyclo-oxygenase-2 (COX-2) thus the potential for gastric injury and intolerance is less. It is also a free radical scavenger, and helps protect against the tissue damage that occurs during inflammation.
Absorption: Well absorbed from GI tract following oral admin. Peak plasma levels:1-3 hr. With bid admin of 100 mg, steady-state is achieved within 24-36 hr.
Distribution: 99% bound to plasma protein.
Metabolism: Hepatic biotransformation; principal metabolite is 4-hydroxy-nimesulide.
Excretion: Elimination half-life: 2-5 hr. Metabolites in urine: 80%, feces: 20% of the administered dose.9% bound to plasma protein.
Administration
Should be taken with food. (Take after meals.)
Storage Conditions
Oral: Protect from heat and humidity; store at <25°C.
ATC Classification
M01AX17 - nimesulide ; Belongs to the class of other non-steroidal antiinflammatory and antirheumatic products.
Storage
Oral: Protect from heat and humidity; store at <25°C.
Available As
  • Nimesulide 0.01% w/w
  • Nimesulide 1%
  • Nimesulide 1% w/w
  • Nimesulide 10 mg
  • Nimesulide 100 mg
  • Nimesulide 125 mg
  • Nimesulide 150 mg
  • Nimesulide 200 mg
  • Nimesulide 25 mg
  • Nimesulide 50 mg
  • Nimesulide 60 mg
  • Nimesulide 75 mg
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