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National Drug Formulary

SEVAMER - SEVELAMER CARBONATE FILM COATED TABLETS 800 MG [SIN17585P]

Active ingredients: SEVELAMER CARBONATE

View product's general information
Last updated on 9 October 2026

Product Info

SEVAMER - SEVELAMER CARBONATE FILM COATED TABLETS 800 MG

[SIN17585P]

Product information

Active Ingredient and Strength

SEVELAMER CARBONATE - 800 MG

Dosage Form

TABLET, FILM COATED

Manufacturer and Country

STRIDES PHARMA SCIENCE LIMITED - INDIA

Registration Number

SIN17585P

Licence Holder

STRIDES PHARMA GLOBAL PTE. LIMITED

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

V03AE02

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

1. INDICATIONS AND USAGE
Sevamer is indicated for the control of hyperphosphataemia in adult patients receiving hemodialysis or peritoneal dialysis.

Sevamer is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.

Sevamer 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.

Dosing

2. DOSAGE AND ADMINISTRATION
Because of the rapid disintegration of the carbonate salt tablet and its rapid reaction with the hydrochloric acid in the stomach, the dosing of Sevamer is anticipated to be similar to that of the hydrochloride salt.

Sevamer should be given three times a day with meals.

Patients Not Taking a Phosphate Binder. The recommended starting dose of Sevamer is 800 to 1600 mg, which can be administered as one or two Sevamer 800 mg Tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Sevamer for patients not taking a phosphate binder.

Sevamer Dosage Table 1



Patients Switching from Sevelamer Hydrochloride. For patients switching from sevelamer hydrochloride, sevelamer carbonate should be prescribed on a gram per gram basis. Further titration to the desired phosphate levels may be necessary. The highest daily dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.

Patients Switching from Calcium Acetate. In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of sevelamer hydrochloride and calcium acetate. Table 2 gives recommended starting doses of Sevamer based on a patient’s current calcium acetate dose.

Sevamer Dosage Table 2



Dose Titration for All Patients Taking Sevamer. The dose should be increased or decreased by one tablet per meal at two week intervals, as necessary, with the goal of controlling serum phosphorus within the target range of 3.5 mg/dL to 5.5 mg/dL.

Contraindications

4. CONTRAINDICATIONS
Sevamer is contraindicated in patients with hypophosphatemia or bowel obstruction. Sevamer is contraindicated in patients with hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.