Management Of Acute Pain And Treatment Of Primary Dysmenorrhea, Osteoarthritis
The anti-inflammatory, analgesic, and antipyretic effects of NSAIDs appear to result from the inhibition of prostaglandin synthesis. Although the exact mechanism of action has not been determined, these effects appear to be mediated through the inhibition of the COX-2 isoenzyme at the sites of inflammation with subsequent reduction in the synthesis of certain prostaglandins from their arachidonic acid precursors. Rofecoxib selectively inhibits the cyclooxygenase-2 (COX-2) enzyme, which is important for the mediation of inflammation and pain. Unlike non-selective NSAIDs, rofecoxib does not inhibit platelet aggregation. It also has little to no affinity for COX-1.
ORAL Osteoarthritis: Adult: Initially, 12.5 mg once daily. Max: 25 mg/day. Rheumatoid arthritis: Adult: 25 mg daily. Max: 25 mg/day. Pain relief: Adult: Initially. 50 mg once daily followed by daily doses of 25-50 mg. Max: 50 mg/day. Treatment duration >5days is not recommended.
Abacavir Rofecoxib may decrease the excretion rate of Abacavir which could result in a higher serum level.
Abametapir The serum concentration of Rofecoxib can be increased when it is combined with Abametapir.
Abatacept The metabolism of Rofecoxib can be increased when combined with Abatacept.
Abciximab The risk or severity of bleeding and hemorrhage can be increased when Rofecoxib is combined with Abciximab.
Abemaciclib The metabolism of Abemaciclib can be increased when combined with Rofecoxib.
Hypersensitivity. Severe renal Impairment. Hepatic dysfunction, pregnancy & lactation. History of ulcer disease or GI bleeding. Elderly or debilitated patients. Prolonged treatment, smoking & alcoholism may increase risk of GI bleeding. lschaemic heart disease.
Mouth ulcers, chest pain, wt gain, atopic eczema, muscle cramps, diarrhoea, headache, nausea; upper resp tract infection, hypertension, ischaemia, dyspepsia, epigastric discomfort, heart burn, nausea, sinusitis, back pain, headache, bronchitis, urinary tract infections. Renal failure; nephrotoxicity; MI.
Rofecoxib must be avoided in late pregnancy (third trimester) due to the risk of premature closure of the ductus arteriosus. There is no data on the excretion of rofecoxib into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
No overdoses of rofecoxib were reported during clinical trials. Administration of single doses of rofecoxib 1000 mg to 6 healthy volunteers and multiple doses of 250 mg/day for 14 days to 75 healthy volunteers did not result in serious toxicity.
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
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