SULINDAC

Posology:

For oral administration. Sulindac should always be taken with fluids either with food or immediately after food and is normally taken twice a day. The usual adult dosage is 400 mg a day and doses above this level are not recommended.

Lower doses may be found sufficient. Seven days treatment is usually sufficient for acute gouty arthritis. For peri-articular disorders treatment should be no longer than 7 to 10 days. 4). Paediatric population Not recommended. Older people Older people 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.

Gastrointestinal:

The most commonly-observed adverse events are gastrointestinal in nature. 4). 4) have been reported following administration. Less frequently, gastritis and gastroenteritis have been observed. Pancreatitis has been reported very rarely.

Hypersensitivity:

Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (hypersensitivity vasculitis) (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm, dyspnoea or epistaxis or (c) assorted skin disorders, including rashes of various types, sore or dry mucous membranes, pruritus, urticaria, purpura, angiodema, alopecia and, more rarely exfoliative and bullous dermatoses (including toxic epidermal necrolysis, erythema multiforme and Stevens- Johnson syndrome).

Cardiovascular:

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Less frequently, congestive heart failure, especially in patients with marginal cardiac function, palpitation, hypertension and arrhythmia have been reported with sulindac.

4).

Other adverse events reported less commonly include:

Genito-urinary: urine discoloration, vaginal bleeding, haematuria, proteinuria, crystalluria, gynaecomastia Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.

Hepatic:

Abnormal liver function, hepatitis, cholestasis and jaundice. 4), depression, nervousness, confusion, hallucinations, convulsions, syncope, psychic disturbances including acute psychosis, tinnitus, vertigo, somnolence, insomnia, sweating, asthenia, dizziness, malaise, fatigue and drowsiness.

2, and GI and cardiovascular risks below). 5). 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.

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 older people.

3). 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 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).

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 our without warning symptoms or a previous history of serious GI events. 3), and in the elderly. These patients should commence treatment on the lowest dose available.

1. g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. 4). 6). 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. 5).