napronil-plus
Generic Name
Naproxen + Esomeprazole
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| napronil plus 500 mg tablet | ৳ 11.50 | ৳ 115.00 |
Description
Overview of the medicine
Napronil-Plus 500 mg Tablet is a combination medicine containing Naproxen, a non-steroidal anti-inflammatory drug (NSAID), and Esomeprazole, a proton pump inhibitor (PPI). It is used to relieve pain and inflammation in various conditions like arthritis, while Esomeprazole helps to protect the stomach from the potential gastrointestinal side effects of Naproxen.
Uses & Indications
Dosage
Adults
One tablet once or twice daily, as directed by a physician. Maximum daily dose should not exceed Naproxen 1000 mg and Esomeprazole 40 mg.
Elderly
Use with caution. Dosage adjustments may be necessary due to increased susceptibility to adverse effects and potential renal impairment.
Renal_impairment
Use with caution. Dosage reduction may be necessary, especially in severe renal impairment. Avoid in severe kidney disease.
How to Take
Take orally with a glass of water, preferably 30-60 minutes before a meal to maximize Esomeprazole's effect. Do not crush, chew, or split the tablet.
Mechanism of Action
Naproxen inhibits cyclooxygenase (COX-1 and COX-2) enzymes, which are involved in the synthesis of prostaglandins, mediators of pain and inflammation. Esomeprazole inhibits the gastric H+/K+-ATPase (proton pump) in the parietal cells of the stomach, thereby reducing gastric acid secretion.
Pharmacokinetics
Onset
Naproxen: Analgesic effect typically within 1 hour; anti-inflammatory effects may take several days. Esomeprazole: Onset of acid suppression within 1 hour.
Excretion
Naproxen and its metabolites are primarily excreted in the urine (approximately 95%), with a small amount excreted in the feces. Esomeprazole and its metabolites are primarily excreted via the kidney (approx. 80%) and the remainder in the feces (approx. 20%).
Half life
Naproxen: Approximately 12-17 hours. Esomeprazole: Approximately 1.5 hours (however, the duration of acid suppression is much longer due to irreversible binding to the proton pump).
Absorption
Naproxen is well absorbed from the GI tract with peak plasma concentrations occurring within 2-4 hours. Esomeprazole is rapidly absorbed with peak plasma concentrations typically achieved within 1-2 hours after oral administration.
Metabolism
Naproxen is primarily metabolized in the liver by the cytochrome P450 system (CYP2C9, CYP1A2, CYP2E1) followed by glucuronidation. Esomeprazole is extensively metabolized in the liver by the cytochrome P450 system, mainly by CYP2C19 and CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to Naproxen, Esomeprazole, or any NSAIDs/benzimidazoles
- Active gastrointestinal bleeding, ulceration, or perforation
- Severe renal or hepatic impairment
- Severe heart failure
- Third trimester of pregnancy
- History of aspirin-sensitive asthma or other allergic-type reactions after taking NSAIDs.
Drug Interactions
Digoxin
Increased digoxin plasma levels.
Clopidogrel
Reduced antiplatelet effect of clopidogrel due to Esomeprazole's inhibition of CYP2C19.
Methotrexate
Increased methotrexate plasma levels and toxicity.
Other NSAIDs or Aspirin
Increased risk of gastrointestinal adverse effects.
Diuretics and ACE Inhibitors
Reduced antihypertensive effect and increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Antifungals (e.g., Ketoconazole, Itraconazole)
Reduced absorption due to Esomeprazole-induced increase in gastric pH.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Naproxen overdose may include drowsiness, heartburn, nausea, vomiting, epigastric pain, and rarely gastrointestinal bleeding. Esomeprazole overdose symptoms are generally mild and non-specific. Management involves symptomatic and supportive treatment. Gastric lavage and activated charcoal may be considered within the first few hours.
Pregnancy & Lactation
Naproxen is contraindicated in the third trimester of pregnancy due to potential fetal harm (premature closure of the ductus arteriosus). Use with caution in the first and second trimesters only if clearly needed. Both Naproxen and Esomeprazole are excreted in breast milk; therefore, caution should be exercised when administered to a nursing mother. Consult a doctor.
Side Effects
Contraindications
- Hypersensitivity to Naproxen, Esomeprazole, or any NSAIDs/benzimidazoles
- Active gastrointestinal bleeding, ulceration, or perforation
- Severe renal or hepatic impairment
- Severe heart failure
- Third trimester of pregnancy
- History of aspirin-sensitive asthma or other allergic-type reactions after taking NSAIDs.
Drug Interactions
Digoxin
Increased digoxin plasma levels.
Clopidogrel
Reduced antiplatelet effect of clopidogrel due to Esomeprazole's inhibition of CYP2C19.
Methotrexate
Increased methotrexate plasma levels and toxicity.
Other NSAIDs or Aspirin
Increased risk of gastrointestinal adverse effects.
Diuretics and ACE Inhibitors
Reduced antihypertensive effect and increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Antifungals (e.g., Ketoconazole, Itraconazole)
Reduced absorption due to Esomeprazole-induced increase in gastric pH.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Naproxen overdose may include drowsiness, heartburn, nausea, vomiting, epigastric pain, and rarely gastrointestinal bleeding. Esomeprazole overdose symptoms are generally mild and non-specific. Management involves symptomatic and supportive treatment. Gastric lavage and activated charcoal may be considered within the first few hours.
Pregnancy & Lactation
Naproxen is contraindicated in the third trimester of pregnancy due to potential fetal harm (premature closure of the ductus arteriosus). Use with caution in the first and second trimesters only if clearly needed. Both Naproxen and Esomeprazole are excreted in breast milk; therefore, caution should be exercised when administered to a nursing mother. Consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date
Availability
Available in pharmacies and hospitals
Approval Status
DGDA Approved
Patent Status
Generic
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of Naproxen for various inflammatory conditions and Esomeprazole for gastric acid suppression and prevention of NSAID-induced ulcers. Combination products like Napronil-Plus have been studied to demonstrate the benefit of co-administration.
Lab Monitoring
- Complete Blood Count (CBC)
- Renal function tests (Creatinine, BUN)
- Liver function tests (ALT, AST)
- Blood pressure monitoring, especially with prolonged use.
Doctor Notes
- Prescribe the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals.
- Monitor patients for signs and symptoms of cardiovascular events, gastrointestinal bleeding, and renal dysfunction throughout therapy.
- Consider drug interactions carefully, especially with anticoagulants, other NSAIDs, and clopidogrel.
- Educate patients on potential risks and symptoms requiring immediate medical attention.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not exceed the recommended dose.
- Report any severe stomach pain, black stools, or unusual bleeding to your doctor immediately.
- Do not stop taking the medicine suddenly without consulting your doctor.
- Avoid alcohol consumption while on this medication.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, drowsiness, or visual disturbances. If you experience these symptoms, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet to support overall well-being.
- Avoid smoking, as it can worsen gastrointestinal side effects.
- Engage in regular, low-impact exercise as appropriate for your condition to help manage pain and inflammation.
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.
Other Medicines in napronil-plus Brand
Other medicines available under the same brand name
