Sevelamer


Full Generic Medicine Info
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.
Contraindications
Hypophosphataemia, bowel obstruction.
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 Obtain serum Ca, P and PTH as clinically indicated. Monitor serum chemistries including chloride and bicarbonate. Assess serum vitamin A, D, E, K, and folic acid levels.
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.
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.
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.
CIMS Class
Antidotes, Detoxifying Agents & Drugs Used in Substance Dependence
ATC Classification
V03AE02 - sevelamer ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.
Disclaimer: This information is independently developed by CIMS based on sevelamer from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 CIMS. All rights reserved. Powered by CIMSAsia.com
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