Celecoxib

CELECOXIB- celecoxib capsule
A-S Medication Solutions

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 capsules are 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 capsules are 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 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 capsules 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° C to 8° C/ 35° F to 45° F).

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 capsules and other treatment options before deciding to use celecoxib capsules. 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 mg 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 capsules 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 capsules are 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 capsules 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 available as size “3” capsules having red opaque cap, imprinted with ‘LU’ in black ink and white opaque body imprinted with ‘N41’ in black ink, containing white to off-white powder.

100 mg are available as size “3” capsules having blue opaque cap, imprinted with ‘LU’ in black ink and white opaque body imprinted with ‘N42’ in black ink, containing white to off-white powder.

200 mg are size “1” capsules having gold opaque cap, imprinted with ‘LU’ in black ink and white opaque body imprinted with ‘N43’ in black ink, containing white to off-white powder.

400 mg are size “00EL” capsules having green opaque cap, imprinted with ‘LU’ in black ink and white opaque body imprinted with ‘N44’ in black ink, containing white to off-white 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 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 cyclooxygenase-2 (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 the celecoxib capsules 400 mg twice daily and celecoxib capsules 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)].

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)].

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