Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)
Zydus Pharmaceuticals USA Inc.
CALCIUM ACETATE
CALCIUM ACETATE 667 mg
ORAL
PRESCRIPTION DRUG
Calcium acetate tablet is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Patients with hypercalcemia. Pregnancy Category C Calcium acetate tablets contain calcium acetate. Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions (5.1)] . Maintenance of normal serum calcium levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. The effects of calcium acetate on labor and delivery are
Each Calcium Acetate Tablet USP, intended for oral administration, is white, round compressed tablet with engraving EP above 114 on one side and plain on the opposite side. Each calcium acetate tablet contains 667 mg of calcium acetate (anhydrous Ca(CH3 COO)2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium and are supplied as follows: NDC 68382-642-66 Bottles of 200 NDC 68382-642-10 Bottles of 1000 STORAGE: Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
CALCIUM ACETATE- CALCIUM ACETATE TABLET ZYDUS PHARMACEUTICALS USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION RX ONLY THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CALCIUM ACETATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CALCIUM ACETATE TABLETS. CALCIUM ACETATE TABLETS USP FOR ORAL USE. INITIAL U.S. APPROVAL: 1990 INDICATIONS AND USAGE Calcium acetate tablet is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (1) DOSAGE AND ADMINISTRATION Starting dose is 2 tablets with each meal.(2) Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus level is reached. Most patients require 3 to 4 tablets with each meal. (2) DOSAGE FORMS AND STRENGTHS Tablets: 667 mg calcium acetate per tablet.(3) CONTRAINDICATIONS Hypercalcemia. (4) WARNINGS AND PRECAUTIONS Treat mild hypercalcemia by reducing or interrupting calcium acetate tablet and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate tablets.(5.1) Hypercalcemia may aggravate digitalis toxicity.(5.2) ADVERSE REACTIONS The most common (>10%) adverse reactions are hypercalcemia, nausea, and vomiting. (6.1). In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy.(6). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HERITAGE PHARMACEUTICALS INC. AT 1- 866-901-DRUG (3784) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. PLEASE ADDRESS MEDICAL INQUIRIES TO _MEDICALAFFAIRS@ZYDUSUSA.COM_, TEL: 1-877-993-9779. DRUG INTERACTIONS Calcium acetate tablet may decrease the bioavailability of tetracyclines or fluoroquinolones. (7) When clinically significant drug interactions are expected, administer the drug at least one hour before or at least three hours after calcium acetate tablet, or consider monitoring blood levels of the drug. (7) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 1/2015 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND AD Đọc toàn bộ tài liệu