Celebrex (Celecoxib) - Indications and Dosage

INDICATIONS AND USAGE

Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

CELEBREX is indicated:

1. 1)For relief of the signs and symptoms of osteoarthritis.
2. 2)For relief of the signs and symptoms of rheumatoid arthritis in adults.
3. 3)For relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years and older (see CLINICAL STUDIES and ADVERSE REACTIONS - Adverse Events from JRA Study).
4. 4)For the relief of signs and symptoms of ankylosing spondylitis.
5. 5)For the management of acute pain in adults (see CLINICAL STUDIES).
6. 6)For the treatment of primary dysmenorrhea.
7. 7)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

Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

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.

Juvenile Rheumatoid Arthritis

Pediatric Patients (2 years and older)	Dose
≥10 kg to ≤25 kg	50 mg capsule twice daily
>25 kg	100 mg capsule twice daily

Method of Administration

For patients who have difficulty swallowing capsules, the contents of a CELEBREX capsule can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2–8° C/ 35–45° F).

Ankylosing Spondylitis (AS)

For the management of the signs and symptoms of AS, the recommended dose of CELEBREX is 200 mg daily single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.

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%. The use of CELEBREX in patients with severe hepatic impairment is not recommended (see CLINICAL PHARMACOLOGY – Special Populations).

HOW SUPPLIED

CELEBREX 50-mg capsules are white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body, supplied as:

NDC Number          Size
0025-1515-01         bottle of 60

CELEBREX 100-mg capsules are white, reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:

NDC Number          Size
0025-1520-31         bottle of 100
0025-1520-51         bottle of 500
0025-1520-34         carton of 100 unit dose

CELEBREX 200-mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:

NDC Number          Size
0025-1525-31         bottle of 100
0025-1525-51         bottle of 500
0025-1525-34         carton of 100 unit dose

CELEBREX 400-mg capsules are white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body, supplied as:

NDC Number          Size
0025-1530-02         bottle of 60
0025-1530-01         carton of 100 unit dose

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Rx only

LAB-0036-11

January 2008