Esomeprazole and naproxen

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop taking this medicine and call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• the first sign of any skin rash, no matter how mild;

• heart failure--shortness of breath (even with mild exertion), swelling or rapid weight gain;

• kidney problems--little or no urinating, blood in your urine, swelling in your feet or ankles;

• liver problems--nausea, right-sided stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low magnesium--dizziness, irregular heartbeats, feeling jittery, muscle pain or weakness, seizure;

• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• stomach discomfort; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Ankylosing Spondylitis:

One tablet (esomeprazole 20 mg-naproxen 375 mg or esomeprazole 20 mg-naproxen 500 mg) orally twice a day

Comments:
-Not interchangeable with the individual components of naproxen and esomeprazole magnesium.

Uses: For the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing nonsteroidal anti-inflammatory drug (NSAID) associated gastric ulcers

Usual Adult Dose for Osteoarthritis:

One tablet (esomeprazole 20 mg-naproxen 375 mg or esomeprazole 20 mg-naproxen 500 mg) orally twice a day

Comments:
-Not interchangeable with the individual components of naproxen and esomeprazole magnesium.

Uses: For the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing nonsteroidal anti-inflammatory drug (NSAID) associated gastric ulcers

Usual Adult Dose for Rheumatoid Arthritis:

One tablet (esomeprazole 20 mg-naproxen 375 mg or esomeprazole 20 mg-naproxen 500 mg) orally twice a day

Comments:
-Not interchangeable with the individual components of naproxen and esomeprazole magnesium.

Uses: For the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing nonsteroidal anti-inflammatory drug (NSAID) associated gastric ulcers

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

12 years or older:
-At least 38 kg to less than 50 kg: One tablet (esomeprazole 20 mg-naproxen 375 mg) orally twice a day
-Greater than 50 kg: One tablet (esomeprazole 20 mg-naproxen 375 mg or esomeprazole 20 mg-naproxen 500 mg) orally twice a day

Comments:
-Not interchangeable with the individual components of naproxen and esomeprazole magnesium.

Use: For the relief of signs and symptoms of juvenile idiopathic arthritis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers

One tablet (esomeprazole 20 mg-naproxen 375 mg or esomeprazole 20 mg-naproxen 500 mg) orally twice a day

Comments:
-Not interchangeable with the individual components of naproxen and esomeprazole magnesium.

Uses: For the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing nonsteroidal anti-inflammatory drug (NSAID) associated gastric ulcers

One tablet (esomeprazole 20 mg-naproxen 375 mg or esomeprazole 20 mg-naproxen 500 mg) orally twice a day

Comments:
-Not interchangeable with the individual components of naproxen and esomeprazole magnesium.

Uses: For the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing nonsteroidal anti-inflammatory drug (NSAID) associated gastric ulcers

12 years or older:
-At least 38 kg to less than 50 kg: One tablet (esomeprazole 20 mg-naproxen 375 mg) orally twice a day
-Greater than 50 kg: One tablet (esomeprazole 20 mg-naproxen 375 mg or esomeprazole 20 mg-naproxen 500 mg) orally twice a day

Comments:
-Not interchangeable with the individual components of naproxen and esomeprazole magnesium.

Use: For the relief of signs and symptoms of juvenile idiopathic arthritis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers

Moderate to severe renal impairment (CrCl less than 30 mL/min): Not recommended

Data not available