Celexa Consumer Drug Information

Why is this drug prescribed?
Celexa is used to treat major depression--a stubbornly low mood that persists nearly every day for at least 2 weeks and interferes with everyday living. Symptoms may include loss of interest in your usual activities, insomnia or excessive sleeping, a change in weight or appetite, constant fidgeting or a slowdown in movement, fatigue, feelings of worthlessness or guilt, difficulty thinking or concentrating, and repeated thoughts of suicide.

Like the antidepressant medications Paxil, Prozac, and Zoloft, Celexa is thought to work by boosting serotonin levels in the brain. Serotonin, one of the nervous system's primary chemical messengers, is known to elevate mood.

Online Canadian Drugstore is the alternative to costly prescription drugs. We will deliver the medications to your door at the price they cost in Canada.

What is the most important information I should know about citalopram?
• You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are under 18 years old. Talk with your doctor about this risk. While you are taking citalopram you will need to be monitored for worsening symptoms of depression and/ or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed. In addition to you watching for changes in your own symptoms, your family or other caregivers should be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
• Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/ or physical hyperactivity), thoughts of suicide or hurting yourself.
• Do not take citalopram together with a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take citalopram. After you stop taking citalopram, you must wait at least 14 days before you start taking an MAOI.
• Some antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking citalopram, do not stop taking the medication without first talking to your doctor.

How should I take this medicine?
Take citalopram tablets by mouth. Follow the directions on the prescription label. Swallow the tablets with a drink of water. Citalopram can be taken with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your prescriber or health care professional's advice.

Celexa Oral Side Effects
Nausea, vomiting, lack of appetite, diarrhea, drowsiness, dizziness, trouble sleeping, dry mouth, muscle/joint pain, fatigue, or yawning may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: changes in sexual ability/desire, increased sweating, persistent nausea/vomiting, uncontrolled movements (tremor), unusual or severe mental/mood changes, weight changes.

Tell your doctor immediately if any of these unlikely but serious side effects occur: black stools, change in frequency of menstrual periods, "coffee-ground" vomit, confusion, easy bruising/bleeding, fast heartbeats, seizures, vision problems.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing.

If you notice other effects not listed above, contact your doctor or pharmacist.

CELEBREX is a prescription medicine for:

Relief of the joint pain, swelling, and stiffness of osteoarthritis (OA). OA is a type of arthritis caused by wear and tear on bones and joints

Relief of the joint pain, swelling, and stiffness of adult rheumatoid arthritis (RA). RA is an autoimmune disease that attacks healthy joint tissue, starting a process of inflammation and joint damage

Management of acute pain in adults (such as pain from strains and sprains) or pain after surgery
Treatment of primary dysmenorrhea (painful menstrual cramps)
Relief of signs and symptoms of ankylosing spondylitis, a painful form of arthritis that primarily affects the spine. Ankylosing spondylitis usually strikes young adults. It can cause inflammation, pain and stiffness in the shoulders, knees, hips, ribs and feet

The most important fact about this drug

Although Celebrex is easy on the stomach, it still poses some degree of risk--especially if you've had a stomach ulcer or gastrointestinal bleeding in the past. If you've ever had such problems, make sure the doctor is aware of it. And be sure to alert the doctor if you develop any digestive problems or black, tarry stools.

What is the most important information you should know about Celebrex?
• Recent information suggests a possible increased risk for heart attack and stroke in patients taking Celebrex. The relevance of this information is still not known. Ask your doctor if Celebrex is right for you.
• Do not take Celebrex without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol, and others) or sulfisoxazole (Gantrisin); aspirin; or another NSAID such as valdecoxib (Bextra), ibuprofen (Motrin, Advil, Nuprin, and others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin). You may experience a similar reaction to Celebrex.
• Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; bloody vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of the skin or eyes;"flu-like" symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects.

  What makes CELEBREX different?

