Sevelamer Taro 800 mg

/ Taro

Starting dose: The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level. Sevelamer Taro 2.4 g powder for oral suspension must be taken three times per day with meals.
Titration and Maintenance: Serum phosphorus should be monitored and the dose of sevelamer carbonate titrated every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Patients taking sevelamer carbonate should adhere to their prescribed diets. In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose is expected to be an average of approximately 6 g per day.
Paediatric population: The safety and efficacy of sevelamer carbonate has not been established in children below the age of 18 years. The medicine is not recommended in children below the age of 18 years.
Method of administration: For oral use. Each sachet of 2.4 g of powder is to be dispersed in 60 ml of water prior to administration. The suspension should be ingested within 30 minutes after being prepared.
Please refer to the license holder for further details.

For the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.Also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.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.

Hypersensitivity to the active substance or to any of the excipients. Hypophosphataemia.
Bowel obstruction.

Efficacy and safety have not been studied in children below the age of 18 years.
The safety and efficacy have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l. Therefore, treatment is currently not recommended in these patients.
The safety and efficacy have not been established in patients with the following disorders: dysphagia; swallowing disorders; severe GI motility disorders, including untreated or severe gastroparesis, retention of gastric contents and abnormal or irregular bowel motion; active inflammatory bowel disease; major GI tract surgery.
Fat-soluble vitamins: Serum vitamin A, D, E and K status should be assessed regularly.
Serum calcium levels should be monitored at regular intervals and elemental calcium should be given as a supplement if required.
Patients with chronic kidney disease are predisposed to developing metabolic acidosis. Monitoring of serum bicarbonate levels is therefore recommended.
Patients on peritoneal dialysis should be closely monitored with the prompt recognition and management of any signs and symptoms associated with peritonitis.
Caution should be exercised when prescribing to patients also taking anti-arrhythmias and anti-seizure medications.
Closer monitoring of patients with hypothyroidism is recommended.
This medicine is not indicated for the control of hyperparathyroidism.
Treatment should be within the context of multiple therapeutic approach, which could include calcium as supplements, 1,25 – dihydroxy vitamin D3 or one of its analogs to lower the intact parathyroid hormone levels.
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Very common: Nausea, vomiting, upper abdominal pain, constipation.
Common: Diarrhea, dyspepsia, flatulence, abdominal pain.
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Interaction studies have not been conducted in patients on dialysis.
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Pregnancy: The potential risk to humans is unknown. Should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the fetus.
Lactation: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.

Please refer to the license holder for further details.