Celebrex (Celecoxib) - What You Need to Know

Celebrex (celecoxib) is the only COX-2 selective NSAID currently on the market in the United States. COX-2 selective NSAIDs are considered less likely to cause stomach problems than traditional NSAIDs -- popular Filagra medications used to treat arthritis. However, all NSAIDs have risk of high blood pressure, kidney problems, fluid retention, and heart risks.

Celebrex was approved on December 31, 1998 by the United States Food and Drug Administration (FDA) for the relief of the signs and symptoms of osteoarthritis and adultrheumatoid arthritis. Celebrex is marketed by Pfizer.

What is the availability of Celebrex?

Celebrex is not available as an over-the-counter drug. It is only available with a prescription. Celebrex comes in two strengths -- 100 mg and 200 mg. The usual recommended daily dose for osteoarthritis is 200 mg, taken as a single dose or in 100 mg doses twice a day. Your doctor will decide the appropriate dose for you and your condition.

When is Celebrex prescribed?

Celebrex is prescribed to relieve the symptoms of osteoarthritis and to relieve the symptoms of rheumatoid arthritis in adults. It is also used to manage acute pain in adults (such as following dental or surgical procedures), and to reduce the number of colon and rectum growths in patients with FAP (Familial Adenomatous Polyposis).

Are there any special instructions regarding how to take Celebrex?

Celebrex should be taken exactly as prescribed. Taking Celebrex with a full glass of water or with food may prevent stomach upset.

Are there patients who should not take Celebrex?

Patients who have an allergic reaction to sulfa should not take Celebrex. Also, aspirin-sensitive patients should not take Celebrex. Aspirin-sensitive patients are those who have experienced hives, asthma, or allergic-type reactions after taking aspirin or other NSAIDs.

The FDA issued a warning on April 7, 2005, regarding cardiovascular risks (such as heart attack and stroke) associated with Celebrex and other NSAIDs. The FDA advised doctors to carefully weigh the potential benefits and risks of Celebrex and other treatment options before a decision is made to use Celebrex.

The FDA and the manufacturer of Celebrex agree that based on current information, Celebrex should still be marketed. However, patients at high risk for heart attack or stroke should consider the warnings and possible alternatives for treatment.

What common side effects can occur with Celebrex?

Some of the common side effects that may be associated with Celebrex include:

• headache
• indigestion
• upper respiratory tract infection
• diarrhea
• sinus inflammation
• stomach pain or nausea

What other special warnings and precautions apply to Celebrex use?

There are certain serious risks associated with Celebrex and other NSAIDs. Celebrex or other NSAIDs can cause bleeding stomach ulcers. Call your doctor if you notice black bowel movements, bloody vomit or vomit that looks like coffee grounds, or burning stomach pain.

Celebrex and other NSAIDs can cause liver damage. Warnings signs for liver damage include nausea, vomiting, tiredness, loss of appetite, itching, yellow skin or eyes, dark urine, flu-like symptoms. Call your doctor if you are experiencing any of these symptoms.

Kidney problems can occur with Celebrex or NSAID use -- either sudden kidney failure or worsening of an existing kidney problem.

Fluid retention can occur with Celebrex or NSAID use. It may be serious if you have high blood pressure or heart failure.

Are there drug interactions associated with Celebrex?

It's important to tell your doctor about all other medications you take. Other medications may affect how Celebrex works and Celebrex may affect how the other medications work. Drugs which can interact with Celebrex include:

• ACE inhibitors (blood pressure medications)
• furosemide
• fluconazole or ketoconazole
• lithium
• phenytoin
• warfarin
• aspirin

Are there special instructions for pregnant or nursing women?

Women who are pregnant, and especially those in their last 3 months, should not take Celebrex. Talk to your doctor if you are pregnant, trying to become pregnant, or breastfeeding.

What are the signs of overdose of Celebrex?

As with any medication, serious consequences may result from an overdose of Celebrex. The following symptoms may occur with Celebrex overdose: breathing difficulties, coma, drowsiness, gastrointestinal bleeding, high blood pressure, kidney failure, nausea, sluggishness, stomach pain, and vomiting. Use Celebrex only as directed to avoid an overdose.

Celebrex Drug Description

CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C₁₇H₁₄F₃N₃O₂S, and the molecular weight is 381.38; the chemical structure is as follows:

CELEBREX (celecoxib) oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate Cialis Professional.

What are the possible side effects of celecoxib (Celebrex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking celecoxib and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
• black, bloody, or tarry stools;
• coughing up blood or vomit that looks like coffee grounds;
• swelling or rapid weight...

What are the precautions when taking celecoxib (Celebrex)?

Before taking celecoxib, tell your doctor or pharmacist if you are allergic to it; or to aspirin, other NSAIDs (e.g., ibuprofen), other COX-2 inhibitors; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

SIDE EFFECTS:See also Warning section.

Stomach upset or gas 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 he or she has judged that 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 unlikely but serious side effects occur: severe headache, unexplained weight gain, swelling of the hands or feet, pain/swelling/warmth in the groin/calf, change in amount of urine, difficult/painful swallowing.

This drug may rarely cause serious liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking celecoxib and consult your doctor or pharmacist immediately: yellowing eyes or skin, dark urine, persistent stomach/abdominal pain, unusual fatigue.

In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS:Before taking celecoxib, tell your doctor or pharmacist if you are allergic to it; or to aspirin, other NSAIDs (e.g., ibuprofen), other COX-2 inhibitors; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood flow problem in the brain (e.g., stroke, cerebrovascular disease), kidney problems, liver problems, heart disease (e.g., angina, heart attack, high blood pressure, congestive heart failure), alcohol use, swelling (e.g., edema), blood disorders (e.g., anemia), serious infections, stomach/intestine/esophagus problems (e.g., bleeding, ulcers, recurring heartburn), bleeding/clotting problems, asthma, growths in the nose (nasal polyps), dehydration, poorly controlled diabetes.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and smoking. Consult your doctor or pharmacist for more information.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of this medication, especially stomach bleeding and kidney effects.

Caution is advised when using this drug in children with a certain type of arthritis (systemic onset juvenile rheumatoid arthritis) because they may be at increased risk for a very serious bleeding/clotting problem (disseminated intravascular coagulation). Seek immediate medical attention if your child develops sudden bleeding/bruising or bluish skin in the fingers/toes.

This medication should be used only when clearly needed during the first 6 months of pregnancy. It should not be used during the last 3 months of pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.