Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)
EXELAN 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 capsules contains 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.
Each capsule is of size ‘00el’ hard gelatin capsule shell with blue opaque cap and white opaque body imprinted with “667 mg” on cap and “IG 377” on body in black ink filled with white to off white powder. Supplied in Bottles of 60 (NDC 76282-377-60) and 200 (NDC 76282-377-02). STORAGE Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature.]
Abbreviated New Drug Application
CALCIUM ACETATE- CALCIUM ACETATE CAPSULE EXELAN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CALCIUM ACETATE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CALCIUM ACETATE CAPSULES. CALCIUM ACETATE CAPSULES USP, 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 capsules with each meal. (2) Titrate the dose every 2 - 3 weeks until acceptable serum phosphorus level is reached. Most patients require 3-4 capsules with each meal. (2) DOSAGE FORMS AND STRENGTHS Capsule: 667 mg calcium acetate capsules. (3) CONTRAINDICATIONS Hypercalcemia. (4) (4) WARNINGS AND PRECAUTIONS Treat mild hypercalcemia by reducing or interrupting calcium acetate capsules and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate capsules. (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 EXELAN PHARMACEUTICALS INC. AT 1-866- 604-3268 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: 6/2021 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 Læs hele dokumentet