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CELEBREX (celecoxib) Contraindications

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Contraindications

CELEBREX (celecoxib) 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 CLINICAL TRIALS – Cardiovascular Safety).
  • 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.
  • Known hypersensitivity to celecoxib or to any of the components/excipients.
  • Demonstrated allergic-type reactions to sulfonamides.
  • History of asthma, urticaria, or allergic-type reactions after taking Acetylsalicylic Acid (ASA) or other NSAIDs (i.e. complete or partial syndrome of ASA-intolerance - rhinosinusitis, urticaria/angioedema, nasal polyps, asthma). Fatal anaphylactoid reactions have occurred in such individuals. Individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse reaction. The potential for cross-reactivity between different NSAIDs must be kept in mind (see WARNINGS AND PRECAUTIONS - Hypersensitivity Reactions - Anaphylactoid Reactions).
  • Active gastric / duodenal / peptic ulcer, active gastrointestinal bleeding.
  • Cerebrovascular bleedings.
  • Inflammatory bowel disease.
  • Severe liver impairment or active liver disease.
  • Severe renal impairment (creatinine clearance <30 mL/min or 0.5 mL/sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored) (see WARNINGS AND PRECAUTIONS - Renal).
  • Known hyperkalemia (see WARNINGS AND PRECAUTIONS - Renal - Fluid and Electrolyte Balance).
  • Safety and efficacy of CELEBREX have not been established in the paediatric population under 18 years of age.

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