| Generic Name: |
Nimesulide
|
| Therapeutic Category: |
Non-steroidal Anti-inflammatory Drug (NSAID)
|
| Pharmacological Class: |
Selective Cyclooxygenase inhibitor
|
| Composition: |
Each uncoated tablet contains Nimesulide BP 100 mg
|
| Pregnancy Category: |
C (up to second trimester); D (in third trimester)
|
| Presentation: |
Available in the pack size as 10 tablets X 30 blisters
|
| Mechanism of Action: |
The mechanism of action of Nimesulide is not completely understood. The therapeutic effects of Nimesulide are postulated to be the result of targeting a number of key mediators of the inflammatory process such as: COX-2 mediated prostaglandins.
|
| Indications: |
- Fever
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis*
- Gouty
- Arthritis
- Headache
- Dental Pain
- Post-Operative
-
Pain During Menstruation
- Arthralgia*
- Myalgia*
|
| Dosage: |
Route of administration: Oral
Adults (18 years or older): The usual dose is 100 mg per day.
Children above 12 years old: 5 mg/kg/day in 2-3 divided doses
Pharmacokinetics
Absorption: Rapidly absorbed following oral administration.
Protein binding: Approximately greater than 97.5%
Metabolism: Hepatic
Route of elimination: Renal (50%), Fecal (29%)
Half-life: 1.8 – 4.7 hours
|
| Adverse Effects: |
- Common side-effects are: Abdominal pain, nausea and vomiting, skin rash, constipation, diarrhea, indigestion, tinnitus, bitterness in mouth,
- Hypersensitivity reactions like bronchospasm, rashes.
- May lead to gastrointestinal bleeding in prolonged use.
|
| Contraindications: |
OMNI is contraindicated in the following populations and situations:
- Hypersensitivity to Nimesulide or any other components of the formulation.
- Asthma
- Urtiaria*
- Liver problems
- Children under 12 years of age
|
| Precautions: |
- In kidney and renal disease.
|
| Drug Interactions: |
- ACE inhibitors: May diminish the anti-hypertensive effect.
- Diuretics: May reduce the therapeutic effect of Diuretics.
Lithium: When administered with Omni, may cause lithium toxicity.
Warfarin: Effects of Omni and warfarin in GI bleeding is synergistic i.e. Increase the bleeding.
|
| Advantages: |
- OMNI has superior gastrointestinal safety than other NSAIDs.
- It has proven benefits in the treatment of acute (short term) pain, osteoarthritis, pain during period.
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| Terminologies: |
Ankylosing Spondylitis: A type of arthritis that affects the spine.
Arthralgia: Pain in a joint.
Myalgia: Pain in a muscle or group of muscles
Urticaria: A kind of skin rash with red, raised, itchy bumps. They may also burn or sting.
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