Napgin-Plus
Generic Name
Naproxen 500 mg + Esomeprazole 20 mg
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| napgin plus 500 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Napgin-Plus 500 mg Tablet is a combination medicine containing Naproxen (an NSAID) and Esomeprazole (a proton pump inhibitor). It is used to relieve pain and inflammation while protecting the stomach from the gastrointestinal side effects often associated with NSAIDs.
Uses & Indications
Dosage
Adults
One tablet (Naproxen 500 mg + Esomeprazole 20 mg) twice daily, preferably at least 30 minutes before meals.
Elderly
Use with caution; consider starting with the lowest effective dose and monitor renal function. Dosage adjustment may be required.
Renal_impairment
Not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min). For moderate impairment, dose adjustment may be necessary and careful monitoring is advised.
How to Take
Take orally with a glass of water, preferably at least 30 minutes before meals. The tablet should be swallowed whole; do not chew, crush, or split it.
Mechanism of Action
Naproxen inhibits cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis, leading to anti-inflammatory, analgesic, and antipyretic effects. Esomeprazole is a proton pump inhibitor that reduces gastric acid secretion by irreversibly binding to and inhibiting the H+/K+-ATPase pump in gastric parietal cells.
Pharmacokinetics
Onset
Naproxen: ~1 hour for pain relief. Esomeprazole: ~1 hour for acid suppression.
Excretion
Naproxen and its metabolites are primarily excreted in the urine. Esomeprazole and its metabolites are excreted in the urine and 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 rapidly absorbed after oral administration.
Metabolism
Both Naproxen and Esomeprazole are primarily metabolized in the liver via CYP450 enzymes (Naproxen via CYP2C9, Esomeprazole primarily via CYP2C19 and CYP3A4).
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.
- Third trimester of pregnancy.
- Severe renal or hepatic impairment.
- Patients with active gastrointestinal bleeding or peptic ulcer.
Drug Interactions
Tacrolimus
Increased serum tacrolimus levels with Esomeprazole.
Methotrexate
Increased plasma concentration and toxicity of methotrexate with Naproxen.
Corticosteroids
Increased risk of gastrointestinal adverse events with Naproxen.
Digoxin, Lithium
Increased plasma levels of digoxin and lithium with Naproxen.
SSRIs (e.g., Citalopram)
Increased risk of gastrointestinal bleeding with Naproxen.
Diuretics and ACE Inhibitors
Reduced hypotensive effect and increased risk of renal impairment with Naproxen.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding with Naproxen.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of gastrointestinal bleeding with Naproxen. Esomeprazole may reduce the antiplatelet effect of clopidogrel.
Storage
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Naproxen overdose include drowsiness, heartburn, nausea, vomiting, epigastric pain, GI bleeding, and rarely, acute renal failure. Esomeprazole overdose symptoms are generally mild and include lethargy, drowsiness, nausea, tachycardia, and diarrhea. Management: There is no specific antidote. Treatment is symptomatic and supportive. Gastric lavage and/or activated charcoal may be considered within 4 hours of ingestion.
Pregnancy & Lactation
Pregnancy: Use of NSAIDs, including naproxen, in the third trimester of pregnancy is contraindicated due to the risk of premature closure of the fetal ductus arteriosus. In the first and second trimesters, use only if the potential benefit outweighs the potential risk to the fetus. Lactation: Naproxen is excreted in breast milk. Esomeprazole is also likely excreted in breast 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, esomeprazole, or any component of the formulation.
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- Third trimester of pregnancy.
- Severe renal or hepatic impairment.
- Patients with active gastrointestinal bleeding or peptic ulcer.
Drug Interactions
Tacrolimus
Increased serum tacrolimus levels with Esomeprazole.
Methotrexate
Increased plasma concentration and toxicity of methotrexate with Naproxen.
Corticosteroids
Increased risk of gastrointestinal adverse events with Naproxen.
Digoxin, Lithium
Increased plasma levels of digoxin and lithium with Naproxen.
SSRIs (e.g., Citalopram)
Increased risk of gastrointestinal bleeding with Naproxen.
Diuretics and ACE Inhibitors
Reduced hypotensive effect and increased risk of renal impairment with Naproxen.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding with Naproxen.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of gastrointestinal bleeding with Naproxen. Esomeprazole may reduce the antiplatelet effect of clopidogrel.
Storage
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Naproxen overdose include drowsiness, heartburn, nausea, vomiting, epigastric pain, GI bleeding, and rarely, acute renal failure. Esomeprazole overdose symptoms are generally mild and include lethargy, drowsiness, nausea, tachycardia, and diarrhea. Management: There is no specific antidote. Treatment is symptomatic and supportive. Gastric lavage and/or activated charcoal may be considered within 4 hours of ingestion.
Pregnancy & Lactation
Pregnancy: Use of NSAIDs, including naproxen, in the third trimester of pregnancy is contraindicated due to the risk of premature closure of the fetal ductus arteriosus. In the first and second trimesters, use only if the potential benefit outweighs the potential risk to the fetus. Lactation: Naproxen is excreted in breast milk. Esomeprazole is also likely excreted in breast 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
Typically 2-3 years from the date of manufacture, refer to the product packaging for specific details.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Numerous clinical trials have demonstrated the efficacy of naproxen in pain and inflammation management and the gastroprotective effect of esomeprazole in reducing NSAID-induced gastrointestinal complications. Combination therapies like Napgin-Plus have been studied to show improved GI safety profiles compared to NSAIDs alone.
Lab Monitoring
- Complete Blood Count (CBC) for signs of anemia or bleeding (especially with long-term use).
- Renal function tests (serum creatinine, BUN) periodically, especially in elderly or renally impaired patients.
- Liver function tests (ALT, AST) periodically.
- Stool occult blood test for gastrointestinal bleeding.
Doctor Notes
- Assess patients for cardiovascular and gastrointestinal risk factors before initiating therapy.
- Prescribe the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
- Educate patients on symptoms of GI bleeding and cardiovascular events, and advise them to seek immediate medical attention if these occur.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Swallow the tablet whole; do not chew, crush, or split it.
- Take with food or milk if stomach upset occurs, although it is best taken before meals for Esomeprazole's efficacy.
- Do not take more than the recommended dose or for a longer duration than advised.
- Report any unusual bleeding, severe stomach pain, or black/tarry stools to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine may cause dizziness, drowsiness, or visual disturbances in some patients. If you experience these side effects, avoid driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption while taking this medicine, as it may increase the risk of stomach irritation and bleeding.
- Discuss all other medications, including over-the-counter drugs and herbal supplements, with your doctor to avoid potential drug interactions.
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