Nimesulide


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Acute pain; Extra-articular disorders; Osteoarthritis; Post-op pain; Primary dysmenorrhoea 100 mg twice daily. Rectal Acute pain; Osteoarthritis; Primary dysmenorrhoea 200 mg twice daily. Topical Sprains; Acute traumatic tendinitis As 3% cream/gel: Apply 2-3 times/day for 7-15 days.
Dosage Details
Oral
Acute pain, Dysmenorrhoea, Osteoarthritis, Postoperative pain
Adult: 100 mg bid. Use in the European Union (EU) is limited to a max of 15 days.

Rectal
Acute pain, Osteoarthritis, Primary dysmenorrhoea
Adult: 200 mg bid

Topical/Cutaneous
Acute traumatic tendinitis, Sprains
Adult: 3% gel/cream: Apply thin layer to affected area bid-tid. Duration: 7-15 days.
Administration
Should be taken with food.
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.
Special 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.
Overdosage
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.
Food Interaction
Alcohol increases the risk of hepatic reactions.
Action
Description: 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.
Pharmacokinetics:
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.
Storage
Oral:
Protect from heat and humidity; store at <25°C.
Disclaimer: This information is independently developed by MIMS based on Nimesulide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • Nise
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in