Naproben-Plus
Generic Name
Naproxen Sodium 500 mg and Esomeprazole Magnesium 20 mg Tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| naproben plus 500 mg tablet | ৳ 15.00 | ৳ 150.00 |
Description
Overview of the medicine
Naproben-Plus 500 mg Tablet is a combination medicine containing Naproxen Sodium, a non-steroidal anti-inflammatory drug (NSAID), and Esomeprazole Magnesium, a proton pump inhibitor (PPI). It is used to relieve pain, inflammation, and stiffness caused by various arthritic conditions while protecting the stomach from the gastrointestinal side effects often associated with NSAIDs.
Uses & Indications
Dosage
Adults
One tablet once or twice daily, or as directed by physician.
Elderly
Use with caution; lower doses may be considered. Monitor renal and hepatic function.
Renal_impairment
Use with caution. Dose adjustment may be necessary in severe renal impairment. Avoid in severe kidney disease.
How to Take
Take the tablet whole with a glass of water. Do not crush, chew, or split the tablet. It can be taken with or without food, but taking it with food might reduce gastric upset.
Mechanism of Action
Naproxen Sodium works by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, which are involved in the synthesis of prostaglandins, mediators of pain and inflammation. Esomeprazole Magnesium, a proton pump inhibitor, reduces gastric acid secretion by irreversibly blocking the H+/K+-ATPase enzyme system (proton pump) in the gastric parietal cells, thereby preventing NSAID-induced gastric ulcers.
Pharmacokinetics
Onset
Naproxen: ~1 hour for pain relief. Esomeprazole: ~1 hour for acid suppression.
Excretion
Naproxen: Primarily excreted in urine (about 95%). Esomeprazole: Mainly excreted via urine (80%) and feces (20%).
Half life
Naproxen: 12-17 hours. Esomeprazole: ~1 to 1.5 hours.
Absorption
Naproxen: Rapidly and completely absorbed from the GI tract. Esomeprazole: Rapidly absorbed, bioavailability is about 64% after a single dose and increases to 89% with repeated once-daily administration.
Metabolism
Naproxen: Primarily metabolized in the liver by the cytochrome P450 system (CYP2C9). Esomeprazole: Extensively metabolized in the liver by CYP2C19 and CYP3A4 enzymes.
Side Effects
Contraindications
- Hypersensitivity to Naproxen, Esomeprazole, or any NSAID/PPI.
- Active gastrointestinal bleeding or peptic ulcer.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Severe renal or hepatic impairment.
- Severe heart failure.
- Third trimester of pregnancy.
Drug Interactions
SSRIs
Increased risk of GI bleeding.
Digoxin
Increased plasma digoxin levels.
Lithium
Increased plasma lithium levels.
Clopidogrel
Increased risk of bleeding.
Methotrexate
Increased methotrexate toxicity.
ACE Inhibitors/ARBs
Reduced antihypertensive effect and increased risk of renal impairment.
Atazanavir, Nelfinavir
Reduced absorption due to altered gastric pH by Esomeprazole.
Tacrolimus, Cyclosporine
Increased risk of nephrotoxicity.
Other NSAIDs or Salicylates
Increased risk of gastrointestinal adverse effects.
Diuretics (e.g., Furosemide)
Reduced diuretic and antihypertensive effects.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, lethargy, nausea, vomiting, epigastric pain, GI bleeding, and convulsions. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered. Monitor vital signs and renal function.
Pregnancy & Lactation
Pregnancy Category C/D. Avoid during the third trimester of pregnancy due to potential for premature closure of the fetal ductus arteriosus. Use with caution in other trimesters if benefits outweigh risks. Lactation: Naproxen is excreted in breast milk. Esomeprazole is also likely excreted. Consult a doctor before use during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to Naproxen, Esomeprazole, or any NSAID/PPI.
- Active gastrointestinal bleeding or peptic ulcer.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Severe renal or hepatic impairment.
- Severe heart failure.
- Third trimester of pregnancy.
Drug Interactions
SSRIs
Increased risk of GI bleeding.
Digoxin
Increased plasma digoxin levels.
Lithium
Increased plasma lithium levels.
Clopidogrel
Increased risk of bleeding.
Methotrexate
Increased methotrexate toxicity.
ACE Inhibitors/ARBs
Reduced antihypertensive effect and increased risk of renal impairment.
Atazanavir, Nelfinavir
Reduced absorption due to altered gastric pH by Esomeprazole.
Tacrolimus, Cyclosporine
Increased risk of nephrotoxicity.
Other NSAIDs or Salicylates
Increased risk of gastrointestinal adverse effects.
Diuretics (e.g., Furosemide)
Reduced diuretic and antihypertensive effects.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, lethargy, nausea, vomiting, epigastric pain, GI bleeding, and convulsions. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered. Monitor vital signs and renal function.
Pregnancy & Lactation
Pregnancy Category C/D. Avoid during the third trimester of pregnancy due to potential for premature closure of the fetal ductus arteriosus. Use with caution in other trimesters if benefits outweigh risks. Lactation: Naproxen is excreted in breast milk. Esomeprazole is also likely excreted. Consult a doctor before use during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Expired for generic versions
WHO Essential Medicine
YesClinical Trials
Clinical trials have demonstrated the efficacy of Naproxen in treating pain and inflammation, and Esomeprazole in reducing gastric acid and preventing NSAID-induced ulcers. Combined formulation trials confirmed improved gastrointestinal safety compared to Naproxen alone.
Lab Monitoring
- Complete Blood Count (CBC) periodically
- Renal function tests (BUN, creatinine) periodically
- Liver function tests (ALT, AST) periodically
- Stool occult blood tests (especially in long-term use)
Doctor Notes
- Assess patient's cardiovascular and gastrointestinal risk factors before prescribing.
- Monitor renal function, liver enzymes, and CBC periodically in patients on long-term therapy.
- Advise patients about warning signs of GI bleeding or cardiovascular events.
- Consider lowest effective dose for shortest duration possible.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Swallow the tablet whole; do not crush, chew, or split.
- Report any unusual bleeding, persistent stomach pain, black stools, or severe side effects to your doctor immediately.
- Avoid concurrent use of other NSAIDs without consulting your doctor.
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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, drowsiness, or visual disturbances. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption as it may increase the risk of stomach irritation and bleeding.
- Maintain adequate hydration, especially if experiencing diarrhea or vomiting.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
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