Sevelamer carbonate 800 mg Tablet, Film Coated, 270-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Phosphate Binder class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Sevelamer is used to control high blood levels of phosphorus in people with chronic kidney disease who are on dialysis (medical treatment to clean the blood when the kidneys are not working properly). Sevelamer is in a class of medications called phosphate binders. It binds phosphorus that you get from foods in your diet and prevents it from being absorbed into your blood stream.
Read the full MedlinePlus article ↗- When your kidneys aren't working properly, they can't remove phosphorus from your blood the way they normally would. Dialysis helps, but it doesn't always bring phosphorus down eno...
- What exactly does sevelamer do, and why do I need it if I'm on dialysis?
- Yes, timing really matters here. Sevelamer needs to be taken with each meal because it works by binding to phosphate in the food you're eating right then. If you take it without fo...
- Does it matter when I take it — can I just take all my doses at once?
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Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII 5Z17386USF
A food-derived fat used as an emulsifier and stabilizer. It helps blend oil and water-based ingredients together and keeps the medicine's texture consistent throughout its shelf life.
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UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 7CV7WJK4UI
Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.219 | $59.02 / 270 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.3584 | $96.77 / 270 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sevelamer Carbonate 800 mg 00904-6707-06 | Major | 1 tablet | $0.219 | AB | Availability likely | — |
| Sevelamer Carbonate 800 mg 11788-0116-07 | AiPing | 270 tablets | $0.219 | AB | Availability likely | — |
| Sevelamer Carbonate 800 mg 16714-0814-01 | NorthStar | 270 tablets | $0.219 | AB | Availability likely | — |
| Sevelamer Carbonate 800 mg 24979-0186-46 | TWi | 270 tablets | $0.219 | AB | Availability likely | — |
| Sevelamer Carbonate 800 mg 33342-0215-58 | Macleods | 270 tablets | $0.219 | AB | Availability likely | — |
| Sevelamer Carbonate 800 mg 50268-0720-15 | AvPAK | 1 tablet | $0.219 | AB | Availability likely | — |
| Sevelamer Carbonate 800 mg 55111-0789-11 | DR. | 4 tablets | $0.219 | AB | Availability likely | — |
| Sevelamer Carbonate 800 mg 60687-0328-31 | American | 1 tablet | $0.219 | AB | Availability likely | — |
| Sevelamer Carbonate 800 mg 68094-0034-64 | Precision | 10 tablets | $0.219 | AB | Availability likely | — |
| Sevelamer carbonate 800 mg 69097-0967-93 | Cipla | 270 tablets | $0.219 | AB | Availability likely | — |
| Sevelamer Carbonate 800 mg 69367-0423-27 | Westminster | 270 tablets | $0.219 | AB | Availability likely | — |
| Sevelamer carbonate 800 mgthis 76282-0407-27 | Exelan | 270 tablets | $0.219 | AB | Availability likely | — |
| Sevelamer carbonate 800 mg 76282-0664-27 | Exelan | 270 tablets | $0.219 | AB | Availability likely | — |
| Sevelamer Carbonate 800 mg 00955-1050-27 | Sanofi-Aventis | 270 tablets | $0.254 | — | FDA listed | +16% |
| Renvela 800 mg 58468-0133-01 | Genzyme | 270 tablets | $5.685 | — | Availability likely | +2500% |
| Sevelamer Carbonate 800 mg 00615-8239-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Sevelamer Carbonate 800 mg 00955-1057-30 | Sanofi-Aventis | 270 tablets | — | — | FDA listed | — |
| Sevelamer Carbonate 800 mg 17856-0921-01 | ATLANTIC | 1 tablet | — | AB | FDA listed | — |
| Sevelamer Carbonate 800 mg 42571-0378-30 | Micro | 30 tablets | — | AB | Discontinued | — |
| Sevelamer Carbonate 800 mg 51407-0706-27 | Golden | 270 tablets | — | AB | FDA listed | — |
| Sevelamer Carbonate 800 mg 55154-3358-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Sevelamer Carbonate 800 mg 55154-8188-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Sevelamer Carbonate 800 mg 58624-5001-02 | Shandong | 30 tablets | — | AB | FDA listed | — |
