Napoxen
Generic Name
Naproxen 250 mg tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| napoxen 250 mg tablet | ৳ 4.00 | N/A |
Description
Overview of the medicine
Naproxen is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain, swelling, and fever. It treats conditions such as arthritis, menstrual cramps, tendinitis, and bursitis.
Uses & Indications
Dosage
Adults
For chronic conditions like arthritis, typically 250-500 mg twice daily (morning and evening). For acute pain or dysmenorrhea, an initial dose of 500 mg, followed by 250 mg every 6-8 hours as needed, not exceeding 1250 mg daily.
Elderly
Use the lowest effective dose for the shortest duration. Monitor renal function and for gastrointestinal side effects closely.
Renal_impairment
Dose reduction may be necessary. Avoid use in patients with severe renal impairment (creatinine clearance < 30 mL/min).
How to Take
Oral administration. Tablets should be swallowed whole with a glass of water, preferably with food or milk to minimize gastrointestinal upset. Do not crush or chew enteric-coated tablets.
Mechanism of Action
Naproxen works by inhibiting the activity of cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2. This inhibition reduces the production of prostaglandins, which are chemicals in the body that contribute to pain, inflammation, and fever.
Pharmacokinetics
Onset
Analgesic effect typically begins within 1 hour. Anti-inflammatory effects may take longer, up to 2 weeks for full effect in chronic conditions.
Excretion
Over 95% of naproxen is excreted in the urine, mainly as the unchanged drug and its metabolites. A small amount is excreted in the feces.
Half life
Approximately 12-17 hours, allowing for twice-daily dosing.
Absorption
Rapid and almost complete from the gastrointestinal tract, peak plasma concentrations reached within 2-4 hours.
Metabolism
Primarily metabolized in the liver by the cytochrome P450 system (specifically CYP2C9) to 6-O-desmethylnaproxen and its conjugates.
Side Effects
Contraindications
- Hypersensitivity to naproxen, aspirin, or other NSAIDs (may cause asthma, urticaria, or allergic-type reactions).
- Active gastrointestinal bleeding or peptic ulcer disease.
- Severe renal or hepatic impairment.
- Severe heart failure.
- Third trimester of pregnancy.
- Coronary artery bypass graft (CABG) surgery (peri-operative pain).
Drug Interactions
Lithium
Increased plasma lithium levels, leading to toxicity.
SSRIs/SNRIs
Increased risk of GI bleeding.
Methotrexate
Increased methotrexate toxicity.
ACE Inhibitors/ARBs
Reduced antihypertensive effect; increased risk of renal impairment.
Cyclosporine/Tacrolimus
Increased nephrotoxicity.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Diuretics (e.g., Furosemide, Thiazides)
Reduced diuretic effect; increased risk of renal impairment.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of GI bleeding.
Storage
Store at room temperature (20-25°C or 68-77°F). Protect from moisture and light. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, nausea, vomiting, epigastric pain, lethargy, dizziness, and sometimes GI bleeding. Rare symptoms include hypertension, acute renal failure, respiratory depression, and coma. Management is supportive and symptomatic; gastric lavage or activated charcoal may be considered if ingestion is recent.
Pregnancy & Lactation
Pregnancy: Category C in first two trimesters, Category D in third trimester. Avoid in the third trimester due to risk of premature closure of the fetal ductus arteriosus. Use only if potential benefit justifies the potential risk to the fetus in first/second trimesters. Lactation: Naproxen is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to naproxen, aspirin, or other NSAIDs (may cause asthma, urticaria, or allergic-type reactions).
- Active gastrointestinal bleeding or peptic ulcer disease.
- Severe renal or hepatic impairment.
- Severe heart failure.
- Third trimester of pregnancy.
- Coronary artery bypass graft (CABG) surgery (peri-operative pain).
Drug Interactions
Lithium
Increased plasma lithium levels, leading to toxicity.
SSRIs/SNRIs
Increased risk of GI bleeding.
Methotrexate
Increased methotrexate toxicity.
ACE Inhibitors/ARBs
Reduced antihypertensive effect; increased risk of renal impairment.
Cyclosporine/Tacrolimus
Increased nephrotoxicity.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Diuretics (e.g., Furosemide, Thiazides)
Reduced diuretic effect; increased risk of renal impairment.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of GI bleeding.
Storage
Store at room temperature (20-25°C or 68-77°F). Protect from moisture and light. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, nausea, vomiting, epigastric pain, lethargy, dizziness, and sometimes GI bleeding. Rare symptoms include hypertension, acute renal failure, respiratory depression, and coma. Management is supportive and symptomatic; gastric lavage or activated charcoal may be considered if ingestion is recent.
Pregnancy & Lactation
Pregnancy: Category C in first two trimesters, Category D in third trimester. Avoid in the third trimester due to risk of premature closure of the fetal ductus arteriosus. Use only if potential benefit justifies the potential risk to the fetus in first/second trimesters. Lactation: Naproxen is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years
Availability
Available in pharmacies and hospitals
Approval Status
Approved by major regulatory bodies
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established naproxen's efficacy and safety for various pain and inflammatory conditions since its approval. Ongoing research often focuses on comparative effectiveness or specific patient populations.
Lab Monitoring
- Complete Blood Count (CBC) periodically for long-term therapy.
- Renal function tests (serum creatinine, BUN) especially in elderly or those with impaired renal function.
- Liver function tests (ALT, AST) periodically for long-term therapy.
- Blood pressure monitoring.
Doctor Notes
- Counsel patients on signs of GI bleeding and cardiovascular risks.
- Use lowest effective dose for shortest duration.
- Caution in elderly, patients with cardiovascular, renal, or hepatic impairment, and those with a history of GI disease.
Patient Guidelines
- Take exactly as prescribed.
- Take with food or milk to reduce stomach upset.
- Do not exceed the recommended dose.
- Report any signs of gastrointestinal bleeding (black, tarry stools; vomiting blood) immediately.
- Avoid alcohol and other NSAIDs while taking naproxen.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. 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 catch up.
Driving Precautions
This medicine may cause dizziness, drowsiness, or visual disturbances. If these effects occur, avoid driving or operating machinery.
Lifestyle Advice
- Maintain good hydration.
- Avoid activities requiring mental alertness if experiencing dizziness or drowsiness.
- Consider using a stomach protector if you have a history of stomach problems or are on long-term therapy.
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