Sevelamer Carbonate label

Sevelamer Carbonate

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Uses

Sevelamer carbonate is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

History

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Other Information

The active ingredient is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same.

Sevelamer carbonate is known chemically as poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1.

a, b = number of primary amine groups a + b = 9
c = number of crosslinking groups c = 1
m = large number to indicate extended polymer network

Figure 1. Chemical Structure of Sevelamer Carbonate

Chemical Structure

Sevelamer Carbonate Tablets: Each film-coated tablet contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are hypromellose, diacetylated monoglycerides, microcrystalline cellulose, sodium chloride and zinc stearate. The tablet imprint contains iron oxide black ink.

Sevelamer Carbonate Powder: Each packet contains 0.8 g or 2.4 g of sevelamer carbonate on an anhydrous basis. The inactive ingredients are natural and artificial citrus flavor, propylene glycol alginate, sodium chloride, sucralose, and ferric oxide (yellow).

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Sevelamer Carbonate Manufacturers

Global Pharmaceuticals Division Of Impax Laboratories, Inc.
No Recall
Sevelamer Carbonate | Global Pharmaceuticals Division Of Impax Laboratories, Inc.
Because of the rapid reaction with the hydrochloric acid in the stomach, the dosing of Sevelamer carbonate powder or tablet is anticipated to be similar to that of the sevelamer hydrochloride salt or tablet.
2.1 General Dosing Information
Sevelamer carbonate should be given three times a day with meals.

Patients Not Taking a Phosphate Binder. The recommended starting dose of sevelamer carbonate is 0.8 to 1.6 g with meals based on serum phosphorus level. Table 1 provides recommended starting doses of sevelamer carbonate for patients not taking a phosphate binder.
Table 1. Starting Dose for Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Sevelamer Carbonate 800 mg Tablet Sevelamer Carbonate Powder > 5.5 and < 7.5 mg/dL 1 tablet three times daily with meals 0.8 g three times daily with meals ≥ 7.5 mg/dL 2 tablets three times daily with meals 1.6 g three times daily with meals
Switching from Sevelamer Hydrochloride Tablets. For patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams. Further titration may be necessary to achieve desired phosphorus levels. The highest daily dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.

Switching between Sevelamer Carbonate Tablets and Powder. Use the same dose in grams. Further titration may be necessary to achieve desired phosphorus levels.

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 sevelamer carbonate based on a patient's current calcium acetate dose.
Table 2. Starting Dose for Dialysis Patients Switching From Calcium Acetate to Sevelamer Carbonate Calcium Acetate 667 mg
(Tablets per meal) Sevelamer Carbonate 800 mg Tablet
(Tablets per meal) Sevelamer Carbonate Powder 1 tablet 1 tablet 0.8 g 2 tablets 2 tablets 1.6 g 3 tablets 3 tablets 2.4 g
Dose Titration for All Patients Taking Sevelamer Carbonate. Titrate the sevelamer carbonate dose by 0.8 g three times per day with meals at two-week intervals as necessary with the goal of controlling serum phosphorus within the target range.
2.2 Sevelamer Carbonate Powder Preparation Instructions
The entire contents of each 0.8 or 2.4 g packet should be placed in a cup and mixed thoroughly with the amount of water described in Table 3.
Table 3. Sevelamer Carbonate Powder Preparation Instructions Sevelamer Carbonate Powder Packet Strength Minimum amount of water for dose preparation
(either ounces, mL or teaspoon/Tablespoon) ounces mL tsp/Tbsp 0.8 g 1 30 6 teaspoons/2 Tablespoons 2.4 g 2 60 4 Tablespoons
Multiple packets may be mixed together with the appropriate amount of water. Patients should be instructed to stir the mixture vigorously (it does not dissolve) and drink the entire preparation within 30 minutes and resuspend the preparation right before drinking.

Based on clinical studies, the average prescribed daily dose of sevelamer carbonate is approximately 7.2 g per day.