Sevelamer Symgens

Sevelamer carbonate

Control of hyperphosphataemia in adults receiving haemodialysis or peritoneal dialysis, & w/ CKD not on dialysis w/ serum P ≥1.78 mmol/L. Control of development of renal bone disease including Ca supplement, 1,25-dihydroxy vit D₃ or 1 of its analogues.

Total daily dose over 3 meals daily: Patient w/ serum P level >2.42 mmol/L (>7.5 mg/dL) 4.8 g; 1.78-2.42 mmol/L (5.5-7.5 mg/dL) 2.4 g. Titration & maintenance: Titrate by 0.8 g 3 times daily (2.4 g daily) increments every 2-4 wk until acceptable serum P level is reached, w/ regular monitoring thereafter. Continuous treatment based on the need to control serum P levels & w/ expected ave daily dose of approx 6 g daily.

Should be taken with food: Swallow whole, do not chew/crush/divide.

Hypersensitivity. Hypophosphataemia; bowel obstruction.

Exclude possibility of folate deficiency during long term treatment. Not indicated for control of hyperparathyroidism. Not recommended in adults w/ CKD not on dialysis w/ serum P <1.78 mmol/L. Serious GIT inflammatory disorders (including serious complications eg, haemorrhage, perforation, ulceration, necrosis, colitis & colonic/caecal mass) associated w/ presence of sevelamer crystals. Monitor therapy in patients suffering from dysphagia, swallowing disorders, severe GI motility disorders including untreated or severe gastroparesis, gastric contents retention & abnormal or irregular bowel motion, active inflammatory bowel disease, major GIT surgery. Re-evaluate treatment in patients who develop severe constipation or other severe GI symptoms. Closely monitor patients on peritoneal dialysis & ensure correct use of appropriate aseptic technique w/ prompt recognition & management of signs & symptoms associated w/ peritonitis; w/ hypothyroidism & recommended to administer w/ levothyroxine. Carefully monitor proper swallowing ability in patients w/ co-morbid conditions. Intestinal obstruction & ileus/sub-ileus. Regularly assess serum vit A, D, E, & K status & folate level in patients not taking supplemental vit & folic acid, respectively. Additional fat-soluble vit & folic acid monitoring in patients undergoing peritoneal dialysis. Monitor serum Ca levels at regular intervals; Na bicarbonate levels. Monitor TSH levels in patients receiving levothyroxine. Hepatic impairment. Pregnancy & lactation. Childn <6 yr or BSA <0.75 m².

Nausea, vomiting, upper abdominal pain, constipation. Diarrhoea, dyspepsia, flatulence.

Decreased bioavailability of ciprofloxacin. Reduced levels of ciclosporin, mycophenolate mofetil & tacrolimus. Concomitant use w/ levothyroxine; anti-arrhythmics & anti-seizure medicinal products; PPIs. Administer other medicinal products at least 1 hr before or 3 hr after treatment as it may affect bioavailability.

Antidotes & Detoxifying Agents

V03AE02 - sevelamer ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.

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