Sulindac


Concise Prescribing Info
Indications/Uses
Listed in Dosage
Dosage/Direction for Use
Adult : PO Symptomatic treatment of rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis 150 mg twice daily. Acute painful shoulder 200mg twice daily; usually for 7-14 days. Acute gouty arthritis200 mg twice daily; usually for 7 days. Max: 400mg/day
Dosage Details
Oral
Acute painful shoulder
Adult: For symptomatic treatment: 200 mg bid; may reduce dose after satisfactory response achieved. Max: 400 mg/day. Treatment duration: 7-14 days is usually adequate.

Oral
Ankylosing spondylitis, Osteoarthritis, Rheumatoid arthritis
Adult: For symptomatic treatment: 150 mg bid; may adjust subsequent doses based on response. Max: 400 mg/day.

Oral
Acute gouty arthritis
Adult: For symptomatic treatment: 200 mg bid; may reduce dose after satisfactory response achieved. Max: 400 mg/day. Treatment duration: 7 days is usually adequate.
Renal Impairment
May need dosage reduction. Not recommended in severe renal impairment.
Hepatic Impairment
Acute and chronic hepatic disease: May need dosage reduction.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Pregnancy (3rd trimester), treatment of peri-operative pain in CABG surgery .
Special Precautions
Use at lowest effective dose for shortest duration possible. NSAIDs may increase risk of severe cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. Risk may be increased with duration of use or pre-existing CV disease or risk factors. Treatment has been associated with new onset hypertension or worsening of pre-existing hypertension. May cause fluid retention and oedema; caution in heart failure. NSAIDs can cause serious GI adverse events including GI inflammation, ulceration, bleeding, and perforation. Caution in patients with history of GI disease; concomitant use of aspirin, anticoagulants and/or oral corticosteroids; smoking, use of alcohol, elderly or debilitated patients. Anaemia may occur, monitor CBC in patients who are on long term NSAIDs. May inhibit platelet aggregation and prolong bleeding in some patients. Rare cases of sever hepatotoxicity including jaundice, fatal fulminant hepatitis, liver necrosis and hepatic failure have been reported. May cause renal impairment; patients with pre-existing renal impairment, heart failure, liver dysfunction, concomitant use of diuretics and ACE inhibitors, volume-depleted and elderly are at greater risk. Use is not recommended in advance renal impairment. Caution in patients with pre-existing asthma; avoid in patients with history of aspirin-sensitive asthma. May cause serious skin reactions including exfoliative dermatitis, Steven-Johnson syndrome and toxic epidermal necrolysis. Aseptic meningitis in patients with SLE; pancreatitis have been reported. Pharmacokinetics has not been studied in paediatric patients. Should not be used during 3rd trimester of pregnancy. Lactation.
Adverse Reactions
Headache, dizziness, nausea, vomiting, dyspepsia, GI cramps and pain, diarrhoea, constipation, flatulence, anorexia, tinnitus, rash, pruritus, erythema multiforme, nervousness, oedema, urine discoloration, muscle weakness, sore or dry mucous membranes, stomatitis, gastritis, peptic ulcer, GI bleeding, alopecia, photosensitivity, congestive heart failure, arrhythmia, hyperkalaemia, thrombocytopenia, leukopenia, agranulocytosis, liver function abnormalities, jaundice, cholestasis, hepatitis, hepatic failure, pancreatitis, proteinuria, renal calculi, interstitial nephritis, nephritic syndrome, renal failure, hypersensitivity reactions, and hypersensitivity vasculitis.
Potentially Fatal: Anaphylaxis reactions; cross-sensitivity reactions in patients with known aspirin triad reactions; Steven-Johnson Syndrome and toxic epidermal necrolysis.
PO: C (Avoid during 3rd trimester or near delivery)
Overdosage
Hypotension, decreased urine output, stupor and coma. Empty stomach by inducing vomiting or by gastric lavage, followed by symptomatic and supportive treatment. Absorption may be decreased by the prompt administration of activated charcoal and excretion may be enhanced by alkalinisation of the urine.
Drug Interactions
Concomittent use with dimethyl sulfoxide may result in peripheral neuropathy. Increased nephrotoxicity with ciclosporin; increased risk of methotrexate toxicity; increased risk of bleeding with other NSAIDs, warfarin and thrombolytic agents. Antagonises effect of antihypertensives. Unpredictable interactions with lithium.
Food Interaction
Increased risk of bleeding with cat's claw, dong quai, evening primrose, feverfew, gingko, red clover, horse chestnut, green tea, ginseng, garlic, ginger. Food reduces rate and extent of absorption.
Action
Description: Sulindac is a prodrug which undergoes reversible reduction to its active sulfide metabolites. It inhibits prostaglandin synthesis by decreasing cyclooxygenase activity.
Pharmacokinetics:
Absorption: About 90% absorbed
Distribution: About 93% of sulindac and 98% of its sulfide metabolite are bound to human albumin. Sulindac and its metabolites undergo extensive enterohepatic circulation.
Metabolism: Metabolised by reversible reduction to biologically active sulfide metabolite, and by irreversible oxidation to sulfone metabolite. Mean plasma half-lives of sulindac and its sulfide metabolite are 7.8hr and 16.4 hr respectively.
Excretion: About 50% excreted in urine mainly as inactive metabolites, with small amounts as sulindac; 25% appears in the faeces mainly as metabolites.
Storage
Store at 15-30°C (59-86°F).
Disclaimer: This information is independently developed by MIMS based on Sulindac from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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