Composition:
Napxon® 500 Tablet: Each delayed release tablet contains Naproxen BP 500 mg (enteric coated, delayed release core) and 20 mg of Esomeprazole as Esomeprazole magnesium trihydrate USP (immediate release coating).
Napxon® 375 Tablet: Each delayed release tablet contains Naproxen BP 375 mg (enteric coated, delayed release core) and 20 mg of Esomeprazole as Esomeprazole magnesium trihydrate USP (immediate release coating).
Indications:
Napxon® is indicated for the relief of sign 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.
Dosage & Administration:
Rheumatoid arthritis, Osteoarthritis and Ankylosing spondylitis: The dosage is one tablet twice daily of Napxon® 500 (500 mg Naproxen and 20 mg of Esomeprazole) or Napxon® 375 (375 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.
Napxon® is to be taken at least 30 minutes before meals.
Geriatric patients: Use caution when high doses are required and 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 and consider a possible dose reduction based on the amount of Naproxen in Napxon®. Napxon® should be avoided in patients with severe hepatic impairment.
Side effects:
The most common side effects persist or become bothersome when using Napxon® delayed release Tablets: Constipation, diarrhea, dizziness, drowsiness, gas, headache, heartburn, nausea, stomach bloating or upset.
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