June 26, 2016
Recommended Topic Related To:

Celebrex

"The US Food and Drug Administration (FDA) has approved tofacitinib citrate extended-release (Xeljanz XR, Pfizer Inc) 11-mg tablets for once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have not responde"...

A A A

Celebrex




Indications
Dosage
How Supplied

INDICATIONS

CELEBREX is indicated

Osteoarthritis (OA)

For the management of the signs and symptoms of OA [see Clinical Studies]

Rheumatoid Arthritis (RA)

For the management of the signs and symptoms of RA [see Clinical Studies]

Juvenile Rheumatoid Arthritis (JRA)

For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies]

Ankylosing Spondylitis (AS)

For the management of the signs and symptoms of AS [see Clinical Studies]

Acute Pain

For the management of acute pain in adults [see Clinical Studies]

Primary Dysmenorrhea

For the management of primary dysmenorrhea [see Clinical Studies]

DOSAGE AND ADMINISTRATION

General Dosing Instructions

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

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

Osteoarthritis

For OA, the dosage is 200 mg per day administered as a single dose or as 100 mg twice daily.

Rheumatoid Arthritis

For RA, the dosage is 100 to 200 mg twice daily.

Juvenile Rheumatoid Arthritis

For JRA, the dosage 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 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 AS, the dosage of CELEBREX 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

For management of Acute Pain and Treatment of Primary Dysmenorrhea, the dosage 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 Impairment

In patients with moderate hepatic impairment (Child-Pugh Class B), reduce the dose by 50%. The use of CELEBREX 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

In adult 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), initiate treatment with half of the lowest recommended dose.

In patients with JRA who are known or suspected to be poor CYP2C9 metabolizers, consider using alternative treatments. [see Use in Specific populations, and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

CELEBREX (celecoxib) capsules:

50 mg white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body.

100 mg white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body.

200 mg white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body.

400 mg white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body.

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 room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]

Distributed by:G.D. Searle LLC Division of Pfizer Inc., NY, NY 10017. Revised: May 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/7/2016

Indications
Dosage
How Supplied

Celebrex - User Reviews

Celebrex User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Celebrex sorted by most helpful. Patient Discussions FAQs

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.


Arthritis

Get the latest treatment options

Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations