Rofecoxib

Indications
 Oral
Osteoarthritis
Adult: Initially, 12.5 mg once daily. Max: 25 mg/day.
Hepatic impairment: Max: 12.5 mg/day.
Oral
Rheumatoid arthritis
Adult: 25 mg daily. Max: 25 mg/day.
Hepatic impairment: Max: 12.5 mg/day.
Oral
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.
Hepatic impairment: Max: 12.5 mg/day.

Special Populations: Max dose in patients with mild hepatic impairment is 12.5 mg once daily.
Contraindications
 Hypersensitivity. Severe renal impairment.
Warnings / Precautions
 Hepatic dysfunction, pregnancy and lactation. History of ulcer disease or GI bleeding. Elderly or debilitated patients. Prolonged treatment, smoking and alcoholism may increase risk of GI bleeding. Ischaemic heart disease.
Adverse Reactions
 Mouth ulcers, chest pain, weight gain, atopic eczema, muscle cramps, diarrhoea, headache, nausea; upper respiratory tract infection, hypertension, ischaemia, dyspepsia, epigastric discomfort, heart burn, nausea, sinusitis, back pain, headache, bronchitis, urinary tract infections.
Potentially Fatal: Renal failure; nephrotoxicity; MI.
Overdose Reactions
 General supportive measures and clinical monitoring should be used.
Drug Interactions
 Increases plasma concentrations of methotrexate and lithium. Increased nephrotoxicity when used with thiazide, loop diuretics and ACE inhibitors. May reduce efficacy of loop diuretics.
See Below for More rofecoxib Drug Interactions
Food Interactions
 High fat meals may delay time to reach peak plasma concentrations.
Mechanism of Actions
 Rofecoxib selectively inhibits cyclooxygenase-2 (COX-2) enzyme that is involved in the synthesis of prostaglandins. It has no significant inhibitory action on cyclooxygenase-1 (COX-1) enzymes.
Onset: 45 min.
Duration: >24 hr.
Absorption: Well absorbed from the GI tract (oral); peak plasma concentrations after 2 hr.
Distribution: Protein-binding: 85%.
Metabolism: Extensively hepatic by reduction to cis- and trans-dihydrorofecoxib.
Excretion: Urine and faeces; 17 hr (elimination T1/2 at steady state).
Storage Conditions
 Oral: Store at 25°C.
ATC Classification
 M01AH02 - rofecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Storage
 Oral: Store at 25°C.
Available As
  • Rofecoxib 1%
  • Rofecoxib 12.5 mg
  • Rofecoxib 20 mg
  • Rofecoxib 25 mg
  • Rofecoxib 50 mg

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