Generic
Naproxen + Esomeprazole
1 brands available in the market
At a glance
Naproxen + Esomeprazole is a combination tablet containing Naproxen, a Non-Steroidal Anti-inflammatory Drug (NSAID), and Esomeprazole, a Proton Pump Inhibitor (PPI). It is primarily used to relieve pain, inflammation, and joint stiffness associated with Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis while reducing the risk of NSAID-associated gastric ulcers. The tablet should generally be taken at least 30 minutes before meals. It is a prescription medicine and should only be used under the supervision of a registered healthcare professional. The medicine is contraindicated during the third trimester of pregnancy and is generally not recommended during breastfeeding. Store below 30°C in a dry place away from light and moisture.
Description
Naproxen + Esomeprazole is a fixed-dose combination medicine designed to provide effective pain and inflammation relief while helping protect the stomach from NSAID-related damage. Naproxen reduces pain and inflammation, whereas Esomeprazole decreases stomach acid production, lowering the risk of gastric ulcers and other gastrointestinal complications associated with long-term NSAID therapy. This combination is particularly beneficial for patients requiring prolonged anti-inflammatory treatment who are at increased risk of gastrointestinal adverse effects.
Indications
This medicine is indicated for: Relief of signs and symptoms of Osteoarthritis. Management of Rheumatoid Arthritis. Treatment of Ankylosing Spondylitis. Reducing the risk of NSAID-associated gastric ulcers. Providing gastric protection in patients requiring long-term NSAID therapy.
Therapeutic class
This medicine belongs to the Non-steroidal Anti-inflammatory Drug (NSAID) and Anti-ulcer combination therapy class. It is commonly prescribed for Osteoarthritis, Rheumatoid Arthritis, and other inflammatory joint disorders.
Pharmacological class
Naproxen is classified as a Propionic Acid Derivative NSAID, while Esomeprazole belongs to the Proton Pump Inhibitor (PPI) class. Together, they provide effective pain relief and gastric protection by reducing inflammation and suppressing stomach acid secretion.
Pharmacology
This tablet is specially formulated so that Esomeprazole is released first in the stomach to suppress gastric acid secretion. The enteric-coated Naproxen core then dissolves in the small intestine, providing anti-inflammatory and analgesic effects while minimizing gastric irritation. This formulation helps reduce the gastrointestinal risks commonly associated with long-term NSAID therapy.
Mechanism of action
Naproxen works by inhibiting Cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis responsible for pain, inflammation, and fever. Esomeprazole inhibits the gastric proton pump (H⁺/K⁺-ATPase) in parietal cells, suppressing gastric acid secretion and lowering the risk of gastric ulcers. Together, these two components provide effective pain relief while protecting the stomach from acid-related injury.
Dosage
The dosage of Naproxen + Esomeprazole Tablet should be individualized according to the patient's age, clinical condition, disease severity, and treatment response. The lowest effective dose should be used for the shortest duration necessary. Adults: One tablet of either 375 mg Naproxen/20 mg Esomeprazole or 500 mg Naproxen/20 mg Esomeprazole twice daily for Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis. Adolescents (12 years and older): Body weight over 50 kg: 375/20 mg or 500/20 mg twice daily. Body weight 38–50 kg: 375/20 mg twice daily. Do not change the prescribed dose without consulting your physician.
Administration
Swallow the tablet whole with water. Do not split, chew, crush, or dissolve it. For optimal effectiveness, take the medicine at least 30 minutes before meals. Taking it at the same time every day helps maintain consistent therapeutic effects.
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for the missed one.
Side effects
Most patients tolerate this medicine well, but some side effects may occur. Common Side Effects Nausea Vomiting Abdominal pain Indigestion Heartburn Diarrhea Constipation Flatulence Headache Dizziness Serious Side Effects Gastric ulcer Gastrointestinal bleeding Black stools Vomiting blood Hypertension Fluid retention Kidney impairment Severe allergic reactions Increased risk of heart attack or stroke Seek immediate medical attention if any serious symptoms develop.
