Napren-ES
Generic Name
Naproxen Sodium and Esomeprazole Magnesium Delayed-Release
Manufacturer
Reputable Pharmaceutical Company
Country
Global
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| napren es 500 mg tablet | ৳ 10.03 | ৳ 60.18 |
Description
Overview of the medicine
Napren-ES is a combination medication containing Naproxen, a nonsteroidal anti-inflammatory drug (NSAID), and Esomeprazole, a proton pump inhibitor (PPI). It is used to relieve pain and inflammation associated with conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, while simultaneously reducing the risk of developing stomach ulcers and acid-related gastrointestinal side effects commonly caused by NSAIDs.
Uses & Indications
Dosage
Adults
One tablet (Naproxen 500 mg / Esomeprazole 20 mg) twice daily, 30 minutes before meals.
Elderly
Similar to adults, but with caution due to increased risk of adverse effects.
Renal_impairment
Use with caution. Not recommended for severe renal impairment (creatinine clearance <30 mL/min).
How to Take
Take orally, whole with water, at least 30 minutes before a meal. Do not crush, chew, or split the tablet.
Mechanism of Action
Naproxen inhibits prostaglandin synthesis by blocking cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing pain and inflammation. Esomeprazole reduces gastric acid secretion by irreversibly inhibiting the H+/K+-ATPase proton pump in gastric parietal cells, protecting the stomach from NSAID-induced damage.
Pharmacokinetics
Onset
Naproxen: 1-2 hours. Esomeprazole: 1 hour for acid suppression.
Excretion
Both primarily excreted in urine.
Half life
Naproxen: 12-17 hours. Esomeprazole: 1-1.5 hours.
Absorption
Naproxen is well absorbed from the GI tract. Esomeprazole is rapidly absorbed after oral administration. Delayed-release formulation ensures gradual release.
Metabolism
Both extensively metabolized in the liver, primarily by CYP enzymes. Naproxen forms 6-O-desmethylnaproxen. Esomeprazole forms hydroxylated and demethylated metabolites.
Side Effects
Contraindications
- Hypersensitivity to naproxen, esomeprazole, or any component of the formulation.
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
- Severe renal impairment.
- Late pregnancy (third trimester).
Drug Interactions
Digoxin
Increased digoxin plasma levels.
Warfarin
Increased risk of bleeding.
Tacrolimus
Increased risk of nephrotoxicity.
Methotrexate
Increased methotrexate toxicity.
St. John's Wort
May reduce esomeprazole efficacy.
Clopidogrel, SSRIs
Increased risk of GI bleeding.
Diuretics and ACE inhibitors
Reduced antihypertensive 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, lethargy, nausea, vomiting, epigastric pain, GI bleeding, coma, renal failure, and respiratory depression. Management involves symptomatic and supportive care. Gastric lavage and activated charcoal may be considered if recent ingestion.
Pregnancy & Lactation
Pregnancy: Category C in early pregnancy, D in third trimester. Avoid use in late pregnancy due to potential for premature closure of the fetal ductus arteriosus. Use only if potential benefit outweighs risk. Lactation: Naproxen is excreted in breast milk. Esomeprazole may also be excreted. 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, esomeprazole, or any component of the formulation.
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
- Severe renal impairment.
- Late pregnancy (third trimester).
Drug Interactions
Digoxin
Increased digoxin plasma levels.
Warfarin
Increased risk of bleeding.
Tacrolimus
Increased risk of nephrotoxicity.
Methotrexate
Increased methotrexate toxicity.
St. John's Wort
May reduce esomeprazole efficacy.
Clopidogrel, SSRIs
Increased risk of GI bleeding.
Diuretics and ACE inhibitors
Reduced antihypertensive 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, lethargy, nausea, vomiting, epigastric pain, GI bleeding, coma, renal failure, and respiratory depression. Management involves symptomatic and supportive care. Gastric lavage and activated charcoal may be considered if recent ingestion.
Pregnancy & Lactation
Pregnancy: Category C in early pregnancy, D in third trimester. Avoid use in late pregnancy due to potential for premature closure of the fetal ductus arteriosus. Use only if potential benefit outweighs risk. Lactation: Naproxen is excreted in breast milk. Esomeprazole may also be excreted. 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
24-36 months
Availability
Pharmacies and hospitals
Approval Status
FDA approved
Patent Status
Generic versions available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy of naproxen for pain and inflammation, and esomeprazole for gastric protection. Combination trials have shown superior GI safety compared to NSAIDs alone.
Lab Monitoring
- Complete blood count (CBC) to monitor for anemia and bleeding.
- Kidney function tests (serum creatinine, BUN) periodically.
- Liver function tests (ALT, AST) periodically.
- Stool for occult blood if GI symptoms occur.
Doctor Notes
- Emphasize the black box warnings for cardiovascular and gastrointestinal risks.
- Regularly assess renal and hepatic function, especially in elderly patients or those with pre-existing conditions.
- Educate patients on symptoms of GI bleeding and cardiovascular events.
Patient Guidelines
- Take exactly as prescribed, do not alter dose or stop without consulting a doctor.
- Take the tablet whole; do not chew, crush, or split.
- Take at least 30 minutes before food for optimal absorption.
- Report any unusual bleeding, persistent stomach upset, dark stools, or swelling to your doctor immediately.
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 take a double dose to make up for a missed one.
Driving Precautions
May cause dizziness or somnolence. Patients should be cautioned about engaging in activities requiring mental alertness, such as driving or operating machinery, until they know how the drug affects them.
Lifestyle Advice
- Avoid alcohol and smoking, as they can worsen GI side effects.
- Maintain a balanced diet to support overall health.
- Regular exercise can help manage arthritic pain.
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