CAVSAMIR FILM COATED TABLET 800MG [SIN16993P]

Product Info

CAVSAMIR FILM COATED TABLET 800MG

[SIN16993P]

1 INDICATIONS AND USAGE
Sevelamer Carbonate is indicated for the control of hyperphosphatemia in adult patients receiving haemodialysis or peritoneal dialysis.

Sevelamer Carbonate is also indicated for the control of hyperphosphatemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.

Sevelamer Carbonate should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxyvitamin D3 or one of its analogues to control the development of renal bone disease.

2 DOSAGE AND ADMINISTRATION
Due to the rapid reaction of the drug with hydrochloric acid in stomach, the dosage of Sevelamer Carbonate tablet is expected to be similar with hydrochloride.

2.1 General Dosing Information
The drug should be taken 3 times daily with meals.
Dose for Adult Patients Not Taking a Phosphate Binder: The recommended starting dose of Sevelamer Carbonate is 0.8 to 1.6 g with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Sevelamer Carbonate for adult patients not taking a phosphate binder.

Switching from Sevelamer Hydrochloride Tablets: For adult patients switching from Sevelamer Hydrochloride tablets to Sevelamer Carbonate tablets or powder, use the same dose in grams. To achieve the target phosphate concentration, further adjusting of dose may be necessary. For CKD patients on dialysis treatment, the highest daily dose of the used Sevelamer Carbonate in the study is 14 grams.

Switching from Calcium Acetate: A research performing on 84 of CKD patients on dialysis indicated that equivalent dose (approximate mg to mg) of Sevelamer Hydrochloride and Calcium Acetate showed similar decreasing serum phosphorus levels. Table 2 gives recommended starting doses of Sevelamer Carbonate based on a patient's current calcium acetate dose.

Adjusting doses for all patients using this product: The dose should be increased or decreased by one tablet per meal at two week intervals, as necessary, with the goal of controlling serum phosphorus within the target range of 3.5 mg/dL to 5.5 mg/dL.
Sevelamer Carbonate tablet should be swallowed entirely and should not be grinded, chewed to fragments or split.

4. CONTRAINDICATIONS
Sevelamer carbonate is contraindicated in patients with hypophosphatemia and bowel obstruction.
Sevelamer carbonate is contraindicated in patients with known hypersensitivity to sevelamer carbonate, or to any of the excipients.