Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)
AvKARE, Inc.
CALCIUM ACETATE
CALCIUM ACETATE 667 mg
ORAL
PRESCRIPTION DRUG
Calcium acetate, USP is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). - Patients with hypercalcemia. Patients with hypercalcemia. Pregnancy Category C Calcium acetate capsules 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
Calcium Acetate Capsules, 667 mg are hard gelatin capsules with white opaque body imprinted with “590” and light-blue opaque cap imprinted with “AMNEAL” with black ink. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH 3 COO) 2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. They are available as follows: Bottles of 200: NDC 42291-189-20 STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
CALCIUM ACETATE- CALCIUM ACETATE CAPSULE AVKARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION CALCIUM ACETATE CAPSULES RX ONLY THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CALCIUM ACETATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CALCIUM ACETATE. CALCIUM ACETATE CAPSULES: 667 MG, FOR ORAL USE INITIAL U.S. APPROVAL: 1990 INDICATIONS AND USAGE Calcium acetate, USP 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 capsules 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 capsules with each meal. (2) DOSAGE FORMS AND STRENGTHS Capsule: 667 mg calcium acetate capsule. (3) CONTRAINDICATIONS Hypercalcemia. (4) WARNINGS AND PRECAUTIONS Treat mild hypercalcemia by reducing or interrupting calcium acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate. (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 AVKARE, INC. AT 1-855-361-3993; EMAIL DRUGSAFETY@AVKARE.COM; 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: 4/2015 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS & USAGE 2 DOSAGE & ADMINISTRATION 3 DOSAGE FORMS & STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 HYPERCALCEMIA 5.2 CONCOMITANT Läs hela dokumentet