Napronil-Plus
Generic Name
Naproxen 375 mg + Esomeprazole Magnesium 20 mg
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| napronil plus 375 mg tablet | ৳ 9.00 | ৳ 90.00 |
Description
Overview of the medicine
Napronil Plus 375 mg Tablet is a combination medicine used to treat pain and inflammation caused by osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It also reduces the risk of stomach ulcers and other gastrointestinal side effects associated with NSAIDs, due to the presence of Esomeprazole.
Uses & Indications
Dosage
Adults
One tablet (Naproxen 375 mg/Esomeprazole 20 mg) orally twice daily at least 30 minutes before meals.
Elderly
No specific dose adjustment typically required, but use with caution due to increased risk of side effects.
Renal_impairment
Use with caution; consider lower doses or alternative therapy in severe impairment.
How to Take
Take orally with a glass of water, at least 30 minutes before a meal. Swallow the tablet whole; do not chew, crush, or split it.
Mechanism of Action
Naproxen works by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing the synthesis of prostaglandins, which are mediators of pain and inflammation. Esomeprazole is a proton pump inhibitor that reduces gastric acid secretion by irreversibly blocking the H+/K+-ATPase enzyme system at the secretory surface of the gastric parietal cells, thereby preventing NSAID-induced ulcers.
Pharmacokinetics
Onset
Naproxen: 1 hour for pain relief. Esomeprazole: Acid suppression within 1 hour.
Excretion
Naproxen and its metabolites are primarily excreted in the urine. Esomeprazole and its metabolites are excreted via urine (approx. 80%) and feces (approx. 20%).
Half life
Naproxen: 12-17 hours. Esomeprazole: 1.5 hours.
Absorption
Naproxen is well absorbed from the GI tract. Esomeprazole is also well absorbed after oral administration, with peak plasma levels occurring within 1-2 hours.
Metabolism
Naproxen is primarily metabolized in the liver by CYP2C9. Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to naproxen, esomeprazole, or other NSAIDs/PPIs
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Active gastrointestinal bleeding or peptic ulcer
- Severe renal or hepatic impairment
- Third trimester of pregnancy
- Severe heart failure
Drug Interactions
SSRIs
Increased risk of GI bleeding.
Digoxin
Increased digoxin levels.
Diazepam
Increased diazepam levels.
Warfarin
Increased risk of bleeding.
Tacrolimus
Increased nephrotoxicity.
Clopidogrel
Increased risk of bleeding.
Methotrexate
Increased methotrexate toxicity.
Diuretics/ACE inhibitors
Reduced hypotensive effect and increased risk of renal impairment.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include drowsiness, nausea, vomiting, epigastric pain, GI bleeding. Management includes symptomatic and supportive care. Gastric lavage and activated charcoal may be considered if recent ingestion. Hemodialysis is ineffective.
Pregnancy & Lactation
Not recommended in the third trimester of pregnancy due to risk of premature closure of fetal ductus arteriosus. Use with caution in other trimesters if benefits outweigh risks. Naproxen passes into breast milk, Esomeprazole also likely passes into breast milk; caution is advised during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to naproxen, esomeprazole, or other NSAIDs/PPIs
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Active gastrointestinal bleeding or peptic ulcer
- Severe renal or hepatic impairment
- Third trimester of pregnancy
- Severe heart failure
Drug Interactions
SSRIs
Increased risk of GI bleeding.
Digoxin
Increased digoxin levels.
Diazepam
Increased diazepam levels.
Warfarin
Increased risk of bleeding.
Tacrolimus
Increased nephrotoxicity.
Clopidogrel
Increased risk of bleeding.
Methotrexate
Increased methotrexate toxicity.
Diuretics/ACE inhibitors
Reduced hypotensive effect and increased risk of renal impairment.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include drowsiness, nausea, vomiting, epigastric pain, GI bleeding. Management includes symptomatic and supportive care. Gastric lavage and activated charcoal may be considered if recent ingestion. Hemodialysis is ineffective.
Pregnancy & Lactation
Not recommended in the third trimester of pregnancy due to risk of premature closure of fetal ductus arteriosus. Use with caution in other trimesters if benefits outweigh risks. Naproxen passes into breast milk, Esomeprazole also likely passes into breast milk; caution is advised during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture
Availability
Pharmacies and hospitals
Approval Status
Approved by regulatory authorities (e.g., DGDA)
Patent Status
Generic available, original patent expired for combination
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of naproxen-esomeprazole combination in reducing pain and inflammation while lowering the risk of NSAID-induced GI adverse events.
Lab Monitoring
- Complete Blood Count (CBC)
- Liver function tests (LFTs)
- Renal function tests (RFTs)
- Fecal occult blood test (if GI symptoms develop)
Doctor Notes
- Advise patients to report any signs of gastrointestinal bleeding promptly.
- Monitor renal function, liver enzymes, and blood pressure periodically, especially in elderly patients or those with pre-existing conditions.
- Educate patients on proper administration to maximize benefits and minimize risks.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not exceed the recommended dose.
- Inform your doctor about all other medications you are taking.
- Report any signs of unusual bleeding, severe stomach pain, or black stools immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness or drowsiness in some individuals. If you experience these symptoms, avoid driving or operating heavy machinery.
Lifestyle Advice
- Avoid alcohol while taking this medicine.
- Maintain a healthy diet and stay hydrated.
- Consult your doctor before taking any over-the-counter pain relievers.
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Global Brand Names
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