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Sevelamer Carbonate

The active content in Nephsev®(Sevelamer Carbonate), a polymeric amine that binds to phosphate and          is meant for oral administration. Sevelamer Carbonate an anion exchange resin, polymeric structure is as  Sevelamer Hydrochloride, in which Carbonate replaces chloride as the counter ion. While the counter ions  differs for the two salt, the polymer itself, the active moiety involved in phosphate binding, is the same.  Sevelamer Carbonate is chemically called as poly(allylamine-co-N,N’-diallyl-1,3diamino-2-hydroxypropane)  carbonate salt. Sevelamer Carbonate is hygroscopic and  insoluble in water. Patients with CKD retain  phosphorus that can develop Hyperphosphatemia. When the product of serum calcium and phosphorus  concentrations (Ca*P) surpasses 55 mg/dL, there is increased risk that ectopic calcification may occur.  Hyperphosphatemia plays a role in the development of secondary hyperparathyroidism in renal insufficiency.  Management of Hyperphosphatemia includes Diet, Dialysis and use of Phosphate Binders. Sevelamer  Carbonate taken with meals has been shown to control Serum Phosphorus concentrations in patients with  CKD who are on dialysis.                                                                                                                                    Nephsev® (Sevelamer Carbonate) is used to lower high blood Phosphorus (phosphate) levels in patients who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and possibly decrease the risk of heart disease and strokes that can result from high phosphate levels. Nephsev® (Sevelamer Carbonate) works by holding onto phosphate from the diet so that it can pass out of your body. 

Presentation

Alu Alu pack of Nephsev® 400 in one strip 10 tablets and 10 strips in a box.
Alu Alu pack of Nephsev® 800 in one strip 10 tablets and 10 strips in a box.

Composition

Each NEPHSEV®-400 tablet contains: Sevelamer Carbonate 400 mg.
Each NEPHSEV®-800 tablet contains: Sevelamer Carbonate 800 mg

Mode of Action

These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract and decreasing absorption, Sevelamer Carbonate lowers the Phosphate concentration in the Serum (serum phosphorus). When taken with meals, it binds to dietary Phosphate and prevents its absorption. Sevelamer Carbonate prevents hyperphosphatemia by binding to dietary phosphate in the gut, preventing its absorption and thus decreasing serum parathyroid hormone levels.

Drug Interactions

Sevelamer Carbonate may develop drug interaction with the following drugs                                                                Ciprofloxacin             Digoxin                  Warfarin                   Enalapril                  Metoprolol                   Iron

Overdosage

Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse effects. In CKD patients on dialysis, the maximum dose studied was 14 grams of Sevelamer Carbonate and 13 grams of Sevelamer Hydrochloride. There are no reports of overdosage with Sevelamer Carbonate or Sevelamer Hydrochloride in patients. Since Sevelamer is not absorbed, the risk of systemic toxicity is low.

Contraindications

Sevelamer Carbonate is contraindicated in patients with bowel obstructions.

Warnings & Precautions

Serious cases of dysphagia, bowel instruction, and perforation have been associated with Sevelamer use some requiring hospitalization and surgery.

Adverse reactions

Sevelamer Carbonate may cause constipation ,if left untreated it may lead to severe complications. Patients should be cautioned to report new onset or worsening of existing constipation promptly to their physician.

Indications
  • Control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
  • Control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.
  • Hyperphosphatemia- Stage 4 and 5 chronic kidney disease on hemodialysis or peritoneal dialysis
  • Control of hyperphosphatemia in CKD not on dialysis with serum phosphorus greater or eq. to 1.78 mmol/L
Dosage

If Serum Phosphorus is Greater than 7.5 mg/dl : Two tablets of Nephsev® 800 three times a day with meals.
If Serum Phosphorus is  Greater than 5.5 and  lesser than 7.5mg/dl : One Tablet of Nephsev® 800 three times a day with meals.
If Serum Phosphorus is Greater than 4.5 and Lesser than 5.5 mg/dl : One Tablet Nephsev® 400 three times a day with meals

Disclaimer:

This information is for registered medical practitioner only. Anyone other than medical practitioner should consult medical practitioner before using this product.