Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL
8mm flat bevel-edged orange yellow tablet marked “SD” breakline “100” on one side and “α” on the reverse.
For oral administration.
Sulindac should always be taken with fluids either with food or immediately after food and is normally taken twice a day. The usual adult dosage is 400 mg a day and doses above this level are not recommended. Lower doses may be found sufficient. Seven days treatment is usually sufficient for acute gouty arthritis. For peri-articular disorders treatment should be no longer than 7 to 10 days.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
Not recommended.
Older people are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, stupor, drowsiness, dizziness, tinnitus, fainting, occasionally convulsions, hypotension and a reduction in urine output.
In cases of significant poisoning acute renal failure and liver damage are possible.
Patients should be treated symptomatically as required.
Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially toxic amounts.
Frequent or prolonged convulsions should be treated with intravenous diazepam.
Other measures may be indicated by the patient’s clinical condition.
Shelf life: 5 years.
Store below 25°C. Store in the original package in order to protect from light and moisture.
Sulindac tablets are available either in PVC/aluminium foil blisters or polypropylene containers with polyethylene caps. The pack sizes available in both pack types are 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112 120, 168 and 180. In the polypropylene containers pack sizes of 50, 200 and 500 are also available.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
