Napro-Aâ„¢ Plus 375: Each tablet contains delayed release Naproxen BP 375 mg and immediate release Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 20 mg.
Napro-Aâ„¢ Plus 500: Each tablet contains delayed release Naproxen BP 500 mg and immediate release Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 20 mg.
Napro-Aâ„¢ Plus (Naproxen & Esomeprazole) is a combination of an immediate release Esomeprazole Magnesium layer on an enteric-coated (EC) Naproxen core. As a result, Esomeprazole is released first in the stomach, prior to the dissolution of Naproxen in the small intestine. The enteric coating prevents Naproxen release at $P^H$ levels below 5 providing protection against possible local gastric toxicity.
Naproxen is a non-steroidal anti-inflammatory drug (NSAID) used as an analgesic and antipyretic. Naproxen is a propionic acid derivative and it inhibits the synthesis of prostaglandins, primarily by inhibiting the enzyme cyclo-oxygenase. Esomeprazole is a proton pump inhibitor and the S-isomer of Omeprazole. It suppresses gastric acid secretion by inhibiting the proton pump in the gastric parietal cell thus reducing gastric acidity.
Napro-Aâ„¢ Plus (Naproxen & Esomeprazole) is indicated for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of developing gastric ulcers in patients at risk for developing NSAID-associated gastric ulcers.
Route of administration:The usual recommended dose for Napro-Aâ„¢ Plus:
Recommended Strength.
Medical Condition.
Recommended (and Maximum) Dose per day.
Napro-Aâ„¢ Plus 375.
Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis and Dysmenorrhoea.
Twice daily.
Napro-Aâ„¢ Plus 500.
The tablet must be swallowed whole with water but not be split, chewed, crushed or dissolved. Napro-Aâ„¢ Plus should be taken at least 30 minutes before meal.
Geriatric use (>65 years):
Patients older than 65 years and frail or debilitated patients are more susceptible to a variety of adverse reactions from NSAIDs. The incidence of these adverse reactions increases with dose and duration of treatment. For such patients, to minimize the potential risk for an adverse event, the lowest effective dose should be used for the shortest possible duration.
Patients with renal impairment:
In patients with mild to moderate renal impairment Naproxen/Esomeprazole should be used cautiously and renal function should be monitored closely. This preparation is contraindicated in patients with severe renal impairment or deteriorating renal disease.
Patients with hepatic impairment:
In patients with mild to moderate hepatic impairment Naproxen/Esomeprazole should be used cautiously and hepatic function should be monitored closely. This preparation is contraindicated in patients with severe hepatic impairment.
Children (<18 years):
Naproxen-Esomeprazole is not recommended for use in children under 18 years of age.
Or as directed by the physician.
Caution should be exercised in prescribing NSAIDs such as Naproxen to any patient with ischemic heart disease, cerebrovascular disease and/or congestive heart failure.