CELEBREX works to relieve arthritis pain by targeting a certain enzyme in the body. An enzyme is a protein that causes chemical changes in other substances in the body. The enzyme that CELEBREX targets is called COX-2. The COX-2 enzyme plays a key role in causing both pain and inflammation.

The body also makes an enzyme called COX-1. This enzyme helps protect the lining of the stomach. Most pain relievers work by blocking the actions of both the COX-1 and COX-2.

CELEBREX is different because, when taken at suggested doses, it targets the COX-2 enzyme, but not the COX-1. For this reason, doctors refer to CELEBREX as a COX-2–specific inhibitor.

David's Canadian Drug Store Inform You
How to take this medication?

For best results, take Celebrex regularly, exactly as prescribed. You can take it with or without food.

--If you miss a dose...

Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.

--Storage instructions...

Store at room temperature.

What should I discuss with my healthcare provider before taking Celebrex?
• Recent information suggests a possible increased risk for heart attack and stroke in patients taking Celebrex. The relevance of this information is still not known. Ask your doctor if Celebrex is right for you.
• Do not take Celebrex without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol, and others) or sulfisoxazole (Gantrisin); aspirin; or another NSAID such as valdecoxib (Bextra), ibuprofen (Motrin, Advil, Nuprin, and others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin). You may experience a similar reaction to Celebrex.

  Before taking Celebrex, tell your doctor if you
•smoke;
• drink alcohol;
• have an ulcer or bleeding in the stomach;
• have liver disease;
• have kidney disease;
• have coronary artery disease (CAD);
• have arteriosclerotic disease (hardening of the arteries, clogged or blocked arteries);
• have asthma;
• have congestive heart failure;
• have fluid retention;
• have heart disease;
• have high blood pressure;
• have a coagulation (bleeding) disorder or are taking an anticoagulant (blood thinner) such as warfarin (Coumadin); or
• are taking a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others.
• You may not be able to take Celebrex, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions, or are taking any of the medicines, listed above.
• Celebrex is in the FDA pregnancy category C. This means that it is not known whether it will harm an unborn baby. Celebrex should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby's heart. Do not take Celebrex without first talking to your doctor if you are pregnant.
• It is not known whether Celebrex passes into breast milk. Do not take Celebrex without first talking to your doctor if you are breast-feeding.
• If you are over the age of 65 years, you may be more likely to experience side effects from Celebrex. You may require a lower dosage or special monitoring during your therapy.

How CELEBREX Works

CELEBREX works to relieve arthritis pain by targeting a certain enzyme in the body. An enzyme is a protein that causes chemical changes in other substances in the body. The enzyme that CELEBREX targets is called COX-2. The COX-2 enzyme plays a key role in causing both pain and inflammation.

The body also makes an enzyme called COX-1. This enzyme helps protect the lining of the stomach. Most pain relievers work by blocking the actions of both the COX-1 and COX-2.

CELEBREX is different because, when taken at suggested doses, it targets the COX-2 enzyme, but not the COX-1. For this reason, doctors refer to CELEBREX as a COX-2–specific inhibitor.

  What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Celebrex.

More common side effects may include:
Abdominal pain, diarrhea, headache, indigestion, nausea, respiratory infection, sinus inflammation

Less common side effects may include:
Back pain, dizziness, gas, insomnia, rash, runny nose, sore throat, swelling

