Novaxen Plus
Generic Name
Naproxen 500 mg and Esomeprazole 20 mg
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| novaxen plus 500 mg tablet | ৳ 10.00 | N/A |
Description
Overview of the medicine
Novaxen 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, swelling, and stiffness caused by conditions like arthritis, while Esomeprazole helps protect the stomach from the potential side effects of Naproxen.
Uses & Indications
Dosage
Adults
Usually one tablet twice daily or as directed by the physician. Doses should be taken with food.
Elderly
Lower doses may be required, closely monitor for adverse effects, especially renal and gastrointestinal.
Renal_impairment
Use with caution; dose adjustment may be necessary. Not recommended in severe renal impairment.
How to Take
Oral. Swallow the tablet whole with water. Do not crush, chew, or break. Take with food or milk to minimize gastrointestinal upset.
Mechanism of Action
Naproxen inhibits cyclooxygenase (COX-1 and COX-2) enzymes, leading to reduced prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, and antipyretic effects. Esomeprazole is a proton pump inhibitor that reduces gastric acid secretion by irreversibly binding to and inhibiting the H+/K+-ATPase pump in gastric parietal cells.
Pharmacokinetics
Onset
Naproxen: Analgesic effect within 1 hour. Esomeprazole: Acid suppression within 1 hour.
Excretion
Naproxen: Primarily excreted in the urine (approx. 95%). Esomeprazole: Primarily excreted in the urine (approx. 80%) and feces (approx. 20%).
Half life
Naproxen: Approximately 12-17 hours. Esomeprazole: Approximately 1.5 hours.
Absorption
Naproxen: Rapidly and completely absorbed from the GI tract, peak plasma concentrations in 2-4 hours. Esomeprazole: Rapidly absorbed, peak plasma concentrations in 1-2 hours.
Metabolism
Naproxen: Extensively metabolized in the liver by demethylation and glucuronidation. Esomeprazole: Extensively metabolized in the liver via CYP enzyme system (mainly CYP2C19 and CYP3A4).
Side Effects
Contraindications
- Hypersensitivity to Naproxen, Esomeprazole, or any components of the formulation.
- A history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Active gastrointestinal bleeding or peptic ulcer.
- Severe renal or hepatic impairment.
- Severe heart failure.
- Last trimester of pregnancy.
- Concomitant use with Atazanavir, Nelfinavir.
Drug Interactions
SSRIs
Increased risk of gastrointestinal bleeding.
Digoxin
Increased digoxin plasma levels.
Lithium
Increased lithium plasma concentrations, leading to toxicity.
Clopidogrel
Reduced antiplatelet effect of clopidogrel due to CYP2C19 inhibition by Esomeprazole.
Methotrexate
Increased methotrexate toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
ACE inhibitors, ARBs
Reduced antihypertensive effects; increased risk of renal impairment.
Warfarin, other anticoagulants
Increased risk of bleeding.
Diuretics (e.g., Furosemide, Thiazides)
Reduced diuretic and antihypertensive effects; increased risk of renal impairment.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Naproxen overdose include lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding. Symptoms of Esomeprazole overdose are generally mild and transient. Management involves symptomatic and supportive care. Gastric emptying and charcoal administration may be considered for Naproxen overdose.
Pregnancy & Lactation
Naproxen: Category C (first and second trimesters), Category D (third trimester - contraindicated). Esomeprazole: Category B. Use only if potential benefit outweighs risk, avoid in late pregnancy. Naproxen and Esomeprazole pass into breast milk; caution advised, consider discontinuing nursing or the drug.
Side Effects
Contraindications
- Hypersensitivity to Naproxen, Esomeprazole, or any components of the formulation.
- A history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Active gastrointestinal bleeding or peptic ulcer.
- Severe renal or hepatic impairment.
- Severe heart failure.
- Last trimester of pregnancy.
- Concomitant use with Atazanavir, Nelfinavir.
Drug Interactions
SSRIs
Increased risk of gastrointestinal bleeding.
Digoxin
Increased digoxin plasma levels.
Lithium
Increased lithium plasma concentrations, leading to toxicity.
Clopidogrel
Reduced antiplatelet effect of clopidogrel due to CYP2C19 inhibition by Esomeprazole.
Methotrexate
Increased methotrexate toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
ACE inhibitors, ARBs
Reduced antihypertensive effects; increased risk of renal impairment.
Warfarin, other anticoagulants
Increased risk of bleeding.
Diuretics (e.g., Furosemide, Thiazides)
Reduced diuretic and antihypertensive effects; increased risk of renal impairment.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Naproxen overdose include lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding. Symptoms of Esomeprazole overdose are generally mild and transient. Management involves symptomatic and supportive care. Gastric emptying and charcoal administration may be considered for Naproxen overdose.
Pregnancy & Lactation
Naproxen: Category C (first and second trimesters), Category D (third trimester - contraindicated). Esomeprazole: Category B. Use only if potential benefit outweighs risk, avoid in late pregnancy. Naproxen and Esomeprazole pass into breast milk; caution advised, consider discontinuing nursing or the drug.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by DGDA/FDA
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials support the efficacy and safety of both Naproxen and Esomeprazole in their respective indications, as well as the combination for gastrointestinal protection.
Lab Monitoring
- Complete Blood Count (CBC) - for signs of anemia or bleeding.
- Liver function tests (LFTs) - periodically, especially with long-term use.
- Renal function tests (Creatinine, BUN) - especially in elderly or those with renal impairment.
- Blood pressure monitoring.
Doctor Notes
- Regularly assess patient for cardiovascular and gastrointestinal risks, especially in elderly or those with pre-existing conditions.
- Consider lowest effective dose for shortest duration possible.
- Monitor renal function, liver enzymes, and blood pressure during long-term therapy.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not exceed the recommended dose.
- Report any signs of unusual bleeding, severe stomach pain, or black/tarry stools immediately.
- Avoid alcohol during treatment, as it may increase the risk of stomach irritation.
- Inform your doctor about all other medications, herbal products, and supplements 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 resume your usual dosing schedule. Do not double the dose.
Driving Precautions
May cause dizziness or drowsiness in some individuals. Avoid driving or operating heavy machinery until you know how the medicine affects you.
Lifestyle Advice
- Maintain a healthy diet to support overall well-being and digestive health.
- Engage in light to moderate exercise as advised by your doctor for joint health and mobility.
- Avoid smoking, as it can worsen gastrointestinal issues and overall health.
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