Sevelamer Carbonate for Oral Suspension

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Starting dose of sevelamer carbonate for oral suspension 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 grams per meal in two week intervals for adult patients as needed to obtain serum phosphorus target (3.5 to 5.5 mg/dL).
• (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 is 0.8 to 1.6 grams 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 and < 7.5 mg/dL 0.8 grams three times daily with meals ≥7.5 mg/dL 1.6 grams three times daily with meals Dose Titration for Adult Patients Taking Sevelamer Carbonate .
• Titrate the sevelamer carbonate dose by 0.8 grams 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 grams 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.
• Titrate the sevelamer carbonate 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 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 1 tablet 0.8 grams 2 tablets 1.6 grams 3 tablets 2.4 grams
• 2.2 Sevelamer Carbonate Powder Preparation Instructions Sevelamer carbonate powder is available in 0.8 or 2.4 grams packets.
• Place the sevelamer carbonate powder in a cup and suspend in the amount of water described in Table 4.
• Table 4.
• Sevelamer Carbonate Powder Preparation Instructions Amount of Sevelamer Carbonate Powder Minimum Amount of Water for Dose Preparation (either ounces, mL or tablespoon) ounces mL Tablespoons 0.8 grams 1 30 2 2.4 grams 2 60 4 Instruct patients to stir the mixture vigorously (it does not dissolve), resuspend, if necessary, right before administration, and drink the entire preparation within 30 minutes.
• As an alternative to water, the entire contents of the packet may be pre-mixed with a small amount of food or beverage and consumed immediately (within 30 minutes) as part of the meal.
• Do not heat sevelamer carbonate powder (e.g., microwave) or add to heated foods or liquids.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and efficacy of sevelamer carbonate in lowering serum phosphorus levels was studied in patients 6 years of age and older with CKD.
• In this study, sevelamer carbonate was apparently less effective in children with a low baseline serum phosphorus, which described children <13 years of age and children not on dialysis.
• Given its mechanism of action, sevelamer carbonate is expected to be effective in lowering serum phosphorus levels in pediatric patients with CKD.
• Most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature.
• No new risks or safety signals were identified with the use of sevelamer carbonate in the trial.
• Sevelamer carbonate has not been studied in pediatric patients below 6 years of age.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• Most of the safety experience is with sevelamer carbonate 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 Dr.
• Reddy’s Laboratories, Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
• 6.1 Clinical 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.
• 6.2 Postmarketing 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 postapproval use of sevelamer hydrochloride or sevelamer carbonate:
• hypersensitivity, pruritus, rash, abdominal pain, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Dosing Inform patients to take sevelamer carbonate for oral suspension 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.
• For sevelamer carbonate powder, brief the patient on preparation of the powder in water.
• Advise patients to report new onset or worsening of existing constipation or bloody stools promptly to their physician [see Warnings and Precautions ( 5.1 )].
• R X only Distributor: Dr.
• Reddy’s Laboratories Inc., Princeton NJ 08540, USA Made in India Issued: 0520

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Powder:
• 0.8 grams and 2.4 grams off white to pale yellow color powder packaged in an opaque, foil lined, heat sealed packets. Powder:
• 0.8 grams and 2.4 grams packets ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Powder:
• Sevelamer carbonate for oral suspension is supplied as opaque, foil lined, heat sealed, packets containing 0.8 grams or 2.4 grams of sevelamer carbonate, colloidal silicon dioxide, iron oxide yellow, lemon spray dry flavour, mannitol, propylene glycol, PHA vanilla flavour, PHA orange flavour, and sucralose. 1 Box of 90 ct 0.8 grams packets NDC 43598-478-90 1 Box of 90 ct 2.4 grams packets NDC 43598-479-90 Storage:
• Store at 20°C to 25°C (68°F to 77°F); [See USP Controlled Room Temperature] Protect from moisture.

Quoted from the official label, section “How Supplied”.

What is in it

• The active ingredient in sevelamer carbonate for oral suspension 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.
• 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 Sevelamer Carbonate Powder:
• Each packet of sevelamer carbonate for oral suspension contains 0.8 grams or 2.4 grams of sevelamer carbonate.
• The inactive ingredients are colloidal silicon dioxide, iron oxide yellow, lemon spray dry flavor, mannitol, propylene glycol, PHA vanilla flavor, PHA orange flavor, and sucralose.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

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