Generic medicine

Nimesulide: Brands, Price & Uses in Bangladesh

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) that preferentially inhibits the COX-2 enzyme.

Forms:Tablet

About Nimesulide

Indications of Nimesulide

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) that preferentially inhibits the COX-2 enzyme. Its use varies significantly by country because several major regulators have restricted or never approved it due to hepatotoxicity concerns.

Established / labeled uses (in countries where marketed)

  • Short-term (generally up to 15 days) relief of acute pain and inflammation, such as acute musculoskeletal and joint pain, sprains, and strains.
  • Primary dysmenorrhea (painful menstrual cramps).
  • Post-operative and post-traumatic pain with an inflammatory component, as an adjunct to standard analgesic care.

Important regulatory context

Nimesulide is not approved in the United States, United Kingdom, Canada, Australia, and several other markets. In the European Union and a number of Asian countries it remains available but under tightened restrictions (adult-only, short-course use, prescription-only, with hepatic-injury warnings) following safety reviews. Where Nimesulide is available, it should only be used for the shortest duration and lowest effective dose needed, and is not intended for chronic/long-term use.

Dosage & Administration of Nimesulide

Per-indication dosing (in countries where Nimesulide is marketed)

IndicationAdult doseNotes
Acute musculoskeletal pain / sprains100 mg twice daily, after mealsMaximum treatment duration generally 15 days; use lowest effective dose for the shortest time
Primary dysmenorrhea100 mg twice daily, started at onset of symptomsLimit to the treatment period needed for the menstrual episode
Post-operative/post-traumatic pain (adjunct)100 mg twice daily, after mealsShort-term adjunct only; reassess if pain persists beyond a few days

Pediatric dosing

Nimesulide is contraindicated in children under 12 years in most markets where it is available (see Contraindications and Use in Special Populations). It is not recommended for pediatric use where safety has not been separately established.

Renal/hepatic adjustment

Nimesulide is contraindicated in patients with hepatic impairment or a history of hepatotoxicity with Nimesulide (see Contraindications). Use with caution and at the lowest effective dose in mild renal impairment; avoid in significant renal impairment (see Precautions and Warnings).

Side Effects of Nimesulide

FrequencyEffects
CommonDiarrhea, nausea, vomiting, dizziness, heartburn
UncommonElevated liver enzymes, itching, rash, sweating increase, gastritis, constipation, flatulence
Rare but seriousSevere hepatotoxicity (including fulminant hepatitis, jaundice), gastrointestinal bleeding/perforation, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), anaphylaxis/angioedema, thrombocytopenia, acute renal failure/interstitial nephritis, hyperkalemia

Patients should seek immediate medical attention for signs of liver injury (yellowing of eyes/skin, dark urine, unusual fatigue, persistent nausea), severe skin reaction, or signs of gastrointestinal bleeding (black stools, vomiting blood) while taking Nimesulide.

Contraindications of Nimesulide

  • Known hypersensitivity to Nimesulide or any component of the formulation.
  • History of hepatotoxicity (liver injury) with prior Nimesulide use, or current hepatic impairment/active liver disease.
  • Children under 12 years of age.
  • History of hypersensitivity reactions (bronchospasm, angioedema, urticaria, or acute rhinitis) to aspirin or other NSAIDs (NSAID cross-reactivity).
  • Third trimester of pregnancy.
  • Active peptic ulcer disease or history of recurrent gastrointestinal ulceration/bleeding.
  • Severe hepatic or severe renal impairment.
  • Concurrent use with other known hepatotoxic medicinal products.
  • History of hyperkalemia.
  • Concomitant alcohol or substance conditions that predispose to hepatic injury, per local prescribing information.

Frequently Asked Questions about Nimesulide

What is Nimesulide used for?

Nimesulide is an NSAID used for short-term (generally up to 15 days) relief of acute pain and inflammation, such as musculoskeletal pain, sprains, and painful menstrual periods, in countries where it remains marketed. It is not approved in some major markets, including the United States.

Why has Nimesulide been withdrawn or restricted in some countries?

Nimesulide has been associated with rare but serious, sometimes fatal, liver injury (hepatotoxicity). Because of this, several countries have withdrawn it from the market entirely, while others restrict it to short-course, adult-only, prescription use with liver-safety warnings.

Can children take Nimesulide?

No. Nimesulide is contraindicated in children under 12 years of age because of reports of serious liver injury in this age group. It should never be given to young children.

Can I take Nimesulide during pregnancy?

Nimesulide is contraindicated in the third trimester of pregnancy. Use in the first and second trimesters is not recommended and should be avoided unless a physician determines the benefit clearly outweighs the potential risk to the fetus. Always consult a physician before using Nimesulide during pregnancy.

What are the warning signs of liver problems while taking Nimesulide?

Stop Nimesulide and seek medical attention immediately if you notice yellowing of the skin or eyes, dark urine, persistent nausea or vomiting, unusual tiredness, loss of appetite, or pain in the upper right abdomen.

What should I do if I take too much Nimesulide?

Seek immediate medical attention or contact emergency services/a poison control center. Do not try to treat an overdose of Nimesulide at home, as it can cause serious effects including gastrointestinal bleeding and liver or kidney injury.

Disclaimer

The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.

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