Novaxen Plus
Generic Name
Naproxen + Esomeprazole
Manufacturer
General Pharmaceuticals Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| novaxen plus 375 mg tablet | ৳ 8.00 | N/A |
| novaxen plus 500 mg tablet | ৳ 10.00 | N/A |
Description
Overview of the medicine
Novaxen Plus 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 while protecting the stomach from potential gastrointestinal side effects caused by Naproxen.
Uses & Indications
Dosage
Adults
One tablet (Naproxen 500 mg / Esomeprazole 20 mg) orally, once or twice daily, or as directed by physician.
Elderly
Consider lower doses or less frequent dosing due to increased risk of side effects and impaired renal function. Use with caution.
Renal_impairment
Use with caution. Dosage reduction may be necessary for severe renal impairment. Contraindicated in severe renal failure.
How to Take
Take the tablet whole with water. Do not crush, chew, or split the tablet. It can be taken with or without food, but taking it with food may reduce gastrointestinal upset.
Mechanism of Action
Naproxen inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis, which is responsible for pain, fever, and inflammation. Esomeprazole inhibits the H+/K+-ATPase (proton pump) in gastric parietal cells, thereby suppressing gastric acid secretion.
Pharmacokinetics
Onset
Naproxen: ~1 hour for analgesia. Esomeprazole: Within 1 hour for acid suppression.
Excretion
Naproxen and its metabolites are primarily excreted via the urine. Esomeprazole metabolites are primarily excreted via urine (about 80%) and feces (about 20%).
Half life
Naproxen: 12-17 hours. Esomeprazole: Approximately 1-1.5 hours.
Absorption
Naproxen is rapidly and completely absorbed from the GI tract. Esomeprazole is rapidly absorbed, with systemic bioavailability of about 64% after a single dose, increasing with repeated dosing.
Metabolism
Naproxen is extensively metabolized in the liver by CYP enzymes. Esomeprazole is extensively metabolized in the liver via CYP2C19 and CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to Naproxen, Esomeprazole, or other NSAIDs.
- Active gastrointestinal bleeding or ulceration.
- Severe renal or hepatic impairment.
- Severe heart failure.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Third trimester of pregnancy.
Drug Interactions
SSRIs
Increased risk of GI bleeding.
Lithium
Increased plasma lithium levels.
Clopidogrel
Reduced antiplatelet effect of clopidogrel (with Esomeprazole).
Methotrexate
Increased methotrexate toxicity.
Other NSAIDs or Aspirin
Increased risk of GI side effects and bleeding.
Diuretics and ACE inhibitors
Reduced antihypertensive effect and increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Diazepam, Phenytoin, Citalopram, Imipramine
Increased plasma levels of these drugs (with Esomeprazole).
Storage
Store in a cool, dry place, away from light and moisture, below 30°C. 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 self-limiting. Management is symptomatic and supportive. Gastric lavage and activated charcoal may be considered within an hour of ingestion.
Pregnancy & Lactation
Pregnancy: Category C in first and second trimesters; Category D in third trimester (Naproxen). Avoid during late pregnancy. Lactation: Naproxen is excreted in breast milk. Esomeprazole is also excreted in human milk. Use with caution, and only if clearly needed after consulting a physician.
Side Effects
Contraindications
- Hypersensitivity to Naproxen, Esomeprazole, or other NSAIDs.
- Active gastrointestinal bleeding or ulceration.
- Severe renal or hepatic impairment.
- Severe heart failure.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Third trimester of pregnancy.
Drug Interactions
SSRIs
Increased risk of GI bleeding.
Lithium
Increased plasma lithium levels.
Clopidogrel
Reduced antiplatelet effect of clopidogrel (with Esomeprazole).
Methotrexate
Increased methotrexate toxicity.
Other NSAIDs or Aspirin
Increased risk of GI side effects and bleeding.
Diuretics and ACE inhibitors
Reduced antihypertensive effect and increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Diazepam, Phenytoin, Citalopram, Imipramine
Increased plasma levels of these drugs (with Esomeprazole).
Storage
Store in a cool, dry place, away from light and moisture, below 30°C. 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 self-limiting. Management is symptomatic and supportive. Gastric lavage and activated charcoal may be considered within an hour of ingestion.
Pregnancy & Lactation
Pregnancy: Category C in first and second trimesters; Category D in third trimester (Naproxen). Avoid during late pregnancy. Lactation: Naproxen is excreted in breast milk. Esomeprazole is also excreted in human milk. Use with caution, and only if clearly needed after consulting a physician.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date. Check package for exact expiry date.
Availability
Available in pharmacies and hospitals in Bangladesh
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Generally expired for individual components
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of Naproxen and Esomeprazole both individually and in combination for the management of pain and prevention of NSAID-induced gastrointestinal ulcers.
Lab Monitoring
- Regular monitoring of renal function (creatinine, BUN) in patients on long-term therapy or with pre-existing renal impairment.
- Liver function tests (ALT, AST) periodically, especially in patients with hepatic impairment.
- Complete blood count (CBC) to monitor for anemia or other hematologic effects.
Doctor Notes
- Consider lowest effective dose for shortest duration possible, especially in elderly patients or those with risk factors.
- Educate patients on symptoms of GI bleeding and cardiovascular events.
- Periodically reassess the need for continued therapy, particularly for long-term use.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not exceed the recommended dose.
- Report any signs of stomach bleeding (e.g., black, tarry stools, vomiting blood) immediately.
- Avoid taking other NSAIDs or aspirin concurrently without medical advice.
- Inform your doctor about all other medications you are taking.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. 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 or drowsiness. Avoid driving or operating machinery if you experience these symptoms.
Lifestyle Advice
- Avoid or limit alcohol consumption as it may increase the risk of stomach bleeding.
- Maintain a healthy diet and stay hydrated.
- Consult your doctor for suitable exercises or physical therapy to 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.