Indications And Clinical Use
CELEBREX (celecoxib) is indicated for relief of symptoms associated with:
- Adult Rheumatoid Arthritis, and
- Ankylosing Spondylitis
CELEBREX is also indicated for the short-term (≤7 days) management of moderate to severe acute pain in adults in conditions such as the following:
- Musculoskeletal and/or soft tissue trauma including sprains,
- Postoperative orthopaedic, and
- Pain following dental extraction
CELEBREX, particularly at doses higher than 200 mg per day, is associated with an increased risk of serious cardiovascular related adverse events (such as myocardial infarction, stroke or thrombotic events, which can be fatal). Doses of CELEBREX >200 mg/day should NOT be used in patients with ischemic heart disease, cerebrovascular disease, patients with congestive heart failure (NYHA II-IV) or patients with risk factors for cardiovascular disease. For patients with an increased risk of developing cardiovascular adverse events, other management strategies that do NOT include the use of NSAIDs, particularly celecoxib, diclofenac, or ibuprofen, should be considered first (see CONTRAINDICATIONS and 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 CONTRAINDICATIONS and 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 CONTRAINDICATIONS and 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.
Geriatrics (>65 years of age):
Evidence from clinical studies and postmarket experience suggests that use in geriatric population is associated with differences in safety (see WARNINGS AND PRECAUTIONS – Special Populations - Geriatrics).
Paediatrics (<18 years of age):
Safety and Efficacy have not been established in the paediatric population (see CONTRAINDICATIONS).