Nefral

Nefral

sevelamer

Manufacturer:

Globela Pharma

Distributor:

Bell-Kenz Pharma
Concise Prescribing Info
Contents
Sevelamer carbonate
Indications/Uses
Control of hyperphosphatemia in adult patients receiving haemodialysis or peritoneal dialysis; or w/ CKD not on dialysis w/ serum P >1.78 mmol/L. Multiple therapeutic approach (including Ca supplement, 1,25-dihydroxy vit D3 or one of its analogues) to control the development of renal bone disease.
Dosage/Direction for Use
Initially 2.4-4.8 g/day based on clinical needs & serum P level to be taken tid. Patient w/ serum P level 1.78-2.42 mmol/L (5.5-7.5 mg/dL) 2.4 g daily to be taken over 3 meals, >2.42 mmol/L (>7.5 mg/dL) 4.8 g daily to be taken over 3 meals. Patient previously on phosphate binders (sevelamer HCl or Ca based) Give a g for g basis w/ monitoring of serum P levels to ensure optimal daily doses. Titrate doses every 2-4 wk until an acceptable serum P level is reached, w/ regular monitoring thereafter.
Administration
Should be taken with food: Swallow whole, do not chew/crush/divide.
Contraindications
Hypersensitivity. Hypophosphatemia, bowel obstruction.
Special Precautions
Not recommended in adult patients w/ CKD not on dialysis w/ serum P <1.78 mmol/L. Patients w/ dysphagia; swallowing disorders; severe GI motility disorder including untreated or severe gastroparesis, retention of gastric contents & 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. Regularly assess serum vit A, D, E & K status in patients not taking supplemental vit but on sevelamer. Possible folate deficiency during long-term treatment. Patients w/ CKD may develop hypocalcaemia or hypercalcaemia & are predisposed to metabolic acidosis. Monitor serum Ca levels at regular intervals & give supplement if required; & serum bicarbonate levels. Closely monitor patients on peritoneal dialysis to ensure correct use of appropriate aseptic technique w/ prompt recognition & management of any signs & symptoms associated w/ peritonitis. Concomitant use w/ anti-arrhythmic & anti-seizure medicines. Hypothyroidism. Long-term chronic treatment (>1 yr). Not indicated for the control of hyperparathyroidism. Contains lactose. Patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation. Not recommended in childn <18 yr.
Adverse Reactions
Nausea, vomiting, upper abdominal pain, constipation. Diarrhoea, dyspepsia, flatulence, abdominal pain.
Drug Interactions
Decreased bioavailability of ciprofloxacin. Reduced levels of ciclosporin, mycophenolate mofetil & tacrolimus. Levothyroxine. Anti-arrhythmic & anti-seizure medicines.
MIMS Class
Antidotes & Detoxifying Agents
ATC Classification
V03AE02 - sevelamer ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.
Presentation/Packing
Form
Nefral FC tab 800 mg
Packing/Price
30's (P1,170/box, P39/film-coated tab)
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