THERAPEUTIC USE :
Rofecoxib is indicated for relief of the signs and symptoms of osteoarthritis; for the management of acute pain in adults and for the treatment of primary dysmenorrhea.

SIDE EFFECTS :
Rofecoxib is generally well tolerated and side-effects reported are generally mild and transient. Commonly reported side-effects with rofecoxib include nausea, dyspepsia, epigastric discomfort, heartburn, diarrhoea, headache and dizziness. Abdominal pain, oedema / fluid retention, hypertension, pruritus, increases in alanine aminotransferase and aspartate aminotransferase, decreased haematocrit have also been reported to occur.

RENAL DISEASE: In patients with advance renal disease, treatment with Rofecoxib is not recommended. If therapy with Rofecoxib must be initiated in such patients, close monitoring of patient’s renal function is advisable.

DEHYDRATION: Caution should be used when initiating treatment with rofecoxib in patients with considerable dehydration. It is advisable to rehydrate patients prior to starting therapy with rofecoxib.

FLUID RETENTION: As with other drugs known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in some patients taking rofecoxib. Because treatment with rofecoxib may result in fluid retention, caution should be exercised in patients with history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing oedema from any other reason.

GERIATRIC: Medically appropriate supervision should be maintained when using rofecoxib in the elderly and in patients with renal, hepatic, or cardiac dysfunction.

HEPATIC: 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 rofecoxib.

ASTHMA: NSAIDs including rofecoxib should not be administered to patients with aspirin-sensitive asthma and should be used with caution in patients with preexisting asthma.

PREGNANT WOMEN: Rofecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. As with other drugs known to inhibit prostaglandin synthesis, use of rofecoxib during the third trimester of pregnancy should be avoided.

MISSED DOSE :
If you miss a dose of this medicine and you are taking one dose daily, take the missed dose if you remember the same day. Skip the missed dose if you do not remember until the next day. DO NOT take two doses at once.

OVER DOSE :
If overdose is suspected, contact your local poison control center or emergency room immediately.

STORAGE : Store this medicine at room temperature below 77 degrees F (25 degrees C) in a tightly-closed container, away from heat, moisture, and light.