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:

McKesson Contract Packaging

INN (International Name):

CALCIUM ACETATE

Composition:

CALCIUM ACETATE 667 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
MCKESSON CONTRACT PACKAGING
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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: 4/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AN