MedexInfo: Naproxen Sodium + Esomeprazole Magnesium

Generic Name: Naproxen Sodium + Esomeprazole Magnesium

Therapeutic Class: NSAID with Proton Pump Inhibitor (PPI)

Indications

This combination is indicated for patients at risk of developing NSAID-associated gastric ulcers who require treatment for:

Osteoarthritis (OA): Relief of joint pain and stiffness.
Rheumatoid Arthritis (RA): Management of chronic inflammation and swelling.
Ankylosing Spondylitis (AS): Long-term management of spinal arthritis symptoms.
Juvenile Idiopathic Arthritis (JIA): In adolescents 12 years and older (weight >38 kg).
Gastric Protection: Reducing the risk of gastric ulcers in chronic NSAID users.

Presentation & Strengths

Available as sequential-delivery delayed-release tablets:

Tablet 375: Naproxen 375 mg + Esomeprazole 20 mg.
Tablet 500: Naproxen 500 mg + Esomeprazole 20 mg.

Description

This formulation consists of an **immediate-release Esomeprazole Magnesium layer** surrounding an **enteric-coated Naproxen core**. Upon ingestion, Esomeprazole is released first to raise the gastric pH and protect the stomach lining before the Naproxen core dissolves in the small intestine. This "sequential delivery" minimizes direct acid-related damage to the gastric mucosa while maintaining the systemic anti-inflammatory efficacy of Naproxen.

Dosage & Administration

To be taken at least **30 minutes before a meal**.

Adults (OA, RA, AS): One tablet (375/20 or 500/20) twice daily.
Adolescents (JIA): 375/20 mg twice daily for weight 38–50 kg; 500/20 mg twice daily for weight >50 kg.
Note: Tablets must be swallowed whole. Do not crush, chew, or split, as this destroys the sequential-release mechanism.
Elderly: Use with caution; monitor for renal or cardiovascular complications.

Side Effects

Common side effects may include:

Gastrointestinal: Diarrhea, dyspepsia, nausea, and flatulence.
CNS: Dizziness, headache, and drowsiness.
PPI-Related: Long-term use may lead to low magnesium or Vitamin B12 deficiency.
Serious: Increased risk of CV events (MI, stroke), renal impairment, and severe skin reactions.

Pregnancy & Lactation

Pregnancy: Avoid in the third trimester (Risk of premature closure of ductus arteriosus). Use during earlier stages only if essential.
Lactation: Naproxen is excreted in breast milk. Not recommended for nursing mothers.

Precautions & Interactions

Contraindications: Severe renal impairment (CrCl <30 mL/min), CABG surgery peri-operative pain, and aspirin-sensitive asthma.
Interactions: