CELEBREX

1 Dosing Considerations Use of CELEBREX should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).

g. hypertension, hyperlipidemia, diabetes mellitus and smoking) (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX). 2 Recommended Dose and Dosage Adjustment Osteoarthritis: The recommended daily dose of CELEBREX is 200 mg administered as a single dose or as two divided doses (100 mg twice per day).

Maximum dose = 200 mg a day.

Rheumatoid Arthritis:

The recommended starting dose of CELEBREX is 100 mg twice per day, which may be increased to 200 mg twice per day if necessary. Maximum dose = 200 mg twice a day.

Ankylosing Spondylitis:

The recommended daily dose of CELEBREX is 200 mg administered as a single dose or as two divided doses (100 mg twice a day). Maximum dose = 200 mg a day.

Management of Acute Pain:

The recommended dose of CELEBREX is 400 mg as a single dose on the first day followed by 200 mg once daily on subsequent days up to a maximum of 7 days. Patients may be instructed to take an additional dose of 200 mg on any given day, if needed.

Maximum dose = 400 mg a day for up to 7 days.

Pediatrics (< 18 years of age):

Health Canada has not authorized an indication for pediatric use.

See 2 CONTRAINDICATIONS Hepatic Impairment:

CELEBREX capsules should be introduced at the lowest dose in patients with mild hepatic impairment (Child-Pugh 5-6). 3 Pharmacokinetics, Special Populations and Conditions). CELEBREX is contraindicated in patients with severe hepatic impairment (Child-Pugh > 9) (see 2 CONTRAINDICATIONS).

3 Pharmacokinetics, Special Populations and Conditions). CELEBREX is contra-indicated in patients with severe renal impairment (estimated creatinine clearance < 30 mL/min) (see 2 CONTRAINDICATIONS). 4 Geriatrics).

). 1 Adverse Reaction Overview).

CYP2C9 Poor Metabolizers:

Patients who are known, or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution. CELEBREX should be introduced at half the lowest recommended dose in CYP2C9 poor CELEBREX (celecoxib) Page 18 of 56 Protected B / Protégé B metabolizers, with a maximum recommended dose of 100 mg daily (see

, Skin, Serious skin reactions 07/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................

2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................

4 1 INDICATIONS .............................................................................................................. 1 Pediatrics...................................................................................................................

2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................

5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ..............................................................................................

2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration .......................................................................................................... 5 Missed Dose ..............................................................................................................

8 5 OVERDOSAGE............................................................................................................. 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS ..................................................................................

and 7 WARNINGS AND PRECAUTIONS). For patients with an increased risk of developing gastrointestinal adverse events, other management strategies that do NOT include the use of NSAIDs, including CELEBREX, should be considered first (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).

Use of CELEBREX should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).

CELEBREX, as a NSAID, does NOT treat clinical disease or prevent its progression. CELEBREX, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it. 1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of CELEBREX in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.

(see 2 CONTRAINDICATIONS). 4 Geriatrics). CELEBREX (celecoxib) Page 5 of 56 Protected B / Protégé B 2 CONTRAINDICATIONS CELEBREX is contraindicated in: • The peri-operative setting of Coronary Artery Bypass Graft Surgery (CABG). Although CELEBREX has NOT been studied in this patient population, a selective COX-2 inhibitor NSAID studied in such a setting has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections and sternal wound complications (see 14 CLINICAL TRIALS, Cardiovascular Safety- Meta- analysis from Chronic Usage Studies).

• The third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus and prolonged parturition. • Women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants. • Severe uncontrolled heart failure.