POM: Prescription only medicine
This information is intended for use by health professionals
Respiratory disorders:Caution is required if etodolac is administered to patients suffering from, or with a previous history of bronchial asthma since NSAIDs have been reported to cause bronchospasm in such patients.
Cardiovascular, Renal and Hepatic Impairment:The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. The dose should be low and renal function should be monitored in these patients (see also section 4.3).Etodolac should be used with caution in patients with fluid retention, hypertension or heart failure.Hepatic and renal function, haematological parameters of patients on long term use of etodolac should be regularly reviewed.
PlateletsAlthough non-steroidal anti-inflammatory drugs do not have the same direct effects on platelets as does aspirin, all such drugs which inhibit the biosynthesis of prostaglandins may interfere with platelet function. Patients who may be adversely affected due to inhibition of platelet function should be carefully observed.
ElderlyNo dosage adjustment is generally necessary in the elderly. However, caution should be exercised in treating the elderly, and when individualising their dosage, extra care should be taken while increasing the dose. The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2).
PaediatricsSafety and efficacy in children have not been established and therefore etodolac is not recommended in children.
Cardiovascular and cerebrovascular effects:Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for Etodolac.Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Etodolac after careful consideration.Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Gastrointestinal bleeding, ulceration and perforation:GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5).When GI bleeding or ulceration occurs in patients receiving Etodolac, the treatment should be withdrawn.NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).
SLE and mixed connective tissue disease:In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8).
Dermatological:Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Etodolac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Impaired female fertility:The use of Etodolac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Etodolac should be considered.This product contains lactose. Patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.
Pregnancy:Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus), use in the last trimester of pregnancy is contraindicated. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see section 4.3). NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.
Lactation:In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. Safety of etodolac during lactation has not been established. Use of etodolac should if possible, be avoided when breastfeeding
FertilitySee section 4.4 Special warnings and precautions for use, regarding female fertility.
Blood and lymphatic system disordersThrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Immune system disordersHypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis, anaphylactoid reaction(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 epidermal necrolysis and erythema multiforme)
Nervous System disordersDepression, headaches, dizziness, insomnia, confusion, hallucinations, disorientation (See section 4.4) paraesthesia, tremor, weakness, nervousness and drowsiness, reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting.
Eye disordersVisual disturbances (abnormal vision), optic neuritis
Ear and labyrinth disordersTinnitus, vertigo
Cardiac disordersOedema, hypertension, palpitation 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) (see section 4.4).
Gastrointestinal disordersPeptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, dyspepsia, epigastric pain, ulcerative stomatitis, abdominal pain, constipation, flatulence, haematemesis, melaena, gastrointestinal ulceration, indigestion, heartburn, rectal bleeding. Exacerbation of colitis and Crohn's disease (See section 4.4) have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.
Hepato-biliary disorders:Abnormal liver function (bilirubinuria) hepatitis and jaundice.
Skin and subcutaneous tissue disorders:Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.
Renal and urinary disordersDysuria, urinary frequency (<1%), nephrotoxicity in various forms, including interstitial nephritis, nephritic syndrome and renal failure.
General disordersMalaise, fatigue, asthenia, chills, fever
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