Celecoxib 200 mg Capsules — Generic For Celebrex — Westminster

These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES.

CELECOXIB capsules, for oral use

Initial U.S. Approval: 1998

Warning: Risk Of Serious Cardiovascular And Gastrointestinal Events

See full prescribing information for complete boxed warning.

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. (5.1)

Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. (4, 5.1)

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. (5.2)

Recent Major Changes

Warnings and Precautions (5.10)04/2021

Warnings and Precautions (5.11)04/2021

Indications And Usage

Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:

Osteoarthritis (OA) (1.1)

Rheumatoid Arthritis (RA) (1.2)

Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)

Ankylosing Spondylitis (AS) (1.4)

Acute Pain (AP) (1.5)

Primary Dysmenorrhea (PD) (1.6)

Dosage And Administration

Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. (2.1)

OA: 200 mg once daily or 100 mg twice daily. (2.2, 14.1)

RA: 100 mg to 200 mg twice daily. (2.3, 14.2)

JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice daily in patients more than 25 kg. (2.4, 14.3)

AS: 200 mg once daily single dose or 100 mg twice daily. If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit. (2.5, 14.4)

AP and PD: 400 mg initially, followed by 200 mg dose if needed on first day. On subsequent days, 200 mg twice daily as needed. (2.6, 14.5)

Hepatic Impairment: Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B). (2.7, 8.6, 12.3)

Poor Metabolizers of CYP2C9 Substrates: Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers. (2.7, 8.8, 12.3)

Dosage Forms And Strengths

Celecoxib capsules: 50 mg, 100 mg, 200 mg (3)

Contraindications

Known hypersensitivity to celecoxib, or any components of the drug product or sulfonamides. (4)

History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. (4)

In the setting of CABG surgery. (4)

Warnings And Precautions

• (5.10) 04/2021 Warnings and Precautions (5.11) 04/2021 INDICATIONS AND USAGE Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
• Osteoarthritis (OA) (1.1)
• Rheumatoid Arthritis (RA) (1.2)
• Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)
• Ankylosing Spondylitis (AS) (1.4)
• Acute Pain (AP) (1.5)
• Primary Dysmenorrhea (PD) (1.6) DOSAGE AND ADMINISTRATION
• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. (2.1)

• (5.10) 04/2021 Warnings and Precautions (5.11) 04/2021 INDICATIONS AND USAGE Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
• Osteoarthritis (OA) (1.1)
• Rheumatoid Arthritis (RA) (1.2)
• Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)
• Ankylosing Spondylitis (AS) (1.4)
• Acute Pain (AP) (1.5)
• Primary Dysmenorrhea (PD) (1.6) DOSAGE AND ADMINISTRATION
• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. (2.1)

Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. (5.3)

Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. (5.4, 7)

Heart Failure and Edema: Avoid use of celecoxib in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. (5.5)

Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of celecoxib in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. (5.6)

Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs. (5.7)

Exacerbation of Asthma Related to Aspirin Sensitivity: Celecoxib is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). (5.8)

Serious Skin Reactions: Discontinue celecoxib at first appearance of skin rash or other signs of hypersensitivity. (5.9)

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically. (5.10)

Fetal Toxicity: Limit use of NSAIDs, including celecoxib, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus. (5.11, 8.1)

Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. (5.12, 7)

Adverse Reactions

Most common adverse reactions in arthritis trials (> 2% and > placebo) are: abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors [SSRIs]/serotonin norepinephrine reuptake inhibitors [SNRIs]): Monitor patients for bleeding who are concomitantly taking celecoxib with drugs that interfere with hemostasis. Concomitant use of celecoxib and analgesic doses of aspirin is not generally recommended. (7)

Angiotensin Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with celecoxib may diminish the antihypertensive effect of these drugs. Monitor blood pressure. (7)

ACE Inhibitors and ARBs: Concomitant use with celecoxib in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function. (7)

Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects. (7)

Digoxin: Concomitant use with celecoxib can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels. (7)

Use In Specific Populations

Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of celecoxib in women who have difficulties conceiving. (8.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 3/2022