CALCIUM ACETATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Clinical Solutions Wholesale

INN (International Name):

CALCIUM ACETATE

Composition:

CALCIUM ACETATE 667 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
CLINICAL SOLUTIONS WHOLESALE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCIUM ACETATE GELCAPS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CALCIUM ACETATE
GELCAPS.
CALCIUM ACETATE GELCAPS (CALCIUM ACETATE): 667 MG
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
1. Calcium Acetate is a phosphate binder indicated for the reduction
of serum phosphorus in patients with end stage renal
disease. ( 1)
DOSAGE AND ADMINISTRATION
1. Starting dose is 2 gelcaps with each meal. ( 2)
2. Titrate the dose every 2-3 weeks until acceptable serum phosphorus
level is reached. Most patients require 3-4 gelcaps
with each meal. ( 2)
DOSAGE FORMS AND STRENGTHS
1. Capsule: 667 mg calcium acetate gelcap. ( 3)
CONTRAINDICATIONS
1. 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
1. The most common (> 10%) adverse reactions are hypercalcemia, nausea
and vomiting. ( 6.1)
2. In clinical studies, patients have occasionally experienced nausea
during calcium acetate therapy. ( 6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FRESENIUS MEDICAL CARE
NORTH AMERICA AT 1-800-323-
5188 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
1. Calcium acetate may decrease the bioavailability of tetracyclines
or fluoroquinolones. ( 7)
2. 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: 10/2017
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 Hy