Foseal-800 Tablets

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 )

• 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 Titrate by 0.8 grams per meal in two week intervals for adult patients as needed to obtain serum phosphorus target
• 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
• 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 Carbonate Tablets
• Titrate the sevelamer carbonate tablets 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. …

Tablets:800 mg white to off-white, oval, film-coated tablets plain on one side and imprinted ‘R789’ on other side. Tablets: : 800 mg (3)

• 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

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.

• 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
• Advise patients to report new onset or worsening of existing constipation or bloody stools promptly to their physician [see Warnings and Precautions ]
• R X only Distributor: Dr
• Reddy’s Laboratories Inc., Princeton NJ, 08540, USA Made in India Revised: 04/2025

• 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
• Known hypersensitivity to sevelamer carbonate,sevelamer hydrochloride, or to any of the excipients

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. …

Serious cases of dysphagia, bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation have been associated with sevelamer use, some requiring hospitalization and surgery. ( 5.1 ) 5.1 Gastrointestinal Adverse Events 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. 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. …

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. …

8.1 Pregnancy 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. …

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.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.