Country: United States
Language: English
Source: NLM (National Library of Medicine)
Sevelamer Carbonate (UNII: 9YCX42I8IU) (Sevelamer - UNII:941N5DUU5C)
DR. REDDY'S LABORATORIES LIMITED
Sevelamer Carbonate
Sevelamer Carbonate 800 mg
ORAL
PRESCRIPTION DRUG
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 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. 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 vitami
Tablets: Sevelamer carbonate Tablets 800 mg are supplied as white to off-white, oval, film-coated tablets plain on one side and imprinted ‘R789’ on other side, containing 800 mg of sevelamer carbonate on an anhydrous basis, ammonium hydroxide, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, lecithin, mannitol, polyvinyl alcohol, propylene glycol, shellac, talc, xanthan gum and zinc stearate. The tablet imprint contains iron oxide black ink. Bottles of 30 NDC 55111-789-30 Bottles of 90 NDC 55111-789-90 Bottles of 270 NDC 55111-789-27 Unit dose package of 100 (25 x 4) NDC 55111-789-11 Storage: Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature] Protect from moisture.
Abbreviated New Drug Application
SEVELAMER CARBONATE- SEVELAMER CARBONATE TABLET, FILM COATED DR. REDDY'S LABORATORIES LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SEVELAMER CARBONATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SEVELAMER CARBONATE TABLETS. SEVELAMER CARBONATE TABLETS, FILM COATED FOR ORAL USE INITIAL U.S. APPROVAL: 2000 INDICATIONS AND USAGE 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 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) DOSAGE FORMS AND STRENGTHS Tablets: : 800 mg (3) CONTRAINDICATIONS Bowel obstruction. (4) Known hypersensitivity to sevelamer carbonate,sevelamer hydrochloride, or to any of the excipients. (4) WARNINGS AND PRECAUTIONS 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) 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, CONTA Read the complete document