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Celebrex Frequently Asked Questions

What is Celebrex?

Celebrex™ is a nonsteroidal anti-inflammatory drug that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models.

How does Celebrex work?

NSAIDs target an enzyme called cyclooxegenase that is responsible for much inflammation behind pain. But it turned out there are two types of this enzyme. Cox-2 was behind the inflammation, while cox-1 actually protects the stomach lining. Unfortunately, NSAIDs target both which often can result in ulcers.

The mechanism of action of Celebrex™ is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2), and at therapeutic concentrations in humans, Celebrex™ does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme.

The theory was that if scientists could develop a more specific drug that targeted just cox-2, it would alleviate pain and inflammation while not effecting the delicate lining of the stomach.

In studies of about 13,000 patients, it appeared to work almost as well as prescription-strength naproxen in-patients with osteoarthritis. In rheumatoid arthritis sufferers, it appeared to work almost as well as another popular NSAID, diclofenac.

Clinical testing involving some 4,500 endoscopies -- probing a tube into patients' stomachs to see if ulcers were forming even before they experienced symptoms. Some 25 percent to 40 percent of patients taking ibuprofen or naproxen showed these mini-ulcers, vs. 5 percent to 10 percent of Celebrex patients.

What other clinical studies have been done?

Celebrex™ has demonstrated significant reduction in joint pain secondary to osteoarthritis (OA) compared to a placebo. Celebrex™ was evaluated for treatment of the signs and the symptoms of OA of the knee and hip in approximately 4,200 patients in placebo- and active-controlled clinical trials of up to 12 weeks duration. In patients with OA, treatment with Celebrex™ 100 mg twice per day or 200 mg once per day resulted in improvement in WOMAC (Western Ontario and McMaster Universities) osteoarthritis index, a composite of pain, stiffness, and functional measures in OA. In three 12-week studies of pain accompanying OA flare, Celebrex™ doses of 100 mg twice per day and 200 mg twice per day provided significant reduction of pain within 24-48 hours of initiation of dosing. At doses of 100 mg twice per day or 200 mg twice per day the effectiveness of Celebrex™ was shown to be similar to that of naproxen 500 mg BID. Doses of 200 mg twice per day provided no additional benefit above that seen with 100 mg twice per day. A total daily dose of 200 mg has been shown to be equally effective whether administered as 100 mg twice per day or 200 mg once per day.

Celebrex™ has demonstrated significant reduction in joint tenderness/pain and joint swelling in Rheumatoid Arthritis compared to placebo. Celebrex™ was evaluated for treatment of the signs and symptoms of RA in approximately 2,100 patients in placebo- and active-controlled clinical trials of up to 24 weeks in duration. Celebrex™ was shown to be superior to placebo in these studies, using the ACR20 Responder Index, a composite of clinical, laboratory, and functional measures in RA. Celebrex™ doses of 100 mg twice per day and 200 mg twice per day were similar in effectiveness and both were comparable to naproxen 500 mg twice per day.

Although Celebrex™ 100 mg twice per day and 200 mg twice per day provided similar overall effectiveness, some patients derived additional benefit from the 200 mg twice per day dose. Doses of 400-mg day provided no additional benefit above that seen with 100-200 mg twice per day.

What is the appropriate dose of Celebrex?

As with any medication, the lowest dose of Celebrex™ should be sought for each patient. For relief of the signs and symptoms of osteoarthritis the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice per day.

For relief of the signs and symptoms of rheumatoid arthritis the recommended oral dose is 100 to 200 mg twice per day. (these doses are only generalizations; doses may vary depending on the patient's medical history).

How is Celebrex supplied?

Celebrex™ 100-mg capsules are white, reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body.

Celebrex™ 200-mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body.

In what populations is Celebrex contraindicated?

Celebrex™ is contraindicated in patients with known hypersensitivity to celecoxib.

Celebrex™ should not be given to patients who have demonstrated allergic-type reactions to sulfonamides.

Celebrex™ should not be given to patients who have experienced asthma, urticaria, or allergic-type NSAIDs have been reported in such patients.

What are side effects associated with Celebrex?

Of the Celebrex treated patients in controlled trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain. More than 8,500 patients have received a total daily dose of Celebrex of 200 mg (100 mg BID or 200 mg QD) or more, including more than 400 treated at 800 mg (400 mg BID). Approximately 3,900 patients have received Celebrex at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more.

Adverse events from controlled trials: Table 1 lists all adverse events, regardless of causality, occurring in >=2% of patients receiving Celebrex from 12 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group.

