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CELEBREX (celecoxib) Warnings And Precautions

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Warnings And Precautions

Serious Warnings and Precautions

  • Risk of Cardiovascular (CV) Adverse Events: Ischemic Heart Disease, Cerebrovascular Disease, Congestive Heart Failure (NYHA II-IV) (see WARNINGS AND PRECAUTIONS – Cardiovascular and CLINICAL TRIALS – Cardiovascular Safety).

CELEBREX (celecoxib) is a non-steroidal anti-inflammatory drug (NSAID). CELEBREX (celecoxib), particularly at doses higher than 200 mg per day, is associated with an increased incidence of serious cardiovascular (CV) thrombotic events (such as myocardial infarction and stroke), which can be fatal. This increased risk is comparable to that with high doses of diclofenac (≥150 mg per day) or ibuprofen (≥2400 mg per day). Doses of CELEBREX >200 mg/day should NOT be used in patients with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax), congestive heart failure (NYHA II-IV), and/or risk factors for cardiovascular disease.

A meta-analysis of randomized clinical trials comparing several different NSAIDs, concluded that CELEBREX is associated with higher cardiovascular risk when compared with placebo. Large population-based observational studies also support these findings.

An increased risk of CV thrombotic events may occur early in the treatment and become higher with the duration of treatment. Patients with CV disease or risk factors for CV disease may be at greater risk (See Cardiovascular in WARNINGS AND PRECAUTIONS). To minimize the potential for an adverse cardiovascular event, the lowest effective dose should be used for the shortest possible duration. For patients with a high risk of developing an adverse cardiovascular event, other management strategies that do NOT include NSAIDs, particularly celecoxib, diclofenac, or ibuprofen, should be considered first.

Use of NSAIDs, such as CELEBREX, can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure (see also WARNINGS AND PRECAUTIONS – Renal - Fluid and Electrolyte Balance).

  • Risk of Gastrointestinal (GI) Adverse Events (see WARNINGS AND PRECAUTIONS – Gastrointestinal (GI) System).

Use of NSAIDs, such as CELEBREX, is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding).

  • Risk in Pregnancy: Caution should be exercised in prescribing CELEBREX during the first and second trimesters of pregnancy. CELEBREX is CONTRAINDICATED for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition) (see CONTRAINDICATIONS).

General

Frail or debilitated patients may tolerate side effects less well and therefore special care should be taken in treating this population. To minimize the potential risk for an adverse event, the lowest effective dose should be used for the shortest possible duration. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.

CELEBREX is NOT recommended for use with other NSAIDs , with the exception of low-dose ASA for cardiovascular prophylaxis, because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions (see DRUG INTERACTIONS – Drug-Drug Interactions – Acetylsalicylic Acid (ASA) or other NSAIDs).

Carcinogenesis and Mutagenesis

See TOXICOLOGY – Carcinogenesis and Mutagenesis.

Cardiovascular

CELEBREX is a non-steroidal anti-inflammatory drug (NSAID). CELEBREX, particularly at doses higher than 200 mg per day, is associated with an increased risk of serious cardiovascular (CV) thrombotic events (such as myocardial infarction and stroke), which can be fatal. This increased risk is comparable to that with high doses of diclofenac (≥150 mg per day) or ibuprofen (≥2400 mg per day). Some observational studies showed that the increased risk of the CV thrombotic events began as early as the first weeks of treatment. Such risk increased with duration of NSAID treatment.

The relative increase in risk of serious CV thrombotic events during NSAID treatment appears to be similar in patients with or without CV disease or CV risk factors. However, patients with CV disease or CV risk factors during the treatment had a higher absolute risk of serious CV thrombotic events due to their increased baseline rate.

Some meta-analyses of randomized clinical trials and epidemiological studies suggest that there is an increase in cardiovascular risk at doses greater than 200 mg/day in these populations. Doses of CELEBREX >200 mg/day should NOT be used in patients with ischemic heart disease, cerebrovascular disease, patients with congestive heart failure (NYHA II-IV) or in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking) (see CLINICAL TRIALS – Cardiovascular Safety – Meta-analysis from Chronic Usage Studies).

