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INDOMETACIN is a brand name for Indomethacin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indometacin is a non-steroidal anti-inflammatory agent indicated for the following conditions: • Active stages of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute musculoskeletal disorders, degenerative joint disease of the hip, low back pain and acute gouty arthritis. • It is also indicated for…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage of Indometacin should be carefully adjusted according to the needs of the individual patient. To reduce the possibility of gastro-intestinal disturbances, Indometacin Capsules should always be taken with food, milk or an antacid.
Chronic condition:
In chronic conditions, starting therapy with a low dosage, increasing this gradually as necessary, and continuing a trial of therapy for an adequate period (in some cases, up to one month) will give the best results with a minimum of unwanted reactions.
The recommended oral dosage range is 50 mg to 200 mg daily in divided doses. Paediatric dosage not established.
Dosage in dysmenorrhoea:
Up to 75 mg a day, starting with onset of cramps or bleeding, and continuing for as long as the symptoms usually last. Dosage in acute gouty arthritis: 150 mg to 200 mg daily in divided doses until all symptoms and signs subside.
Use in the elderly:
Indometacin should be used with particular care in older patients who are more prone to adverse reactions.
Paediatric population:
The safety and efficacy of indometacin in children has not yet been established. Method of Administration For oral administration To be taken preferably with or after food
• Nervous system disorders- Headaches, dizziness and light-headedness are common side effects. Starting therapy with a low dose and increasing gradually minimises the incidence of headache. These symptoms frequently disappear on continued therapy or reducing the dosage, but if headache persists despite dosage reduction, indomethacin should be withdrawn.
4), depression, vertigo, , fatigue , malaise, dysarthria, syncope, coma, cerebral oedema, nervousness, confusion, anxiety and other psychiatric disturbances , depersonalisation, hallucinations, drowsiness, convulsions and aggravation of epilepsy and Parkinsonism, peripheral neuropathy, paraesthesia, involuntary movements and insomnia.
These effects are often transient and abate or disappear on reduced or stopping treatment. However, the severity of these may, on occasion, require cessation of the therapy. • Gastrointestinal disorders: The most commonly-observed adverse events are gastrointestinal in nature.
Anorexia, epigastric discomfort, ulceration at any point in the gastro-intestinal tract (even with resultant stenosis and obstruction), bleeding (even without obvious ulceration or from a diverticulum) and perforation of pre-existing sigmoid lesions (such as diverticulum or carcinoma), increased abdominal pain or exacerbation of the condition in patients with ulcerative colitis or Crohn’s disease (or the development of this condition), intestinal strictures and regional ileitis have been rarely reported.
4). If gastro- intestinal bleeding does occur treatment with indometacin should be discontinued. Gastrointestinal disorders which occur can be reduced by giving indometacin with food, milk or antacids. 4) have been reported following administration.
Less frequently, gastritis, duodenal ulcer, gastric ulcer and gastrointestinal perforation have been observed. Pancreatitis has been reported very rarely. • Cardiac disorder - oedema, increased blood pressure, tachycardia, chest pain, arrhythmia, palpitation, hypotension, syncope and congestive heart failure.
2, and GI and cardiovascular risks below). 5).
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 Indometacin. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with indometacin after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus, and smoking). Indometacin should be used cautiously in patients with impaired renal function, bleeding disorders, psychiatric disorders, epilepsy or Parkinsonism, as it may tend to aggravate these.
Gastro-intestinal disturbances may be minimised by giving indomethacin orally with food, milk or an antacid. They usually disappear on reducing the dosage; if not, the risks of continuing therapy should be weighed against the possible benefits.
Indometacin may mask the signs and symptoms of an infection, so antibiotic therapy should be initiated promptly if an infection occurs during therapy with indometacin. It should be used with cautiously in patients with existing but controlled infection.
