Celecoxib precautions
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-525-6884
List of precautions
General
Hepatic Effects
Hematological Effects
General
CELEBREX cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency.
Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroid-responsive illness.
Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is
made to discontinue corticosteroids. Return to top
Hepatic Effects
Borderline elevations of one or more liver associated enzymes may occur in up to 15% of patients
taking NSAIDs, and notable elevations of ALT or AST (approximately 3 or more times the upper limit
of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. These
laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing
therapy. Rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure (some with fatal outcome) have been reported with NSAIDs, including CELEBREX (see ADVERSE REACTIONS – post-marketing experience). In controlled clinical trials
of CELEBREX, the incidence of borderline elevations (greater than or equal to 1.2 times and less than 3 times the upper limit of normal) of liver associated enzymes was 6% for CELEBREX and 5% for
placebo, and approximately 0.2% of patients taking CELEBREX and 0.3% of patients taking placebo had
notable elevations of ALT and AST. Return to top
Hematological Effects
Anemia is sometimes seen in patients receiving CELEBREX. In controlled clinical trials the incidence of
anemia was 0.6% with CELEBREX and 0.4% with placebo. Patients on long-term treatment with
CELEBREX should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms
of anemia or blood loss. CELEBREX does not generally affect platelet counts, prothrombin time (PT),
or partial thromboplastin time (PTT), and does not inhibit platelet aggregation at indicated dosages.
Preexisting Asthma
Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirinsensitive
asthma has been associated with severe bronchospasm which can be fatal. Since cross
reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs
has been reported in such aspirin-sensitive patients, CELEBREX should not be administered to patients
with this form of aspirin sensitivity and should be used with caution in patients with preexisting
asthma. Return to top
The content of this page is taken from the FDA package insert for this drug and should not be edited.
