Asacol

/ Tradis Gat

Ulcerative colitis:
Maintenance of remission: 1.2 to 2.4 g per day in divided doses.
There is no specific dose recommendation for children.
Crohn’s disease:
2.4 g per day in divided doses.
There is no specific dose recommendation for children.
Use in the elderly should be handled with caution and only for patients having a normal renal function. The tablets should be taken before meals and must be swallowed whole and preferably with some liquid. They must not be chewed, crushed or broken before swallowing.

Maintenance of remission in ulcerative colitis and for treatment of acute episodes in Crohn’s disease.

– Hypersensitivity to salicylates.
– Hypersensitivity to mesalazine or any of the excipients.
– Severe renal impairment (GFR less than 30 mL/min/1.73 m²).
– Severe liver impairment.
– Children under the age of 2 years.

Not recommended for use in patients with renal impairment, and caution should be exercised in patients with a raised blood urea or proteinuria. Renal function should be evaluated prior to initiation of therapy and periodically during treatment. In case of lung function impairment, especially asthma, patients need to be very closely monitored. Mesalazine induced nephrotoxicity should be suspected in patients developing renal failure during treatment. Use in the elderly should be cautious and subject to patients having a normal renal function. Serious blood dyscrasias have been reported very rarely with this medicdbinal product. Hematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anemia, fever or sore throat. Treatment should be stopped immediately if there is a suspicion or evidence of blood dyscrasias, or if acute symptoms of intolerance occur, such as cramps, abdominal pain, fever, severe headache, or rash. The product should be used under the direction of a specialist with appropriate facilities for monitoring.
Pregnancy and lactation: Only when potential benefits outweigh potential risks.

Adverse reactions occur in a small proportion of patients and are predominantly gastrointestinal. Nausea, diarrhea, abdominal pain, fever, alopecia and headache have been reported. Reversible peripheral neuropathy has been associated with mesalazine treatment and paraesthesia has been reported. Has been associated with the exacerbation of the symptoms of colitis.
See prescribing information for full details.

No interaction studies have been performed.
There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin.
In patients who are concomitantly treated with azathioprine, or 6-ercaptopurine or thioguanine, a possible increase in the myelosuppressive effects of azathioprine, or 6-mercaptopurine or thioguanine should be taken into account. As a result, life-threatening infection can occur. Patients should be closely observed for signs of infection and myelosuppression. Haematological parameters, especially the leucocyte, thrombocyte, and lymphocyte cell counts should be monitored regularly (weekly), especially at initiation of such combination therapy. If white blood cells are stable after 1 month, testing every 4 weeks for the following 12 weeks followed by 3 monthly monitoring intervals appears to be justified.

Pregnancy: There are no adequate data on the use of Asacol in pregnant women. However, data on a limited number (627) of exposed pregnancies indicate no adverse effect of mesalazine on pregnancy or on the health of the fetus/newborn child. To date no other relevant epidemiologic data are available.
Asacol should only be used during pregnancy if the potential benefit outweighs the possible risk.
Breast-feeding: N-acetyl-5-aminosalicylic acid and to a lesser degree mesalazine are excreted in breast milk. The clinical significance of this has not been determined. Only limited experience during lactation in women is available to date. Hypersensitivity reactions such as diarrhoea in the infant cannot be
excluded. Therefore, Asacol should only be used during breast-feeding, if the potential benefit outweighs the possible risk. If the infant develops diarrhoea, breast-feeding should be discontinued.
The use of mesalazine during pregnancy and lactation should be restricted to those cases where in the physician’s opinion potential benefits from this therapy outweigh potential risks.
See prescribing information for full details.

There is little data on overdose (e.g. intended suicide with high oral doses of mesalazine), which do not indicate renal or hepatic toxicity.
In principle, the signs and symptoms would be expected to be similar to those observed in cases of salicylate intoxication: mixed acidosis-alkalosis, hyperventilation, pulmonary edema, dehydration as a result of sweating and vomiting, and hypoglycemia.
Treatment for mixed acidosis-alkalosis: restoration of the acid-base balance in line with the specific situation and replacement of electrolytes.
For dehydration due to sweating and vomiting: administration of fluids.
For hypoglycemia: glucose administration.
In addition gastric lavage and intravenous transfusion of electrolytes to promote diuresis. There is no specific antidote and treatment is symptomatic and supportive.