Celebrex - Indications & Dosage

INDICATIONS AND USAGE

CELEBREX is indicated:

1) For relief of the signs and symptoms of osteoarthritis.

2) For relief of the signs and symptoms of rheumatoid arthritis in adults.

3) For the management of acute pain in adults (see CLINICAL STUDIES).

4) For the treatment of primary dysmenorrhea.

5) To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), as an adjunct to usual care (e.g., endoscopic surveillance, surgery). It is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in FAP patients. It is also not known whether the effects of CELEBREX treatment will persist after CELEBREX is discontinued. The efficacy and safety of CELEBREX treatment in patients with FAP beyond six months have not been studied (see CLINICAL STUDIES, WARNINGS and PRECAUTIONS sections).

DOSAGE AND ADMINISTRATION

For osteoarthritis and rheumatoid arthritis, the lowest dose of CELEBREX should be sought for each patient. These doses can be given without regard to timing of meals. Osteoarthritis: For relief of the signs and symptoms of osteoarthritis the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice per day.

Rheumatoid arthritis:

For relief of the signs and symptoms of rheumatoid arthritis the recommended oral dose is 100 to 200 mg twice per day.

Management of Acute Pain and Treatment of Primary Dysmenorrhea:

The recommended dose of CELEBREX is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.

Familial adenomatous polyposis (FAP):

Usual medical care for FAP patients should be continued while on CELEBREX. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg twice per day to be taken with food.

Special Populations

Hepatic insufficiency:

The daily recommended dose of CELEBREX capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by approximately 50% (see CLINICAL PHARMACOLOGY - Special Populations).