Mesacol Special Precautions

Diarrhea, which appears to be dose-related, may occur. It may sometimes be difficult to distinguish it from diarrhea due to ulcerative colitis. Some of the absorbed 5-aminosalicylic acid or its metabolite may produce renal tubular damage. Care should be taken if renal tubular damage already exists; urinalysis, BUN and serum creatinine determination is advised. As Mesacol tablets will not disintegrate at lower pH, it should not be given with drugs that lower pH of stools.
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Mesacol should be used only if the potential benefits justify the potential risks to the fetus.
Use in lactation: 5-Aminosalicylic acid is excreted in mother's milk. Caution should be exercised as diarrhea may occur in neonate. In lactating rats, doses from 100-400 mg/kg produced growth retardation in pups.
Use in children: Safety and effectiveness have not been completely established in this age group (see Contraindications). In children >2 years, 5-aminosalicylic acid may be used if the benefits outweigh the risk to the child.