Generic Medicine Info
Should be taken with food.
Hypersensitivity to flurbiprofen, aspirin or other NSAIDs. History of gastrointestinal bleeding or perforation related to NSAID therapy. Active or history of gastrointestinal inflammatory disease (e.g. ulcerative colitis, Crohn's disease), ulceration, or haemorrhage, aspirin-sensitive asthma, severe heart failure, treatment of pain in the setting of CABG. Patients with epithelial herpes simplex keratitis, known haemostatic defects, or those receiving other drugs which may prolong bleeding time (ophthalmic). Avoid ophthalmic use during surgical procedures. Severe renal and hepatic impairment. Pregnancy (3rd trimester).
Special Precautions
Patients with history of mild to moderate heart failure, peripheral arterial disease, other risk factors for CV disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking); SLE, asthma, oedema, hypovolaemia. Dehydrated and debilitated patients. Renal and hepatic impairment. Elderly. Pregnancy (1st-2nd trimester) and lactation. Patients with CYP2C9*1/*3 allele. Concomitant use of corticosteroids, SSRIs, antiplatelets, or anticoagulants. Not for prolonged use. Patient Counselling This drug may cause dizziness, drowsiness, fatigue and visual disturbances, if affected, do not drive or operate machinery. Monitoring Parameters Monitor blood pressure, CBC, chemistry profile, occult blood loss, periodic LFT, renal function (e.g. urine output, serum BUN, creatinine); ophthalmic exam (prolonged use), signs and symptoms of gastrointestinal bleeding.
Adverse Reactions
Significant: Renal papillary necrosis (prolonged use). Rarely, anaphylactoid reactions, blood dyscrasias (e.g. agranulocytosis, thrombocytopenia, aplastic anaemia), hyperkalaemia. Cardiac disorders: Cardiac failure. Ear and labyrinth disorders: Tinnitus. Eye disorders: Eye irritation, eye pain, eye haemorrhage, prolonged mydriasis, eye hyperaemia, visual disturbance, miosis. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dyspepsia, flatulence, constipation, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastritis. Lozenge/throat spray: Throat irritation, mouth ulceration, oral pain or discomfort, oral paraesthesia, oropharyngeal pain. General disorders and administration site conditions: Fatigue, malaise. Hepatobiliary disorders: Rarely, jaundice. Investigations: Increased liver enzymes, prolonged bleeding time. Metabolism and nutrition disorders: Fluid retention. Nervous system disorders: Headache, dizziness, paraesthesia, tremor. Psychiatric disorders: Anxiety, insomnia, amnesia, depression, nervousness, somnolence. Respiratory, thoracic and mediastinal disorders: Rhinitis. Skin and subcutaneous tissue disorders: Rash, photosensitivity. Vascular disorders: Hypertension.
Potentially Fatal: Gastrointestinal inflammation, bleeding, ulceration or perforation, CV thrombotic events (e.g. myocardial infarction, stroke), bronchospasm. Rarely, hepatotoxicity (e.g. fulminant hepatitis, hepatic necrosis, hepatic failure), exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis.
C Avoid during 3rd trimester or late pregnancy.
Drug Interactions
Decreased effect of diuretics, ACE inhibitors, angiotensin II antagonists, and mifepristone. Increased plasma concentration and risk of toxicity of lithium, cardiac glycosides (e.g. digoxin), phenytoin and methotrexate. Enhanced anticoagulant effect of warfarin. Increased risk of nephrotoxicity with ciclosporin, tacrolimus and diuretics. Increased risk of gastrointestinal ulceration or bleeding with other NSAIDs, corticosteroids, SSRIs, and anticoagulants or antiplatelet agents (e.g. aspirin). Increased haematological toxicity with zidovudine.
ATC Classification
R02AX01 - flurbiprofen ; Belongs to the class of other throat preparations.
M02AA19 - flurbiprofen ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
M01AE09 - flurbiprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
S01BC04 - flurbiprofen ; Belongs to the class of non-steroidal antiinflammatory agents. Used in the treatment of inflammation of the eye.
Disclaimer: This information is independently developed by CIMS based on flurbiprofen from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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