Table 1
Adverse Events Occurring in >= 2% of Celebrex Patients

Celebrex
(100-200 mg BID
or 200 mg QD)

Placebo

Naproxen
500 mg BID

Ibuprofen
800 mg TID

Diclofenac
75 mg BID

(N=4146)

(N=1366)

(N=1864)

(N=387)

(N=345)

Gastrointestinal

Abdominal pain

4.1%

2.8%

7.7%

9.0%

9.0%

Diarrhea

5.6%

3.8%

5.3%

9.3%

5.8%

Dyspepsia

8.8%

6.2%

12.2%

10.9%

12.8%

Flatulence

2.2%

1.0%

3.6%

4.1%

3.5%

Nausea

3.5%

4.2%

6.0%

3.4%

6.7%

Body as a whole

Back pain

2.8%

3.6%

2.2%

2.6%

0.9%

Peripheral edema

2.1%

1.1%

2.1%

1.0%

3.5%

Injury-accidental

2.9%

2.3%

3.0%

2.6%

3.2%

Central and peripheral nervous system

Dizziness

2.0%

1.7%

2.6%

1.3%

2.3%

Headache

15.8%

20.2%

14.5%

15.5%

15.4%

Psychiatric

Insomnia

2.3%

2.3%

2.9%

1.3%

1.4%

Respiratory

Pharyngitis

2.3%

1.1%

1.7%

1.6%

2.6%

Rhinitis

2.0%

1.3%

2.4%

2.3%

0.6%

Sinusitis

5.0%

4.3%

4.0%

5.4%

5.8%

Upper respiratory tract infection

8.1%

6.7%

9.9%

9.8%

9.9%

Skin

Rash

2.2%

2.1%

2.1%

1.3%

1.2%

In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving Celebrex and 6.1% for patients receiving placebo. Among the most common reasons for discontinuation due to adverse events in the Celebrex treatment groups were dyspepsia and abdominal pain (cited as reasons for discontinuation in 0.8% and 0.7% of Celebrex patients, respectively). Among patients receiving placebo, 0.6% discontinued due to dyspepsia and 0.6% withdrew due to abdominal pain.

The following adverse events occurred in 0.1-1.9% of patients regardless of causality.

Celebrex
(100-200 mg BID or 200 mg QD)

Gastrointestinal: Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting

Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disease, myocardial infarction

General: Allergy aggravated, allergic reaction, asthenia, chest pain, cyst NOS, edema generalized, face edema, fatigue, fever, hot flushes, influenza-like symptoms, pain, peripheral pain

Resistance mechanism disorders: Herpes simplex, herpes zoster, infection bacterial, infection fungal, infection soft tissue, infection viral, moniliasis, moniliasis genital, otitis media

Central, peripheral nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo

Female reproductive: Breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhea, menstrual disorder, vaginal hemorrhage, vaginitis

Male reproductive: Prostatic disorder

Hearing and vestibular: Deafness, ear abnormality, earache, tinnitus

Heart rate and rhythm: Palpitation, tachycardia

Liver and biliary system: Hepatic function abnormal, SGOT increased, SGPT increased

Metabolic and nutritional: BUN increased, CPK increased, diabetes mellitus, hypercholesterolemia, hyperglycemia, hypokalemia, NPN increase, creatinine increased, alkaline phosphatase increased, weight increase

Musculoskeletal: Arthralgia, arthrosis, bone disorder, fracture accidental, myalgia, neck stiffness, synovitis, tendinitis

Platelets (bleeding or clotting): Ecchymosis, epistaxis, thrombocythemia

Psychiatric: Anorexia, anxiety, appetite increased, depression, nervousness, somnolence

Hemic: Anemia

Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnea, laryngitis, pneumonia

Skin and appendages: Alopecia, dermatitis, nail disorder, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, skin dry, sweating increased, urticaria

Application site disorders: Cellulitis, dermatitis contact, injection site reaction, skin nodule

Special senses: Taste perversion

Urinary system: Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus, urinary incontinence, urinary tract infection

Vision: Blurred vision, cataract, conjunctivitis, eye pain, glaucoma

Other serious adverse reactions which occur rarely (<0.1%), regardless of causality: The following serious adverse events have occurred rarely in patients, taking Celebrex.

Cardiovascular: Syncope, congestive heart failure, ventricular fibrillation, pulmonary embolism, cerebrovascular accident, peripheral gangrene, thrombophlebitis

Gastrointestinal: Intestinal obstruction, intestinal perforation, gastrointestinal bleeding, colitis with bleeding, esophageal perforation, pancreatitis, cholelithiasis, ileus

Hemic and lymphatic: Thrombocytopenia

Nervous system: Ataxia

Renal: Acute renal failure

General: Sepsis, sudden death

How does the risk for ulcers, bleeding, perforation etc. compare with other NSAIDs?

Serious gastrointestinal toxicity such as 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.