Precautions & warnings
Inform your healthcare provider about your complete medical history before starting treatment. Use with caution in patients with: History of stomach ulcers Hypertension or cardiovascular disease Kidney or liver impairment Use of anticoagulants Long-term NSAID therapy Elderly age (over 65 years) Regular medical monitoring is recommended during prolonged treatment.
Contraindications
Do not use this medicine if you have: Hypersensitivity to Naproxen, Esomeprazole, or related drugs. History of asthma or allergic reactions after taking aspirin or other NSAIDs. During the peri-operative period of CABG surgery. Any other condition where your physician has advised against its use.
Drug interactions
This medicine may interact with: Warfarin ACE inhibitors Beta-blockers Diuretics Ketoconazole Digoxin Iron supplements Aspirin Other NSAIDs Corticosteroids SSRIs These combinations may increase the risk of bleeding or other adverse effects.
Food interactions
Taking the tablet with a high-fat meal does not significantly affect the overall absorption of Naproxen, but it may delay the onset of action and slightly reduce the peak plasma concentration. Therefore, the tablet should be taken at least 30 minutes before meals for optimal effectiveness.
Use in pregnancy
Naproxen + Esomeprazole Tablet should be used during pregnancy only if clearly recommended by a physician. In women who are planning to become pregnant or are in the first or second trimester, the medicine should be prescribed only when the expected benefit outweighs the potential risk to the fetus. This medicine is contraindicated during the third trimester of pregnancy, as it may adversely affect fetal development and interfere with normal labor and delivery. Pregnant women should never use this medicine without medical supervision.
Use in lactation
Naproxen is excreted into breast milk in small amounts. It is not known whether Esomeprazole passes into human breast milk. Therefore, Naproxen + Esomeprazole Tablet is generally not recommended during breastfeeding unless the physician determines that the benefits outweigh the potential risks to the infant.
Pediatric use
The safety and effectiveness of this medicine have not been adequately established in children under 12 years of age. Therefore, it should not be used in younger children unless specifically prescribed. For adolescents aged 12 years and older with Juvenile Idiopathic Arthritis, the dosage is determined according to body weight and should always follow the physician's instructions.
Geriatric use
Older adults are at a higher risk of NSAID-related adverse effects, including gastrointestinal bleeding, ulceration, kidney impairment, and cardiovascular complications. The lowest effective dose should be used, and regular medical monitoring is recommended. Dose adjustment may be required depending on the patient's overall health and kidney function.
Renal / hepatic impairment
Renal Impairment: Naproxen-containing products are generally not recommended in patients with moderate to severe renal impairment (creatinine clearance below 30 mL/min). Hepatic Impairment: Patients with mild to moderate liver disease should be monitored carefully, and dose reduction may be considered. The medicine is generally not recommended in patients with severe hepatic impairment.
Overdose effects
An overdose may cause drowsiness, dizziness, severe abdominal pain, nausea, vomiting, gastrointestinal bleeding, breathing difficulty, kidney dysfunction, confusion, or even coma in severe cases. If an overdose is suspected, seek immediate medical attention. There is no specific antidote for Naproxen + Esomeprazole overdose, and treatment is mainly supportive and symptomatic.
Storage conditions
Store below 30°C. Protect from light and moisture. Keep the medicine in its original packaging. Keep out of the reach of children. Do not use the medicine after the expiry date.
Chemical structure
Naproxen Molecular Formula: C₁₄H₁₄O₃ Drug Class: Propionic Acid Derivative NSAID Esomeprazole (Magnesium) Molecular Formula: C₁₇H₁₉N₃O₃S Drug Class: Proton Pump Inhibitor (PPI) Together, these two ingredients provide effective relief from pain and inflammation while helping protect the stomach from excessive acid-related damage.