Nepafix-TS
Generic Name
Nimesulide Suspension
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nepafix ts 03 suspension | ৳ 225.00 | N/A |
Description
Overview of the medicine
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) used for the symptomatic treatment of acute pain, osteoarthritis, and primary dysmenorrhea. In pediatric formulations like suspension, it is used for fever and pain associated with inflammatory conditions.
Uses & Indications
Dosage
Adults
Not typically for suspension. For tablets: 100 mg twice daily.
Elderly
No specific dosage adjustment is usually required, but caution should be exercised and a lower effective dose may be considered due to potential reduced renal function.
Children
For children over 12 years: 5 mg/kg body weight per day in 2-3 divided doses. Maximum dose 100 mg/day. (Use in children under 12 years is restricted or contraindicated in some countries due to hepatotoxicity risk).
Renal_impairment
In severe renal impairment (CrCl <30 mL/min), use is contraindicated. For moderate impairment, dose adjustment may be necessary. For mild impairment, no dose adjustment usually required.
How to Take
Administer orally, preferably after meals to minimize gastrointestinal upset. Shake the bottle well before each use. Use a calibrated measuring device to ensure accurate dosing.
Mechanism of Action
Nimesulide acts as a preferential cyclooxygenase (COX)-2 inhibitor, thereby inhibiting prostaglandin synthesis, which is responsible for mediating inflammation, pain, and fever.
Pharmacokinetics
Onset
Analgesic effect usually starts within 30-60 minutes.
Excretion
Approximately 65% of the dose is excreted in urine and 35% in feces, mainly as metabolites.
Half life
Plasma elimination half-life is approximately 2 to 5 hours.
Absorption
Rapidly and well absorbed after oral administration. Peak plasma concentrations are achieved within 1-2 hours.
Metabolism
Extensively metabolized in the liver primarily via cytochrome P450 2C9 (CYP2C9) to its main active metabolite, 4'-hydroxy nimesulide.
Side Effects
Contraindications
- Hypersensitivity to Nimesulide or any NSAID
- History of gastrointestinal bleeding or peptic ulcer
- Severe hepatic impairment
- Severe renal impairment (CrCl <30 mL/min)
- Children under 12 years (in some regions due to hepatotoxicity concerns)
- Last trimester of pregnancy
- Lactation
- Severe heart failure
- Active gastrointestinal ulceration
- Coagulopathy or receiving anticoagulant therapy
Drug Interactions
Lithium
Increased plasma lithium levels, leading to potential toxicity.
Warfarin
Increased risk of bleeding due to enhanced anticoagulant effect.
Cyclosporine
Increased risk of nephrotoxicity.
Methotrexate
Increased plasma levels and toxicity of methotrexate.
ACE Inhibitors / Diuretics
Reduced antihypertensive and diuretic effects; increased risk of renal impairment.
Storage
Store below 30°C in a dry place. Protect from light and moisture. Do not freeze. Keep out of reach and sight of children.
Overdose
Symptoms of overdose include lethargy, drowsiness, nausea, vomiting, epigastric pain, and gastrointestinal bleeding. Management involves symptomatic and supportive care. Gastric lavage and activated charcoal may be considered within the first hour. Monitor renal and hepatic function closely.
Pregnancy & Lactation
Contraindicated during pregnancy, especially in the last trimester, due to potential adverse effects on fetal cardiovascular system (premature closure of ductus arteriosus). Also contraindicated during lactation as it is excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to Nimesulide or any NSAID
- History of gastrointestinal bleeding or peptic ulcer
- Severe hepatic impairment
- Severe renal impairment (CrCl <30 mL/min)
- Children under 12 years (in some regions due to hepatotoxicity concerns)
- Last trimester of pregnancy
- Lactation
- Severe heart failure
- Active gastrointestinal ulceration
- Coagulopathy or receiving anticoagulant therapy
Drug Interactions
Lithium
Increased plasma lithium levels, leading to potential toxicity.
Warfarin
Increased risk of bleeding due to enhanced anticoagulant effect.
Cyclosporine
Increased risk of nephrotoxicity.
Methotrexate
Increased plasma levels and toxicity of methotrexate.
ACE Inhibitors / Diuretics
Reduced antihypertensive and diuretic effects; increased risk of renal impairment.
Storage
Store below 30°C in a dry place. Protect from light and moisture. Do not freeze. Keep out of reach and sight of children.
Overdose
Symptoms of overdose include lethargy, drowsiness, nausea, vomiting, epigastric pain, and gastrointestinal bleeding. Management involves symptomatic and supportive care. Gastric lavage and activated charcoal may be considered within the first hour. Monitor renal and hepatic function closely.
Pregnancy & Lactation
Contraindicated during pregnancy, especially in the last trimester, due to potential adverse effects on fetal cardiovascular system (premature closure of ductus arteriosus). Also contraindicated during lactation as it is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 24 to 36 months from the date of manufacture, when stored under recommended conditions.
Availability
Pharmacies, Hospitals
Approval Status
Approved in certain regions (e.g., Bangladesh, India)
Patent Status
Generic
Clinical Trials
Numerous clinical trials have evaluated Nimesulide's efficacy in various pain and inflammatory conditions, with ongoing studies focusing on its safety profile, particularly concerning hepatotoxicity in different populations. Some trials have investigated its use in pediatric fever and pain, often leading to restricted guidelines.
Lab Monitoring
- Liver function tests (LFTs) should be monitored periodically, especially during prolonged use or if symptoms of liver injury appear.
- Renal function tests (KFTs) should be performed, especially in patients with pre-existing renal impairment or during long-term therapy.
Doctor Notes
- Exercise extreme caution when prescribing Nimesulide, especially in children, due to significant hepatotoxicity risk.
- Regular monitoring of liver function tests (LFTs) is crucial during treatment.
- Avoid co-administration with other hepatotoxic drugs or NSAIDs.
Patient Guidelines
- Do not exceed the recommended dose.
- Take the medicine with or after food to reduce stomach upset.
- Report any symptoms of liver injury (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual tiredness) immediately to your doctor.
- Avoid concomitant use with other NSAIDs or pain relievers without consulting a doctor.
- Keep out of reach of children.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, drowsiness, or visual disturbances in some individuals. Patients should be cautioned about driving or operating machinery until they are certain that Nimesulide does not adversely affect their ability to perform such activities.
Lifestyle Advice
- Avoid consuming alcohol during the treatment period as it may increase the risk of adverse effects, especially on the gastrointestinal tract and liver.
- Maintain adequate hydration.
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