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Drug Catalog - Product Detail

SEVELAMER CARBONATE 800MG TAB 270CT

NDC Mfr Size Str Form
00115-1309-27 IMPAX GENERICS 270 800MG TABLET
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Description
11 DESCRIPTION The active ingredient in sevelamer carbonate tablets 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 (Renagel ® ). 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. Figure 1. Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups a + b = 9 c = number of cross-linking groups c = 1 m = large number to indicate extended polymer network Chemical Structure - Figure 1 Sevelamer carbonate tablets: Each film-coated tablet of sevelamer carbonate contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are microcrystalline cellulose, colloidal silicon dioxide, stearic acid 50, polyvinyl alcohol, titanium dioxide, macrogel/PEG 3350 and talc.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Tablets: Sevelamer carbonate tablets 800 mg are supplied as white to off-white, film-coated, oval tablets, debossed with "L3" on one side and plain on the other side, containing 800 mg of sevelamer carbonate on an anhydrous basis. 1 Bottle of 30 Tablets (NDC 0115-1309-08) 1 Bottle of 270 Tablets (NDC 0115-1309-27) 1 Bottle of 700 Tablets (NDC 0115-1309-38) Storage: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.
Indications & Usage
1 INDICATIONS AND USAGE Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Sevelamer carbonate tablets are a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Starting dose of sevelamer carbonate is 0.8 or 1.6 grams administered orally three times per day with meals based on serum phosphorus levels for adult patients and based on body surface area (BSA) category for pediatric patients. ( 2.1 ) Titrate by 0.8 g per meal in two week intervals for adult patients as needed to obtain serum phosphorus target. ( 2.1 ) Titrate based on BSA category for pediatric patients in two week intervals for 6 weeks and then every 4 weeks as needed to obtain serum phosphorus target. ( 2.1 ) 2.1 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 for adult patients not taking a phosphate binder. Table 1: Starting Dose for Adult Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Sevelamer Carbonate > 5.5 and < 7.5 mg/dL 0.8 g three times daily with meals ≥ 7.5 mg/dL 1.6 g three times daily with meals Dose Titration for Adult Patients Taking Sevelamer Carbonate Tablets. Titrate the sevelamer carbonate tablets dose by 0.8 g three times per day with meals at two-week intervals as necessary to achieve target serum phosphorus levels. Based on clinical studies, the average prescribed adult daily dose of sevelamer carbonate is approximately 7.2 g per day. The highest daily adult dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis. Starting Dose for Pediatric Patients Not Taking a Phosphate Binder. The recommended starting dose for pediatric patients 6 years of age and older is 0.8 g to 1.6 g taken three times per day with meals based on the patient’s body surface area (BSA) category; see Table 2. Table 2: Recommended Starting Dosage and Titration Increment Based on Pediatric Patient’s Body Surface Area (m 2 ) BSA (m 2 ) Starting Dose Per Meal/Snack Titration Increases/Decreases Per Dose ≥0.75 to <1.2 0.8 g Titrate by 0.4 g ≥1.2 1.6 g Titrate by 0.8 g Dose Titration for Pediatric Patients Taking Sevelamer Carbonate Tablets. Titrate the sevelamer carbonate tablets dose as needed to achieve target levels at two-week intervals based on BSA category, as shown in Table 2. Switching from Sevelamer Hydrochloride Tablets . For adult patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams. Switching between Sevelamer Carbonate Tablets and Powder. Use the same dose in grams. Switching from Calcium Acetate . Table 3 gives recommended starting doses of sevelamer carbonate tablets based on a patient’s current calcium acetate dose. Table 3: Starting Dose for Dialysis Patients Switching from Calcium Acetate to Sevelamer Carbonate Tablets Calcium Acetate 667 mg (Tablets per meal) Sevelamer Carbonate 1 tablet 0.8 g 2 tablets 1.6 g 3 tablets 2.4 g