COMPOSITION: Each tablet contains sulindac 200 mg.
PHARMACOLOGICAL CLASSIFICATION: A 3.1 Antirheumatics (Anti-inflammatory Agents)
ADCO-SULINDAC 200 mg 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.
ADCO-SULINDAC 200 mg is indicated for the symptomatic treatment of the following:-
Periarticular inflammatory disorders.
Acute gouty arthritis.
CONTRA-INDICATIONS: Patients known to be allergic to sulindac.
Patients in whom acute asthmatic attacks, urticaria or rhinitis have been precipitated by aspirin or other non-steroidal anti-inflammatory agents.
Patients with a history of active gastro-intestinal bleeding or peptic ulceration. ADCO-SULINDAC 200 mg should not be given to children. ADCO-SULINDAC 200 mg should not be given to pregnant or lactating women.
WARNINGS: Patients intolerant of one of the non-steroidal anti-inflammatory analgesics, including aspirin, may be intolerant of ADCO-SULINDAC 200 mg tablets.
DOSAGE AND DIRECTIONS FOR USE: The usual dosage is 100 mg to 200 mg twice a day, although dosages should be optimised 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. ADCO-SULINDAC 200 mg should be taken with a full glass of water or food.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Gastro-intestinal side-effects are the most common and consist of abdominal pain, nausea and constipation. Gastro-intestinal 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, inflamed glands or lymph nodes, and arthralgia has 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.
Sulindac should be administered with caution to patients with impaired renal function and to those with bleeding disorders, epilepsy, parkinsonism or psychiatric disorders.
In the presence of liver function impairment the half life of ADCO-SULINDAC 200 mg is prolonged and a reduction of daily dosage may be required.
INTERACTIONS: Sulindac and it's 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 it's sulfone metabolite, and slightly decrease the plasma concentration of the active sulfide metabolite.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Reported symptoms have generally reflected the gastro-intestinal, renal and central nervous system toxicities of sulindac.
Treatment is symptomatic and supportive.
IDENTIFICATION: Hexagonal yellow tablet with a scoreline on one side.
PRESENTATION: Securitainers of 60 tablets.
STORAGE INSTRUCTIONS: Store below 25°C. Protect from moisture. Keep out of reach of children.
REGISTRATION NUMBER: Y/3.1/19
NAME AND BUSINESS ADDRESS OF THE APPLICANT: ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Private Bag X69, Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT: February 1991
New addition to this site: April 2004
Source: Pharmaceutical Industry