Esomeprazole / Naproxen Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Ankylosing Spondylitis

Initial dose: Esomeprazole 20 mg-naproxen 500 mg orally twice a day

Duration of therapy: The lowest dose given for the shortest duration (consistent with individual patient treatment goals) should be used.

Comments:
-A lower daily dose of naproxen or another NSAID should be considered for patients that have not been previously treated with an NSAID. This may necessitate using a non-fixed combination product.

General 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 NSAID associated gastric ulcers.

Usual Adult Dose for Osteoarthritis

Initial dose: Esomeprazole 20 mg-naproxen 500 mg orally twice a day

Duration of therapy: The lowest dose given for the shortest duration (consistent with individual patient treatment goals) should be used.

Comments:
-A lower daily dose of naproxen or another NSAID should be considered for patients that have not been previously treated with an NSAID. This may necessitate using a non-fixed combination product.

General 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 NSAID associated gastric ulcers.

Usual Adult Dose for Rheumatoid Arthritis

Initial dose: Esomeprazole 20 mg-naproxen 500 mg orally twice a day

Duration of therapy: The lowest dose given for the shortest duration (consistent with individual patient treatment goals) should be used.

Comments:
-A lower daily dose of naproxen or another NSAID should be considered for patients that have not been previously treated with an NSAID. This may necessitate using a non-fixed combination product.

General 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 NSAID associated gastric ulcers.

Renal Dose Adjustments

Moderate to severe renal impairment (CrCl less than 30 mL/min): Naproxen-containing products are not recommended

Liver Dose Adjustments

Not recommended for use in patients with severe hepatic impairment because esomeprazole doses should not exceed 20 mg daily in these patients.

Precautions

BOXED WARNINGS:
-CARDIOVASCULAR: Nonsteroidal anti-inflammatory drugs (NSAIDs), such as naproxen, may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
-GASTROINTESTINAL: NSAIDs (including naproxen) cause an increased risk of serious GI adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. This can occur at any time during use and without warning. Elderly patients are at greater risk.
-SURGERY: Esomeprazole-naproxen is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Safety and effectiveness have not been established in patients less than 18 years of age.

Consult WARNINGS section for additional precautions.

Dialysis

Both esomeprazole and naproxen are highly protein bound and are unlikely to be removed.

Other Comments

Administration advice:
-Esomeprazole-naproxen should be administered at least 30 minutes prior to a meal.
-The tablet should be swallowed whole with water and should not be split, chewed, or crushed.
-The dose should be swallowed whole, not split, chewed, crushed, or dissolved.
-The dose should be taken with a full glass of liquid.
-The dose should be taken at least 30 minutes before meals.

General:
-The benefits versus risks ratio of esomeprazole-naproxen therapy should be assessed prior to commencing treatment.
-Since esomeprazole-naproxen is available in a fixed-dose oral formulation; dosage modification should be done using separate esomeprazole and naproxen formulations.
-Prior to commencing esomeprazole-naproxen, existing treatment with non-aspirin NSAIDs (including COX-2 selective inhibitors) and gastroprotective medications (such as proton pump inhibitors or H2 receptor antagonists) should be ceased.
-Esomeprazole-naproxen is not recommended for initial treatment of acute pain.

Monitoring:
General: Regular surveillance is recommended in patients on long-term treatment, e.g., those treated for more than one year.
Cardiovascular: Blood pressure, myocardial infarction and stroke (particularly in patients with cardiovascular disease or cardiovascular risk factors)
Hematologic: Clinically significant bleeding from any source
Hepatic: Liver function tests, particularly ALT levels.
Renal: Renal function (serum creatinine and/or creatinine clearance)

Patient advice:
-Patients should be cautioned against driving or operating machinery until they are reasonably certain that esomeprazole-naproxen will not adversely affect their ability to safely engage in such activities.

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