Naprosyn Plus
Generic Name
Naproxen 375 mg & Esomeprazole 20 mg
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| naprosyn plus 375 mg tablet | ৳ 17.00 | ৳ 170.00 |
Description
Overview of the medicine
Naprosyn Plus 375 mg Tablet is a combination medication containing Naproxen, a non-steroidal anti-inflammatory drug (NSAID), and Esomeprazole, a proton pump inhibitor (PPI). It is used to relieve pain, inflammation, and stiffness caused by various conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, while simultaneously protecting the stomach from potential NSAID-induced ulcers and gastrointestinal side effects.
Uses & Indications
Dosage
Adults
One tablet twice daily, taken at least 30 minutes before meals.
Elderly
Caution advised; lowest effective dose for shortest duration. Adjust based on renal function.
Renal_impairment
Not recommended for severe renal impairment (creatinine clearance < 30 mL/min). For moderate impairment, start with lower doses and monitor renal function.
How to Take
Take the tablet whole with water, at least 30 minutes before a meal. Do not crush, chew, or split the tablet.
Mechanism of Action
Naproxen inhibits cyclooxygenase (COX-1 and COX-2) enzymes, leading to reduced prostaglandin synthesis, which in turn decreases inflammation, pain, and fever. Esomeprazole is a proton pump inhibitor that irreversibly blocks the H+/K+-ATPase enzyme system (proton pump) in gastric parietal cells, thereby reducing gastric acid secretion and protecting the stomach lining.
Pharmacokinetics
Onset
Naproxen: ~1 hour for pain relief. Esomepraloe: 30-60 minutes for acid suppression.
Excretion
Naproxen and its metabolites are primarily excreted in the urine. Esomeprazole and its metabolites are primarily excreted in the urine, with a smaller portion in feces.
Half life
Naproxen: 12-17 hours. Esomeprazole: 1-1.5 hours.
Absorption
Naproxen is rapidly and completely absorbed from the GI tract. Esomeprazole is absorbed after passing through the stomach in its enteric-coated formulation.
Metabolism
Naproxen is extensively metabolized in the liver by demethylation and glucuronidation. Esomeprazole is extensively metabolized in the liver by the cytochrome P450 system (primarily CYP2C19 and CYP3A4).
Side Effects
Contraindications
- Known hypersensitivity to naproxen, esomeprazole, or any components
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
- In the setting of coronary artery bypass graft (CABG) surgery
- Late pregnancy (third trimester)
- Severe heart failure
- Severe renal impairment
- Severe hepatic impairment
Drug Interactions
Digoxin
Increased serum digoxin concentrations.
Lithium
Increased plasma lithium levels, leading to toxicity.
Tacrolimus
Increased risk of nephrotoxicity.
SSRIs/SNRIs
Increased risk of GI bleeding.
Methotrexate
Increased methotrexate levels, potentially leading to toxicity.
Clarithromycin
Increased esomeprazole and clarithromycin plasma levels.
Corticosteroids
Increased risk of GI side effects, including ulceration and bleeding.
Other NSAIDs/Aspirin
Increased risk of adverse effects; concurrent use is not recommended.
Warfarin, other anticoagulants
Increased risk of bleeding.
ACE inhibitors, ARBs, Diuretics
Reduced antihypertensive effect and increased risk of renal impairment.
Rifampin (CYP2C19/CYP3A4 inducer)
Decreased esomeprazole exposure.
Clopidogrel and other antiplatelets
Increased risk of bleeding.
Ketoconazole, Itraconazole, Voriconazole (CYP2C19/CYP3A4 inhibitors)
Increased esomeprazole exposure.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of naproxen overdose may include drowsiness, heartburn, nausea, vomiting, epigastric pain, GI bleeding. Symptoms of esomeprazole overdose are generally minimal but may include drowsiness, confusion, blurred vision. Management involves symptomatic and supportive care. Gastric lavage and activated charcoal may be considered in acute ingestion. Hemodialysis is not effective for naproxen removal.
