Calcium Acetate

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

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Calcium Acetate

Patients with advanced renal insufficiency (creatinine clearance less than 30 mL/min) exhibit phosphate retention and some degree of hyperphosphatemia. The retention of phosphate plays a pivotal role in causing secondary hyperparathyroidism associated with osteodystrophy, and soft-tissue calcification. The mechanism by which phosphate retention leads to hyperparathyroidism is not clearly delineated. Therapeutic efforts directed toward the control of hyperphosphatemia include reduction in the dietary intake of phosphate, inhibition of absorption of phosphate in the intestine with phosphate binders, and removal of phosphate from the body by more efficient methods of dialysis. The rate of removal of phosphate by dietary manipulation or by dialysis is insufficient. Dialysis patients absorb 40 percent to 80 percent of dietary phosphorus. Therefore, the fraction of dietary phosphate absorbed from the diet needs to be reduced by using phosphate binders in most renal failure patients on maintenance dialysis. Calcium acetate when taken with meals, combines with dietary phosphate to form insoluble calcium phosphate which is excreted in the feces. Maintenance of serum phosphorus below 6.0 mg/dl is generally considered as a clinically acceptable outcome of treatment with phosphate binders. Calcium acetate is highly soluble at neutral pH, making the calcium readily available for binding to phosphate in the proximal small intestine. Orally administered calcium acetate from pharmaceutical dosage forms has been demonstrated to be systemically absorbed up to approximately 40 percent under fasting conditions and up to approximately 30 percent under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.

Calcium Acetate Capsules are indicated for the control of hyperphosphatemia in end stage renal failure and do not promote aluminum absorption.

Patients with hypercalcemia.

Patients with end stage renal failure may develop hypercalcemia when given calcium with meals. No other calcium supplements should be given concurrently with calcium acetate capsules. Progressive hypercalcemia due to overdose of calcium acetate may be severe as to require emergency measures. Chronic hypercalcemia may lead to vascular calcification, and other soft-tissue calcification. The serum calcium level should be monitored twice weekly during the early dose adjustment period. Theserum calcium times phosphate(CaXP) product should not be allowedto exceed 66. Radiographic evaluation of suspect anatomical region may be helpful in early detection of soft-tissue calcification.



This section has a crossreference ( See Adverse Reactions)

General

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.

Information for patients

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).

Drug interactions

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

 Teratogenic effects: Category C:

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.

In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy. Hypercalcemia may occur during treatment with calcium acetate. Mild hypercalcemia (Ca less than 10.5 mg/dl) may be asymptomatic or manifest itself as constipation, anorexia, nausea and vomiting. More severe hypercalcemia (Ca less than 12 mg/dl) is associated with confusion, delirium, stupor and coma. Mild hypercalcemia is easily controlled by reducing the calcium acetate dose or temporarily discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate therapy. Decreasing dialysate calcium concentration could reduce the incidence and severity of calcium acetate induced hypercalcemia. The long-term effect of calcium acetate on the progression of vascular or soft-tissue calcification has not been determined. Isolated cases of pruritus have been reported which may represent allergic reactions.

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).


The recommended initial dose of calcium acetate capsules for the adult dialysis patient is 2 capsules with each meal. The dosage may be increased gradually to bring the serum phosphate value below 6 mg/dl, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal.

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 TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0615-2303 (0054-0088)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium Acetate (Calcium) Calcium Acetate667 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (BLUE OPAQUE) Score no score
ShapeCAPSULESize1mm
FlavorImprint Code 54215
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10615-2303-3930 CAPSULE In 1 BLISTER PACKNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07772802/26/2008

Labeler - NCS Healthcare of KY, Inc. dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS Healthcare of KY, Inc. dba Vangard Labs050052943relabel, repack
Revised: 03/2010NCS Healthcare of KY, Inc. dba Vangard Labs