| Sevelamer Carbonate 800 mg 64380-0872-04 | Strides | 30 tablets | — | AB | FDA listed | — |
| Sevelamer Carbonate 800 mg 65162-0058-09 | Amneal | 90 tablets | — | AB | FDA listed | — |
| Sevelamer Carbonate 800 mg 65862-0921-18 | Aurobindo | 180 tablets | — | AB | FDA listed | — |
| Sevelamer carbonate 800 mg 68382-0824-10 | Zydus | 1000 tablets | — | AB | FDA listed | — |
| Sevelamer carbonate 800 mg 68475-0010-01 | Navinta | 30 tablets | — | AB | FDA listed | — |
| Sevelamer carbonate 800 mg 69097-0893-93 | Cipla | 270 tablets | — | AB | FDA listed | — |
| Sevelamer carbonate 800 mg 70710-2170-03 | Zydus | 30 tablets | — | AB | FDA listed | — |
| Sevelamer carbonate 800 mg 70771-1520-00 | Zydus | 1000 tablets | — | AB | FDA listed | — |
| Sevelamer Carbonate 800 mg 71205-0966-67 | Proficient | 270 tablets | — | AB | FDA listed | — |
| Sevelamer Carbonate 800 mg 71335-3021-01 | Bryant | 50 tablets | — | AB | Discontinued | — |
| Sevelamer Carbonate 800 mg 72162-2499-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Sevelamer Carbonate 800 mg 72789-0562-94 | PD-Rx | 270 tablets | — | AB | FDA listed | — |
| Sevelamer Carbonate 800 mg 73190-0014-27 | AvKARE | 270 tablets | — | AB | FDA listed | — |
| Sevelamer Carbonate 800 mg 85898-0101-27 | Marp | 270 tablets | — | — | FDA listed | — |
| Sevelamer Carbonate 800 mg 87367-0266-12 | INSIGNAMEDEX | 270 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 76282-0407-27 You're viewing this | 270 TABLET, FILM COATED in 1 BOTTLE (76282-407-27) | 2017-11-08 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Sevelamer carbonate is 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. However, due to Genzyme Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information Sevelamer carbonate is a phosphate binder indicated for the control of serum phosphorus in adults 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 ( 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 )
2.1General Dosing Information Starting Dose for Adult Patients Not Taking a Phosphate Binder. The recommended starting dose of sevelamer carbonate 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 800 mg Tablet > 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 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. 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 based on a patient's current calcium acetate dose. Table 3. Starting Dose for Dialysis Patients Switching From Calcium Acetate to Sevelamer carbonate Calcium Acetate 667 mg (Tablets per meal) Sevelamer Carbonate Tablet 1 tablet 0.8 g 2 tablets 1.6 g 3 tablets 2.4 g Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets.
However, due to Genzyme Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: 0.8 g off-white, film coated, modified capsule shaped, biconvex tablets de-bossed with 'I 8' on one side. Tablets: 0.8 g ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Sevelamer carbonate is contraindicated in patients with bowel obstruction. Sevelamer carbonate is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. Bowel obstruction. ( 4 ) Known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serious cases of dysphagia, bowel obstruction, and perforation have been associated with sevelamer use, some requiring hospitalization and surgery. ( 5.1 )
5.1Gastrointestinal 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.
Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery were not included in the sevelamer carbonate clinical studies.
5.2Reductions in Vitamins D, E, K (clotting factors) and Folic Acid Levels In preclinical studies in rats and dogs, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, reduced vitamins D, E, and K (coagulation parameters) and folic acid levels at doses of 6 to 10 times the recommended human dose. In short-term clinical trials, there was no evidence of reduction in serum levels of vitamins. However, in a one-year clinical trial, 25-hydroxyvitamin D (normal range 10 to 55 ng/mL) fell from 39 ± 22 ng/mL to 34 ± 22 ng/mL (p <0.01) with sevelamer hydrochloride treatment.
