Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take Celecoxib with food or milk to lessen stomach upset. Do not crush, chew, break, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you take Celecoxib for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using Celecoxib. Store Celecoxib at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to Celecoxib, or if you have a history of allergic reaction to aspirin or other NSAIDs. Before taking Celecoxib tell your doctor if you are allergic to any drugs, or if you have:

• History of Heart Attack, Stroke, or Blood Clot
• Heart Disease, Congestive Heart Failure, High Blood Pressure
• History of Stomach Ulcers or Bleeding
• Seizure Disorder Such As Epilepsy
• Asthma
• Polyps In Your Nose
• Bleeding or Blood Clotting Disorder
• Kidney Disease
• Liver Disease

If you have any of these conditions, you may not be able to use Celecoxib, or you may need a dosage adjustment or special tests during treatment

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking Celecoxib during the last 3 months of pregnancy may result in birth defects. Do not take Celecoxib during pregnancy unless your doctor has told you to. Celecoxib passes into breast milk and may affect a nursing baby. Do not take Celecoxib without first talking to your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 2 years old without the advice of a doctor.

If you are taking Celecoxib on a regular schedule, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose.

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an Celecoxib overdose may include:

• nausea
• vomiting
• stomach pain
• drowsiness
• black or bloody stools
• coughing up blood
• shallow breathing
• fainting
• coma

Do not drink alcohol while taking Celecoxib. Alcohol can increase the risk of stomach bleeding caused by Celecoxib.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to Celecoxib such as:

• ibuprofen
• ketoprofen
• naproxen

If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Celecoxib can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Side Effects

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 gain
• Urinating less than usual or not at all
• Nausea, stomach pain, low fever, loss of appetite
• dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
• Fever, sore throat, and headache with a severe blistering, peeling, and red skin rash
• Bruising, severe tingling, numbness, pain, muscle weakness

Less serious side effects may be more likely to occur, such as:

• Upset Stomach, Mild Heartburn, Diarrhea, Constipation
• Bloating, Gas
• Dizziness, Nervousness, Headache
• Skin Rash, Itching
• Blurred Vision
• Ringing In Your Ears

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Before taking Celecoxib, tell your doctor if you are taking any of the following drugs:

• Aspirin
• diclofenac (Voltaren®)
• etodolac (Lodine®)
• flurbiprofen (Ansaid®)
• ibuprofen (Advil®, Motrin®)
• ketoprofen (Orudis®)
• ketorolac (Toradol®)
• mefenamic acid (Ponstel®)
• meloxicam (Mobic®)
• nabumetone (Relafen®)
• naproxen (Aleve®, Naprosyn®)
• piroxicam (Feldene®)
• warfarin (Coumadin®)
• furosemide (Lasix®)
• Lithium (Eskalith®, Lithobid®)
• Methotrexate (Rheumatrex®, Trexall®)
• benazepril (Lotensin®)
• captopril (Capoten®)
• fosinopril (Monopril®)
• enalapril (Vasotec®)
• lisinopril (Prinivil®, Zestril®)
• moexipril (Univasc®)
• perindopril (Aceon®)
• quinapril (Accupril®)
• ramipril (Altace®)
• trandolapril (Mavik®)

If you are using any of these drugs, you may not be able to use Celecoxib or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Celecoxib. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

FDA Alert: 4/7/2005:

Celecoxib has been associated with an increased risk of serious adverse cardiovascular events in a long-term placebo controlled trial. Based on the currently available data, FDA has concluded that an increased risk of serious adverse cardiovascular events appears to be a class effect of non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin).

FDA has requested that the package insert for all NSAIDs, including Celecoxib, be revised to include a boxed warning to highlight the potential increased risk of cardiovascular events and the well described risk of serious, and potentially life-threatening, gastrointestinal bleeding.

FDA has also requested that the package insert for all NSAIDs be revised to include a contraindication for use in patients immediately post-operative from coronary artery bypass surgery.