Asacol Special Precautions

Not recommended for use in patients with renal impairment and caution should be exercised in patients with raised blood urea or proteinuria. The possibility of mesalazine-induced nephrotoxicity should be considered in patients developing impairment of renal function during treatment. It is recommended that all patients have an evaluation of their renal function prior to initiation of Asacol therapy and periodically while on Asacol therapy. Such a test is generally recommended within 14 days of initiation of therapy with 2-3 repeat evaluations each after another 4 weeks. If the results are normal, tests are recommended quarterly. In case additional signs of illness appear, further control tests are necessary.
In case of lung function impairment, especially asthma, patients need to be very closely monitored.
In patients with history of sensitivity to sulphasalazine, therapy should be initiated only under close medical supervision. Treatment must be stopped immediately if acute symptoms of intolerance such as cramps, abdominal pain, fever, severe headache, or rash.
Very rarely serious blood dyscrasia has been reported. Hematological investigations, including a complete blood count, should be performed prior to initiation and whilst on therapy according to the physician's judgment. Such tests are generally recommended within 14 days of initiation of therapy with 2-3 repeat tests each after another 4 weeks.
If the results are normal, tests are recommended quarterly. In case additional signs of illness appear, further control tests are necessary.
This procedure is to be followed especially, if a patient develops signs or symptoms pointing to blood dyscrasia during treatment, such as unexplained bleeding, hematoma, purpura, anemia. continuous fever, or a sore throat. Treatment with Asacol should be stopped immediately if there is a suspicion or evidence of blood dyscrasia and patients should seek immediate medical advice.
Safety and effectiveness of Asacol tablets and suppositories have not been fully established in pediatric patients.
Use in the elderly should be handled with caution and only for patients having a normal renal function.