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Celebrex

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Celebrex

Celebrex

INDICATIONS

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

Osteoarthritis (OA)

CELEBREX (celecoxib) is indicated for relief of the signs and symptoms of OA [see Clinical Studies]

Rheumatoid Arthritis (RA)

CELEBREX (celecoxib) is indicated for relief of the signs and symptoms of RA [see Clinical Studies]

Juvenile Rheumatoid Arthritis (JRA)

CELEBREX (celecoxib) is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies]

Ankylosing Spondylitis (AS)

CELEBREX (celecoxib) is indicated for the relief of signs and symptoms of AS [see Clinical Studies]

Acute Pain (AP)

CELEBREX (celecoxib) is indicated for the management of AP in adults [see Clinical Studies]

Primary Dysmenorrhea (PD)

CELEBREX (celecoxib) is indicated for the treatment of PD [see Clinical Studies]

DOSAGE AND ADMINISTRATION

Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient.

These doses can be given without regard to timing of meals.

Osteoarthritis

For relief of the signs and symptoms of OA the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.

Rheumatoid Arthritis

For relief of the signs and symptoms of RA the recommended oral dose is 100 to 200 mg twice daily.

Juvenile Rheumatoid Arthritis

For the relief of the signs and symptoms of JRA the recommended oral dose for pediatric patients (age 2 years and older) is based on weight. For patients > 10 kg to < 25 kg the recommended dose is 50 mg twice daily.

For patients > 25 kg the recommended dose is 100 mg twice daily. For patients who have difficulty swallowing capsules, the contents of a CELEBREX (celecoxib) 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

For the management of the signs and symptoms of AS, the recommended dose of CELEBREX (celecoxib) is 200 mg daily in 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 (celecoxib) 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.

Special Populations

Hepatic insufficiency

The daily recommended dose of CELEBREX (celecoxib) capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%. The use of CELEBREX (celecoxib) in patients with severe hepatic impairment is not recommended [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY].

Poor Metabolizers of CYP2C9 Substrates

Patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin) should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose in poor metabolizers (i.e. CYP2C9*3/*3). Consider using alternative management in JRA patients who are poor metabolizers. [see Use In Specific Populations, and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

Capsules: 50 mg, 100 mg, 200 mg and 400 mg

Storage And Handling

CELEBREX (celecoxib) 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 (celecoxib) 100 mg capsules are white, with 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 (celecoxib) 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 (celecoxib) 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

Storage

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

Distributed by: G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017. January 2011

Last reviewed on RxList: 4/4/2011
This monograph has been modified to include the generic and brand name in many instances.

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Celebrex - User Reviews

Celebrex User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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