Description

The granules must not be chewed. The contents of the sachet should be emptied onto the tongue and washed down with some water or orange juice. Alternatively, the entire content of the sachet can be taken with yogurt and consumed immediately.

Concurrent use of other known nephrotoxic agents such as NSAIDs and Azathioprine may increase the risk of renal reactions.

Hypersensitivity to salicylates or to any other component of the formulation.

The commonly reported adverse events are headache, nausea, dizziness, asthenia, dyspepsia, vomiting, pruritus etc.

It should be given in pregnancy only if the potential beneft justifes the potential risk to the fetus. Caution is advised when it is administered to a nursing mother.

Patients with pyloric stenosis may have prolonged gastric retention of Mesalamine tablets which could delay release of Mesalamine in the colon. Renal impairment, including minimal change nephropathy and acute and chronic interstitial nephritis has been reported in patients taking Mesalamine. Therefore, caution should be exercised when using Mesalamine in patients with known renal dysfunction or history of renal disease. Patients should have renal function monitored, prior to treatment start and then it should be monitored periodically during treatment. There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered Mesalamine. Caution should be exercised when administering Mesalamine to patients with liver impairment.

Geriatrics: Patients who are 65 years or older, caution should be taken to closely monitor blood cell counts during Mesalamine therapy. Elderly: Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. It is recommended that all patients have an evaluation of renal function prior to initiation of Mesalamine tablets. Monitor blood cell counts during drug therapy. Paediatric: Safety and effectiveness have not been established.