CALCIUM ACETATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Unit Dose Services

INN (International Name):

CALCIUM ACETATE

Composition:

CALCIUM ACETATE 667 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Product: 50436-0621 NDC: 50436-0621-1 1 TABLET in a POUCH / 50 in a BOX, UNIT-DOSE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCIUM ACETATE- CALCIUM ACETATE TABLET
UNIT DOSE SERVICES
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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 HERITAGE
PHARMACEUTICALS INC. AT 1-866-901-DRUG
(3784) OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_. (6)
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: 4/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS & USAGE
2 DOSAGE & ADMINISTRATION
3 DOSAGE FORMS & STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypercalcem