Sulindac is indicated for the symptomatic treatment of:

• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis
• Periarticular inflammatory disorders
• Acute painful shoulder
• Acute gouty arthritis
• Diabetic neuropathy
• Diabetic retinopathy

Sulindac is a non-steroidal anti-inflammatory (NSAID) agent with anti-inflammatory, analgesic, and antipyretic properties. Inhibition of prostaglandin synthesis is considered the main mechanism of action of NSAIDs. After absorption, Sulindac undergoes two major metabolic conversions: it is first oxidized to a sulfone and then reversibly reduced to a sulfide. The sulfide metabolite is the biologically active form and acts as the inhibitor of prostaglandin synthesis.

Sulindac should be administered orally twice a day with food. The maximum dosage is 400 mg per day. Dosages above 400 mg per day are not recommended. In osteoarthritis, rheumatoid arthritis & ankylosing spondylitis, the recommended starting dosage is 150 mg. In acute painful shoulder & acute gouty arthritis the recommended dosage is 200 mg twice a day. The dosage may be lowered or raised depending on the response. After a satisfactory response has been achieved, the dosage may be reduced according to the response. Or, as directed by the registered physicians.

Sulindac and its active sulfide metabolite are highly protein-bound. Patients should be closely monitored, especially when used with anticoagulants or hypoglycemic agents, until it is confirmed that dose adjustments are not required. Aspirin may reduce the bioavailability of the active sulfide metabolite of sulindac. Prolonged concurrent use of paracetamol with sulindac may increase the risk of renal adverse effects; therefore, close medical supervision is recommended. Probenecid may increase plasma levels of sulindac and its sulfone metabolite, while slightly decreasing the level of the active sulfide metabolite.

Sulindac is contraindicated in patients with known hypersensitivity to the drug and in those who experience asthma attacks, urticaria, or rhinitis triggered by aspirin or other NSAIDs. It is also contraindicated in patients with a history of active gastrointestinal bleeding or peptic ulcer disease. It should not be used in children, pregnant women, or lactating mothers.

The most common adverse effects are gastrointestinal, including abdominal pain, nausea, and constipation. Gastrointestinal ulceration and bleeding may also occur. Central nervous system effects include drowsiness, dizziness, headache, and nervousness. Other reported reactions include depression, tinnitus, confusion, insomnia, psychiatric disturbances, syncope, convulsions, coma, peripheral neuropathy, blurred vision, ocular effects, edema, weight gain, hypertension, hematuria, skin rash, pruritus, urticaria, stomatitis, alopecia, and hypersensitivity reactions. A hypersensitivity syndrome has been reported, including fever, chills, rash, liver toxicity, kidney toxicity (including renal failure), leukopenia, thrombocytopenia, eosinophilia, lymph node inflammation, and joint pain. Blood disorders such as aplastic anemia, hemolytic anemia, agranulocytosis, and purpura have also been reported. Other effects include epistaxis, hyperglycemia, hyperkalemia, vaginal bleeding, hepatitis, jaundice, and renal failure.

Use in pregnancy: Sulindac should be used during the first two trimesters only if clearly needed. Use during the third trimester is not recommended.

Use in lactation: It is unknown whether sulindac is excreted in breast milk. A decision should be made whether to discontinue breastfeeding or the drug, considering its importance to the mother.

Sulindac should be used cautiously in patients with renal impairment, bleeding disorders, epilepsy, parkinsonism, or psychiatric conditions. In hepatic impairment, the half-life is prolonged and dose reduction may be required. NSAID therapy with sulindac may sometimes cause anemia.

Renal impairment: Use with caution in renal dysfunction and bleeding disorders, epilepsy, parkinsonism, or psychiatric illness.

Hepatic impairment: Dose adjustment may be required due to prolonged half-life.

Symptoms mainly reflect gastrointestinal, renal, and central nervous system toxicity. Treatment is supportive and symptomatic.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Drugs used in Gout, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Store below 25°C, protected from light and moisture. Keep out of reach of children.