Caution is advised with concomitant use of live vaccines. During prolonged therapy, periodic ophthalmic examinations are recommended, as corneal deposits and retinal disturbances have been reported. In patients with rheumatoid arthritis, eye changes may occur which may be related to the underlying disease or to the therapy.
g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other non- steroidal anti-inflammatory drugs. 1. 4). • Not to be used in patients who have nasal polyps. • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 6 'Pregnancy and lactation'). • Safety in children has not been established.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• Vascular disorders: Flushing has been reported rarely. • Respiratory, thoracic and mediastinal disorders: Pulmonary eosinophilia. There may be bronchospasm in patients with a history of bronchial asthma or other allergic disease. Epistaxis has been reported rarely.
• Skin and subcutaneous tissue disorders: Pruritus, urticaria, angioneurotic oedema, angiitis, erythema nodosum, rash, photosensitivity, exfoliative dermatitis, bullous reactions including Stevens Johnson syndrome and Toxic Epidermal Necrolysis (very rare).
Photosensitivity, erythema multiforme, hair loss, sweating and exacerbation of psoriasis • Musculo-skeletal, connective tissue and bone disorders: Muscle weakness and acceleration of cartilage degeneration. • Hypersensitivity: 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, rhinitis or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis, erythema multiforme).
• Blood and lymphatic disorders: Blood dyscrasias (such as thrombocytopenia, neutropenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia), bone marrow depression, petechiae, ecchymoses, purpura, and disseminated intravascular coagulation may occur infrequently.
As some patient manifest anaemia secondary to obvious or occult gastro-intestinal bleeding, appropriate blood determinations are recommended. • Metabolic and nutrition disorders: Hyperglycaemia, glycosuria, hyperkalaemia has been reported rarely.
• Eye disorder- Visual disturbances, blurred vision, diplopia, optic neuritis and orbital and peri-orbital pain are seen infrequently. Corneal deposits and retinal or macular disturbances have been reported in some patients with rheumatoidnarthritis on prolonged therapy with indometacin.
Ophthalmic examinations are desirable in patients given prolonged treatment. • Ear and labyrinth disorders: Tinnitus or hearing disturbances (rarely deafness) have been reported. • Renal and urinary disorders: Haematuria, nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure, renal insufficiency, proteinuria have all been reported.
In patients with renal, cardiac or hepatic impairment, caution is required since the use of non-steroidal anti- inflammatory drugs may result in deterioration of renal function. The dose should be kept as low as possible and renal function should be monitored.
• Hepato-biliary disorders: Cholestasis, borderline elevations of one or more liver tests may occur, and significant elevations of ALT (SGPT) or AST (SGOT) have been seen in less than 1% of patients receiving therapy with NSAIDs in controlled clinical trials.
If abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations such as rash or eosinophilia occur, indometacin should be stopped. Abnormal liver function, hepatitis and jaundice.
• Reproductive system and breast disorders: Vaginal bleeding, breast changes (enlargement, tenderness, gynaecomastia) • Clinical trial and epidemiological […]
Therefore, in chronic rheumatoid disease, ophthalmological examinations at periodic intervals are recommended. Therapy should be discontinued if eye changes are observed. Patients should be carefully observed to detect any unusual manifestations of drug sensitivity.
8). The dose should be kept as low as possible and renal function should be monitored. NSAIDs may also cause fluid retention which may further aggravate these conditions. In patients with reduced renal blood flow where renal prostaglandins play a major role in maintaining renal perfusion, administration of NSAID may precipitate overt renal decompensation.
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, the elderly, diabetes mellitus, extracellular volume depletion, congestive heart failure, sepsis, or concomitant use of any nephrotoxic drug.
3). Discontinuation of non-steroidal anti-inflammatory therapy is usually followed by recovery to the pre-treatment state. 2).
Respiratory disorders:
Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.
Gastrointestinal bleeding, ulceration and perforation:
Caution is advised in patients with pre-existing sigmoid lesions (such as diverticulum or carcinoma) (or the development of these conditions) as indometacin can aggravate these conditions. 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.
When GI bleeding or ulceration occurs in patients receiving indometacin, the treatment should be withdrawn. 3), and in the elderly. These patients should commence treatment on the lowest dose available. g. 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.
5). NSAIDs should only be given with care to patients with a history of gastrointestinal disease […]