Generic

Naproxen+Esomeprazole

Therapeutic Class

Analgesic, Anti-Inflammatory

Pack Size

Naprosyn-Plus 375 mg / 20 mg tablet: Each box contains 48 tablets (6 X 8’s) in Alu-Alu blister pack.
Naprosyn-Plus 500 mg / 20 mg tablet: Each box contains 40 tablets (5 X 8’s) in Alu-Alu blister pack.

Indications

It is indicated for the relief of signs & symptoms of osteoarthritis, rheumatoid arthritis & ankylosing spondylitis & to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers.

Therapeutic Class

Analgesic, Anti-Inflammatory

Dosage & 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.

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

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.

Pregnancy & 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

Precautions

Patients with known CV disease/risk factors may be at greater risk. Naprosyn-Plus® should be used with caution in patients with fluid retention or heart failure.

Storage Conditions

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