Finished product reference

Sevelamer Carbonate

Powder, for Suspension · Oral · 2.4 g

List code
50111

What it is and how it works

Mechanism of Action Sevelamer carbonate tablets contain sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. 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).

Indications

Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis. Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets and Renvela (sevelamer carbonate) for oral suspension. However, due to Genzyme Corporation’s marketing exclusivity rights, these drug products are not labeled with that pediatric information. Sevelamer carbonate tablets are a phosphate binder indicated for the control of serum phosphorus in adults with chronic kidney disease on dialysis.

Dosage and administration (summary)

Starting dose of sevelamer carbonate tablets is 0.8 or 1.6 grams administered orally three times per day with meals based on serum phosphorus levels for adult patients. Titrate by 0.8 g per meal in two week intervals for adult patients as needed to obtain serum phosphorus target. General Dosing Information Starting Dose for Adult Patients Not Taking a Phosphate Binder. The recommended starting dose of sevelamer carbonate tablets is 0.8 to 1.6 g taken orally with meals based on serum phosphorus level. Table 1 provides recommended starting doses of sevelamer carbonate tablets for adult patients not taking a phosphate binder. Table 1.

Contraindications

Sevelamer carbonate tablets are contraindicated in patients with bowel obstruction. Sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. Bowel obstruction. Known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.

Warnings and precautions

Serious cases of dysphagia, bowel obstruction, and perforation have been associated with sevelamer use, some requiring hospitalization and surgery. Gastrointestinal Adverse Events Cases of dysphagia and esophageal tablet retention have been reported in association with use of the tablet formulation of sevelamer, some requiring hospitalization and intervention. Consider using sevelamer suspension in patients with a history of swallowing disorders. Cases of bowel obstruction and perforation have also been reported with sevelamer use.

Pregnancy

Pregnancy Risk Summary Sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women . Consider supplementation.

Storage and supply

Sevelamer Carbonate Tablets, 800 mg are supplied as white to off-white, oval shaped, film-coated tablets, imprinted with “J 75” on one side with edible black ink and plain on other side, containing 800 mg of sevelamer carbonate on an anhydrous basis, acetylated monoglycerides, ammonium hydroxide, black iron oxide, colloidal silicon dioxide, crospov…

Source: Sevelamer Carbonate (Sevelamer Carbonate) — US FDA prescribing information, 2025-06-27, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Other presentations of the same active ingredient

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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