Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
SEVELAMER CARBONATE (UNII: 9YCX42I8IU) (SEVELAMER - UNII:941N5DUU5C)
Exelan Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
Sevelamer carbonate is 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. However, due to Genzyme Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information Sevelamer carbonate is contraindicated in patients with bowel obstruction. Sevelamer carbonate is 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/
Sevelamer carbonate 800 mg tablets are supplied as off-white, film coated, modified capsule shaped, biconvex tablets de-bossed with 'I 8' on one side. Bottle of 270 (NDC 76282-407-27) Storage: Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Protect from moisture. Dispense in tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
SEVELAMER CARBONATE- SEVELAMER CARBONATE TABLET, FILM COATED EXELAN PHARMACEUTICALS 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, FILM COATED 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 is 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 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 EXELAN PHARMACEUTICALS, INC., AT 1-855-295-7455 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 it Διαβάστε το πλήρες έγγραφο