CALCIUM ACETATE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)

Disponible desde:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Designación común internacional (DCI):

CALCIUM ACETATE

Composición:

CALCIUM ACETATE 667 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Each Calcium Acetate Tablet USP, intended for oral administration, is white, round tablet, Debossed EP 114 on one side and plain on the reverse 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 follow: Bottles of 200:    NDC 23155-621-02 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].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CALCIUM ACETATE- CALCIUM ACETATE TABLET
HERITAGE PHARMACEUTICALS INC. D/B/A AVET 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 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 AVET PHARMACEUTICALS
INC. AT 1-866-
901-DRUG (3784) OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
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: 7/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS & USAGE
2 DOSAGE & ADMINISTRATION
3 DOSAGE FORMS & STRENGTHS
4 CONTRAINDICATI