Naprosyn-Plus® Consists of an immediate release Esomeprazole Magnesium layer & an enteric coated Naproxen core. As a result Esomeprazole is released first into the stomach, prior to the dissolution of Naproxen in the small intestine. Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/k+ –ATP ase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
Carefully consider the potential benefits & risks of Naprosyn-Plus® & other treatment options before deciding to use Naprosyn-Plus®. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. If a dose of Esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered. Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis Do not split, chew, crush or dissolve the tablet. Naprosyn plus is to be taken at least 30 minutes before meals. Elderly patients: 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 & some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly use the lowest effective dose. 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 & consider a possible dose reduction based on the Naproxen component of Naprosyn-Plus®. Naprosyn-Plus® is not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients. Children: Dosage in children less than 18 years has not been established.
In general, Naprosyn-Plus® is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.
Pregnancy & Lactation
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.