CALCIUM ACETATE description, usages, side effects, indications, overdosage, supplying and lots more!

CALCIUM ACETATE

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION




CLINICAL PHARMACOLOGY



INDICATIONS & USAGE




CONTRAINDICATIONS



WARNINGS



PRECAUTIONS



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).

Calcium acetate may decrease the bioavailability of tetracyclines.

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:


PEDIATRIC USE



GERIATRIC USE




ADVERSE REACTIONS



OVERDOSAGE



DOSAGE & ADMINISTRATION



HOW SUPPLIED







PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION















PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

CALCIUM ACETATE

CALCIUM ACETATE CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-064(NDC:0054-0088)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
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
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
ALUMINUM CHLOROHYDREX PROPYLENE GLYCOL
SHELLAC

Product Characteristics

Color Size Imprint Code Shape
blue 23 mm 54215 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-064-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077728 2010-11-11


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