Pentasa Special Precautions

In certain cases, patients allergic to sulfasalazine may also suffer allergic reactions to Pentasa (risk of allergy to salicylates).
In case of impaired liver or kidney function, further actions should be discussed with the physician. Pentasa is not recommended for use in patients with impaired kidney function. The kidney function should be regularly monitored, especially during the initial phase of treatment.
Serious changes in the blood components and inflammation of the cardiac muscle and sack (myo- and pericarditis) are seen in rare cases. On suspicion of these adverse reactions, contact the physician and discontinue treatment.
Symptoms can be bleeding, bruises, sore throat and fever or in case of inflammation of the cardiac muscle and sack, fever and chest pain accompanied by shortness of breath.
Granules: Most patients who are intolerant or hypersensitive to sulphasalazine are able to take Mesalazine (Pentasa) without risk of similar reactions. However, caution is recommended when treating patients allergic to sulphasalazine (risk of allergy to salicylates). Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment. In case of acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, and severe headache and/or the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other signs of hypersensitivity, therapy should be discontinued immediately.
Caution is recommended in patients with impaired liver function. Liver function parameters like ALT or AST should be assessed prior to and during treatment, at the discretion of the treating physician.
The drug is not recommended for use in patients with renal impairment. The renal function should be monitored regularly (e.g. serum creatinine), especially during the initial phase of treatment. Urinary status (dip sticks) should be determined prior to and during treatment at the discretion of the treating physician. Mesalazine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment. The concurrent use of other known nephrotoxic agents should increase monitoring frequency of renal function.
Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment; please refer to Adverse Reactions.
Mesalazine-induced cardiac hypersensitivity reactions (myo- and pericarditis) have been reported rarely. Serious blood dyscrasias have been reported very rarely with mesalazine. Blood test for differential blood count is recommended prior to and during treatment, at the discretion of the treating physician. As stated in Interactions, concomitant treatment with mesalazine can increase the risk of blood dyscrasia in patients receiving azathioprine, or 6-mercaptopurine or thioguanine. Treatment should be discontinued on suspicion or evidence of these adverse reactions.
Cases of nephrolithiasis with mesalazine content have been reported during treatment with mesalazine. Adequate fluid intake must be ensured during treatment.
As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks. If the findings are normal, follow-up tests should be carried out every three months. If additional symptoms occur, these tests should be performed immediately.
Effects on the Ability to Drive or Operate Machinery: Tablet/Suppository: None.
Granules: Treatment with Mesalazine (Pentasa) is unlikely to affect the ability to drive and/or use machines.
Use in Pregnancy & Lactation: Limited experience. Pentasa should not be used during pregnancy and lactation except on doctor's advice.
Use in Children: Pentasa is not recommended in children <2 years.