It is unclear, at the present time, how the above rates apply to Celebrex™ Among 5,285 patients who received Celebrex™ in controlled clinical trials of 1 to 6 months duration (most were 3 month studies) at a daily dose of 200 mg or more, 2 (0.04%) experienced significant upper GI bleeding, at 14 and 22 days after initiation of dosing. Approximately 40% of these 5,285 patients were in studies that required them to be free of ulcers by endoscopy at study entry. Thus it is unclear if this study population is representative of the general population. Prospective, long-term studies required to compare the incidence of serious, clinically significant upper GI adverse events in patients taking Celebrex™ vs. comparator NSAID products have not been performed. 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.

Does age effect the excretion of the medication?

At steady state, elderly subjects (over 65 years old) had a 40% higher Cmax and a 50% higher AUC compared to the young subjects. In elderly females, celecoxib Cmax and AUC are higher than those for elderly males, but these increases are predominantly due to lower body weight in elderly females. Dose adjustment in the elderly is not generally necessary. However, for patients of less than 50 kg in body weight, initiate therapy at the lowest recommended dose.

Can Celebrex be used in pediatric populations?

Celebrex™ capsules have not been investigated in pediatric patients below 18 years of age. Therefore, the use in this population is not recommended at this time

Should pregnant women take Celebrex?

There are no studies in pregnant women or nursing mothers. Therefore, Celebrex™ should not used during pregnancy or while nursing. In late pregnancy Celebrex may cause premature closure of the ductus arteriosus. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Celebrex™ is not recommended in this population.

Should individuals with hepatic impairment take Celebrex?

Celebrex™ capsules should be introduced at a reduced dose in patients with moderate hepatic impairment. Patients with severe hepatic impairment have not been studied, therefore, the use of Celebrex™ in these patients is not recommended at this time.

What about patients with renal insufficiency?

In a cross-study comparison, celecoxib AUC was approximately 40% lower in patients with chronic renal insufficiency (GFR 35-60 ml/min) than that seen in subjects with normal renal function. No significant relationship was found between GFR and celecoxib clearance. Patients with severe renal insufficiency have not been studied.

Should individuals with a history of asthma take Celebrex?

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive 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.

Celebrex™ can cause discomfort and, rarely, more serious side effects, such as gastrointestinal bleeding, which may result in hospitalization and even fatal outcomes. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative signs or symptoms. Patients should promptly report signs or symptoms of gastrointestinal ulceration or bleeding, skin rash, unexplained weight gain, or edema to their physicians.

Are there any significant drug interactions associated with Celebrex?

NSAIDS: Reports suggest that NSAIDs may diminish the antihypertensive effect of Angiotensin Converting Enzyme (ACE) inhibitors. This interaction should be given consideration in patients taking Celebrex™ concomitantly with ACE-inhibitors. Clinical studies, as well as post marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.

Aspirin: Celebrex™ can be used with low dose aspirin. However, concomitant administration of aspirin with Celebrex™ may result in an increased rate of GI ulceration or other complications, compared to use of Celebrex™ alone. Because of its lack of platelet effects, Celebrex™ is not a substitute for aspirin for cardiovascular prophylaxis.

Fluconazole: Concomitant administration of fluconazole at 200 mg QD resulted in a two-fold increase in celecoxib plasma concentration. This increase is due to the inhibition of celecoxib metabolism via P450 2C9 by fluconazole (see Pharmacokinetics � Metabolism). Celebrex™ should be introduced at the lowest recommended dose in patients receiving fluconazole.

Lithium: In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg twice per day with Celebrex™ 200 mg twice per day as compared to subjects receiving lithium alone. Patients on lithium treatment should be closely monitored when Celebrex™ is introduced or withdrawn.

Methotrexate: In an interaction study of rheumatoid arthritis patients taking methotrexate, Celebrex™ did not have a significant effect on the pharmacokinetics of methotrexate.

Warfarin: Anticoagulant activity should be monitored, particularly in the first few days, after initiating or changing CELEBREX therapy in patients receiving warfarin or similar agents, since these patients are at an increased risk of bleeding complications. The effect of celecoxib on the anticoagulant effect of warfarin was studied in a group of healthy subjects receiving daily doses of 2 to 5 mg of warfarin. In these subjects, celecoxib did not alter the anticoagulant effect of warfarin as determined by prothrombin time. However, in post-marketing experience, bleeding events have been reported, predominantly in the elderly, in association with increases in prothrombin time in patients receiving CELEBREX concurrently with warfarin

Is it safe to use Celebrex while taking aspirin?

