GELOXIB-200 Capsule

For the relief of pain, fever, swelling, and tenderness caused by osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Celecoxib does not prevent the progression of either type of arthritis. It reduces only the symptoms and signs of arthritis. Celecoxib also is approved for patients with familial FAP who have not had their colons removed. Celecoxib also is approved for the relief of acute pain and the pain of menstrual cramps (primary dysmenorrhea).

Posology and Method of administration

For the management of osteoarthritis, the dose usually is 100mg twice daily or 200mg as a single dose.

For rheumatoid arthritis, the dose usually is 100mg or 200mg twice daily.

For acute pain or menstrual cramps, the dose is 400mg as a single dose on the first day followed by an additional 200mg if needed, then 200mg twice daily as needed.

For FAP, the recommended dose is 400mg twice daily.

In patients with known hypersensitivity to celecoxib. Celecoxib not be given to patients who have demonstrated allergic-type reactions to sulfonamides.

Celecoxib should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.

Celecoxib is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.

The most common adverse effects are headache, abdominal pain, dyspepsia, diarrhea, nausea, flatulence and insomnia. Other side effects include fainting, kidney failure, heart failure, aggravation of hypertension, chest pain, ringing in the ears, deafness, stomach and intestinal ulcers, bleeding, blurred vision, anxiety, photosensitivity, weight gain, water retention, flu-like symptoms, drowsiness and weakness. Although stomach and intestinal ulcers occur with the use of celecoxib, their incidence is less than with other NSAIDs in short-term studies.

Concomitant use of celecoxib with aspirin or other NSAIDs (e.g. ibuprofen, naproxen, etc.) may increase the occurrence of stomach and intestinal ulcers.

Fluconazole increases the concentration of celecoxib in the body inhibiting the breakdown of celecoxib in the liver.

Celecoxib increases the concentration of lithium in the blood by 17%. Therefore, lithium therapy should be closely monitored during and after therapy with celecoxib.

Persons taking the anticoagulant (blood thinner) warfarin should have their blood tested when initiating or changing celecoxib treatment, particularly in the first few days, for any changes in the effects of the anticoagulant.

The celecoxib has not been studied in pregnant women. In animal studies, doses that were twice the maximally recommended dose were harmful to the fetus. Celecoxib should only e used in pregnant women when the benefits outweigh the potential risk to the fetus.

The use of celecoxib in nursing mothers has not been evaluated.

People who take NSAIDs (other than aspirin) such as celecoxib may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes.

Celecoxib is a highly selective COX-2 inhibitor and primarily inhibits this isoform of cyclooxygenase (inhibition of prostaglandin production), whereas traditional NSAIDs inhibit both COX-1 and COX-2.Celecoxib is approximately 7.6 times more selective for COX-2 inhibition over COX-1. In theory, this specificity allows celecoxib and other COX-2 inhibitors to reduce inflammation (and pain) while minimizing gastrointestinal adverse drug reactions (e.g. stomach ulcers) that are common with non-selective NSAIDs.