CeleXib 100-EZS

CELEXIB 100-EZS- celecoxib
PureTek Corporation

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. [see Warnings and Precautions (5.1) ]
Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. [ see Contraindications (4) and Warnings and Precautions (5.1) ]

Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events.[ see Warnings and Precautions (5.2) ]

1 INDICATIONS AND USAGE

Celecoxib is indicated

1.1 Osteoarthritis (OA)

For the management of the signs and symptoms of OA [see Clinical Studies (14.1) ]

1.2 Rheumatoid Arthritis (RA)

For the management of the signs and symptoms of RA [see Clinical Studies (14.2) ]

1.3 Juvenile Rheumatoid Arthritis (JRA)

For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3) ]

1.4 Ankylosing Spondylitis (AS)

For the management of the signs and symptoms of AS [see Clinical Studies (14.4) ]

1.5 Acute Pain

For the management of acute pain in adults [see Clinical Studies (14.5) ]

1.6 Primary Dysmenorrhea

For the management of primary dysmenorrhea [see Clinical Studies (14.5) ]

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Instructions

Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ].

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

2.2 Osteoarthritis

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

2.3 Rheumatoid Arthritis

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

2.4 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 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 to 8° C/ 35 to 45° F).

2.5 Ankylosing Spondylitis

For AS, the dosage of 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.

2.6 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.

2.7 Special Populations

Hepatic Impairment

In patients with moderate hepatic impairment (Child-Pugh Class B), reduce the dose by 50%. The use of celecoxib in patients with severe hepatic impairment is not recommended [see Warnings and Precautions (5.5), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ].

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 (8.8), and Clinical Pharmacology (12.5) ].

3 DOSAGE FORMS AND STRENGTHS

Celecoxib capsules:
50 mg are opaque white/opaque white hard gelatin capsules size “5” having imprinting “134” on body with red ink and “A” on cap with red ink filled with white to off-white colored granular powder.
100 mg are opaque white/opaque white hard gelatin capsules size “3” having imprinting “135” on body with blue ink and “A” on cap with blue ink filled with white to off-white colored granular powder.
200 mg are opaque white/opaque white hard gelatin capsules size “1” having imprinting “136” on body with golden yellow ink and “A” on cap with golden yellow ink filled with white to off-white colored granular powder.
400 mg are opaque white/opaque white hard gelatin capsules size “00” having imprinting “137” on body with green ink and “A” on cap with green ink filled with white to off-white colored granular powder.

4 CONTRAINDICATIONS

Celecoxib is contraindicated in the following patients:

· Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions)to celecoxib, any components of the drug product [see Warnings and Precautions (5.7, 5.9) ].

· History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients [see Warnings and Precautions (5.7, 5.8) ].

· In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ].

· In patients who have demonstrated allergic-type reactions to sulfonamides.

5 WARNINGS AND PRECAUTIONS

5.1 Cardiovascular Thrombotic Events


Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

In the APC (Adenoma Prevention with Celecoxib) trial, there was about a threefold increased risk of the composite endpoint of cardiovascular death, MI, or stroke for celecoxib 400 mg twice daily and celecoxib 200 mg twice daily treatment arms compared to placebo. The increases in both celecoxib dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction [see Clinical Studies (14.7) ].

A randomized controlled trial entitled the Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen (PRECISION) was conducted to assess the relative cardiovascular thrombotic risk of a COX-2 inhibitor, celecoxib, compared to the non-selective NSAIDs naproxen and ibuprofen. Celecoxib 100 mg twice daily was non-inferior to naproxen 375 to 500 mg twice daily and ibuprofen 600 to 800 mg three times daily for the composite endpoint of the Antiplatelet Trialists’ Collaboration (APTC), which consists of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, and non-fatal stroke [See Clinical Studies (14.6) ].

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as celecoxib, increases the risk of serious gastrointestinal (GI) events [see Warnings and Precautions (5.2) ].

Status Post Coronary Artery Bypass Graft (CABG) Surgery

Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG [see Contraindications (4) ].

Post-MI Patients

Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.

Avoid the use of celecoxib in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If celecoxib is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

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