Esomeprazoledosage

Administration Use the lowest naproxen dose for the shortest duration consistent with individual patient treatment goals.. If a total daily dose of less than 40 mg esomeprazole is more appropriate, a different treatment should be considered. Swallow naproxen and Esomeprazole magnesium delayed-release tablets whole with liquid at least 30 minutes before meals. Recommended Dosage Adolescents 12 years of age and older weighing 38 kg to less than 50 kg: One naproxen and esomeprazole magnesium delayed-release tablet twice daily of 375 mg naproxen/20 mg of esomeprazole Adults and adolescents 12 years of age and older greater than 50 kg: One naproxen and esomeprazole magnesium delayed-release tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg of naproxen/20 mg of esomeprazole Renal or Hepatic Impairment Avoid in moderate/severe renal impairment or severe hepatic impairment. Consider dose reduction in mild/moderate hepatic impairment.

2.1 Important

Administration Instructions Use the lowest naproxen dose for the shortest duration consistent with individual patient treatment goals. Carefully consider the potential benefits and risks of naproxen and esomeprazole magnesium delayed-release tablets and other treatment options before deciding to use naproxen and esomeprazole magnesium delayed-release tablets. Naproxen and esomeprazole magnesium delayed-release tablets does not allow for administration of a lower daily dose of esomeprazole magnesium. If a total daily dose of less than 40 mg esomeprazole is more appropriate, a different treatment should be considered. Swallow naproxen and esomeprazole magnesium delayed-release tablets whole with liquid. Do not split, chew, crush or dissolve the tablet. Take naproxen and esomeprazole magnesium delayed-release tablets at least 30 minutes before meals. Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose. Antacids may be used while taking naproxen and esomeprazole magnesium delayed-release tablets.

2.2 Recommended

Dosage The recommended dosage of naproxen and esomeprazole magnesium delayed-release tablets by indication is shown in the table: Indication Patient Population Recommended Dosage Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis Adults One naproxen and esomeprazole magnesium delayed-release tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole Juvenile Idiopathic Arthritis in Adolescent Patients 12 Years of Age and Older and Weighing at Least 38 kg Greater than 50 kg 38 kg to less than 50 kg One naproxen and esomeprazole magnesium delayed-release tablet twice daily of: 375 mg naproxen/20 mg of esomeprazole

2.3 Use in Renal

Impairment or Hepatic Impairment Renal Impairment Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance less than 30 mL/min). Hepatic Impairment Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the naproxen component of naproxen and esomeprazole magnesium delayed-release tablets. Naproxen and esomeprazole magnesium delayed-release tablets should be avoided in patients with severe hepatic impairment.