Rare side effects may include:
Allergic reactions, anxiety, belching, blisters in mouth and eyes, blood disorders, blood infections, blurred vision, bone disorders, breast pain, breast problems, bronchitis, cataracts, chest pain, colitis, conjunctivitis (pinkeye), constipation, coughing, cysts, dark-tarry stools, deafness, depression, dermatitis, diabetes, difficult urination, difficulty breathing, difficulty swallowing, drowsiness, dry mouth, dry skin, earache, ear infection, ear ringing, esophageal perforation, eye infection, eye pain, fainting, fatigue, fever, flu symptoms, fungal infection, gallstones, gangrene, general swelling, glaucoma (pressure in the eye), hair loss, heart failure, heart irregularities, hemorrhoids, hepatitis, hernia of the stomach, herpes infection, hives, hot flashes, increased appetite, increased blood pressure, increased heart rate, increased muscle tone, increased urination, infection, inflammation of the digestive tract, inflammation of the bladder, inflammation of the blood vessels, intestinal bleeding, intestinal obstruction or perforation, itching, jaundice, joint pain or inflammation, kidney problems, laryngitis, leg cramps, liver problems, loss of appetite, loss of balance, low blood sugar, menstrual disorders, migraine headache, mouth ulcers, muscle ache, nail disorders, neck stiffness, nerve pain, nervousness, nosebleeds, pain, painful urination, pancreatitis, phlebitis, pneumonia, poor coordination, prostate problems, severe diarrhea, severe skin rash and peeling, skin reaction due to sunlight, skin sensitivity, skin tingling, stroke, suicide, sweating, swollen face and throat, taste disturbances, tendonitis, tiredness, tooth disorders, urinary incontinence, urinary tract infections, vaginal problems, vomiting, weakness, weight gain

What you shouldavoid while taking Celebrex?
• There are no restrictions on food, beverages, or activity while taking Celebrex unless otherwise directed by your doctor.

What happens if you miss a dose?
• Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose as directed. Do not take a double dose of this medication unless your doctor directs otherwise.

  What are the most common side effects of CELEBREX?

All medicines have possible side effects. Although CELEBREX is usually well-tolerated, in clinical trials some common side effects were indigestion, diarrhea, and abdominal pain. In studies, the percentage of patients who stopped taking CELEBREX due to side effects was similar to the percentage of patients who were taking a placebo (a sugar pill) and stopped because of side effects.

Why should this drug not be prescribed?

Do not take Celebrex if you are allergic to sulfonamide drugs such as sulfadiazine, sulfisoxazole, Gantanol, and Thiosulfil. Also avoid Celebrex if you've ever suffered an asthma attack, face and throat swelling, or skin eruptions after taking aspirin or other NSAIDs. If you find that you are allergic to Celebrex, you will not be able to use it.

Are there other side effects?

CELEBREX may increase the chance of serious heart problems such as heart attacks or strokes which can be fatal. Serious skin reactions or stomach problems such as bleeding can occur without warning and may be fatal. As always, patients should discuss their individual health history with their doctors to understand these risks.

Special warnings about this medication

Remember to tell your doctor about any stomach ulcers or bleeding you've had in the past. Also alert your doctor if you develop any digestive problems, swelling, or rash.

If you have asthma, use Celebrex with caution. It could trigger an attack, especially if you are also sensitive to aspirin.

If you are taking a steroid medication for your arthritis, do not discontinue it abruptly when you begin therapy with Celebrex. Celebrex is not a substitute for such drugs.

Celebrex has been known to cause kidney or liver problems, particularly in people with an existing condition. If you have such a disorder, take Celebrex with caution. If you develop symptoms of liver poisoning, stop taking the drug and see your doctor immediately. Warning signs include nausea, fatigue, itching, yellowish skin, pain in the right side of the stomach, and flu-like symptoms.

If you are prone to anemia (loss of red blood cells), make sure the doctor knows about it. Celebrex occasionally fosters this problem.

Celebrex sometimes causes water retention, which can aggravate swelling, high blood pressure, and heart failure. Use this drug with caution if you have any of these conditions.

There is no proof that Celebrex reduces the odds of cancer in people who take the drug for FAP. Although Celebrex can reduce the number of growths, you'll still need the other treatments and frequent checkups that this condition requires.

