Dosage/Direction for Use
Oral Hyperphosphataemia in chronic kidney disease Adult: In patients on haemodialysis or peritoneal dialysis, or for those not requiring dialysis: As sevelamer carbonate or sevelamer hydrochloride: Initially, 800-1,600 mg tid. Dose should be initiated based on serum phosphorus level: >5.5 to <7.5 mg/dL: 800 mg tid; ≥7.5 mg/dL: 1,600 mg tid. Adjust the dose gradually by 800 mg tid increment every 2-4 weeks until achieving the desired serum phosphorus levels. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines). Child: As sevelamer carbonate: ≥6 years BSA ≥0.75-<1.2 m2: 800 mg tid, titrate by 400 mg tid every 2-4 weeks as necessary; BSA ≥1.2 m2: 1,600 mg tid, titrate by 800 mg tid every 2-4 weeks as necessary. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines). |
Administration
Should be taken with food.
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Contraindications
Hypophosphataemia, bowel obstruction.
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Special Precautions
Patient with dysphagia, swallowing disorders, active inflammatory bowel disease, severe gastrointestinal motility disorders (e.g. untreated or severe gastroparesis, gastric contents retention, abnormal or irregular bowel motion, severe constipation), major gastrointestinal tract surgery; hypothyroidism. Pregnancy and lactation. < I>Monitoring Parameters
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Adverse Reactions
Significant: Serious gastrointestinal tract inflammatory disorders (e.g. haemorrhage, obstruction, perforation, ulceration, necrosis, colitis, colonic or caecal mass), peritonitis, metabolic acidosis; dysphagia and oesophageal tablet retention (tab).
Gastrointestinal disorders: Nausea, vomiting, abdominal pain, constipation, dyspepsia, diarrhoea, flatulence.
Skin and subcutaneous tissue disorders: Rash, pruritus.
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Drug Interactions
May decrease the serum concentration of ciclosporin, mycophenolate mofetil, tacrolimus, and levothyroxine. Decreases the bioavailability of ciprofloxacin. May increase phosphate levels with PPIs. May reduce the absorption of vitamin A, D, E, K, and folic acid.
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Action
Sevelamer is a polymer compound which acts by binding phosphate in the gastrointestinal tract thereby limiting absorption and reducing serum phosphate levels without changing the concentrations of Ca, Al, or bicarbonate.
Absorption: Not systemically absorbed. Excretion: Via faeces. |
Storage
Oral: Tab: Store between 15-30°C. Protect from moisture.
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ATC Classification
V03AE02 - sevelamer ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.
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