Rofecoxib
Anti-rheumatic, Systemic · Cox-2 inhibitor
Indications
Osteoarthritis, rheumatoid arthritis, management of acute pain in adults, treatment of primary dysmenorrhoea, acute treatment of migraine attacks with or without aura in adults, pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis (JRA) in patients >2 yrs and wt =10 kg.
Dosage
Osteoarthritis: Adults: Initial: 12.5 mg once daily. Max: 25 mg. Children: Not recommended. Rheumatoid Arthritis: Adults: 25 mg once daily. Children: Not recommended. Pauciarticular and Polyarticular Course Juvenile Rheumatoid Arthritis: Children: =2 yrs-=11 yrs: Wt: =10 kg- <42 kg: 0.6 mg/kg, max: 25 mg. =42 kg: 25 mg. =12 yrs-=18 yrs: 25 mg. Oral susp is recommended in children. Acute Pain and Primary Dysmenorrhoea: Adults: 50 mg once daily. Chronic use for >5 days is not recommended. Children: Not recommended. Migraine attacks with or without aura: Adults: Initial: 25 mg once daily. Max: 50 mg. Chronic use is not recommended. Treatment of more than 5 migraine attacks in a month is not recommended. Children: Not recommended.
Adverse Effects
Mouth ulcers, chest pain, weight gain, atopic eczema, muscle cramps, diarrhoea, headache, nausea, upper RTI, hypertension, ischaemia, dyspepsia, epigastric discomfort, heartburn, nausea, sinusitis, back pain, headache, bronchitis, UTIs. Fatal: Renal failure, nephrotoxicity, MI.
Risk Factor (Pregnancy/Lactation)
Pregnancy: Contraindicated in pregnancy. Lactation: Caution advised or effect undetermined. Contraindications: History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. In the setting of coronary artery bypass graft (CABG) surgery. Severe hepatic impairment. Severe renal impairment. Precautions: Moderate hepatic impairment. Elderly or debilitated patients. Ischaemic heart disease.
Interactions
Methotrexate, lithium, thiazide/loop diuretics, ACE inhibitors, aspirin, rifampin, warfarin, aspirin.
Advice to Patient
Take with or without meals. High-fat meals may delay absorption. Report signs and symptoms of GI ulceration or bleeding, skin rash, unexplained wt gain, oedema, hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, flu-like symptoms).
Pharmacokinetics
Bioavailability: 93%. Metabolism: Hepatic. Half-life elimination: 17 hrs. Time to peak: 2-3 hrs. Excretion: Urine (72%). Faeces (14%).
Brands with this active ingredient
Compiled by Healify Pharmacy from published drug references. How we compile it →
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