Nasfen-TR
Generic Name
Nimesulide (Timed Release) 100 mg capsule
Manufacturer
Renata Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nasfen tr 100 mg capsule | ৳ 2.50 | ৳ 25.00 |
Description
Overview of the medicine
Nasfen-TR 100 mg capsule contains Nimesulide, a non-steroidal anti-inflammatory drug (NSAID) used for relieving pain and inflammation. The 'TR' indicates Timed Release formulation, which allows for prolonged action.
Uses & Indications
Dosage
Adults
100 mg once daily (for Timed Release formulation). In some cases, 100 mg twice daily may be prescribed, but generally, once daily is sufficient due to TR.
Elderly
Use with caution and at the lowest effective dose. Dosage adjustment may be required based on renal and hepatic function.
Renal_impairment
Contraindicated in severe renal impairment. In moderate impairment, start with the lowest dose and monitor renal function.
How to Take
Take orally, preferably after meals, with a glass of water to minimize gastrointestinal discomfort. Do not crush or chew the capsule; swallow it whole.
Mechanism of Action
Nimesulide primarily acts as a preferential inhibitor of cyclooxygenase-2 (COX-2), an enzyme involved in the synthesis of prostaglandins. By inhibiting COX-2, it reduces the production of prostaglandins, which are mediators of pain, inflammation, and fever, thereby exerting its analgesic, anti-inflammatory, and antipyretic effects.
Pharmacokinetics
Onset
Analgesic effects typically begin within 30-60 minutes, with full anti-inflammatory effects developing over several days.
Excretion
Approximately 65% of the dose is excreted in the urine and 35% in the feces.
Half life
Elimination half-life is approximately 2-5 hours for the parent drug, but the sustained release formulation extends its duration of action.
Absorption
Well absorbed orally. Peak plasma concentrations for TR formulations are delayed, typically occurring 4-8 hours post-dose, providing sustained release.
Metabolism
Extensively metabolized in the liver, primarily by CYP2C9, to its main active metabolite, 4'-hydroxynimesulide.
Side Effects
Contraindications
- History of gastrointestinal bleeding, ulceration, or perforation related to previous NSAID therapy
- Active peptic ulceration/hemorrhage
- Severe hepatic impairment or active liver disease
- Severe renal impairment (creatinine clearance < 30 mL/min)
- Severe heart failure
- Third trimester of pregnancy
- Known hypersensitivity to nimesulide or other NSAIDs
- Children under 12 years of age
Drug Interactions
Lithium
May increase plasma lithium levels.
Cyclosporine
May increase nephrotoxicity.
Methotrexate
May increase methotrexate toxicity.
Diuretics and ACE Inhibitors
May reduce the antihypertensive effect and increase the risk of renal impairment.
Anticoagulants (e.g., Warfarin)
May increase the risk of bleeding.
Other NSAIDs or Corticosteroids
Increased risk of gastrointestinal adverse effects.
Storage
Store in a cool, dry place, below 30°C. Protect from light 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 is primarily supportive and symptomatic. Gastric lavage and activated charcoal may be considered within the first hour of ingestion.
Pregnancy & Lactation
Category C during early pregnancy and Category D during the third trimester (due to risk of premature closure of fetal ductus arteriosus). Not recommended during lactation as nimesulide is excreted in breast milk.
Side Effects
Contraindications
- History of gastrointestinal bleeding, ulceration, or perforation related to previous NSAID therapy
- Active peptic ulceration/hemorrhage
- Severe hepatic impairment or active liver disease
- Severe renal impairment (creatinine clearance < 30 mL/min)
- Severe heart failure
- Third trimester of pregnancy
- Known hypersensitivity to nimesulide or other NSAIDs
- Children under 12 years of age
Drug Interactions
Lithium
May increase plasma lithium levels.
Cyclosporine
May increase nephrotoxicity.
Methotrexate
May increase methotrexate toxicity.
Diuretics and ACE Inhibitors
May reduce the antihypertensive effect and increase the risk of renal impairment.
Anticoagulants (e.g., Warfarin)
May increase the risk of bleeding.
Other NSAIDs or Corticosteroids
Increased risk of gastrointestinal adverse effects.
Storage
Store in a cool, dry place, below 30°C. Protect from light 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 is primarily supportive and symptomatic. Gastric lavage and activated charcoal may be considered within the first hour of ingestion.
Pregnancy & Lactation
Category C during early pregnancy and Category D during the third trimester (due to risk of premature closure of fetal ductus arteriosus). Not recommended during lactation as nimesulide is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the manufacturing date, consult the specific packaging for details.
Availability
Pharmacies in Bangladesh
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Off-patent
Clinical Trials
While Nimesulide has been extensively studied, specific clinical trial data for 'Nasfen-TR' would be proprietary to Renata. General Nimesulide trials focus on efficacy in pain/inflammation and safety profiles, particularly concerning hepatotoxicity.
Lab Monitoring
- Liver function tests (ALT, AST, Bilirubin) - periodically, especially in long-term therapy or if symptoms of liver dysfunction appear.
- Renal function tests (Creatinine, BUN) - especially in patients with pre-existing renal impairment or those on diuretics.
- Complete Blood Count (CBC) - periodically to check for anemia or other hematological effects.
- Fecal occult blood test - if GI bleeding is suspected.
Doctor Notes
- Emphasize the shortest duration and lowest effective dose for Nimesulide due to hepatotoxicity concerns.
- Advise patients to report any jaundice, dark urine, or upper abdominal pain immediately.
- Consider alternative NSAIDs or analgesics for patients with high cardiovascular or gastrointestinal risk.
Patient Guidelines
- Take exactly as prescribed by your doctor. Do not exceed the recommended dose or duration of treatment.
- Report any signs of liver problems (e.g., unusual fatigue, dark urine, yellowing of skin/eyes, abdominal pain) immediately to your doctor.
- Avoid concomitant use with other NSAIDs.
- If you experience any stomach upset, take the capsule with food or milk.
- Do not crush, chew, or break the capsule, swallow it whole.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
Nimesulide may cause dizziness or drowsiness in some individuals. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption, especially during treatment with Nimesulide, to reduce the risk of gastrointestinal and liver side effects.
- Maintain adequate hydration.
- For musculoskeletal pain, consider incorporating gentle exercises or physical therapy as advised by your doctor.
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