Symptoms
Symptoms of overdosage may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting and occasionally convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible.
Therapeutic measures
Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially toxic amounts.
Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient's clinical condition.
None known.
Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, dyspepsia, flatulence, constipation, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following flurbiprofen administration. Less frequently, gastritis, has been observed. Pancreatitis has been reported very rarely.
Immune system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely exfoliative and bullous dermatoses (including toxic epidermal necrolysis and erythema multiforme).
Cardiac disorders and Vascular disorders: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Respiratory, thoracic and mediastinal disorders: Respiratory tract reactivity (asthma, bronchospasm, dyspnoea).
Other adverse events reported less commonly and for which causality has not necessarily been established include:
Blood and lymphatic system disorders: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Psychiatric disorders: Depression, confusional state, hallucination
Nervous system disorders: Cerebrovascular accident, optic neuritis, headache, paraesthesia, dizziness, and somnolence.
Aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation).
Eye disorders: Visual disturbance
Ear and labyrinth disorders: Tinnitus, vertigo
Hepatobiliary disorders: Abnormal liver function, hepatitis and jaundice.
Skin and subcutaneous tissue disorders: Skin disorders including rash, pruritis, urticaria, purpura and very rarely, bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme) and photosensitivity reaction.
Renal and urinary disorders: Toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.
General disorders and administration site conditions: Malaise, fatigue
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Not applicable.
Flurbiprofen has analgesic, anti-inflammatory and antipyretic properties. These are thought to result from the drug's ability to inhibit prostaglandin synthesis.
Flurbiprofen is readily absorbed from the gastrointestinal tract, with peak plasma concentrations occurring about 90 minutes after ingestion. It is about 99% protein-bound and has an elimination half-life of about three to four hours.
The rate of urinary excretion of flurbiprofen and its two major metabolites ([2-(2-fluoro-4′-hydroxy-4-biphenylyl) propionic acid] and [2-(2-fluoro-3′-hydroxy-4′-methoxy-4-biphenylyl) propionic acid]) in both free and conjugated states is similar for both the oral and rectal routes of administration. Metabolic patterns are quantitatively similar for both routes of administration.
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.
None stated.