Approximately 11% of patients (440/4,000) enrolled in 4 of the 5 endoscopic studies were taking aspirin (<=325 mg/day). In the Celebrex™ groups, the endoscopic ulcer rate appeared to be higher in aspirin users than in non-users. However, the increased rate of ulcers in these aspirin users was less than the endoscopic ulcer rates observed in the active comparator groups, with or without aspirin.

Does Celebrex provide the same benefits as aspirin for cardiovascular prophylaxis?

In clinical trials, Celebrex™ at single doses up to 800 mg and multiple doses of 600 mg BID for up to 7 days duration (higher than recommended therapeutic doses) had no effect on platelet aggregation and bleeding time. Comparators (naproxen 500 mg two times per day, ibuprofen 800 mg three time per day, diclofenac 75 mg two times per day) significantly reduced platelet aggregation and prolonged bleeding time.

Significant upper GI bleeding, at 14 and 22 days after initiation of dosing. Approximately 40% of these 5,285 patients were in studies that required them to be free of ulcers by endoscopy at study entry. Thus it is unclear if this study population is representative of the general population. Prospective, long-term studies required to compare the incidence of serious, clinically significant upper GI adverse events in patients taking Celebrex™ vs. comparator NSAID products have not been performed.

How does the intake of food effect Celebrex?

When Celebrex™ capsules were taken with a high fat meal, peak plasma levels were delayed for about 1 to 2 hours with an increase in total absorption (AUC) of 10% to 20%. Coadministration of Celebrex™ with an aluminum- and magnesium-containing antacid resulted in a reduction in plasma celecoxib concentrations with a decrease of 37% in Cmax and 10% in AUC. Celebrex™ capsules can be administered without regard to the timing of meals.

Should Celebrex be prescribed in individuals with a history of ulcers?

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 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.

Are anaphylactic reactions associated with Celebrex?

Anaphylactoid reactions were not reported in patients receiving Celebrex™ in clinical trials. However, as with NSAIDs in general, anaphylactoid reactions may occur in patients without known prior exposure to Celebrex™. Celebrex™ should not be given to patients with the aspirin 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 aspirin or other NSAIDs. Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Should individuals with a history of asthma take Celebrex?

Should individuals with advanced renal disease take Celebrex?

No information is available regarding the use of Celebrex™ in patients with advanced kidney disease. Therefore, treatment with Celebrex™ is not recommended in these patients. If Celebrex™ therapy must be initiated, close monitoring of the patient's kidney function is advisable.

Can Celebrex replace the use of corticosteroids?

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.

Does Celebrex effect any liver tests?

Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs, and notable elevations of ALT or AST (approximately three 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. 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 monitored carefully for evidence of the development of a more severe hepatic reaction while on therapy with Celebrex™. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Celebrex™ should be discontinued.

What are the warning signs and symptoms of hepatotoxicity?

The warning signs and symptoms of hepatotoxicity include: nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness and "flu-like" symptoms. If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.

Does Celebrex effect any other laboratory values?

During the controlled clinical trials, there was an increased incidence of hyperchloremia in patients receiving celecoxib compared with patients on placebo. Other laboratory abnormalities that occurred more frequently in the patients receiving celecoxib included hypophosphatemia, and elevated BUN. These laboratory abnormalities were also seen in patients who received comparator NSAIDs in these studies. The clinical significance of these abnormalities has not been established.

Does Celebrex have any effect on the kidneys?

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. Clinical trials with Celebrex™ have shown renal effects similar to those observed with comparator NSAIDs.

Caution should also be used when initiating treatment with Celebrex™ in patients with considerable dehydration. It is advisable to rehydrate patients first and then start therapy with Celebrex™.

What effect does Celebrex have on the blood?

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 appear to inhibit platelet aggregation at indicated dosages.

Does Celebrex cause fluid retention or edema?

Fluid retention and edema have been observed in some patients taking Celebrex™. Therefore, Celebrex™ should be used with caution in patients with fluid retention, hypertension, or heart failure.

Is Celebrex indicated in the pediatric population?

Safety and effectiveness in pediatric patients below the age of 18 years have not been evaluated. Therefore it is not in the pediatric population.

Has the safety and efficacy been examined in elderly population aged 65 plus?

Of the total number of patients who received Celebrex™ in clinical trials, more than 2,100 were 65-74 years of age, while approximately 800 additional patients were 75 years and over. 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 subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

In clinical studies comparing renal function as measured by the GFR, BUN and creatinine, and platelet function as measured by bleeding time and platelet aggregation, the results were not different between elderly and young volunteers.

What about an overdose with Celebrex?

Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. If an overdose should occur individuals should seek immediate medical attention.

How should Celebrex be stored?

Store at 25�C (77�F); excursions permitted to 15-30�C (59-86�F). Like all medications out of the reach of children.

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