It is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers. Esomeprazole & Naproxen combination is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxencontaining products. Controlled studies do not extend beyond 6 months.
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
is a NSAID with analgesic and antipyretic properties. The mechanism of action of Naproxen is like that of other NSAIDs, related to prostaglandin synthetase inhibition.
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase in the gastric parietal cell. By acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis: The dosage is one tablet twice daily of 375 mg naproxen and 20 mg of esomeprazole or 500 mg naproxen and 20 mg of esomeprazole. The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet. This is to be taken at least 30 minutes before meals.
Several studies conducted with naproxen and esomeprazole combination have shown no interaction between the two components.
Contraindicated in known hypersensitivity to any component of Progesic or substituted benzimidazoles, history of asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs, use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery, late pregnancy
The adverse effects reported with this combination may include gastrointestinal disorders like dyspepsia, diarrhea, nausea, flatulence, abdominal pain etc.
Naproxen & Esomeprazole both are pregnancy category B drug. This combination should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Naproxen & Esomeprazole are likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Patients with known CV disease/risk factors may be at greater risk. Progesic should be used with caution in patients with fluid retention or heart failure.
Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.
Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.
: Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Use caution when high doses are required and some adjustment of dosage may be required in elderly patients.
Pediatric Patients: The safety and efficacy of naproxen & esomeprazole in children younger than 18 years have not been established. This is therefore not recommended for use in children.
Patients With Moderate to Severe Renal Impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance < 30 mL/min).
Hepatic Insufficiency: Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the naproxen. This combination is not recommended in patients with severe hepatic impairment because esomeprazole doses should not exceed 20 mg daily in these patients.