Novaxen Plus
Generic Name
Naproxen 375 mg + Esomeprazole 20 mg Tablet
Manufacturer
Renata Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| novaxen plus 375 mg tablet | ৳ 8.00 | N/A |
Description
Overview of the medicine
Novaxen Plus 375 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, inflammation, and stiffness caused by conditions like arthritis, while also reducing the risk of stomach ulcers and other gastrointestinal side effects often associated with NSAIDs.
Uses & Indications
Dosage
Adults
One tablet (Naproxen 375 mg + Esomeprazole 20 mg) twice daily, preferably at least 30 minutes before meals.
Elderly
Use with caution. Dosage may need to be adjusted based on renal function. Generally, the lowest effective dose for the shortest duration.
Renal_impairment
Use with caution in mild to moderate renal impairment. Avoid in severe renal impairment. Dose adjustment may be necessary.
How to Take
Take the tablet whole with water. Do not crush, chew, or split the tablet, as this may affect the delayed-release properties of Esomeprazole and the enteric coating of Naproxen. It is generally recommended to take it at least 30 minutes before a meal.
Mechanism of Action
Naproxen works by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, which are involved in the synthesis of prostaglandins, chemicals that cause pain, fever, and inflammation. Esomeprazole works by irreversibly blocking the H+/K+-ATPase pump (proton pump) in the gastric parietal cells, thereby reducing gastric acid secretion and protecting the stomach lining.
Pharmacokinetics
Onset
Pain relief for Naproxen generally occurs within 1 hour. Acid suppression for Esomeprazole starts within 1 hour.
Excretion
Naproxen and its metabolites are primarily excreted in the urine (approximately 95%). Esomeprazole metabolites are primarily excreted in the urine (approximately 80%) and feces (approximately 20%).
Half life
Naproxen has a plasma elimination half-life of 12-17 hours. Esomeprazole has a plasma elimination half-life of approximately 1-1.5 hours.
Absorption
Naproxen is rapidly and completely absorbed from the GI tract. Esomeprazole is rapidly absorbed after oral administration, with peak plasma levels occurring at 1-2 hours. Food may delay but not significantly affect the absorption of Naproxen. Esomeprazole absorption is reduced with food.
Metabolism
Naproxen is extensively metabolized in the liver by CYP enzymes. Esomeprazole is extensively metabolized in the liver by the cytochrome P450 enzyme system, primarily by CYP2C19 and CYP3A4.
Side Effects
Contraindications
- Known 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.
- Active gastrointestinal bleeding or ulceration.
- Severe renal or hepatic impairment.
- Severe heart failure.
- Third trimester of pregnancy due to risk of premature closure of the fetal ductus arteriosus.
Drug Interactions
Digoxin
Increased plasma digoxin levels.
Lithium
Increased plasma lithium levels.
Clopidogrel
Esomeprazole may reduce the antiplatelet effect of clopidogrel.
Methotrexate
Increased methotrexate toxicity.
Other NSAIDs or Aspirin
Increased risk of gastrointestinal adverse effects.
Diuretics and ACE inhibitors
Reduced effectiveness of these medications; increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Phenytoin, Diazepam, Citalopram
Esomeprazole may increase plasma concentrations of drugs metabolized by CYP2C19.
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 temporary gastrointestinal disturbances. Management is symptomatic and supportive, including gastric emptying or activated charcoal, and monitoring of vital signs and laboratory parameters.
Pregnancy & Lactation
Pregnancy: Not recommended during pregnancy, especially in the third trimester due to the risk of premature closure of the fetal ductus arteriosus. Category C/D. Lactation: Both Naproxen and Esomeprazole are excreted in human 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
- Known 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.
- Active gastrointestinal bleeding or ulceration.
- Severe renal or hepatic impairment.
- Severe heart failure.
- Third trimester of pregnancy due to risk of premature closure of the fetal ductus arteriosus.
Drug Interactions
Digoxin
Increased plasma digoxin levels.
Lithium
Increased plasma lithium levels.
Clopidogrel
Esomeprazole may reduce the antiplatelet effect of clopidogrel.
Methotrexate
Increased methotrexate toxicity.
Other NSAIDs or Aspirin
Increased risk of gastrointestinal adverse effects.
Diuretics and ACE inhibitors
Reduced effectiveness of these medications; increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Phenytoin, Diazepam, Citalopram
Esomeprazole may increase plasma concentrations of drugs metabolized by CYP2C19.
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 temporary gastrointestinal disturbances. Management is symptomatic and supportive, including gastric emptying or activated charcoal, and monitoring of vital signs and laboratory parameters.
Pregnancy & Lactation
Pregnancy: Not recommended during pregnancy, especially in the third trimester due to the risk of premature closure of the fetal ductus arteriosus. Category C/D. Lactation: Both Naproxen and Esomeprazole are excreted in human 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
24 months
Availability
Pharmacies nationwide in Bangladesh
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Generic versions available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of both Naproxen and Esomeprazole individually, as well as their fixed-dose combination, in reducing pain and inflammation while mitigating GI risks.
Lab Monitoring
- Complete Blood Count (CBC) periodically, especially with long-term use.
- Renal function tests (e.g., serum creatinine, BUN) periodically.
- Liver function tests (e.g., ALT, AST) periodically.
- Occult blood tests for gastrointestinal bleeding.
Doctor Notes
- Prescribe the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
- Monitor patients for signs and symptoms of cardiovascular events and gastrointestinal adverse effects.
- Assess renal and hepatic function periodically, especially in elderly or at-risk patients.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Do not crush, chew, or break the tablet.
- Report any unusual bleeding, persistent stomach pain, or black/tarry stools to your doctor immediately.
- Avoid alcohol while taking this medicine.
- Do not take other NSAIDs or aspirin 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 resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine may cause dizziness or drowsiness. If you experience these effects, avoid driving or operating heavy machinery.
Lifestyle Advice
- Maintain a balanced diet.
- Avoid smoking and excessive alcohol consumption, which can worsen GI side effects.
- Engage in regular, moderate exercise (as advised by your doctor).
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