Roxen
Generic Name
Naproxen
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| roxen 250 mg tablet | ৳ 4.02 | N/A |
Description
Overview of the medicine
Naproxen is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain, inflammation, and fever. It is commonly prescribed for conditions like arthritis, menstrual pain, muscle aches, and various other inflammatory disorders.
Uses & Indications
Dosage
Adults
For mild to moderate pain, dysmenorrhea, or acute gout: 250-500 mg initially, then 250 mg every 6-8 hours as needed. Maximum daily dose for short-term use is usually 1250 mg on the first day, then 1000 mg/day. For chronic conditions (e.g., arthritis): 250-500 mg twice daily. Total daily dose should not exceed 1000 mg (or 1500 mg for a limited period in some conditions).
Elderly
Start with lower doses (e.g., 250 mg once or twice daily) and monitor renal function closely due to increased risk of adverse effects.
Renal_impairment
Use with caution; dose reduction may be necessary. Avoid in patients with severe renal impairment (creatinine clearance < 30 mL/min).
How to Take
Take Roxen 250 mg tablet orally with a full glass of water. It is recommended to take it with food, milk, or an antacid to minimize gastrointestinal upset. Do not crush, chew, or break extended-release tablets.
Mechanism of Action
Naproxen works by inhibiting the activity of cyclooxygenase (COX-1 and COX-2) enzymes, which are responsible for the synthesis of prostaglandins. Prostaglandins are inflammatory mediators that contribute to pain, fever, and swelling. By reducing prostaglandin production, naproxen effectively alleviates these symptoms.
Pharmacokinetics
Onset
Analgesic effect begins within 1 hour, anti-inflammatory effect may take longer (up to 2 weeks for chronic conditions).
Excretion
Approximately 95% of the dose is excreted in the urine as unchanged naproxen, 6-O-desmethylnaproxen, and their conjugates.
Half life
Approximately 12-17 hours, allowing for twice-daily dosing.
Absorption
Rapidly and completely absorbed from the gastrointestinal tract following oral administration. Peak plasma concentrations are reached within 2-4 hours.
Metabolism
Primarily metabolized in the liver by the CYP450 enzyme system, mainly to 6-O-desmethylnaproxen, which is then conjugated.
Side Effects
Contraindications
- Known hypersensitivity to naproxen, aspirin, or other NSAIDs (risk of allergic reactions, asthma, urticaria).
- History of aspirin-exacerbated respiratory disease (e.g., asthma, rhinitis, nasal polyps).
- Active gastrointestinal bleeding or peptic ulcer disease.
- Severe renal or hepatic impairment.
- Third trimester of pregnancy due to risk of premature closure of the fetal ductus arteriosus.
- Coronary artery bypass graft (CABG) surgery (contraindicated for peri-operative pain).
Drug Interactions
Lithium
Increased plasma lithium levels, leading to potential lithium toxicity, due to reduced renal clearance of lithium.
Methotrexate
Increased plasma methotrexate levels, leading to enhanced toxicity, due to reduced renal tubular secretion of methotrexate.
SSRIs / SNRIs
Increased risk of gastrointestinal bleeding.
Cyclosporine / Tacrolimus
Increased risk of nephrotoxicity.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding due to additive antiplatelet effects and potential displacement from plasma protein binding.
Diuretics (e.g., Furosemide, Thiazides)
Reduced diuretic and antihypertensive effects; increased risk of renal failure.
ACE Inhibitors / Angiotensin Receptor Blockers (ARBs)
Reduced antihypertensive effect and increased risk of renal impairment, especially in elderly or dehydrated patients.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, heartburn, nausea, vomiting, epigastric pain, and rarely gastrointestinal bleeding. More severe effects like acute renal failure, respiratory depression, and coma may occur with massive overdose. Management involves symptomatic and supportive treatment, including gastric lavage or activated charcoal if ingested recently. Monitoring of renal and liver function is advised.
Pregnancy & Lactation
Pregnancy Category C (first and second trimesters), Category D (third trimester). Avoid naproxen in the third trimester due to the risk of premature closure of the fetal ductus arteriosus. Use in the first and second trimesters only if the potential benefit justifies the potential risk to the fetus. Naproxen is excreted in breast milk; therefore, it should be used with caution during lactation, or consider an alternative drug, or discontinue nursing.
