CALCIUM ACETATE  - calcium acetate capsule 
NCS Healthcare of KY, Inc. dba Vangard Labs

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Calcium Acetate

The serum calcium times phosphate (CaXP) product should not be allowed to exceed 66.



This section has a crossreference ( See Adverse Reactions)

Excessive dosage of calcium acetate induces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. Should hypercalcemia develop, the dosage should be reduced or the treatment discontinued immediately depending on the severity of hypercalcemia. Calcium acetate should not be given to patients on digitalis, because hypercalcemia may precipitate cardiac arrhythmias. Calcium acetate therapy should always be started at low dose and should not be increased without careful monitoring of serum calcium. An estimate of daily calcium intake should be made initially and the intake adjusted as needed. Serum phosphorus should also be determined periodically.

The patients should be informed about compliance with dosage instructions, adherence to instructions about diet and avoidance of the use of nonprescription antacids. Patients should be informed about the symptoms of hypercalcemia (see ADVERSE REACTIONS).

Calcium acetate may decrease the bioavailability of tetracyclines.

Carcinogenesis, mutagenesis, impairment of fertility

Long-term animal studies have notbeen performed to evaluate the carcinogenic potential, mutagenicity, or effect on fertility of calcium acetate.

Pregnancy

 

Animal reproduction studies have not been conducted with calcium acetate. It is not known whether calcium acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Calcium acetate should be given to a pregnant woman only if clearly needed.

Pediatric use

Safety and effectiveness in pediatric patients have not been established.

Geriatric use

Of the total number of subjects in clinical studies of calcium acetate (N equals 91), 25 percent were 65 and over, while 7 percent were 75 and over. No overall differences in safety or effectiveness were

observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This section has a cross reference (see Adverse Reactions)


Administration of calcium acetate in excess of the appropriate daily dosage can cause severe hypercalcemia (see ADVERSE REACTIONS).


Calcium Acetate Capsules are supplied as white opaque/blue opaque capsules imprinted with “54 215” on the cap and body.

0054-0088-26 667 mg, white opaque/ blue opaque capsule, bottle of 200

STORAGE

Store at 20 deegrees to 25 degrees C (68 degrees to 77 degrees F). [See USP Controlled Room Temperature.]

10003705/01

Revised January 2008

© RLI, 2008

0054-0088-26 - 200 Capsules

Rx Only

Roxane Laboratories, Inc.



Calcium blister package    Calcium blister package


CALCIUM ACETATE 
calcium acetate   capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0615-2303 (0054-0088)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Calcium Acetate (Calcium) Calcium Acetate 667 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1  
FD&C RED NO. 3  
GELATIN  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOL 8000  
TITANIUM DIOXIDE  
ALCOHOL  
FD&C BLUE NO. 2  
FD&C YELLOW NO. 6  
FERROSOFERRIC OXIDE  
PROPYLENE GLYCOL  
Product Characteristics
Color white (BLUE OPAQUE) Score no score
Shape CAPSULE Size 1mm
Flavor Imprint Code 54215
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0615-2303-39 30 CAPSULE In 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077728 02/26/2008

Labeler - NCS Healthcare of KY, Inc. dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS Healthcare of KY, Inc. dba Vangard Labs 050052943 relabel, repack
Revised: 03/2010 NCS Healthcare of KY, Inc. dba Vangard Labs