Sevelamer Carbonate for Oral Suspension 2400 mg/1
Sevelamer Carbonate for Oral Suspension · POWDER, FOR SUSPENSION · Dr. Reddys Laboratories Inc
Sevelamer carbonate is a powder medication that you mix with water and take by mouth to help control phosphorus levels in patients with chronic kidney disease who are on dialysis. It works by binding phosphorus in your digestive system so your body absorbs less of it.
Key Facts
- Brand Name
- Sevelamer Carbonate for Oral Suspension
- Generic Name
- Sevelamer Carbonate for Oral Suspension
- NDC Code (Product)
43598-479- Manufacturer
- Dr. Reddys Laboratories Inc
- Strength
- 2400 mg/1
- Dosage Form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210464
- Marketing Start
- 10/25/2018
Recall History
Dr. Reddy's Laboratories, Inc.
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Sevelamer carbonate for oral suspension is 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 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 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 Ta…
Contraindications
4 CONTRAINDICATIONS Sevelamer carbonate for oral suspension is contraindicated in patients with bowel obstruction. Sevelamer carbonate for oral suspension 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 )
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 for Oral Suspension used for?
Sevelamer carbonate is a powder medication that you mix with water and take by mouth to help control phosphorus levels in patients with chronic kidney disease who are on dialysis. It works by binding phosphorus in your digestive system so your body absorbs less of it.
Is Sevelamer Carbonate for Oral Suspension a controlled substance?
Sevelamer Carbonate for Oral Suspension is not classified as a controlled substance by the DEA.
What is the generic name for Sevelamer Carbonate for Oral Suspension?
The generic name for Sevelamer Carbonate for Oral Suspension is Sevelamer Carbonate for Oral Suspension. There are no other listed brand versions of Sevelamer Carbonate for Oral Suspension.
What is the NDC code for Sevelamer Carbonate for Oral Suspension 2400 mg/1?
The NDC (National Drug Code) for Sevelamer Carbonate for Oral Suspension 2400 mg/1 is 43598-479, listed by Dr. Reddys Laboratories Inc.
Other Sevelamer Carbonate for Oral Suspension Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)