Side Effects
Contraindications
- Known hypersensitivity to naproxen, aspirin, or other NSAIDs (risk of allergic reactions, asthma, urticaria).
- History of aspirin-exacerbated respiratory disease (e.g., asthma, rhinitis, nasal polyps).
- Active gastrointestinal bleeding or peptic ulcer disease.
- Severe renal or hepatic impairment.
- Third trimester of pregnancy due to risk of premature closure of the fetal ductus arteriosus.
- Coronary artery bypass graft (CABG) surgery (contraindicated for peri-operative pain).
Drug Interactions
Lithium
Increased plasma lithium levels, leading to potential lithium toxicity, due to reduced renal clearance of lithium.
Methotrexate
Increased plasma methotrexate levels, leading to enhanced toxicity, due to reduced renal tubular secretion of methotrexate.
SSRIs / SNRIs
Increased risk of gastrointestinal bleeding.
Cyclosporine / Tacrolimus
Increased risk of nephrotoxicity.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding due to additive antiplatelet effects and potential displacement from plasma protein binding.
Diuretics (e.g., Furosemide, Thiazides)
Reduced diuretic and antihypertensive effects; increased risk of renal failure.
ACE Inhibitors / Angiotensin Receptor Blockers (ARBs)
Reduced antihypertensive effect and increased risk of renal impairment, especially in elderly or dehydrated patients.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, heartburn, nausea, vomiting, epigastric pain, and rarely gastrointestinal bleeding. More severe effects like acute renal failure, respiratory depression, and coma may occur with massive overdose. Management involves symptomatic and supportive treatment, including gastric lavage or activated charcoal if ingested recently. Monitoring of renal and liver function is advised.
Pregnancy & Lactation
Pregnancy Category C (first and second trimesters), Category D (third trimester). Avoid naproxen in the third trimester due to the risk of premature closure of the fetal ductus arteriosus. Use in the first and second trimesters only if the potential benefit justifies the potential risk to the fetus. Naproxen is excreted in breast milk; therefore, it should be used with caution during lactation, or consider an alternative drug, or discontinue nursing.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Generally 24 to 36 months from the date of manufacture, depending on the manufacturer and specific formulation. Always check the expiry date on the packaging.
Availability
Pharmacies, Hospitals
Approval Status
Approved by DGDA/FDA
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Naproxen has been subject to extensive clinical trials over decades, establishing its efficacy and safety for various pain and inflammatory conditions. Studies have compared its effectiveness and side effect profile against other NSAIDs and placebos, contributing to its well-established role in pain management.
Lab Monitoring
- Complete Blood Count (CBC) for signs of GI bleeding or blood dyscrasias, especially with long-term use.
- Renal function tests (serum creatinine, BUN) to monitor for renal impairment.
- Liver function tests (ALT, AST) for potential hepatotoxicity.
Doctor Notes
- Counsel patients on the importance of taking naproxen with food to minimize GI upset.
- Emphasize the black box warnings regarding cardiovascular and gastrointestinal risks, especially for elderly patients or those with pre-existing conditions.
- Consider prescribing a proton pump inhibitor (PPI) or H2 blocker concomitantly for high-risk patients to prevent GI complications.
- Advise patients to promptly report any signs of bleeding, severe abdominal pain, chest pain, or swelling.
- Periodically monitor renal function, liver enzymes, and blood pressure during long-term therapy.
Patient Guidelines
- Take exactly as prescribed by your doctor and do not exceed the recommended dose.
- Always take with food, milk, or an antacid to reduce stomach upset.
- Report any signs of gastrointestinal bleeding (e.g., black, tarry stools; vomiting blood), unusual swelling, or skin rash to your doctor immediately.
- Avoid concurrent use with other NSAIDs (including aspirin) unless directed by a doctor.
- Be aware of the potential cardiovascular risks, especially if you have heart disease.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next 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
Naproxen may cause dizziness, drowsiness, or visual disturbances in some individuals. If you experience these side effects, avoid driving or operating machinery until you know how the medication affects you.
Lifestyle Advice
- Limit or avoid alcohol consumption while taking naproxen, as it can increase the risk of stomach irritation and bleeding.
- Maintain adequate hydration, especially if you are elderly or have pre-existing kidney conditions.
- Discuss with your doctor any other medications or supplements you are taking to avoid potential interactions.
- If you experience persistent stomach upset, consider dietary modifications or consult a healthcare professional.
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