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Clinorel 100 mg Tablet
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Sulindac is indicated for the symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, periarticular inflammatory disorders, acute painful shoulder (acute subacromial bursitis/ supraspinatus tendinitis), acute gouty arthritis.
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Drugs used in Gout, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
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.
Dosage & Administration
The usual dosage is 100 mg to 200 mg twice a day, although dosages should be optimized for each individual. The maximal daily dose is 400 mg. Therapy for seven days in acute gouty arthritis and for seven to fourteen days in acute painful shoulder is usually sufficient. After a satisfactory response has been achieved, the dosage may be reduced according to the response. Sulindac should be taken with food
Sulindac and its sulphide metabolite are highly protein bound. Patients should be monitored carefully until it is certain that no change in their anticoagulant or hypoglycaemic dosage is required. Aspirin has been shown to decrease the bioavailability of the active sulfide metabolite of Sulindac. The combination showed an increase in the incidence of gastrointestinal side-effects, without providing additional symptomatic relief, and is therefore not recommended. Prolonged concurrent use of Paracetamol with Sulindac may increase the risk of adverse renal effects. It is recommended that patients be 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.
Patients known to be allergic to Sulindac and those in whom acute asthmatic attacks, urticaria or rhinitis have been precipitated by Aspirin or other non-steroidal anti-inflammatory agents. Sulindac is also contraindicated in patients with a history of active gastro-intestinal bleeding or peptic ulceration. It should not be given to children, pregnant or lactating women.
Gastrointestinal side effects are the most common and consist of abdominal pain, nausea and constipation. Gastrointestinal ulceration and bleeding may also occur. The most frequently reported central nervous system side effects are drowsiness, dizziness, headache and nervousness. Other adverse effects include depression, tinnitus, confusion, light-headedness, insomnia, psychiatric disturbances, syncope, convulsions, coma, peripheral neuropathy, blurred vision and other ocular effects, oedema and mass gain, hypertension, hematuria, skin rashes, pruritus, urticaria, stomatitis, alopecia and hypersensitivity reactions. A hypersensitivity syndrome consisting of fever and chills, skin rashes or other cutaneous manifestations, hepatotoxicity, renal toxicity (including renal failure), leukopenia, thrombocytopenia, eosinophilia, inflammed glands or lymph nodes, and arthralgia have been reported. Leucopenia, purpura, thrombocytopenia, aplastic anaemia, haemolytic anaemia, agranulocytosis, epitaxis, hyperglycaemia, hyperkalaemia and vaginal bleeding have been reported. There have also been reports of hepatitis and jaundice or renal failure.
Pregnancy & Lactation
Use in pregnancy: Sulindac should be used during the first two trimesters of pregnancy only if the potential benefit justifies the potential risk to the foetus. Use of Sulindac during the third trimester of pregnancy is not recommended.
Use in lactation: It is not known whether Sulindac is excreted in human milk. So a decision should be made whether to discontinue nursing or discontinue the medicine taking into account the importance of the medicine to the mother.
Precautions & Warnings
Patients intolerant of one of the non-steroidal anti-inflammatory analgesics, including Aspirin, may be intolerant of Sulindac.
Use in Special Populations
Patient with renal impairment: Sulindac should be administered with caution to patients with impaired renal function and to those with bleeding disorders, epilepsy, parkinsonism or psychiatric disorders.
Patient with hepatic impairment: In the presence of liver function impairment the half life of Sulindac is prolonged and a reduction of daily dosage may be required.
Reported symptoms have generally reflected the gastro-intestinal, renal and central nervous system toxicities of Sulindac. Treatment is symptomatic and supportive.
Store in a cool and dry place protected from light. Keep out of reach of children.
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