Clinorel 200 mg

INDICATIONS

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

PHARMACOLOGY

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

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.

INTERACTION

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.

SIDE EFFECTS

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

Sulindac should be administered with caution to patients with impaired renal function and bleeding disorders, epilepsy, parkinsonism or psychiatric disorders. Patient with hepatic impairment the half life of sulindac is prolonged and a reduction of daily dosage may be required. Anemia is some time seen in patients receiving NSAIDs with 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.

THERAPEUTIC CLASS

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

STORAGE CONDITIONS

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.