Celebrex Prescribing Information



Celebrex Prescribing Information


Celebrex prescribing information:
For osteoarthritis: 200 mg once a day or 100 mg twice per day
For rheumatoid arthritis: 100 to 200 mg twice per day
For pain: 400 mg to start, then 200 mg twice a day, if needed
For colon polyps: 400 mg twice a day with food,
as celebrex prescribing informatiom stated in the FDA files.

Contra indications:
Celebrex is contraindicated in patients with known hypersensitivity to celecoxib. Celebrex should not be used by patients who have demonstrated allergic-type reactions to sulfonamides.
Celebrex should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs (NSAID= non-steroidal anti-inflammatory drug). Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.

Gastrointestinal (GI) Effects–Risk of GI Ulceration, Bleeding, and Perforation.
Serious gastrointestinal toxicity like bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms, in patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs). Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. Therefore, physicians and patients should remain alert for ulceration and bleeding, even in the absence of previous GI tract symptoms. Patients should be informed about the signs and/or symptoms of serious GI toxicity and the steps to take if they occur. The utility of periodic laboratory monitoring has not been demonstrated, nor has it been adequately assessed. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. It has been demonstrated that upper GI ulcers, gross bleeding or perforation, caused by NSAIDs, appear to occur in approximately 1% of patients treated for 3–6 months, and in about 2–4% of patients treated for one year. These trends continue thus, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

NSAIDs should be prescribed with extreme caution in patients with a prior history of ulcer disease or gastrointestinal bleeding. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore special care should be taken in treating this population. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.

Studies have shown that patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding and who use NSAIDs, have a greater than 10-fold higher risk for developing a GI bleed than patients with neither of these risk factors. In addition to a past history of ulcer disease, pharmacoepidemiological studies have identified several other co-therapies or co-morbid conditions that may increase the risk for GI bleeding such as: treatment with oral corticosteroids, treatment with anticoagulants, longer duration of NSAID therapy, smoking, alcoholism, older age, and poor general health status.
Resource:FDA.

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