CALCIUM ACETATE - calcium acetate capsule
NCS Healthcare of KY, Inc. dba Vangard Labs
----------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
Store at 20 deegrees to 25 degrees C (68 degrees to 77 degrees F). [See USP Controlled Room Temperature.]
Revised January 2008
© RLI, 2008
0054-0088-26 - 200 Capsules
Roxane Laboratories, Inc.
calcium acetate capsule
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|Labeler - NCS Healthcare of KY, Inc. dba Vangard Labs (050052943)|
|NCS Healthcare of KY, Inc. dba Vangard Labs||050052943||relabel, repack|