What other drugs will affect Celebrex?
• Before taking Celebrex, tell your doctor if you are taking any of the following drugs:
• aspirin or another salicylate (form of aspirin) such as salsalate (Disalcid), choline salicylate-magnesium salicylate (Trilisate, Tricosal, others), and magnesium salicylate (Doan's, Bayer Select Backache Formula, others);
• an over-the-counter cough, cold, allergy, or pain medicine that contains aspirin, ibuprofen, naproxen, or ketoprofen;
• a diuretic (water pill) such as furosemide (Lasix), hydrochlorothiazide (HydroDiuril, others), chlorothiazide (Diuril, others), chlorthalidone (Hygroton, Thalitone), and others;
• an angiotensin-converting-enzyme inhibitor (ACE inhibitor) such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), and others;
• a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others;
• an anticoagulant (blood thinner) such as warfarin (Coumadin);
• lithium (Eskalith, Lithobid, others); or
• fluconazole (Diflucan).
• You may not be able to take Celebrex, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Celebrex. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines including vitamins, minerals, and herbal products.

How to Take CELEBREX

CELEBREX makes it easy for your doctor to customize your treatment to fit your individual treatment needs. For most people, one CELEBREX works hard all day and night to help relieve your arthritis pain and can be taken as needed for relief from acute pain. It targets the pain, inflammation, and stiffness that's part of arthritis. CELEBREX is available in 100-mg and 200-mg capsules. CELEBREX is also available in a 400-mg capsule. Your doctor will find the dosage that's right for your pain. CELEBREX should always be taken exactly as your doctor has prescribed. Taking CELEBREX on a regular basis will help it work better against your arthritis pain.

When to take CELEBREX

CELEBREX can be taken with or without food at any time of the day. You may find that if you take it at the same time every day, you'll be less likely to skip a dose by mistake. If you do forget to take a dose, don't double up. Taking too much of any medication at one time can present a health risk. Wait and take it at your next regularly scheduled time. If you have questions, be sure to call your doctor. It's important to take the time to talk with your doctor or pharmacist about how you should take CELEBREX.

Possible food and drug interactions when taking this medication

If Celebrex is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Celebrex with the following:

ACE-inhibitors (a type of blood pressure and heart medication, including such drugs as Capoten, Vasotec, and Prinivil)
Blood thinning agents such as Coumadin
Fluconazole (Diflucan)
Furosemide (Lasix)
Lithium (Eskalith, Lithobid)
Thiazide diuretics (water pills) such as hydrochlorothiazide and Dyazide

If you take low-dose aspirin to protect against heart attack, you can continue taking it with Celebrex. Using aspirin increases your risk of stomach ulcers or bleeding, but Celebrex does not have aspirin's protective effect on the heart.

Who Can Take CELEBREX

CELEBREX can be taken by adults suffering from arthritis pain, inflammation, and stiffness. It can also be taken for relief from acute pain. Some examples of acute pain include pain from strains and sprains or pain after surgery. Sometimes CELEBREX is prescribed to relieve painful menstrual cramps.

What to do if you are pregnant or nursing?

No studies of CELEBREX in pregnant women have been performed. CELEBREX should be used during pregnancy only if you and your doctor decide that the potential benefit justifies the potential risk to the fetus. Women in the third trimester of pregnancy should not take CELEBREX. The effects of CELEBREX on labor and delivery in pregnant women are unknown.

You should not take CELEBREX if you are breast-feeding because CELEBREX is passed into human milk. Limited data from one subject indicates that CELEBREX is also passed in human milk. Because many drugs are passed in human milk, a decision should be made whether to stop nursing or to stop taking CELEBREX.

Special information if you are pregnant or breastfeeding

Celebrex can harm a developing baby if taken during the third trimester, and its safety earlier in pregnancy has not been confirmed. Take it during pregnancy only if you feel the risk is justified.

It's possible that Celebrex makes its way into breast milk (scientists aren't sure), and it could cause serious reactions in a nursing infant. If this drug is essential to your health, your doctor may advise you to discontinue breastfeeding.

Why is this drug prescribed?