A randomized double-blind, safety study entitled the Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen (PRECISION) compared celecoxib with naproxen and ibuprofen in patients with or at high risk for cardiovascular disease. Celecoxib 100 to 200 mg twice daily (average total daily dose [TDD] 209 mg) was non-inferior to naproxen 375 to 500 mg twice daily (average TDD 852 mg) and ibuprofen 600 to 800 mg three times daily (average TDD 2045 mg) with regards to the first occurrence of Antiplatelet Trialists Collaboration (APTC) composite cardiovascular (CV) endpoint (CV death [including hemorrhagic death], non-fatal myocardial infarction [MI], non-fatal stroke). The average dose of ibuprofen tested in this trial exceeded current dosage recommendations (i.e., maximum daily maintenance dose of 1200 mg administered in divided doses).(See CLINICAL TRIALS – Special Studies).

Caution should be exercised in prescribing CELEBREX to patients with risk factors for cardiovascular disease, cerebrovascular disease or renal disease, such as any of the following (NOT an exhaustive list):

  • Hypertension
  • Dyslipidemia / Hyperlipidemia
  • Diabetes Mellitus
  • Congestive Heart Failure (NYHA I)
  • Coronary Artery Disease (Atherosclerosis)
  • Peripheral Arterial Disease
  • Smoking
  • Creatinine Clearance <60 mL/min or 1 mL/sec
  • Acute myocardial infarction, history of myocardial infarction and/or angina
  • Stroke, cerebrovascular accident, transient ischaemic attacks, and/or amaurosis fugax

Use of NSAIDs, such as CELEBREX, can lead to new hypertension or can worsen pre-existing hypertension, either of which may increase the risk of cardiovascular events as described above. Thus blood pressure should be monitored regularly. Consideration should be given to discontinuing CELEBREX should hypertension either develop or worsen with its use.

Use of NSAIDs, such as CELEBREX, can induce fluid retention and edema, and may exacerbate congestive heart failure, through a renal-mediated mechanism (see WARNINGS AND PRECAUTIONS - Renal - Fluid and Electrolyte Balance).

For patients with a high risk of developing an adverse CV event, other management strategies that do NOT include the use of NSAIDs, particularly celecoxib, diclofenac, or ibuprofen, should be considered first. To minimize the potential risk for an adverse CV event, the lowest effective dose should be used for the shortest possible duration.

One of three randomized clinical trials of about 3 years duration showed a dose-related increase in serious cardiovascular events (mainly myocardial infarction), detectable at doses of CELEBREX 200 mg twice daily or more, compared to placebo.

Endocrine and Metabolism

Corticosteroids: CELEBREX is not a substitute for corticosteroids. It does NOT 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 (see DRUG INTERACTIONS – Drug-Drug Interactions – Glucocorticoids).

Gastrointestinal (GI) System

Serious GI toxicity (sometimes fatal), such as peptic / duodenal ulceration, inflammation, perforation, obstruction and gastrointestinal bleeding, can occur at any time, with or without warning symptoms, in patients treated with NSAIDs, such as CELEBREX. Minor upper GI problems, such as dyspepsia, commonly occur at any time. Health care providers should remain alert for ulceration and bleeding in patients treated with CELEBREX, even in the absence of previous GI tract symptoms. 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 (see WARNINGS AND PRECAUTIONS - Special Populations - Geriatrics).

Patients should be informed about the signs and/or symptoms of serious GI toxicity and instructed to discontinue using CELEBREX and seek emergency medical attention if they experience any such symptoms. The utility of periodic laboratory monitoring has NOT been demonstrated, nor has it been adequately assessed. Most patients who develop a serious upper GI adverse event on NSAID therapy have no symptoms. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs, appear to occur in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 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. Even short-term therapy has its risks.

Caution should be taken if prescribing CELEBREX to patients with a prior history of peptic / duodenal ulcer disease and/or gastrointestinal bleeding as these individuals have a greater than 10-fold higher risk for developing a GI bleed when taking NSAID than patients with neither of these risk factors. Other risk factors for GI ulceration and bleeding include the following: Helicobacter pylori infection, increased age, prolonged use of NSAID therapy, excess alcohol intake, smoking, poor general health status or concomitant therapy with any of the following:

  • Anti-coagulants (e.g. warfarin)
  • Anti-platelet agents (e.g. ASA, clopidogrel)
  • Oral corticosteroids (e.g. prednisone)
  • Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g. citalopram, paroxetine, fluoxetine, sertraline)

There is no definitive evidence that the concomitant administration of histamine H2-receptor antagonists and/or antacids will either prevent the occurrence of gastrointestinal side effects or allow the continuation of CELEBREX when and if these adverse reactions appear.

