Drugplain

SEVELAMER CARBONATE 800 mg/1

SEVELAMER CARBONATE · TABLET · AiPing Pharmaceutical, Inc.

2 Recalls on Record
Plain English

SEVELAMER CARBONATE is a tablet containing sevelamer carbonate at 800 mg/1, taken oral. Manufactured by AiPing Pharmaceutical, Inc..

Key Facts

Brand Name
SEVELAMER CARBONATE
Generic Name
SEVELAMER CARBONATE
NDC Code (Product)
11788-116
Manufacturer
AiPing Pharmaceutical, Inc.
Strength
800 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA215998
Marketing Start
12/15/2025

Recall History

2 Recalls on Record
Class II07/02/2013

Aidapak Services, LLC

Labeling:Label Mixup; SEVELAMER CARBONATE Tablet, 800 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD46265_16, EXP: 5/15/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD70629_13, EXP: 5/29/2014; QUEtiapine FUMARATE, Tablet, 100 mg, NDC 60505313301, Pedigree: W002777, EXP: 6/6/2014; VALSARTAN, Tablet, 160 mg, NDC 0007803

TerminatedVoluntary: Firm initiated
Class III06/26/2024

Dr. Reddy's Laboratories, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

constipation188 reports
diarrhoea126 reports
nausea97 reports
pruritus93 reports
death82 reports
vomiting80 reports
fatigue71 reports
end stage renal disease69 reports
off label use69 reports
renal failure69 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 tablet is 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 & Administration

2 DOSAGE AND ADMINISTRATION Starting dose of sevelamer carbonate tablet 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. ( 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 are 0.8 to 1.6 grams 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. Starting Dose for Adult Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Sevelamer Carbonate > 5.5 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 …

Contraindications

4 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. ( 4 ) Known hypersensitivity to sevelamer carbonate,sevelamer hydrochloride, or to any of the excipients. ( 4 )

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 Ciprofloxacin Mycophenolate mofetil Dosing Recommendations Take at least 2 hours be…

Adverse Reactions

6 ADVERSE REACTIONS 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-ove…

Frequently Asked Questions

What is SEVELAMER CARBONATE used for?

SEVELAMER CARBONATE contains SEVELAMER CARBONATE. It is a tablet taken oral. Consult your doctor for specific uses.

Is SEVELAMER CARBONATE a controlled substance?

SEVELAMER CARBONATE is not classified as a controlled substance by the DEA.

What is the generic name for SEVELAMER CARBONATE?

The generic name for SEVELAMER CARBONATE is SEVELAMER CARBONATE. There are 11 other brand versions of SEVELAMER CARBONATE.

What is the NDC code for SEVELAMER CARBONATE 800 mg/1?

The NDC (National Drug Code) for SEVELAMER CARBONATE 800 mg/1 is 11788-116, listed by AiPing Pharmaceutical, Inc..

Product NDC

11788-116

Package NDC

11788-116-07

Other SEVELAMER CARBONATE Dosages

Other Sevelamer Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)