Nugesic
Generic Name
Nimesulide
Manufacturer
ACME Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
nugesic 100 mg tablet | ৳ 9.00 | ৳ 90.00 |
Description
Overview of the medicine
Nugesic 100 mg tablet contains Nimesulide, a non-steroidal anti-inflammatory drug (NSAID) used for the treatment of various pain and inflammatory conditions, including osteoarthritis, acute pain, and primary dysmenorrhea. It provides analgesic, anti-inflammatory, and antipyretic effects.
Uses & Indications
Dosage
Adults
100 mg twice daily, after meals. Maximum daily dose is 200 mg.
Elderly
No specific dose reduction required, but caution is advised due to increased risk of side effects, especially gastrointestinal and renal.
Renal_impairment
Contraindicated in severe renal impairment. In moderate impairment (creatinine clearance 30-80 mL/min), consider reducing the dose or extending the dosing interval. Not recommended for creatinine clearance < 30 mL/min.
How to Take
To be taken orally, preferably after meals, with water.
Mechanism of Action
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory, and antipyretic properties. Its primary mechanism of action involves the inhibition of cyclooxygenase-2 (COX-2), which is responsible for the synthesis of prostaglandins involved in pain, inflammation, and fever. It has a relatively selective action on COX-2 over COX-1, which theoretically leads to fewer gastrointestinal side effects compared to non-selective NSAIDs.
Pharmacokinetics
Onset
Pain relief usually within 30 minutes to 1 hour.
Excretion
Mainly excreted in urine (about 50-60%) and feces (about 20-30%) as metabolites.
Half life
Approximately 2-5 hours.
Absorption
Rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached within 1-2 hours.
Metabolism
Extensively metabolized in the liver, primarily by cytochrome P450 2C9 (CYP2C9), to its main active metabolite, 4-hydroxynimesulide.
Side Effects
Contraindications
- Hypersensitivity to Nimesulide or other NSAIDs
- Active gastrointestinal ulceration or bleeding
- Severe renal impairment
- Severe hepatic impairment
- Heart failure
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Third trimester of pregnancy
- Children under 12 years of age
Drug Interactions
Lithium
Increased plasma levels of lithium, leading to toxicity.
Cyclosporine
Increased nephrotoxicity.
Methotrexate
Increased plasma levels of methotrexate, leading to toxicity.
Diuretics and ACE inhibitors
Reduced antihypertensive effect and increased risk of renal impairment.
Warfarin and other anticoagulants
Increased risk of bleeding.
Storage
Store in a cool, dry place below 30°C, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms may include lethargy, drowsiness, nausea, vomiting, epigastric pain, and gastrointestinal bleeding. Rarely, hypertension, acute renal failure, respiratory depression, and coma may occur. Management includes symptomatic and supportive care. Gastric decontamination (e.g., activated charcoal) may be considered within an hour of ingestion.
Pregnancy & Lactation
Contraindicated in the third trimester of pregnancy due to risk of premature closure of the ductus arteriosus and renal dysfunction in the fetus. Not recommended during breastfeeding as Nimesulide is excreted in milk.
Side Effects
Contraindications
- Hypersensitivity to Nimesulide or other NSAIDs
- Active gastrointestinal ulceration or bleeding
- Severe renal impairment
- Severe hepatic impairment
- Heart failure
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Third trimester of pregnancy
- Children under 12 years of age
Drug Interactions
Lithium
Increased plasma levels of lithium, leading to toxicity.
Cyclosporine
Increased nephrotoxicity.
Methotrexate
Increased plasma levels of methotrexate, leading to toxicity.
Diuretics and ACE inhibitors
Reduced antihypertensive effect and increased risk of renal impairment.
Warfarin and other anticoagulants
Increased risk of bleeding.
Storage
Store in a cool, dry place below 30°C, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms may include lethargy, drowsiness, nausea, vomiting, epigastric pain, and gastrointestinal bleeding. Rarely, hypertension, acute renal failure, respiratory depression, and coma may occur. Management includes symptomatic and supportive care. Gastric decontamination (e.g., activated charcoal) may be considered within an hour of ingestion.
Pregnancy & Lactation
Contraindicated in the third trimester of pregnancy due to risk of premature closure of the ductus arteriosus and renal dysfunction in the fetus. Not recommended during breastfeeding as Nimesulide is excreted in milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture. Check the expiry date on the packaging.
Availability
Pharmacies
Approval Status
Approved in many countries, but restricted/not approved in some (e.g., USA, UK, Canada) due to hepatotoxicity concerns. Approved in Bangladesh.
Patent Status
Generic available, original patent expired
Clinical Trials
Nimesulide has undergone numerous clinical trials demonstrating its efficacy in acute pain, osteoarthritis, and dysmenorrhea. However, trials have also highlighted concerns regarding hepatotoxicity, leading to restrictions in some regions.
Lab Monitoring
- Liver function tests (LFTs) periodically, especially with long-term use
- Renal function tests (e.g., serum creatinine, BUN) periodically
- Complete blood count (CBC) with long-term therapy
Doctor Notes
- Monitor liver function closely, especially in patients with pre-existing liver conditions or during prolonged therapy.
- Advise patients about potential gastrointestinal and cardiovascular risks.
- Should be used for the shortest duration and at the lowest effective dose.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not exceed the recommended dose.
- Take with food to minimize stomach upset.
- Report any signs of liver problems (e.g., yellow skin/eyes, dark urine, persistent nausea, abdominal pain) immediately.
- Avoid alcohol consumption while taking this medicine.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose.
Driving Precautions
May cause dizziness or drowsiness in some individuals. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet and stay hydrated.
- Avoid smoking.
- Limit alcohol intake.
- Engage in moderate exercise as advised by your doctor.
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