CELEBREX 100mg 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 200mg capsules are white, reverse printed white on gold band of body and cap with markings of 7767 on the cap and 200 on the body.

HOW DOES CELEBREX WORK?

In the body, 2 enzymes are called COX-1 and COX-2. COX-1 helps regulate normal cell function in the stomach and blood. COX-2 plays a role in causing arthritis pain and inflammation by causing the release of specific compounds into the blood called cytokines. Cytokines are compounds that lead to pain and inflammation of joint tissue. CELEBREX is a scientific breakthrough; the first product to target only the COX-2 enzyme. By inhibiting COX-2 those compounds that lead to inflammation and pain are inhibited from being released into the blood.

HOW EFFECTIVE IS CELEBREX?

OSTEOARTHRITIS:

The effectiveness of CELEBREX was evaluated for the treatment of the signs and symptoms of Osteoarthritis of the knee and hip. To make this determination a placebo (sugar pill) was compared with CELEBREX treated patients in controlled clinical trials involving approximately 4,200 patients with Osteoarthritis. The clinical trials lasted up to 12 weeks in duration. In patients with Osteoarthritis, treatment with CELEBREX 100 mg BID or 200 mg one time each day resulted in an improvement in patient and physician assessments in Osteoarthritis severity taking into account joint pain, stiffness, and range of motion measures. In three 12-week studies of joint pain accompanying Osteoarthritis flare, CELEBREX doses of 100 mg given twice daily and 200 mg given twice daily provided significant reduction of pain within 24-48 hours of initiation of dosing. A total daily dose of 200 mg has been shown to be equally effective whether administered as 100 mg twice a day or 200 mg once a day.

RHEUMATOID ARTHRITIS:

Patients treated with CELEBREX demonstrated a significant reduction in joint tenderness/pain and joint swelling compared to placebo (sugar pill). CELEBREX was evaluated for treatment of the signs and symptoms of Rheumatoid Arthritis in approximately 2,100 patients by comparing placebo and CELEBREX treated patients in clinical trials of up to 24 weeks in duration. CELEBREX was shown to be superior to placebo in these studies, using a Rheumatoid Arthritis severity index, a composite score taking into account join pain, stiffness, and range of motion measures as well as laboratory measures. In this study, it was shown that CELEBREX doses of 100 mg twice a day and 200 mg twice a day were similar in effectiveness. Although in general, the higher dosage is recommended for more severe disease.

HOW TO USE THIS MEDICATION:

You should continue to take CELEBREX as prescribed even when you are feeling better. CELEBREX can be taken with or without food. CELEBREX capsules come in 2 strengths: 100 mg and 200 mg.

In Osteoarthritis, the recommended dose for CELEBREX is 200 mg a day. CELEBREX delivers 24-hour relief from a once-daily dose of 200 mg. Or if preferred, a dose of 100 mg twice a day is available.

In Rheumatoid Arthritis, the recommended dose for CELEBREX is 100 mg to 200 mg, twice a day. CELEBREX provides relief through the day and through the night.

CAN I TAKE CELEBREX IF I AM TAKING OTHER MEDICATIONS?

If you are one of the many people who take low-dose aspirin for the prevention of heart attack or stroke, you can still take CELEBREX. However, taking CELEBREX and aspirin together can increase your risk for developing stomach ulcers compared to taking CELEBREX alone. CELEBREX is not a substitute for aspirin for heart attack or stroke prevention.

CAN I TAKE CELEBREX IF I AM PREGNANT?

In late pregnancy CELEBREX should be avoided because it may cause problems in the final development of the heart in the fetus.

IS CELEBREX A SUBSTITUTE FOR CORTICOSTEROIDS?

NO. CELEBREX cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of this medicine 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 this medication.

INCLUDE IN YOUR MEDICAL HISTORY/PERSONAL PROFILE:

- If you are pregnant or plan to become pregnant. Celebrex should not be used in late pregnancy because it may harm the fetus.

- If you are breast-feeding or plan to breast-feed. It is not known whether Celebrex is passed through to human breast milk and what its effects could be on a nursing child.

- If you have kidney disease

- If you have liver disease

- If you have heart failure

- If you have high blood pressure

- If you have had an allergic reaction to aspirin or other NSAIDs

- If you have had a serious stomach problem (ulcers) in the past.

DRUG INTERACTIONS:

Include on your medical history/personal profile all of the other medicines you are taking or plan to take while you are on CELEBREX, even other medicines that you can get without a prescription. CELEBREX has significant drug interactions with:

- Methotrexate (a medicine used to suppress the immune system).

- Warfarin (a blood thinner).

- Rifampin (an antibiotic).

- ACE inhibitors (medicines used for high blood pressure and heart failure).

- Lithium (a medicine used to treat a certain type of depression).

ADVERSE REACTIONS:

Serious but rare side effects that have been reported in patients taking CELEBREX are delineated below:

Serious stomach problems, such as stomach and intestinal bleeding, can occur with or without warning symptoms. These problems, if severe, could lead to hospitalization or death. Although this happens rarely, you should watch for signs that you may have this serious side effect.

Serious allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing and wheezing occur rarely but may require treatment right away. Severe skin reactions have also been reported.

Serious kidney problems occur rarely, including acute kidney failure and worsening of chronic kidney failure.

Severe liver problems, including hepatitis, jaundice and liver failure, occur rarely in patients taking NSAIDs, including CELEBREX. Symptoms of liver problems include nausea, tiredness, itching, tenderness in the right upper abdomen, and flu-like symptoms.

In addition, the following side effects have been reported: anxiety, confusion, depression, hair loss, hallucinations, increased levels of potassium in the blood, low blood cell counts, palpitations, pancreatitis, tingling sensation, unusual headache with stiff neck (aseptic meningitis), vertigo.

WARNINGS:

Do not take CELEBREX:

- have had an allergic reaction such as asthma attacks, hives, or swelling of the throat and face to aspirin or other NSAIDs (for example, ibuprofen and naproxen).

- have had an allergic reaction to celecoxib, which is the active ingredient of CELEBREX any of its inactive ingredients.