CELEBREX exhibited a low incidence of gastroduodenal ulceration and serious clinically significant GI events within clinical trials (see ADVERSE REACTIONS - Clinical Trial Adverse Drug Reactions). In a prospective long-term outcome study (CLASS), there were no significant differences in the incidence of complicated ulcers between patients who received a higher-than-therapeutic dose of CELEBREX (400 mg BID) for OA and RA, in the presence of concomitant ASA (N = 882 patients), compared to ibuprofen 800mg TID and diclofenac 75mg BID. The incidence of complicated and symptomatic ulcers was lower for CELEBREX than for Ibuprofen in patients not taking ASA. In active-controlled studies, the endoscopic gastroduodenal ulceration rate observed with all doses of CELEBREX was less than what was seen with the NSAID comparator and, in placebo-controlled studies, was similar to that seen with placebo (see CLINICAL TRIALS - Endoscopic Studies).

Genitourinary

Some NSAIDs are associated with persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria or cystitis. The onset of these symptoms may occur at any time after the initiation of therapy with a NSAID. Should urinary symptoms occur, in the absence of alternate explanation, treatment with CELEBREX should be stopped to ascertain if symptoms disappear. This should be done before urological investigations or treatments are carried out.

Hematologic

NSAIDs inhibiting prostaglandin biosynthesis interfere with platelet function to varying degrees; patients who may be adversely affected by such an action, such as those on anti-coagulants or suffering from hemophilia or platelet disorders should be carefully observed when CELEBREX is administered.

CELEBREX does not generally affect platelet counts, prothrombin time (PT), or partial thromboplastin time (PTT), and does not appear to inhibit platelet aggregation at indicated dosages (see CLINICAL TRIALS - Special Studies - Platelets).

Anti-coagulants: The concomitant use of NSAIDs and anticoagulants increases the risk of bleeding and should be done with caution. Concurrent therapy of CELEBREX with anticoagulants requires close monitoring of the international normalized ratio (INR)/anticoagulation (see DRUG INTERACTIONS).

Even with therapeutic INR monitoring, increased bleeding may occur.

In post-marketing experience, serious bleeding events (some of them fatal) have been reported, predominantly in the elderly, in patients receiving CELEBREX concurrently with warfarin or similar agents (see ADVERSE REACTIONS - Post-Market Adverse Drug Reactions).

Anti-platelet Effects: NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike Acetylsalicylic Acid (ASA), their effect on platelet function is quantitatively less, or of shorter duration, and is reversible. CELEBREX does not appear to inhibit platelet aggregation at indicated dosages (see CLINICAL TRIALS - Special Studies - Platelets).

CELEBREX and other NSAIDs have no proven efficacy as anti-platelet agents and should NOT be used as a substitute for ASA or other anti-platelet agents for prophylaxis of cardiovascular thromboembolic diseases. Anti-platelet therapies (e.g. ASA) should NOT be discontinued. There is some evidence that use of NSAIDs with ASA can markedly attenuate the cardioprotective effects of ASA (see DRUG INTERACTIONS - Drug-Drug Interactions - Acetylsalicylic Acid or other NSAIDs).

Concomitant administration of CELEBREX with low dose ASA increases the risk of GI ulceration and associated complications.

Blood dyscrasias: Blood dyscrasias (such as neutropenia, leukopenia, thrombocytopenia, aplastic anemia and agranulocytosis) associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) are rare, but could occur with severe consequences.

Anemia is sometimes seen in patients receiving NSAIDs, including CELEBREX. This may be due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including CELEBREX, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia or blood loss.

