Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)
Atlantic Biologicals Corps
ORAL
PRESCRIPTION DRUG
Calcium Acetate Capsules are 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 [ ]. 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. see Warnings
Abbreviated New Drug Application
CALCIUM ACETATE- CALCIUM ACETATE CAPSULE ATLANTIC BIOLOGICALS CORPS ---------- 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, 667 MG INITIAL U.S. APPROVAL: 1990 INDICATIONS AND USAGE Calcium Acetate Capsules 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 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 ROXANE LABORATORIES, INC. AT 1-800-962-8364 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH DRUG INTERACTIONS Calcium Acetate Capsules 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 Capsules or consider monitoring blood levels of the drug. (7) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 4/2011 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 Izlasiet visu dokumentu