Naprox-Plus
Generic Name
Naproxen and Esomeprazole Magnesium delayed-release tablet
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| naprox plus 375 mg tablet | ৳ 13.00 | ৳ 78.00 |
Description
Overview of the medicine
Naprox-Plus is a combination medicine containing Naproxen, a nonsteroidal anti-inflammatory drug (NSAID), and Esomeprazole, a proton pump inhibitor (PPI). It is used to relieve pain and inflammation while protecting the stomach from NSAID-induced ulcers.
Uses & Indications
Dosage
Adults
One tablet (375 mg naproxen/20 mg esomeprazole magnesium) twice daily, taken at least 30 minutes before meals.
Elderly
Use with caution. Consider lower doses, especially with impaired renal or hepatic function. Monitor for adverse effects.
Renal_impairment
Avoid in patients with severe renal impairment. In moderate impairment, reduce dose and monitor renal function closely.
How to Take
Take orally with a glass of water. Swallow the tablet whole; do not crush, chew, or split it. Take at least 30 minutes before a meal.
Mechanism of Action
Naproxen inhibits prostaglandin synthesis by blocking cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing pain and inflammation. Esomeprazole suppresses gastric acid secretion by inhibiting the H+/K+-ATPase (proton pump) in gastric parietal cells, providing gastroprotection.
Pharmacokinetics
Onset
Naproxen: Analgesic effects within 1 hour. Esomeprazole: Acid suppression within 1 hour.
Excretion
Naproxen: Primarily (95%) in urine, as naproxen, 6-O-desmethylnaproxen, or their conjugates. Esomeprazole: Approximately 80% via urine and 20% via feces.
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 peak plasma levels occurring at 1-2 hours after dose.
Metabolism
Naproxen: Primarily hepatic via CYP enzymes (demethylation) to 6-O-desmethylnaproxen. Esomeprazole: Extensively metabolized in the liver by CYP2C19 and CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to naproxen, esomeprazole, substituted benzimidazoles, or any component of the formulation
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- In the setting of coronary artery bypass graft (CABG) surgery
- Third trimester of pregnancy
- Concomitant nelfinavir therapy
Drug Interactions
Digoxin
Increased serum digoxin levels.
Lithium
Increased plasma lithium levels and risk of toxicity.
Tacrolimus
Increased tacrolimus levels and risk of toxicity.
Methotrexate
Increased methotrexate toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Diuretics (e.g., Furosemide, Thiazides)
Reduced natriuretic effect of diuretics.
Selective Serotonin Reuptake Inhibitors (SSRIs)
Increased risk of gastrointestinal bleeding.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of bleeding. Clopidogrel's antiplatelet effect may be decreased.
Drugs dependent on gastric pH for absorption (e.g., Ketoconazole, Atazanavir, Nelfinavir)
Esomeprazole can alter the absorption of these drugs.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, heartburn, nausea, vomiting, epigastric pain, and in rare cases, gastrointestinal bleeding. Management involves symptomatic and supportive treatment. Gastric lavage and activated charcoal may be considered. Hemodialysis is not effective in removing naproxen.
Pregnancy & Lactation
Pregnancy: Avoid in the third trimester due to potential premature closure of the fetal ductus arteriosus (NSAID component). Use with caution in the first and second trimesters only if the potential benefit justifies the potential risk to the fetus. Lactation: It is unknown whether naproxen or esomeprazole are excreted in human milk. Exercise caution when administering to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to naproxen, esomeprazole, substituted benzimidazoles, or any component of the formulation
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- In the setting of coronary artery bypass graft (CABG) surgery
- Third trimester of pregnancy
- Concomitant nelfinavir therapy
Drug Interactions
Digoxin
Increased serum digoxin levels.
Lithium
Increased plasma lithium levels and risk of toxicity.
Tacrolimus
Increased tacrolimus levels and risk of toxicity.
Methotrexate
Increased methotrexate toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Diuretics (e.g., Furosemide, Thiazides)
Reduced natriuretic effect of diuretics.
Selective Serotonin Reuptake Inhibitors (SSRIs)
Increased risk of gastrointestinal bleeding.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of bleeding. Clopidogrel's antiplatelet effect may be decreased.
Drugs dependent on gastric pH for absorption (e.g., Ketoconazole, Atazanavir, Nelfinavir)
Esomeprazole can alter the absorption of these drugs.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, heartburn, nausea, vomiting, epigastric pain, and in rare cases, gastrointestinal bleeding. Management involves symptomatic and supportive treatment. Gastric lavage and activated charcoal may be considered. Hemodialysis is not effective in removing naproxen.
Pregnancy & Lactation
Pregnancy: Avoid in the third trimester due to potential premature closure of the fetal ductus arteriosus (NSAID component). Use with caution in the first and second trimesters only if the potential benefit justifies the potential risk to the fetus. Lactation: It is unknown whether naproxen or esomeprazole are excreted in human milk. Exercise caution when administering to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date.
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Patent expired, generics available
Clinical Trials
Clinical trials have demonstrated the efficacy and safety of Naproxen and Esomeprazole combination in reducing pain and inflammation associated with various musculoskeletal conditions, while significantly lowering the incidence of NSAID-induced gastrointestinal ulcers compared to Naproxen alone.
Lab Monitoring
- Complete Blood Count (CBC) (for anemia or bleeding)
- Liver function tests (LFTs) (for hepatic effects)
- Kidney function tests (KFTs) (for renal impairment)
- Stool for occult blood (for gastrointestinal bleeding)
Doctor Notes
- Prescribe the lowest effective dose for the shortest duration consistent with patient treatment goals.
- Monitor for signs and symptoms of cardiovascular events, gastrointestinal bleeding, and renal dysfunction, especially in elderly patients or those with pre-existing conditions.
- Educate patients on proper administration (before meals, swallow whole) and potential adverse effects.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking the medicine abruptly without consulting your doctor.
- Report any unusual bleeding, severe stomach pain, black or tarry stools immediately to your doctor.
- Avoid alcohol consumption while taking this medication as it may increase the risk of stomach bleeding.
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 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. If you experience these effects, avoid driving or operating heavy machinery.
Lifestyle Advice
- Avoid smoking, as it can worsen gastrointestinal irritation and ulcer risk.
- Maintain a healthy diet and stay hydrated.
- Engage in light to moderate exercise if your condition permits.
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