国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)
Camber Pharmaceuticals, Inc.
CALCIUM ACETATE
CALCIUM ACETATE 667 mg
ORAL
PRESCRIPTION DRUG
Calcium acetate 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 unknown. A c
Calcium acetate tablets, USP are available in tablet form with “IG ” debossed on one side and “393 ” on the other, for oral administration. Each white round tablet contains 667 mg of calcium acetate equivalent to 169 mg of calcium. Inactive Ingredients: polyethylene glycol 8000, sodium lauryl sulfate, crospovidone and sodium stearyl fumarate. NDC 31722-393-60 Bottles of 60 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
CALCIUM ACETATE- CALCIUM ACETATE TABLET CAMBER PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 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, 667 MG INITIAL U.S. APPROVAL: 1990 INDICATIONS AND USAGE • Calcium acetate 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 2-3 weeks until acceptable serum phosphorus level is reached. Most patients require 3-4 tablets with each meal. (2) DOSAGE FORMS AND STRENGTHS • Tablets: 667 mg calcium acetate tablet. (3) CONTRAINDICATIONS • Hypercalcemia. (4) WARNINGS AND PRECAUTIONS Treat mild hypercalcemia by reducing or interrupting calcium acetate tablets 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 CAMBER PHARMACEUTICALS INC. AT 1-866-495-8330 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS Calcium acetate 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 or consider monitoring blood levels of the drug. (7) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 1/2014 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Hypercalcemia 5.2 Concomitant Use 完全なドキュメントを読む