Pregnancy & Lactation
Pregnancy Category C (first and second trimesters), Category D (third trimester for NSAIDs). Avoid in late pregnancy due to risk of premature closure of the fetal ductus arteriosus. Use during lactation is generally not recommended as naproxen is excreted in breast milk. Esomeprazole is also excreted in breast milk.
Side Effects
Contraindications
- Known hypersensitivity to naproxen, esomeprazole, or any components
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
- In the setting of coronary artery bypass graft (CABG) surgery
- Late pregnancy (third trimester)
- Severe heart failure
- Severe renal impairment
- Severe hepatic impairment
Drug Interactions
Digoxin
Increased serum digoxin concentrations.
Lithium
Increased plasma lithium levels, leading to toxicity.
Tacrolimus
Increased risk of nephrotoxicity.
SSRIs/SNRIs
Increased risk of GI bleeding.
Methotrexate
Increased methotrexate levels, potentially leading to toxicity.
Clarithromycin
Increased esomeprazole and clarithromycin plasma levels.
Corticosteroids
Increased risk of GI side effects, including ulceration and bleeding.
Other NSAIDs/Aspirin
Increased risk of adverse effects; concurrent use is not recommended.
Warfarin, other anticoagulants
Increased risk of bleeding.
ACE inhibitors, ARBs, Diuretics
Reduced antihypertensive effect and increased risk of renal impairment.
Rifampin (CYP2C19/CYP3A4 inducer)
Decreased esomeprazole exposure.
Clopidogrel and other antiplatelets
Increased risk of bleeding.
Ketoconazole, Itraconazole, Voriconazole (CYP2C19/CYP3A4 inhibitors)
Increased esomeprazole exposure.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of naproxen overdose may include drowsiness, heartburn, nausea, vomiting, epigastric pain, GI bleeding. Symptoms of esomeprazole overdose are generally minimal but may include drowsiness, confusion, blurred vision. Management involves symptomatic and supportive care. Gastric lavage and activated charcoal may be considered in acute ingestion. Hemodialysis is not effective for naproxen removal.
Pregnancy & Lactation
Pregnancy Category C (first and second trimesters), Category D (third trimester for NSAIDs). Avoid in late pregnancy due to risk of premature closure of the fetal ductus arteriosus. Use during lactation is generally not recommended as naproxen is excreted in breast milk. Esomeprazole is also excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months
Availability
Pharmacies, hospitals
Approval Status
Approved by FDA (for branded combination Vimovo)
Patent Status
Generics available, original patent expired
Clinical Trials
Clinical trials demonstrated the efficacy of naproxen in pain and inflammation and the superior gastroprotective effect of the naproxen/esomeprazole combination compared to naproxen alone in reducing NSAID-associated gastric ulcers.
Lab Monitoring
- Complete blood count (CBC)
- Liver function tests (LFTs)
- Renal function tests (Creatinine, BUN)
- Blood pressure monitoring
Doctor Notes
- Emphasize the importance of taking this medication exactly as prescribed to maximize gastroprotection and minimize NSAID-related risks.
- Monitor patients for signs of cardiovascular, renal, and gastrointestinal adverse events, especially in elderly patients or those with pre-existing conditions.
- Educate patients on symptoms requiring immediate medical attention (e.g., severe abdominal pain, black stools, swelling).
Patient Guidelines
- Take as directed by your doctor, preferably 30 minutes before a meal.
- Do not crush, chew, or split the tablet.
- Report any signs of stomach bleeding (black, tarry stools; vomiting blood) immediately.
- Avoid concomitant use with other NSAIDs or aspirin.
- Do not stop taking this medicine suddenly without consulting your doctor.
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
May cause dizziness or drowsiness in some individuals. If you experience these side effects, avoid driving or operating heavy machinery.
Lifestyle Advice
- Avoid alcohol consumption, which can increase the risk of stomach irritation and bleeding.
- Maintain a healthy diet to support overall well-being.
- Stay hydrated.
- Engage in regular, low-impact exercise if appropriate for your condition.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.