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SULINDAC is a brand name for Sulindac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sulindac is a non-steroidal, analgesic/anti-inflammatory agent with antipyretic properties. Indicated in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis, peri-articular disorders such as bursitis, tendinitis, and tenosynovitis.
Verbatim from this product's MHRA label. Tap a section to expand.
4 ‘Special warnings and special precautions for use’). For oral use to be taken preferably with or after food. The dosage should be taken twice a day and adjusted to the severity of the disease. The usual dosage is 200 mg twice daily.
However, the dosage may be lowered depending on the response. Doses above 400 mg per day are not recommended. In the treatment of acute gouty arthritis, therapy for seven days is usually adequate. In peri-articular disorders, treatment should be limited to seven to ten days.
Sulindac should be administered preferably with fluids or food.
Children:
The use of sulindac in children is contra-indicated.
Use in the elderly:
The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
Sulindac is generally well tolerated. Those side effects experienced are usually mild and may often respond to a reduction in dosage. Side effects reported frequently Gastro intestinal: the most frequent types of side effects occurring with sulindac are gastro intestinal; these include gastro intestinal pain, dyspepsia, nausea with or without vomiting, diarrhoea, constipation, flatulence, anorexia, and gastro intestinal cramps.
Dermatological: rash, pruritus. Central nervous system: dizziness, headache, nervousness. Special senses: tinnitus. Miscellaneous: oedema. Side effects reported less frequently The following side effects were reported less frequently. The probability exists of a causal relationship between sulindac and these side effects: Gastro intestinal: stomatitis, gastritis or gastro enteritis.
4‘Special warnings and precautions for use’) have been reported, as well as gastro intestinal bleeding and gastro-intestinal perforations, sometimes fatal, particularly in the elderly. Pancreatitis, ageusia, glossitis, intestinal strictures (diaphragms), haematemisis, melaena, nausea.
It has also been reported that a probable sulindac metabolite has been found in biliary sludge in patients with symptoms of cholecystitis who underwent a cholecystectomy.
Hepatic:
Liver-function-test abnormalities, jaundice sometimes with fever, cholestasis, hepatitis, hepatic failure. Dermatological: purpura, sore or dry mucous membranes, alopecia, photosensitivity, erythema multiforme, toxic epidermal necrolysis, Stevens Johnson syndrome, exfoliative dermatitis.
Cardiovascular: congestive heart failure, especially in patients with marginal cardiac function; palpitation, hypertension. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4 ‘Special warnings and precautions for use’).
2 ‘Posology and method of administration’ and GI and cardiovascular risks below). 5 ‘Interaction with other medicinal products and other forms of interaction’ ). 5 ‘Interaction with other medicinal products and other forms of interaction’).
2 ‘Posology and method of administration’) Platelet aggregation Sulindac has less effect on platelet function and bleeding time than aspirin; however, since sulindac is an inhibitor of platelet function, patients who may be adversely affected should be carefully observed when sulindac is administered.
Gastro-intestinal effects Sulindac should be used with caution in patients having a history of gastro-intestinal haemorrhage, ulcers, ulcerative colitis or Crohn’s disease. Gastro-intestinal 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.
Patients should report experiencing any of these effects, particularly the elderly and the treatment should be withdrawn. Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding).
In patients with a history of peptic ulcer disease and in the elderly, NSAIDs should be given only after other forms of treatment have been considered. 3 ‘Contraindications’), and in the elderly. These patients should commence treatment on the lowest dose available.
g. 5 ‘Interaction with other medicinal products and other forms of interaction’). Respiratory effects 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 some patients.
Hypersensitivity syndrome A potentially life-threatening, apparent hypersensitivity syndrome has been reported. In cases where the syndrome is suspected, therapy should be discontinued immediately, and not recontinued. 8 ‘Undesirable Effects’), conjunctivitis, involvement of major organs (changes in liver- function tests, hepatic failure, jaundice, pancreatitis, pneumonitis with or without pleural effusion, leucopenia, leucocytosis, eosinophilia, disseminated intravascular coagulation, anaemia, renal impairment, including renal failure), and other less specific findings (adenitis, arthralgia, arthritis, myalgia, fatigue, malaise, hypotension, chest pain, tachycardia).
Hypersensitivity to any component of this product. Severe heart failure. The use of sulindac is contra-indicated in severe renal failure and in patients with hepatic insufficiency. Poor liver function may alter the blood levels of circulating metabolites of sulindac.
Sulindac should not be used in patients in whom acute asthmatic attacks, urticaria, rhinitis, or angioedema have been precipitated by ibuprofen, aspirin or other non-steroidal anti-inflammatory agents. The drug should not be administered to patients with active gastro-intestinal bleeding or a history of gastro-intestinal bleeding or perforation related to previous NSAID therapy.
The use of sulindac should be avoided in patients with active or previous peptic ulcer or haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Since paediatric indications and dosage have not yet been established, sulindac should not be given to children.
6 ‘Pregnancy and lactation’).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Haematological: thrombocytopenia; ecchymosis; purpura; leucopenia; agranulocytosis; neutropenia; bone-marrow depression, including aplastic anaemia; haemolytic anaemia, increased prothrombin time in patients on oral anticoagulants.
Renal/Genito urinary: urine discoloration, dysuria, vaginal bleeding, haematuria, proteinuria, crystalluria, renal impairment including renal failure, interstitial nephritis, nephrotic syndrome. 4 ‘Special warnings and precautions for use’).
Metabolic:
Hyperkalaemia.
Musculoskeletal:
Muscle weakness. Special senses: visual disturbances including blurred vision, optic neuritis, decreased hearing, metallic or bitter taste. Respiratory: epistaxis.
Hypersensitivity:
Hypersensitivity reactions have been reported following treatment with NSAIDs. 4 ‘Special warnings and precautions for use’). Causal relationship unknown: other reactions have been reported in clinical trials or since the drug was marketed, but occurred under circumstances where a causal relationship could not be established.
However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to serve as alerting information to physicians. Cardiovascular: arrhythmia. Metabolic: hyperglycaemia. Nervous system: neuritis.
Special senses: disturbances of the retina and its vasculature. Miscellaneous: gynaecomastia. 4 ‘Special warnings and precautions for use’). 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. uk/yellowcard.
Infections Non-steroidal anti-inflammatory drugs, including sulindac, may mask the usual signs and symptoms of infection; therefore, the physician must be continually on the alert for this and should use the drug with extra care in the presence of existing infection.
Ocular effects Because of reports of adverse eye findings with agents of this class it is recommended that patients who develop eye complaints during treatment with sulindac have ophthalmological evaluations. Cardiovascular and cerebrovascular effects Peripheral oedema has been observed in some patients taking sulindac; therefore, as with other drugs in this class, sulindac should be used with caution in patients with compromised cardiac function, hypertension, or other conditions predisposed to fluid retention.
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 sulindac. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with sulindac after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Hepatic effects A patient with signs and/or symptoms suggesting liver dysfunction, or in whom an abnormal liver-function test has occurred, should be evaluated for evidence of a more severe hepatic reaction while on therapy.
Significant elevations of AST (SGOT) and ALT (SGPT) (three times higher than normal) were seen in less than 1% of patients in controlled clinical trials. Cases of hepatitis, jaundice, or both, with or without fever, may occur within the first three […]