PRODUCT DETAILS
Naprosyn-Plus® 375/20 Tablet: Each tablet contains delayed release Naproxen USP 375 mg & immediate release Esomeprazole Magnesium USP equivalent to Esomeprazole 20 mg. Naprosyn-Plus® 500/20 Tablet: Each tablet contains delayed release Naproxen USP 500 mg & immediate release Esomeprazole Magnesium USP equivalent to Esomeprazole 20 mg.

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.

  Dosage and Administration

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.

  Side Effects

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.

  Contraindications

• Known hypersensitivity to any component of Naprosyn-Plus® 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

  Use in Pregnancy and Lactation

In pregnancy:
Pregnancy category C. In late pregnancy, it should be avoided because it may cause premature closure of the ductus arteriosus.

In lactation:
Naprosyn-Plus® should not be used in nursing mothers due to the Naproxen component

  Drug Interaction

• Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers
• Concomitant use of Naprosyn-Plus® and warfarin may result in increased risk of bleeding complication.
• Esomeprazole inhibits gastric acid secretion & may interfere with absorption of drugs where gastric pH is an important determinant of bioavailability (eg. Ketoconazole, iron salts and digoxin).

  Over Dosage

There is no clinical data on overdosage with Naprosyn-Plus®.
Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alteration 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.

  Storage

Store in a cool & dry place, protect from light.
Keep out of reach of children.

  Commercial Pack

Naprosyn-Plus® 375/20 Tablet : Each box contains 6X8’s tablets in Alu-Alu blister strip.
Naprosyn-Plus® 500/20 Tablet : Each box contains 3X8’s tablets in Alu-Alu blister strip.

  • Naprosyn-Plus®