Nispore
Generic Name
Nimesulide
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nispore 50 mg suspension | ৳ 78.00 | N/A |
Description
Overview of the medicine
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain, fever, and inflammation, particularly for short-term treatment. Nispore 50 mg Suspension is formulated for oral administration.
Uses & Indications
Dosage
Adults
While available in other forms for adults, 50 mg suspension is primarily for pediatric use. For adults, usually 100 mg twice daily (not in suspension form).
Elderly
Lower doses may be considered, and careful monitoring for adverse effects, particularly gastrointestinal, renal, and hepatic issues, is advised.
Renal_impairment
Dose adjustment is necessary for patients with moderate renal impairment (creatinine clearance 30-80 ml/min). Contraindicated in severe renal impairment (creatinine clearance <30 ml/min).
Children_6_months_to_12_years
Recommended dosage is 1.5-5 mg/kg body weight per day, administered in 2-3 divided doses. The maximum daily dose should not exceed 100 mg (or 10 ml of Nispore 50 mg/5 ml suspension). Duration of treatment should be as short as possible.
How to Take
Administer orally. Shake the bottle well before each use. Preferably take after meals to minimize gastrointestinal irritation. Use the provided calibrated measuring cup or spoon for accurate dosing.
Mechanism of Action
Nimesulide primarily works by selectively inhibiting the cyclooxygenase-2 (COX-2) enzyme, which is responsible for the synthesis of prostaglandins involved in pain, inflammation, and fever.
Pharmacokinetics
Onset
Analgesic and antipyretic effects usually begin within 30-60 minutes.
Excretion
Mainly excreted in urine (about 50-65%) and feces (about 35%), as metabolites.
Half life
Plasma elimination half-life ranges from 2 to 5 hours.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations reached within 1-2 hours.
Metabolism
Extensively metabolized in the liver, primarily by the cytochrome P450 enzyme CYP2C9, forming 4'-hydroxynimesulide (a major active metabolite).
Side Effects
Contraindications
- Known hypersensitivity to Nimesulide, aspirin, or other NSAIDs
- History of gastrointestinal bleeding, ulceration, or perforation
- Severe hepatic impairment or active liver disease
- Severe renal impairment (creatinine clearance <30 ml/min)
- Severe heart failure
- Third trimester of pregnancy
- Children under 12 years (especially for fever treatment in some countries and for prolonged use)
Drug Interactions
Lithium
Nimesulide can increase plasma lithium levels, leading to lithium toxicity. Monitor lithium levels closely.
Phenytoin
May increase phenytoin plasma levels.
Cyclosporine
Increased nephrotoxicity risk due to effects on renal prostaglandins.
Methotrexate
Increased methotrexate toxicity due to reduced renal clearance of methotrexate.
Diuretics and ACE inhibitors
Reduced hypotensive effect and increased risk of renal impairment, especially in dehydrated patients.
Anticoagulants (e.g., Warfarin, Aspirin)
Increased risk of bleeding due to enhanced anticoagulant effect and potential gastric irritation.
Storage
Store in a cool and dry place, below 30°C. Protect from direct sunlight and moisture. Do not freeze. Keep the bottle tightly closed and out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, lethargy, nausea, vomiting, epigastric pain, and gastrointestinal bleeding. Rarely, hypertension, acute renal failure, respiratory depression, and coma may occur. Management involves symptomatic and supportive treatment. Gastric lavage and activated charcoal may be considered if ingested recently.
Pregnancy & Lactation
Nimesulide is contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and potential for renal dysfunction in the fetus. Use in the first and second trimesters should only be considered if the potential benefit outweighs the potential risk. Avoid during lactation as Nimesulide and its metabolites may pass into breast milk.
Side Effects
Contraindications
- Known hypersensitivity to Nimesulide, aspirin, or other NSAIDs
- History of gastrointestinal bleeding, ulceration, or perforation
- Severe hepatic impairment or active liver disease
- Severe renal impairment (creatinine clearance <30 ml/min)
- Severe heart failure
- Third trimester of pregnancy
- Children under 12 years (especially for fever treatment in some countries and for prolonged use)
Drug Interactions
Lithium
Nimesulide can increase plasma lithium levels, leading to lithium toxicity. Monitor lithium levels closely.
Phenytoin
May increase phenytoin plasma levels.
Cyclosporine
Increased nephrotoxicity risk due to effects on renal prostaglandins.
Methotrexate
Increased methotrexate toxicity due to reduced renal clearance of methotrexate.
Diuretics and ACE inhibitors
Reduced hypotensive effect and increased risk of renal impairment, especially in dehydrated patients.
Anticoagulants (e.g., Warfarin, Aspirin)
Increased risk of bleeding due to enhanced anticoagulant effect and potential gastric irritation.
Storage
Store in a cool and dry place, below 30°C. Protect from direct sunlight and moisture. Do not freeze. Keep the bottle tightly closed and out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, lethargy, nausea, vomiting, epigastric pain, and gastrointestinal bleeding. Rarely, hypertension, acute renal failure, respiratory depression, and coma may occur. Management involves symptomatic and supportive treatment. Gastric lavage and activated charcoal may be considered if ingested recently.
Pregnancy & Lactation
Nimesulide is contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and potential for renal dysfunction in the fetus. Use in the first and second trimesters should only be considered if the potential benefit outweighs the potential risk. Avoid during lactation as Nimesulide and its metabolites may pass into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the manufacturing date. Refer to the product packaging for the exact expiry date.
Availability
Pharmacies, Hospitals
Approval Status
Approved for specific indications
Patent Status
Off-patent
Clinical Trials
Nimesulide has been extensively studied in various clinical trials for its efficacy in acute pain, osteoarthritis, and dysmenorrhea. Post-marketing surveillance continues globally to monitor its long-term safety profile, especially concerning hepatotoxicity and cardiovascular risks.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, bilirubin) should be performed before and periodically during treatment, especially with prolonged use or in patients with risk factors for liver disease.
- Renal function tests (serum creatinine, BUN) should be monitored, especially in elderly patients or those with pre-existing renal impairment.
- Complete blood count (CBC) to monitor for blood dyscrasias.
Doctor Notes
- Emphasize the importance of using Nimesulide for the shortest possible duration and at the lowest effective dose, particularly for children, due to the potential for serious hepatotoxicity.
- Educate patients/caregivers about the signs and symptoms of liver toxicity and gastrointestinal bleeding, advising immediate medical attention if they occur.
- Regularly monitor liver and renal function, especially in patients on prolonged therapy or with co-morbidities.
- Nimesulide is generally not considered a first-line agent for fever in children in many countries; alternative antipyretics like paracetamol or ibuprofen are often preferred.
Patient Guidelines
- Do not exceed the prescribed dose or duration of treatment, as this increases the risk of serious side effects.
- Always take Nispore 50 mg Suspension with food or milk to minimize stomach upset.
- Immediately report any signs of liver problems (e.g., unusual fatigue, dark urine, yellow skin or eyes, persistent nausea, abdominal pain) or stomach bleeding (e.g., black, tarry stools, vomiting blood) to your doctor.
- Avoid concomitant use with other NSAIDs or pain relievers without consulting your doctor.
- Keep out of reach and sight of children.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Nimesulide may cause dizziness, drowsiness, or visual disturbances. Patients should be cautious when driving, operating machinery, or performing tasks requiring alertness until they know how the medicine affects them.
Lifestyle Advice
- Avoid concurrent use of other NSAIDs or aspirin unless specifically advised by your doctor.
- Limit alcohol intake while on this medication, as it can increase the risk of gastrointestinal irritation and liver damage.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
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