Most (approximately 75%) patients in sevelamer hydrochloride clinical trials were receiving vitamin supplements.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most of the safety experience is with sevelamer tablets and sevelamer hydrochloride. In long-term studies with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, the most common adverse events included: vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%) and constipation (8%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Exelan Pharmaceuticals, Inc., at 1-855-295-7455 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. There are limited clinical trial data on the safety of sevelamer carbonate. However, because it contains the same active ingredient as the hydrochloride salt, the adverse event profiles of the two salts are expected to be similar.
In a cross-over study in hemodialysis patients with treatment durations of eight weeks each and no washout, and another cross-over study in hemodialysis patients, with treatment durations of four weeks each and no washout between treatment periods, the adverse reactions on sevelamer carbonate powder were similar to those reported for sevelamer hydrochloride. In a parallel design study of sevelamer hydrochloride with treatment duration of 52 weeks, adverse reactions reported for sevelamer hydrochloride (n=99) were similar to those reported for the active-comparator group (n=101).
Overall adverse reactions among those treated with sevelamer hydrochloride occurring in > 5% of patients included: vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%) and constipation (8%). A total of 27 patients treated with sevelamer and 10 patients treated with comparator withdrew from the study due to adverse reactions. Based on studies of 8 to 52 weeks, the most common reason for withdrawal from sevelamer hydrochloride was gastrointestinal adverse reactions (3 to 16%).
In 143 peritoneal dialysis patients studied for 12 weeks using sevelamer hydrochloride, most common adverse reactions were similar to adverse reactions observed in hemodialysis patients. The most frequently occurring treatment emergent serious adverse reaction was peritonitis (8 reactions in 8 patients [8%] in the sevelamer group and 2 reactions in 2 patients [4%] on active-control). Thirteen patients (14%) in the sevelamer group and 9 patients (20%) in the active-control group discontinued, mostly for gastrointestinal adverse reactions.
6.2Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of sevelamer hydrochloride or sevelamer carbonate: hypersensitivity, pruritus, rash, abdominal pain, fecal impaction, and uncommon cases of ileus, intestinal obstruction, and intestinal perforation. Appropriate medical management should be given to patients who develop constipation or have worsening of existing constipation to avoid severe complications.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS There are no empirical data on avoiding drug interactions between sevelamer carbonate and most concomitant oral drugs. For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy (e.g., cyclosporine, tacrolimus, levothyroxine), consider separation of the timing of the administration of the two drugs [see Clinical Pharmacology (12.3) ] . The duration of separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate release or an extended release product.
Where possible consider monitoring clinical responses and/or blood levels of concomitant drugs that have a narrow therapeutic range. Table 5. Sevelamer Drug Interactions Oral drugs for which sevelamer did not alter the pharmacokinetics when administered concomitantly Digoxin Enalapril Iron Metoprolol Warfarin Oral drugs that have demonstrated interaction with sevelamer and are to be dosed separately from sevelamer carbonate Dosing Recommendations Ciprofloxacin Mycophenolate mofetil Take at least 2 hours before or 6 hours after sevelamer Take at least 2 hours before sevelamer For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy consider separation of the timing of administration and/or monitor clinical responses or blood levels of the concomitant medication.
( 7 ) Sevelamer did not alter the pharmacokinetics of digoxin, enalapril, iron, metoprolol and warfarin. ( 7 ) Sevelamer has demonstrated interaction with ciprofloxacin, mycophenolate mofetil, and therefore these drugs should be dosed separately from sevelamer carbonate. ( 7 ) Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets.
However, due to Genzyme Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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 [see Clinical Pharmacology (12.2)]. Consider supplementation.
Data Animal Data In pregnant rats given dietary doses of 0.5, 1.5 or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred in mid-and high-dose groups (human equivalent doses approximately equal to 3-4 times the maximum clinical trial dose of 13 g). In pregnant rabbits given oral doses of 100, 500 or 1000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical trial dose).
8.2Lactation Risk Summary Sevelamer carbonate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to sevelamer carbonate. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see Clinical Pharmacology (12.2)]. Consider supplementation.
8.4Pediatric Use Sevelamer carbonate tablets has not been studied in pediatric patients below 6 years of age. Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets. However, due to Genzyme Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
8.5Geriatric Use Clinical studies of sevelamer carbonate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.
🤰 Pregnancy ▾
8.1Pregnancy 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 [see Clinical Pharmacology (12.2)]. Consider supplementation.
