The safety and efficacy of Sevelamer Carbonate in patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders including severe constipation or major gastrointestinal tract surgery have not been established. Consequently, caution should be exercised when Sevelamer Carbonate is used in patients with these disorders. Sevelamer Carbonate treatment should be reevaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Uncommon case reports of difficulty swallowing the tablet have been report. Many of these cases involved patients with contributing co-morbid conditions affecting the ability to swallow including disorders of oroesophageal abnormalities. Caution should be exercised when the tablets are used in these patients. Consider using powder for oral suspension in patients with a history of difficulty swallowing.
Patients with CKD may develop low vitamin A, D, E and K levels, depending on dietary intake and the severity of their disease. Treatment with Sevelamer in preclinical studies, approximately at the equivalent of 6-10 times the maximum clinical trial dose, has been shown to reduce the absorption of vitamins D, E and K folic acid. Therefore, in patients not taking supplemental vitamins but on Sevelamer, serum vitamin A, D, and E levels and vitamin K status should be assessed regularly.
Other Services
Country
Account