Celecoxib can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Celebrex is not approved for use by anyone younger than 2 years old. How should I take Celebrex? Take Celebrex exactly as prescribed by your doctor.
Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition. You may take Celebrex with or without food.
Take with food if Celebrex upsets your stomach. To make swallowing easier, you may open the Celebrex capsule and sprinkle the medicine into a spoonful of applesauce. Swallow right away without chewing. Discard the empty capsule. If you do not take the mixture right away, keep it in the refrigerator and take it within 6 hours.
If you use this medicine long-term, you may need frequent medical tests. Store at room temperature away from moisture and heat. Read all patient information, medication guides, and instruction sheets provided to you. Celecoxib may also cause stomach or intestinal bleeding, which can be fatal.
These conditions can occur without warning while you are using this medicine, especially in older adults. You should not take this medicine if you already have bleeding in your stomach or intestines. Before taking this medicine Celecoxib can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease.
Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine. These conditions can occur without warning while you are using celecoxib, especially in older adults. You should not use celecoxib if you are allergic to it, or if you have: To make sure celecoxib is safe for you, tell your doctor if you have: Taking celecoxib during the last 3 months of pregnancy may harm the unborn baby.
Tell your doctor if you are pregnant or plan to become pregnant while using celecoxib. Celecoxib can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby. Celecoxib is not approved for use by anyone younger than 2 years old. How should I take celecoxib? Take celecoxib exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended.
Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of cardiovascular events; alternative therapies should be considered for patients at high risk. These events may occur at any time during therapy and without warning. Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of GI adverse events; alternate therapies should be considered for patients at high risk.
Anemia may occur; monitor hemoglobin or hematocrit in people on long-term treatment. Celecoxib does not usually affect prothrombin time , partial thromboplastin time or platelet counts; it does not inhibit platelet aggregation at approved doses.
People with prior history of ulcer disease or GI bleeding require special precaution. In patients who are elderly, volume-depleted including those on diuretic therapy , or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure.
These effects are usually reversible. When these drugs are administered concomitantly, , patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics e. The concomitant use of Celecoxib with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.
NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. Celebrex has no effect on methotrexate pharmacokinetics. NSAIDs with short elimination half-lives e.
In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives e. Coadministration of celecoxib with drugs that are known to inhibit CYP2C9 e. Intervention Evaluate each patient's medical history when consideration is given to prescribing celecoxib.
A dosage adjustment may be warranted when celecoxib is administered with CYP2C9 inhibitors or inducers. In vitro studies indicate that celecoxib, although not a substrate, is an inhibitor of CYP2D6.
Therefore, there is a potential for an in vivo drug interaction with drugs that are metabolized by CYP2D6 e. A dosage adjustment may be warranted when celecoxib is administered with CYP2D6 substrates. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate.
Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. Cumulative rates for this composite endpoint over 3 years were 3.
The increases in both celecoxib dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction [see Clinical Studies ]. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms.
Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of Celebrex in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events.
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