Celecoxib 100 mg Capsules — Generic For Celebrex — Nivagen

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 capsules are 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 (

5.9) 11/2024

Indications And Usage

Celecoxib capsules are nonsteroidal anti-inflammatory drug indicated for:

1.1)

1.2)

1.3)

1.4)

1.5)

1.6)

Dosage And Administration

(2.1)

2.2,

14.1)

2.3,

14.2)

2.4,

14.3)

2.5,

14.4)

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 and 400 mg (

3)

Contraindications

4)

4)

4)

Warnings And Precautions

• ( 5.9) 11/2024 INDICATIONS AND USAGE Celecoxib capsules are 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)

• ( 5.9) 11/2024 INDICATIONS AND USAGE Celecoxib capsules are 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)

5.3)

5.4,

7)

5.5)

(5.6)

5.7)

5.8)

5.9)

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 Nivagen Pharmaceuticals, Inc. at 1-877-977-0687 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 inhibitor [SSRIs] / serotonin norepinephrine reuptake inhibitors [SNRIs]):Monitor patients for bleeding who are concomitantly taking celecoxib capsules with drugs that interfere with hemostasis. Concomitant use of celecoxib capsules 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 capsules may diminish the antihypertensive effect of these drugs. Monitor blood pressure. (7)

ACE Inhibitors and ARBs: Concomitant use with celecoxib capsules 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 capsules 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 capsules in women who have difficulties conceiving (

8.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 12/2024