Country: United States
Language: English
Source: NLM (National Library of Medicine)
SEVELAMER CARBONATE (UNII: 9YCX42I8IU) (SEVELAMER - UNII:941N5DUU5C)
REMEDYREPACK INC.
SEVELAMER CARBONATE
SEVELAMER CARBONATE 800 mg
ORAL
PRESCRIPTION DRUG
Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis. Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets and Renvela (sevelamer carbonate) for oral suspension. However, due to Genzyme Corporation’s marketing exclusivity rights, these drug products are not labeled with that pediatric information. 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
Sevelamer Carbonate Tablets, 800 mg are supplied as white to off-white, oval shaped, film-coated tablets, imprinted with “J 75” on one side with edible black ink and plain on other side, containing 800 mg of sevelamer carbonate on an anhydrous basis, acetylated monoglycerides, ammonium hydroxide, black iron oxide, colloidal silicon dioxide, crospovidone, glyceryl behenate, hydroxypropyl cellulose, hypromellose, mannitol, propylene glycol, shellac glaze and talc. Bottles of 30 NDC 65862-921-30 Bottles of 180 NDC 65862-921-18 Bottles of 270 NDC 65862-921-27 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from moisture.
Abbreviated New Drug Application
SEVELAMER CARBONATE- SEVELAMER CARBONATE TABLET, FILM COATED REMEDYREPACK INC. ---------- 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, FOR ORAL USE INITIAL U.S. APPROVAL: 2000 RECENT MAJOR CHANGES Indications and Usage (1) 11/2016 Dosage and Administration (2) 11/2016 Contraindications (4) 03/2016 INDICATIONS AND USAGE Sevelamer carbonate tablets are a phosphate binder indicated for the control of serum phosphorus in adults with chronic kidney disease on dialysis. (1) DOSAGE AND ADMINISTRATION Starting dose of sevelamer carbonate tablets is 0.8 or 1.6 grams administered orally three times per day with meals based on serum phosphorus levels for adult patients. ( 2.1) Titrate by 0.8 g per meal in two week intervals for adult patients as needed to obtain serum phosphorus target. ( 2.1) DOSAGE FORMS AND STRENGTHS Tablets: 0.8 g (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, 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 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 AUROBINDO PHARMA USA, INC. AT 1-866-850-2876 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH DRUG INTERACTIONS For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its Read the complete document