Nimesulide


Full Prescribing Info
Dosage/Direction for Use

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.
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
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.
Storage
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.
M02AA26 - nimesulide ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
Disclaimer: This information is independently developed by CIMS 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 CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 CIMS. All rights reserved. Powered by CIMSAsia.com
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