In controlled clinical trials the incidence of anemia was 0.6% with CELEBREX and 0.4% with placebo. Serious potentially fatal bleeding events have been reported, predominantly in the elderly, in patients receiving CELEBREX concurrently with warfarin or similar agents (see DRUG INTERACTIONS - Drug-Drug Interactions and ADVERSE REACTIONS - Post-Market Adverse Drug Reactions).

Hepatic / Biliary / Pancreatic

As with other NSAIDs, borderline elevations of one or more liver enzyme tests (AST, ALT, alkaline phosphatase) may occur in up to 15% of patients. These laboratory abnormalities may progress, may remain essentially unchanged, or may be transient with continuing therapy.

In controlled clinical trials of CELEBREX, the incidence of borderline elevations of liver tests 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.

A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with CELEBREX. Severe hepatic reactions, including liver necrosis and hepatic failure (with fatal outcomes or requiring liver transplant), fulminant hepatitis (with fatal outcome), cholestatic hepatitis (with fatal outcome) and jaundice have been reported with CELEBREX.

Although such reactions are rare, if abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop (e.g. jaundice), or if systemic manifestations occur (e.g., eosinophilia, associated with rash, etc.), CELEBREX should be discontinued (see CONTRAINDICATIONS).

If there is a need to prescribe this drug in the presence of impaired liver function, it must be done under strict observation.

Hypersensitivity Reactions

Allergies to Sulfonamides: See CONTRAINDICATIONS

Anaphylactoid Reactions: As with NSAIDs in general, anaphylactoid reactions have occurred in patients without known prior exposure to CELEBREX. In post-marketing experience, very rare cases of anaphylactic/anaphylactoid reactions and angioedema have been reported in patients receiving CELEBREX. CELEBREX should NOT be given to patients with the ASA-triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking ASA or other NSAIDs (see CONTRAINDICATIONS).

ASA-Intolerance: CELEBREX should not be given to patients with the complete or partial syndrome of ASA-intolerance (rhinosinusitis, urticaria/angioedema, nasal polyps, asthma) in whom asthma, anaphylaxis, urticaria/angioedema, rhinitis or other allergic manifestations are precipitated by ASA or other NSAIDs. Fatal anaphylactoid reactions have occurred in such individuals. As well, 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 (see CONTRAINDICATIONS).

Cross-Sensitivity: Patients sensitive to one NSAID may be sensitive to any of the other NSAID as well.

Serious Skin Reactions: see WARNINGS AND PRECAUTIONS - Skin

Immune

See WARNINGS AND PRECAUTIONS – Infection – Aseptic Meningitis

Infection

CELEBREX, in common with other NSAIDs, may mask signs and symptoms of an underlying infectious disease.

Aseptic Meningitis: Rarely, with some NSAIDs, the symptoms of aseptic meningitis (stiff neck, severe headaches, nausea and vomiting, fever or clouding of consciousness) have been observed. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissues diseases, etc.) seem to be pre-disposed. Therefore, in such patients, the physician must be vigilant to the development of this complication.

Neurologic

Some patients may experience drowsiness, dizziness, blurred vision, vertigo, tinnitus, hearing loss, insomnia or depression with the use of NSAIDs, such as CELEBREX. If patients experience such adverse reaction(s), they should exercise caution in carrying out activities that require alertness.

Ophthalmologic

Blurred and/or diminished vision has been reported with the use of NSAIDs. If such symptoms develop CELEBREX should be discontinued and an ophthalmologic examination performed. Ophthalmic examination should be carried out at periodic intervals in any patient receiving CELEBREX for an extended period of time.

Peri-Operative Considerations

Coronary Artery Bypass Graft Surgery: See CONTRAINDICATIONS

Psychiatric

See WARNINGS AND PRECAUTIONS – Neurologic

Renal

Long-term administration of NSAIDs to animals has resulted in renal papillary necrosis and other abnormal renal pathology. In humans, there have been reports of acute interstitial nephritis, hematuria, low grade proteinuria and occasionally nephrotic syndrome and acute glomerulonephritis.