Data Animal Data In pregnant rats given dietary doses of 0.5, 1.5 or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred in mid-and high-dose groups (human equivalent doses approximately equal to 3-4 times the maximum clinical trial dose of 13 g). In pregnant rabbits given oral doses of 100, 500 or 1000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical trial dose).
🧒 Pediatric Use ▾
8.4Pediatric Use Sevelamer carbonate tablets has not been studied in pediatric patients below 6 years of age. Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets. However, due to Genzyme Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of sevelamer carbonate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.
🆘 Overdosage ▾
10 OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Sevelamer carbonate tablets contains 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).
12.2Pharmacodynamics In addition to effects on serum phosphorus levels, sevelamer hydrochloride has been shown to bind bile acids in vitro and in vivo in experimental animal models. Because sevelamer binds bile acids, it may interfere with normal fat absorption and thus may reduce absorption of fat soluble vitamins such as A, D and K. In clinical trials of sevelamer hydrochloride, both the mean total and LDL cholesterol declined by 15-31%; the clinical significance of this finding, which was observed after 2 weeks, is unclear.
Triglycerides, HDL cholesterol and albumin did not change.
12.3Pharmacokinetics A mass balance study using 14 C-sevelamer hydrochloride, in 16 healthy male and female volunteers showed that sevelamer hydrochloride is not systemically absorbed. No absorption studies have been performed in patients with renal disease. Drug Interactions In vivo Sevelamer carbonate has been studied in human drug-drug interaction studies (9.6 grams once daily with a meal) with warfarin and digoxin.
Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been studied in human drug-drug interaction studies (2.4 to 2.8 grams single dose or three times daily with meals or two times daily without meals) with ciprofloxacin, digoxin, enalapril, iron, metoprolol, mycophenolate mofetil and warfarin. Co-administered single dose of 2.8 grams of sevelamer hydrochloride in fasted state decreased the bioavailability of ciprofloxacin by approximately 50% in healthy subjects. Concomitant administration of sevelamer and mycophenolate mofetil in adult and pediatric patients decreased the mean MPA C max and AUC 0–12h by 36% and 26% respectively.
Sevelamer carbonate or sevelamer hydrochloride did not alter the pharmacokinetics of enalapril, digoxin, iron, metoprolol and warfarin when co-administered. During postmarketing experience, cases of increased thyroid stimulating hormone (TSH) levels have been reported in patients co-administered sevelamer hydrochloride and levothyroxine. Reduction in concentrations of cyclosporine and tacrolimus leading to dose increases has also been reported in transplant patients when co-administered with sevelamer hydrochloride without any clinical consequences (for example, graft rejection).
The possibility of an interaction cannot be excluded with these drugs.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Sevelamer carbonate tablets contains 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).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Sevelamer carbonate 800 mg tablets are supplied as off-white, film coated, modified capsule shaped, biconvex tablets de-bossed with 'I 8' on one side. Bottle of 270 (NDC 76282-407-27) Storage: Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Protect from moisture. Dispense in tight, light-resistant container as defined in the USP.
📋 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 crosslinking groups c = 1 m = large number to indicate extended polymer network Sevelamer Carbonate Tablets: Each film-coated tablet contains 800 mg of sevelamer carbonate on an anhydrous basis.
The inactive ingredients are microcrystalline cellulose, silicified microcrystalline cellulose, crospovidone, hydroxy propyl cellulose, talc, colloidal silicon dioxide, sodium stearyl fumarate, hydroxy propyl methyl cellulose and diacetylated monoglycerides. Chemical Structure/Figure 1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Inform patients to take sevelamer carbonate tablets with meals and adhere to their prescribed diets. For patients using an oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, advise the patient to take the oral medication at least one hour before or three hours after sevelamer carbonate tablets. Advise patients to report new onset or worsening of existing constipation promptly to their physician.
Disclaimer: Other brands listed are the registered trademarks of their respective owners and are not trademarks of Exelan Pharmaceuticals, Inc., Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Exelan Pharmaceuticals, Inc. Lawrenceville, GA 30046 Revised: 09/2017 Barcode: 407-09-2017