Celebrex is prescribed for acute pain, menstrual cramps, and the pain and inflammation of osteoarthritis and rheumatoid arthritis. It is the first of a new class of nonsteroidal anti-inflammatory drugs (NSAIDs) called "COX-2 inhibitors." Like older NSAIDs such as Motrin and Naprosyn, Celebrex is believed to fight pain and inflammation by inhibiting the effect of a natural enzyme called COX-2. Unlike the older medications, however, it does not interfere with a similar substance, called COX-1, which exerts a protective effect on the lining of the stomach. Celebrex is therefore less likely to cause the bleeding and ulcers that sometimes accompany sustained use of the older NSAIDs.

Celebrex has also been found to reduce the number of colorectal polyps (growths in the wall of the lower intestine and rectum) in people who suffer from the condition called familial adenomatous polyposis (FAP), an inherited tendency to develop large numbers of colorectal polyps that eventually become cancerous.

Most important fact about this drug

Although Celebrex is easy on the stomach, it still poses some degree of risk--especially if you've had a stomach ulcer or gastrointestinal bleeding in the past. If you've ever had such problems, make sure the doctor is aware of it. And be sure to alert the doctor if you develop any digestive problems or black, tarry stools.

Recommended dosage

Osteoarthritis

The recommended daily dose is 200 milligrams, taken as a single dose or in 100-milligram doses twice a day.

Rheumatoid Arthritis

The recommended dose is 100 to 200 milligrams twice a day.

Acute Pain and Menstrual Cramps

The recommended starting dose is 400 milligrams, followed by an additional 200 milligrams if needed on the first day. On subsequent days, the recommended dosage is 200 milligrams twice a day.

Familial Adenomatous Polyposis

The recommended dose is 400 milligrams twice a day with food.

Dosage is typically cut in half for people with moderate liver problems.

OVERDOSE
No overdoses of CELEBREX were reported during clinical trials. Doses up to 2400 mg/day for up to 10 days in 12 patients did not result in serious toxicity. 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.

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. No information is available regarding the removal of celecoxib by hemodialysis, but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

 More About Overdosage
Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

Symptoms of Celebrex overdose may include:
Breathing difficulties, coma, drowsiness, gastrointestinal bleeding, high blood pressure, kidney failure, nausea, sluggishness, stomach pain, vomiting

Why is this drug prescribed?

Celebrex is prescribed for acute pain, menstrual cramps, and the pain and inflammation of osteoarthritis and rheumatoid arthritis. It is the first of a new class of nonsteroidal anti-inflammatory drugs (NSAIDs) called "COX-2 inhibitors." Like older NSAIDs such as Motrin and Naprosyn, Celebrex is believed to fight pain and inflammation by inhibiting the effect of a natural enzyme called COX-2. Unlike the older medications, however, it does not interfere with a similar substance, called COX-1, which exerts a protective effect on the lining of the stomach. Celebrex is therefore less likely to cause the bleeding and ulcers that sometimes accompany sustained use of the older NSAIDs.

Celebrex has also been found to reduce the number of colorectal polyps (growths in the wall of the lower intestine and rectum) in people who suffer from the condition called familial adenomatous polyposis (FAP), an inherited tendency to develop large numbers of colorectal polyps that eventually become cancerous.

 David's Canadian Drug Store - PRECAUTIONS
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.

The pharmacological activity of CELEBREX in reducing inflammation, and possibly fever, may diminish the utility of these diagnostic signs in detecting infectious complications of presumed noninfectious, painful conditions.

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.

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.

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 (see CLINICAL PHARMACOLOGY—Platelets).

Preexisting Asthma: 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.

Who should not take CELEBREX?

You should not take CELEBREX if you:

Are allergic to celecoxib, the active ingredient in CELEBREX
Have had allergic reactions to certain drugs called sulfonamides
Have experienced asthma, hives, or allergic reactions after taking aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs)
Are in late pregnancy
Are breast-feeding
Are having or have recently had a certain kind of heart surgery called coronary artery bypass graft (CABG)