Renal insufficiency due to NSAID use is seen in patients with pre-renal conditions leading to reduction in renal blood flow or blood volume. Under these circumstances, renal prostaglandins help maintain renal perfusion and glomerular filtration rate (GFR). In these patients, administration of a NSAID may cause a reduction in prostaglandin synthesis leading to impaired renal function. Patients at greatest risk of this reaction are those with pre-existing renal insufficiency (GFR <60 mL/min or 1 mL/s), dehydrated patients, patients on salt restricted diets, those with congestive heart failure, cirrhosis, liver dysfunction, taking angiotensin-converting enzyme inhibitors, angiotensin-II receptor blockers, cyclosporin, diuretics, and those who are elderly. In such patients, renal function should be monitored. Serious or life-threatening renal failure has been reported in patients with normal or impaired renal function after short term therapy with NSAIDs. Even patients at risk who demonstrate the ability to tolerate a NSAID under stable conditions may decompensate during periods of added stress (e.g. dehydration due to gastroenteritis). Discontinuation of NSAIDs is usually followed by recovery to the pre-treatment state.

Clinical trials with CELEBREX have shown renal effects similar to those observed with comparator NSAIDs (see CONTRAINDICATIONS).

Caution should be used when initiating treatment with NSAIDS, such as CELEBREX, in patients with considerable dehydration. Such patients should be rehydrated prior to initiation of therapy. Caution is also recommended in patients with pre-existing kidney disease.

Advanced Renal Disease: No information is available from controlled clinical studies regarding the use of CELEBREX in patients with advanced kidney disease. In post-marketing experience, serious renal failure, including the need for dialysis, and fatalities have been reported in patients with impaired renal function. Therefore, treatment with CELEBREX, as with NSAIDs, is not recommended in these patients with advanced renal disease. Kidney function should be monitored, especially in high-risk populations, such as the elderly, patients with cardiovascular disease and diabetes mellitus, as well as in the setting of concomitant use of diuretics and ACE inhibitors (see CONTRAINDICATIONS).

Fluid and Electrolyte Balance: Use of NSAIDs, such as CELEBREX, can promote sodium retention in a dose-dependent manner, which can lead to fluid retention and edema, and consequences of increased blood pressure and exacerbation of congestive heart failure. Thus, caution should be exercised in prescribing CELEBREX in patients with a history of congestive heart failure, compromised cardiac function, hypertension, increased age or other conditions predisposing to fluid retention (see WARNINGS AND PRECAUTIONS – Cardiovascular).

Use of NSAIDs, such as CELEBREX, can increase the risk of hyperkalemia, especially in patients with diabetes mellitus, renal failure, increased age, or those receiving concomitant therapy with adrenergic blockers, angiotensin-converting enzyme inhibitors, angiotensin-II receptor antagonists, cyclosporin, or some diuretics.

Electrolytes should be monitored periodically (see CONTRAINDICATIONS).

Fluid retention has been observed in 2.1% of patients taking CELEBREX in clinical trials (see ADVERSE REACTIONS – Clinical Trials Adverse Drug Reactions). In a prospective long-term outcome study (CLASS), hypertension was observed in 2.0%, 3,1% and 2.0% of patients receiving 400 mg BID CELEBREX (N=3987), 800mg TID ibuprofen (N=1985) and 75mg BID diclofenac (N=1996), respectively. The corresponding rates for edema were: 3.7%, 5.2% and 3.5%, respectively (see ADVERSE REACTIONS - Clinical Trials Adverse Drug Reactions).

Respiratory

ASA-induced asthma is an uncommon but very important indication of ASA and NSAID sensitivity. It occurs more frequently in patients with asthma who have nasal polyps.Cases of pneumonitis, some serious, were identified in patients taking celecoxib.

Sexual Function / Reproduction

The use of CELEBREX, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. Therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of CELEBREX should be considered.

Skin

In rare cases, serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme have been associated with the use of some NSAIDs. Because the rate of these reactions is low, they have usually been noted during post-marketing surveillance in patients taking other medications also associated with the potential development of these serious skin reactions. Thus, causality is NOT clear. These reactions are potentially life threatening but may be reversible if the causative agent is discontinued and appropriate treatment instituted. Patients should be advised that if they experience a skin rash they should discontinue their NSAID and contact their physician for assessment and advice, including which additional therapies to discontinue.

