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:

Atlantic Biologicals Corps

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
ATLANTIC BIOLOGICALS CORPS
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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: 4/2011
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