Naptodin Plus
Generic Name
Naproxen 500 mg and Esomeprazole 20 mg
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
naptodin plus 500 mg tablet | ৳ 13.00 | ৳ 130.00 |
Description
Overview of the medicine
Naptodin Plus 500 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 and inflammation associated with conditions like arthritis, while Esomeprazole helps reduce the risk of stomach ulcers and other gastrointestinal side effects that can be caused by Naproxen.
Uses & Indications
Dosage
Adults
One tablet once or twice daily, or as directed by the physician. Take at least 30 minutes before meals with water.
Elderly
Use with caution and at the lowest effective dose. Monitoring for adverse effects, especially gastrointestinal, is recommended.
Renal_impairment
Use with caution; dose adjustment may be necessary. Not recommended for severe renal impairment.
How to Take
Take the tablet whole with a glass of water, at least 30 minutes before a meal. Do not crush, chew, or break the tablet.
Mechanism of Action
Naproxen inhibits 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 irreversibly blocks the H+/K+-ATPase enzyme system (proton pump) in gastric parietal cells, leading to decreased gastric acid secretion.
Pharmacokinetics
Onset
Naproxen: Analgesic effects usually begin within 1 hour; Anti-inflammatory effects may take days to weeks. Esomeprazole: Acid suppression begins within 1 hour.
Excretion
Naproxen and its metabolites are primarily excreted in the urine. Esomeprazole and its metabolites are primarily excreted in the urine, with a smaller proportion excreted in the feces.
Half life
Naproxen: Approximately 12-17 hours. Esomeprazole: Approximately 1-1.5 hours.
Absorption
Naproxen is rapidly and completely absorbed from the gastrointestinal tract. Esomeprazole is also rapidly absorbed, with peak plasma levels occurring within 1-2 hours.
Metabolism
Naproxen is extensively metabolized in the liver by the cytochrome P450 system (primarily CYP2C9). Esomeprazole is extensively metabolized in the liver via CYP2C19 and CYP3A4 enzymes.
Side Effects
Contraindications
- Hypersensitivity to Naproxen, Esomeprazole, other NSAIDs, or any component of the formulation
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Active gastrointestinal bleeding or peptic ulcer disease
- Severe heart failure
- Severe renal or hepatic impairment
- Third trimester of pregnancy
- Concomitant use with Atazanavir or Nelfinavir
Drug Interactions
Digoxin
Increased plasma levels of digoxin.
Lithium
Increased plasma levels of lithium.
Tacrolimus
Increased risk of nephrotoxicity.
Methotrexate
Increased plasma concentration and toxicity of methotrexate.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Other NSAIDs or corticosteroids
Increased risk of gastrointestinal adverse effects.
Atazanavir, Nelfinavir, Ritonavir
Decreased absorption and efficacy of antivirals (for Esomeprazole component).
Citalopram, Imipramine, Clomipramine, Diazepam
Esomeprazole may increase plasma levels of drugs metabolized by CYP2C19.
Diuretics (e.g., Furosemide) and ACE inhibitors
Reduced efficacy of diuretics and ACE inhibitors, increased risk of renal impairment.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of bleeding, especially gastrointestinal.
Iron salts, Ketoconazole, Itraconazole, Erlotinib
Altered absorption due to reduced gastric acidity (for Esomeprazole component).
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 include drowsiness, heartburn, nausea, vomiting, epigastric pain, and gastrointestinal bleeding. Symptoms of Esomeprazole overdose are generally mild and include lethargy, confusion, agitation, and blurred vision. Management: There is no specific antidote. Treatment should be symptomatic and supportive. Gastric lavage and activated charcoal may be considered. Closely monitor renal and hepatic function.
Pregnancy & Lactation
Pregnancy: Not recommended during the third trimester of pregnancy due to potential fetal harm (premature closure of the ductus arteriosus, renal dysfunction). Use in first and second trimesters only if clearly needed and the potential benefits outweigh the risks. Lactation: Naproxen and its metabolites are excreted in human milk. Esomeprazole is also excreted in human milk. Therefore, use is generally not recommended during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to Naproxen, Esomeprazole, other NSAIDs, or any component of the formulation
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Active gastrointestinal bleeding or peptic ulcer disease
- Severe heart failure
- Severe renal or hepatic impairment
- Third trimester of pregnancy
- Concomitant use with Atazanavir or Nelfinavir
Drug Interactions
Digoxin
Increased plasma levels of digoxin.
Lithium
Increased plasma levels of lithium.
Tacrolimus
Increased risk of nephrotoxicity.
Methotrexate
Increased plasma concentration and toxicity of methotrexate.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Other NSAIDs or corticosteroids
Increased risk of gastrointestinal adverse effects.
Atazanavir, Nelfinavir, Ritonavir
Decreased absorption and efficacy of antivirals (for Esomeprazole component).
Citalopram, Imipramine, Clomipramine, Diazepam
Esomeprazole may increase plasma levels of drugs metabolized by CYP2C19.
Diuretics (e.g., Furosemide) and ACE inhibitors
Reduced efficacy of diuretics and ACE inhibitors, increased risk of renal impairment.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of bleeding, especially gastrointestinal.
Iron salts, Ketoconazole, Itraconazole, Erlotinib
Altered absorption due to reduced gastric acidity (for Esomeprazole component).
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 include drowsiness, heartburn, nausea, vomiting, epigastric pain, and gastrointestinal bleeding. Symptoms of Esomeprazole overdose are generally mild and include lethargy, confusion, agitation, and blurred vision. Management: There is no specific antidote. Treatment should be symptomatic and supportive. Gastric lavage and activated charcoal may be considered. Closely monitor renal and hepatic function.
Pregnancy & Lactation
Pregnancy: Not recommended during the third trimester of pregnancy due to potential fetal harm (premature closure of the ductus arteriosus, renal dysfunction). Use in first and second trimesters only if clearly needed and the potential benefits outweigh the risks. Lactation: Naproxen and its metabolites are excreted in human milk. Esomeprazole is also excreted in human milk. Therefore, use is generally not recommended during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Clinical trials have demonstrated the efficacy of Naproxen in pain and inflammation management and Esomeprazole in gastric acid suppression. Combination formulations aim to reduce NSAID-induced gastrointestinal side effects while maintaining therapeutic benefits. Specific trials for this combination confirm its safety and efficacy profile.
Lab Monitoring
- Complete blood count (CBC) with differential (especially for long-term use)
- Renal function (BUN, creatinine)
- Liver function tests (ALT, AST)
- Blood pressure monitoring
Doctor Notes
- Prescribe the lowest effective dose for the shortest duration consistent with patient treatment goals.
- Monitor patients for signs of gastrointestinal bleeding, cardiovascular events, and renal toxicity.
- Consider discontinuing other NSAIDs or aspirin (unless for cardiac prophylaxis) to avoid additive risks.
- Advise patients on lifestyle modifications to mitigate risks.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not exceed the recommended dose or duration of treatment.
- Report any unusual or severe stomach pain, black/tarry stools, or vomit that looks like coffee grounds immediately.
- Avoid alcohol while taking this medication.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
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.
Driving Precautions
This medication may cause dizziness, drowsiness, or visual disturbances in some individuals. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet and stay hydrated.
- Limit alcohol intake and avoid smoking to reduce gastrointestinal risks.
- Regular exercise, as advised by your doctor, can help manage pain and inflammation.
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