Serious skin reactions, some of them fatal, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), exfoliative dermatitis , and toxic epidermal necrolysis, have been reported very rarely in association with the use of CELEBREX (see ADVERSE REACTIONS - Post-Market Adverse Drug Reactions). Patients appear to be at higher risk for these events early in the course of therapy: the onset of the event occurring in the majority of cases within the first month of treatment. CELEBREX should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Special Populations

Pregnant Women: CELEBREX is CONTRAINDICATED for use during the third trimester of pregnancy because of risk of premature closure of the ductus arteriosus and the potential to prolong parturition (see TOXICOLOGY). Caution should be exercised in prescribing CELEBREX during the first and second trimesters of pregnancy (see TOXICOLOGY).

NSAIDs including CELEBREX may result in reduction of amniotic fluid volume and even oligohydramnios. Such effects may occur within a few days after treatment initiation and are usually reversible. The rate of oligohydramnios after treatment with some NSAIDs for 2 to 8 weeks was reported as high as 38% or even higher.  NSAIDs were also shown to cause significant reduction in fetal urine production prior to reduction of amniotic fluid volume. Pregnant women on CELEBREX should be closely monitored for amniotic fluid volume.

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or the embryo-fetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation after use of a prostaglandin synthesis inhibitor in early pregnancy.

In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-fetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.

Nursing Women: See CONTRAINDICATIONS

Paediatrics (<18 years of age): See CONTRAINDICATIONS

Geriatrics (>65 years of age): Patients older than 65 years (referred to in this document as older or elderly) and frail or debilitated patients are more susceptible to a variety of adverse reactions from NSAIDs. The incidence of these adverse reactions increases with dose and duration of treatment. In addition, these patients are less tolerant to ulceration and bleeding. Most reports of fatal GI events are in this population. Older patients are also at risk of lower esophageal injury including ulceration and bleeding. For such patients, consideration should be given a starting dose lower than the one usually recommended, with individual adjustment when necessary and under close supervision.

CELEBREX has been studied in elderly patients. Of the total number of patients who received CELEBREX in clinical trials, more than 3,300 patients (25%) were 65-74 years of age, while approximately 1,300 additional patients (10%) were 75 years and over (see ADVERSE REACTIONS). While the incidence of adverse experiences tended to be higher in elderly patients, no substantial differences in safety and effectiveness were observed between these subjects and younger patients (see WARNINGS AND PRECAUTIONS – Gastrointestinal (GI) System and ADVERSE REACTIONS – Adverse Drug Reaction Overview).

CYP2C9 Poor Metabolizers: Patients who are known, or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution. CELEBREX should be introduced at half the lowest recommended dose in CYP2C9 poor metabolizers, with a maximum recommended dose of 100 mg daily (see DRUG INTERACTIONS and DOSAGE AND ADMINISTRATION).

Monitoring and Laboratory Tests

Cardiovascular (Hypertension): Blood pressure should be monitored regularly during therapy with CELEBREX.

Hematologic: Patients on long-term treatment with NSAIDs, including CELEBREX, should have their hemoglobin, hematocrit, and blood cell count checked if they exhibit any signs or symptoms of anemia or blood loss.

Concurrent therapy of CELEBREX with anticoagulants requires close monitoring of the international normalized ratio (INR)/anticoagulation.

Hepatic: Patient with symptoms and/or signs of liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored carefully for evidence of the development of a more severe hepatic reaction while on therapy with CELEBREX. If abnormal liver tests persist or worsen, CELEBREX should be discontinued.

Pregnancy: Pregnant women on CELEBREX should be closely monitored for amniotic fluid volume since CELEBREX may result in reduction of amniotic fluid volume and even oligohydramnios (see Special Populations). CELEBREX is CONTRAINDICATED for use during the third trimester of pregnancy.

Renal: Renal function (serum creatinine and serum urea etc.) should be monitored in high-risk populations, such as the elderly, patients with advanced renal disease, patients with cardiovascular disease and diabetes mellitus, as well as in the setting of concomitant use of diuretics and ACE inhibitors (see CONTRAINDICATIONS). If abnormal renal tests persist or worsen, CELEBREX should be discontinued.

Patients on long-term treatment with NSAIDs, including CELEBREX, should have their electrolytes, such as serum potassium, checked regularly if they exhibit any signs or symptoms of renal disease.

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