Important Safety Information

Cardiovascular Risk

  • CELEBREX may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All nonsteroidal anti-inflammatory drugs (NSAIDs) may have a similar risk. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk.
  • CELEBREX is contraindicated for the treatment of perioperative pain in coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

  • NSAIDs, including CELEBREX, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

CELEBREX is contraindicated in patients with active gastrointestinal bleeding; in patients who have demonstrated allergic-type reactions to sulfonamides; or in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.

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

As with all NSAIDs, CELEBREX can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Blood pressure should be monitored closely with all NSAIDs.

Fluid retention and edema have been observed in some patients taking NSAIDs, including CELEBREX. NSAIDs should be used with caution in patients with fluid retention or heart failure.

NSAIDs, including CELEBREX, may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors and angiotensin II antagonists, and in some patients can reduce the natriuretic effect of furosemide and thiazides.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, may result in deterioration of renal function, including possible acute renal failure. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

CELEBREX can be used with low-dose aspirin. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.

Concomitant administration of aspirin with CELEBREX increases the rate of GI ulceration or other complications, compared with use of CELEBREX alone.

Treatment with NSAIDs, including CELEBREX, is not recommended in those patients with advanced renal disease. In addition, NSAIDs may cause renal toxicity.

Serious skin reactions such as exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis have been reported in patients receiving CELEBREX. These reactions can be fatal. They can occur without warning and in patients without prior known sulfa allergy. CELEBREX should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Rare cases of anaphylactic reactions and angioedema have been reported in patients receiving CELEBREX. Patients should seek immediate emergency assistance if they have swelling of the face or throat or have difficulty breathing.

CELEBREX should be avoided in late pregnancy.

NSAIDs, including CELEBREX, should be used with caution in pediatric patients with systemic onset JRA, due to the risk of disseminated intravascular coagulation.

Please see Full Prescribing Information including BOXED WARNING and Medication Guide.

Indications

CELEBREX is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults; the treatment of primary dysmenorrhea; and for relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years and older.

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Indications and Dosing

  • CELEBREX should be used at the lowest effective dose for the shortest duration consistent with treatment goals for the individual patient
  • CELEBREX can be administered without regard to timing of meals
  • CELEBREX is available in 4 strengths: 50 mg, 100 mg, 200 mg, and 400 mg capsules
Download a 1-page dosing reference for CELEBREX.

Osteoarthritis (OA)

CELEBREX is indicated for relief of the signs and symptoms of OA.

200 mg QD or 100 mg BID

Rheumatoid Arthritis (RA)

CELEBREX is indicated for relief of the signs and symptoms of RA.

100 mg to 200 mg BID

Acute Pain in Adults

CELEBREX is indicated for the management of acute pain in adults.

Day 1: 400-mg initial dose + 200 mg if needed
Days >1: 200 mg BID as needed

Ankylosing Spondylitis

CELEBREX is indicated for the relief of signs and symptoms of ankylosing spondylitis.

Starting dose 200 mg in single or divided doses
If no effect
after 6 weeks
A trial of 400 mg daily may be worthwhile
If no effect after 6 weeks on 400 mg daily A response is not likely and an alternate treatment should be considered

Primary Dysmenorrhea

CELEBREX is indicated for the treatment of primary dysmenorrhea.

Day 1: 400-mg initial dose + 200 mg if needed
Days >1: 200 mg BID as needed

Juvenile Rheumatoid Arthritis (JRA)

CELEBREX is indicated for relief of the signs and symptoms of JRA in patients ≥2 years.

Patients 10 kg to 25 kg (22 lb to 55 lb): 50 mg BID
Patients >25 kg (>55 lb): 100 mg BID

NSAIDs, including CELEBREX, should be used with caution in pediatric patients with systemic onset JRA, due to the risk of disseminated intravascular coagulation.

Special Populations

Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B).
Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers.

*Eligibility required. Terms and conditions apply. Card will be accepted only at participating pharmacies. Card is not health insurance. No membership fee. Savings of up to $125 per fill for a maximum savings of up to $1,750 per year. For more information, visit www.Celebrex.com, call 1-855-612-1956, or write: CELEBREX $4 Co-pay Card, 14001 Weston Parkway, Suite 103, Cary, NC 27513.
Generic prescription celecoxib patients with commercial insurance pay an average co-pay of $23.21 as of January 2015.1

Reference:

1. IMS PayerTrak data, January 2015.

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