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Celebrex - Indications & Dosage

[celecoxib]



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).

HOW SUPPLIED

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 Revised: January 2004

Manufactured for:
G.D. Searle LLC
A subsidiary of Pharmacia Corporation
Chicago, IL 60680, USA
Pfizer Inc
New York, NY 10017, USA
by: Searle Ltd.
Caguas, PR 00725

PHARMACIA

CELEBREX ®
celecoxib capsules
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