Sevelamer Carbonate
FOSFAMER
Regulatory Class: Rx
Generic Name: Sevelamer Carbonate
Formulation/s: 800 mg Film-coated tablet
Indications or Use: Sevelamer Carbonate is indicated for the control of hyperphosphatemia in adult patients receiving hemodialysis or peritoneal dialysis. It is also indicated for the control of hyperphosphatemia in adult patients with chronic kidney disease (CKD) 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-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Dosage and Directions for Use: Folate-deficient megaloblastic anemia 5 mg daily for 4 months. Malabsorption states up to 15 mg daily. Chronic haemolytic state Continue with 5 mg every 1-7 days. Prevention of neural tube defects in the offspring of pregnant & women w/ child-bearing potential 5 mg daily prior to pregnancy & continued through the 1st trimester.
Administration: Take with food. Swallow whole, do not chew/crush/divide.
Contraindication: Hypersensitivity. Hypophosphatemia or bowel obstruction.
Special Precaution: Patients with dysphagia, swallowing disorders, severe GI motility disorders including severe constipation or major GIT surgery; contributing co-morbid conditions affecting ability to swallow including swallowing disorders or oroesophageal abnormalities. Reevaluate treatment in patients who develop severe constipation or other severe GI symptoms. Consider using powd for oral susp in patients with history of difficulty swallowing. Assess serum vit A, D, & E levels & vitamin K status regularly in patients not taking supplemental vitamin but on treatment. Pregnancy. Childn <18 yr.
Adverse Reaction: Nausea, vomiting; diarrhea, dyspepsia, abdominal pain, flatulence, constipation.
Interactions: Decreased bioavailability of ciprofloxacin. Reduced conc of cyclosporin, mycophenolate mofetil & tacrolimus in transplant patients w/o any clinical consequences (ie, graft rejection). Very rare cases of increased Thyroid Stimulating Hormones levels with levothyroxine. Very rare cases of increased phosphate levels with Proton Pump Inhibotors.
Presentation/ Packaging: Film-coated tablet 800 mg x 30’s
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