دواعي استعمال روفكوكس 12.5مجم/5مل 60مل معلق

Rofecoxib 12.5 mg/5 ml oral suspension, 60 ml bottle, Sigma (Egypt). Rofecoxib (Vioxx) was withdrawn from the US market and FDA approval was withdrawn in 2022.

• Relief of signs and symptoms of osteoarthritis and of rheumatoid arthritis in adults (historical US approval).U.S. Food and Drug Administration (Drugs@FDA)
• Pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients 2 years and older weighing 10 kg or more (historical US approval).U.S. Food and Drug Administration (Drugs@FDA)
• Management of acute pain in adults, treatment of primary dysmenorrhoea and acute treatment of migraine (historical US approval).U.S. Food and Drug Administration (Drugs@FDA)

• Known hypersensitivity to rofecoxib or any component.نشرة دولية لنفس التركيبة · U.S. Food and Drug Administration (Drugs@FDA)
• Patients who have had asthma, urticaria or allergic-type reactions after aspirin or other NSAIDs.نشرة دولية لنفس التركيبة · U.S. Food and Drug Administration (Drugs@FDA)

• Serious gastrointestinal toxicity (bleeding, ulceration, perforation) can occur at any time, with or without warning symptoms.نشرة دولية لنفس التركيبة · U.S. Food and Drug Administration (Drugs@FDA)
• In the VIGOR study, serious cardiovascular thrombotic events were significantly more frequent with rofecoxib 50 mg daily than with naproxen; caution in patients with ischaemic heart disease.نشرة دولية لنفس التركيبة · U.S. Food and Drug Administration (Drugs@FDA)
• FDA withdrew approval of VIOXX (rofecoxib) tablets and suspension, including 12.5 mg/5 mL, as of 2022-09-13 at Merck's request; distribution in the US without an approved application is illegal.نشرة دولية لنفس التركيبة · Federal Register (U.S. Government)

• ACE inhibitorsNSAIDs may diminish the antihypertensive effect; rofecoxib 25 mg raised mean arterial pressure by about 3 mm Hg with benazepril.U.S. Food and Drug Administration (Drugs@FDA)
• LithiumNSAIDs raised plasma lithium levels and reduced renal lithium clearance; monitor.U.S. Food and Drug Administration (Drugs@FDA)
• RifampinCo-administration with rifampin (a potent hepatic enzyme inducer) lowers rofecoxib exposure.U.S. Food and Drug Administration (Drugs@FDA)
• WarfarinMonitor anticoagulant activity, particularly in the first days after starting or changing rofecoxib.U.S. Food and Drug Administration (Drugs@FDA)

• No studies in pregnant women; use during pregnancy only if the potential benefit justifies the potential risk to the fetus.نشرة دولية لنفس التركيبة · U.S. Food and Drug Administration (Drugs@FDA)
• Not known whether excreted in human milk (excreted in rat milk); decide whether to discontinue nursing or the drug.نشرة دولية لنفس التركيبة · U.S. Food and Drug Administration (Drugs@FDA)