FDA Label for Celecoxib

View Indications, Usage & Precautions

    1. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
    2. 1INDICATIONS AND USAGE
    3. 1.1 OSTEOARTHRITIS (OA)
    4. 1.2 RHEUMATOID ARTHRITIS (RA)
    5. 1.3 JUVENILE RHEUMATOID ARTHRITIS (JRA)
    6. 1.4 ANKYLOSING SPONDYLITIS (AS)
    7. 1.5 ACUTE PAIN
    8. 1.6 PRIMARY DYSMENORRHEA
    9. 2.1 GENERAL DOSING INSTRUCTIONS
    10. 2.2 OSTEOARTHRITIS
    11. 2.3 RHEUMATOID ARTHRITIS
    12. 2.4 JUVENILE RHEUMATOID ARTHRITIS
    13. 2.5 ANKYLOSING SPONDYLITIS
    14. 2.6 MANAGEMENT OF ACUTE PAIN AND TREATMENT OF PRIMARY DYSMENORRHEA
    15. 2.7 SPECIAL POPULATIONS
    16. 3DOSAGE FORMS AND STRENGTHS
    17. 4CONTRAINDICATIONS
    18. 5.1 CARDIOVASCULAR THROMBOTIC EVENTS
    19. 5.2 GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
    20. 5.3 HEPATOTOXICITY
    21. 5.4 HYPERTENSION
    22. 5.5 HEART FAILURE AND EDEMA
    23. 5.6 RENAL TOXICITY AND HYPERKALEMIA
    24. 5.7 ANAPHYLACTIC REACTIONS
    25. 5.8 EXACERBATION OF ASTHMA RELATED TO ASPIRIN SENSITIVITY
    26. 5.9 SERIOUS SKIN REACTIONS
    27. 5.10 DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS)
    28. 5.11 FETAL TOXICITY
    29. 5.12 HEMATOLOGICAL TOXICITY
    30. 5.13 MASKING OF INFLAMMATION AND FEVER
    31. 5.14 LABORATORY MONITORING
    32. 5.15 DISSEMINATED INTRAVASCULAR COAGULATION (DIC)
    33. 6ADVERSE REACTIONS
    34. 6.1 CLINICAL TRIALS EXPERIENCE
    35. 6.2 POSTMARKETING EXPERIENCE
    36. 7DRUG INTERACTIONS
    37. 8.1 PREGNANCY
    38. 8.2 LACTATION
    39. 8.3 FEMALES AND MALES OF REPRODUCTIVE POTENTIAL
    40. 8.4 PEDIATRIC USE
    41. 8.5 GERIATRIC USE
    42. 8.6 HEPATIC IMPAIRMENT
    43. 8.7 RENAL IMPAIRMENT
    44. 8.8 POOR METABOLIZERS OF CYP2C9 SUBSTRATES
    45. 10OVERDOSAGE
    46. 11DESCRIPTION
    47. 12.1 MECHANISM OF ACTION
    48. 12.2 PHARMACODYNAMICS
    49. 12.3 PHARMACOKINETICS
    50. 12.5 PHARMACOGENOMICS
    51. 13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
    52. 13.2 ANIMAL TOXICOLOGY
    53. 14.1 OSTEOARTHRITIS
    54. 14.2 RHEUMATOID ARTHRITIS
    55. 14.3 JUVENILE RHEUMATOID ARTHRITIS (NCT00652925)
    56. 14.4 ANKYLOSING SPONDYLITIS
    57. 14.5 ANALGESIA, INCLUDING PRIMARY DYSMENORRHEA
    58. 14.6 CARDIOVASCULAR OUTCOMES TRIAL: PROSPECTIVE RANDOMIZED EVALUATION OF CELECOXIB INTEGRATED SAFETY VS. IBUPROFEN OR NAPROXEN (PRECISION; NCT00346216)
    59. 14.7 SPECIAL STUDIES
    60. 16HOW SUPPLIED/STORAGE AND HANDLING
    61. 17 PATIENT COUNSELING INFORMATION
    62. MEDICATION GUIDE
    63. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Celecoxib Product Label

The following document was submitted to the FDA by the labeler of this product Asclemed Usa, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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