Drug Information

Drug Interaction:

Valproic acid, tolubutamide, frusemide , methotrexate,

Aspirin, oral anticoagulants

Indication:

Date of Approval- Jan 1995- {DCGCI)

U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08

Drug name Indication Date of Approval

100. Nimesulide 100mg ER 28-03-08

+ Levocetrizine estradiol 0.02mg tablets

(Addl ,stgth)

For symptomatic treatment of acute rhinosinusitis

Pain and inflammation

Primary dysmemorrhoea

U.S FDA APPROVED DRUGS DURING 2004

211. Nimesulide Injection 75mg/ml 28-06-2004

For short term treatment of post-operative pain

246. Nimesulide Injection (100mg/ml) 08-10-2004

(Veterinary)

Veterinary use

Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.Nimesulide NSAID Jan 1995

2.Nimesulide 1.0%w/w 17-11-2009

+ Ethanol 31% w/w

Tropical solution

For the local application in releiving paining acute low backache,

Tendonitis, Tensosinovitis and sprains

3.Nimesulide 100mg ER 28-03-2008

+ Levocetrizine Hcl 5mg tablets

For symptomatic treatment of acute Rhinosimusitis

4.Nimesulide ER 200mg 18-05-2009

Addl.Indn.

Acute pain in orthopedic, ENT,Dental and Post operative pain

5.Nimesulide Injection 08-10-2004

100mg/ml

Veterinary

Veterinary use

6.Nimesulide injection 28-06-2004

75mg/ml

For short term treatment of post-operative pain

INFORMATION UPDATE-

NIMESULIDE BANNED-

Ireland, Singapore, and Nogeria and many other countries have banned the use of Nimesulide
due to unacceptable side effects.

The European Medicine Agency (EMA) has restricted the use of nimesilide in adults to

- Acute pain for short term use

- Osteoarthiritis and

- Dysmenorrehea only

It is not to be used for fever. The use in children is prohibited

Nimesulide was discovered by 3M Pharmaceuticals , a US company but its use is not permitted
in America.

It is also not approved for use in Britian, Canada, Sweden, Denmark, Australia, New Zealand,
Japan and 168 other countries.

In India Nimesulide is permitted to be sold (MIMS)

Adverse Reaction:

Headache, somnolence, dizziness, abdominal pain

peptic ulcers, perforation or g-i bleeding,

heartburn, diarrhea, constipation,

rash ,urticaria, pruritus, erythema,

angioedema, changes in hepatic parameters ( as transaminases)
usually transitory and reversible but may lead to damage in some cases
(discontinue treatment and do not rechallenge )

acute hepatitis, fulminant hepatic failure.
Oliguria, oedema, hematuria,

isolated response of purpura in all age groups and
Reys syndrome in children (suscepted )

rarely bullous eruptions , eryhthma multiforme,
Stevens- Johnson syndrome

Contra-Indications:

Children-
Active peptic ulcer, History of recurrent ulceration
Gastro-intestinal bleeding,
Hepatic impairment
Severe renal impaitment
Severe coagulation disorders
Pregnancy , lactation

Special Precautions-
Elderly. Monitor renal and cardiac impairment
History of peptic ulceration or inflammatory bowel disease
Intracranial bleeding
Aspirin/NSAIDs induced hypersensitivity reactions
Patients who experience symptoms compatible with hepatic injury treatment with nimesilde
(eg anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine, or jaundice ) should be
carefully monitored.

Dosages/ Overdosage Etc:

Indication-

Pain and inflammation
Primary dysmemorrhoea

Dosage-
100mg twice daily

Other Information:

For Availability/supplies

Contact -

1.Indian Drug Manufacturers Association (IDMA)

Phone- 022- 24944624/ 24974308

Fax- 022- 24950723

Email- idma@vsnl.com

Website: www.idma-assn.org

2.Bulk Drug Manufacturers Association (India)(BDMA)

Phone - 040-23703910/ 23706718

Fax- 040-23704804

Email- info@bdmai.org

Website: www.info@bdmai.org

Pregnancy and lactation:

Use contraindicated to be used during pregnancy and lactation.

Nimesulide - Non-steroid anti-inflammatory drugs- (Jan 1995 DCGI)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Other Information

Pregnancy and lactation