Indicated for acute or long-term use in the relief of signs and symptoms of Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis, Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis), Acute gouty arthritis.
Acetic acid derivative & related substances; NSAIDs/ Antirheumatoid Drug
Sulindac is a non-steroidal antirheumatic agent possessing anti-inflammatory, analgesic and anti-pyretic properties. Prostaglandin synthetase inhibition is probably the basis of the mechanism of action of non-steroidal anti-inflammatory agents. Following absorption, Sulindac undergoes two major transformations. It is oxidised to the sulphone and then reversibly reduced to the sulphide. The sulphide metabolite is the biologically active form which is an inhibitor of prostaglandin synthesis.
Usual Adult Dose for Acute Gout Initial dose: 200 mg orally twice a day Maximum dose: 400 mg orally per day Duration of therapy: 7 days is usually adequate. Usual Adult Dose for Ankylosing Spondylitis Initial dose: 150 mg orally twice a day Maximum dose: 400 mg orally per day. Usual Adult Dose for Osteoarthritis Initial dose: 150 mg orally twice a day Maximum dose: 400 mg orally per day. Usual Adult Dose for Rheumatoid Arthritis Initial dose: 150 mg orally twice a day Maximum dose: 400 mg orally per day. Usual Adult Dose for Bursitis Initial dose: 200 mg orally twice a day Maximum dose: 400 mg orally per day Duration of therapy: 7 to 14 days is usually adequate. Usual Adult Dose for Tendonitis Initial dose: 200 mg orally twice a day Maximum dose: 400 mg orally per day Duration of therapy: 7 to 14 days is usually adequate.
Sulindac and its sulphide metabolite are highly protein bound. Patient should be monitored carefully until it is certain that no chance in their anticoagulant or hypoglycemic dosage is required. Aspirin has been shown to decrease the bioavailability of the active sulfide metabolite of sulindac. Prolonged concurrent use of Paracetamol with sulindac may increase the risk of adverse renal effects. That patient is under close medical supervision while receiving such combined therapy. Probenecid may increase the plasma concentration of sulindac and its sulfone metabolite and slightly decrease the plasma concentration of the active sulfide metabolite.
Hypersensitivity. Pregnancy (3rd trimester), treatment of peri-operative pain in CABG surgery. Use at lowest effective dose for shortest duration possible. NSAIDs may increase risk of severe CV (CV) thrombotic events, myocardial infarction, & stroke. Risk may be increased w/ duration of use or pre-existing CV disease or risk factors. Treatment has been associated w/ new onset HTN or worsening of pre-existing hypertension. May cause fluid retention & oedema; caution in heart failure. NSAIDs can cause serious GI adverse events including GI inflammation, ulceration, bleeding, & perforation. Caution in patients w/ 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 & prolong bleeding in some patients. Rare cases of sever hepatotoxicity induding jaundice, fatal fulminant hepatitis, liver necrosis & hepatic failure have been reported. May cause renal impairment; patients wI pre-existing renal impairment, heart failure, liver dysfunction, concomitant use of diuretics & ACE inhibitors, volume- depleted & elderly are at greater risk. Use is not recommended in advance renal impairment. Caution in patients w/ preexisting asthma; avoid in patients w/ history of aspirin-sensitive asthma. May cause serious skin reactions including exfoliative dermatitis, Steven-Johnson syndrome & toxic epidermal necrolysis. Aseptic meningitis in patients w/ SLE; pancreatitis have been reported. Pharmacokinetics has not been studied in paed patients. Should not be used during 3rd trimester of pregnancy. Lactation.
Headache, dizziness, nausea, vomiting, dyspepsia. GI cramps & 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, Gl 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, & hypersensitivity vasculitis. Anaphylaxis reactions; cross-sensitivity reactions in patients w/ known aspirin triad reactions; Steven-Johnson Syndrome & toxic epidermal necrolysis.
Avoid use during third trimester as it may cause premature closure of the ductus arteriosus. Not recommended in women attempting to conceive as may impair female fertility. Use is not recommended during lactation.
Reported symptoms have generally reflected the gastro-intestinal, renal and central nervous system toxicities of Sulindac. Treatment is symptomatic and supportive.
Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
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