Rofecoxib


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Osteoarthritis Initial: 12.5 mg once daily. Max: 25 mg/day. Rheumatoid arthritis 25 mg/day. Max: 25 mg/day. Pain relief Initial: 50 mg once daily, then 25-50 mg/day. Max: 50 mg/day. Treatment duration >5 days is not recommended.
Dosage Details
Oral
Osteoarthritis
Adult: Initially, 12.5 mg once daily. Max: 25 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.

Oral
Rheumatoid arthritis
Adult: 25 mg daily. Max: 25 mg/day.
Hepatic Impairment
Max: 12.5 mg/day.
Contraindications
Hypersensitivity. Severe renal impairment.
Special 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.
PO: C (Avoid in 3rd trimester or near delivery)
Overdosage
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.
Food Interaction
High fat meals may delay time to reach peak plasma concentrations.
Action
Description: 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.
Pharmacokinetics:
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
Store at 25°C.
Disclaimer: This information is independently developed by MIMS based on Rofecoxib from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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