Usual Adult Dose for Ankylosing Spondylitis

Initial: 15 mg lansoprazole once daily with naproxen 375 mg twice daily. In the morning before eating take the lansoprazole capsule together with one tablet of naproxen 375 mg with a full glass of water, followed by naproxen 375 mg in the evening with a full glass of water.

The maximum daily naproxen dose is 1000 mg.

The lansoprazole capsule should be swallowed whole. Do not chew or crush.

Usual Adult Dose for Osteoarthritis

Initial: 15 mg lansoprazole once daily with naproxen 375 mg twice daily. In the morning before eating take the lansoprazole capsule together with one tablet of naproxen 375 mg with a full glass of water, followed by naproxen 375 mg in the evening with a full glass of water.

The maximum daily naproxen dose is 1000 mg.

The lansoprazole capsule should be swallowed whole. Do not chew or crush.

Usual Adult Dose for Rheumatoid Arthritis

Initial: 15 mg lansoprazole once daily with naproxen 375 mg twice daily. In the morning before eating take the lansoprazole capsule together with one tablet of naproxen 375 mg with a full glass of water, followed by naproxen 375 mg in the evening with a full glass of water.

The maximum daily naproxen dose is 1000 mg.

The lansoprazole capsule should be swallowed whole. Do not chew or crush.

Renal Dose Adjustments

A lower dose should be considered in patients with renal impairment or in elderly patients.

Liver Dose Adjustments

A lower dose should be considered in patients with liver impairment or in elderly patients.

Precautions

There is an increased risk of serious, sometimes fatal, cardiovascular (CV) thrombotic events, myocardial infarction, and stroke in patients receiving NSAID therapy. Duration of use may increase this risk. Patients with CV disease or risk factors for CV disease may be at greater risk. The lowest effective dose for the shortest duration possible should be used to minimize the potential risk for an adverse CV event in patients receiving NSAID therapy. Physicians and patients should remain vigilant for such events, even in the absence of previous CV events. Patients should be advised about the signs and/or symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.

Serious, sometimes fatal, gastrointestinal (GI) toxicity such as bleeding, ulceration, and perforation can occur at any time with or without warning symptoms in patients receiving chronic NSAID therapy. The incidence of symptomatic upper GI ulcers, gross bleeding, or perforation increases with duration of use. However, even short-term therapy is not without risk. Only 1 in 5 patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Caution should be exercised when using NSAIDs in patients with a prior history of peptic ulcer disease and/or GI bleeding, in the elderly and debilitated, because most of the spontaneous reports of fatal GI adverse events are in this population. Patients with a prior history of peptic ulcer disease and/or GI bleeding and who use NSAIDs have a greater than 10-fold risk of developing GI bleeding than patients with neither of these risk factors. Additionally, comorbid conditions may increase the risk of GI bleeding, such as longer duration of NSAID therapy, smoking, alcoholism, older age, and poor general health status. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. If GI ulceration or bleeding is suspected during NSAID therapy, additional evaluation and treatment should be initiated. Until serious GI adverse events are ruled out, naproxen should be discontinued. In high-risk patients, an alternate treatment should be considered. If naproxen is required, coadministration with 15 mg of lansoprazole-naproxen has been proven effective to reduce the risk of NSAID-associated gastric ulcers in patients with a previous history of gastric ulcer(s). NSAIDs should be administered with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.

Dialysis

Lansoprazole-naproxen is not dialyzable.

Other Comments

The duration of the controlled studies of lansoprazole-naproxen was 12 weeks.

Lansoprazole-naproxen is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of documented gastric ulcer who require the use of an NSAID for treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.