REMEDYREPACK INC.
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
CALCIUM ACETATE DESCRIPTION
CLINICAL PHARMACOLOGY
INDICATIONS & USAGE
CALCIUM ACETATE 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
CALCIUM ACETATE ADVERSE REACTIONS
OVERDOSAGE
DOSAGE & ADMINISTRATION
HOW SUPPLIED
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
|
Product Characteristics
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|
Color
|
Size
|
Imprint Code
|
Shape
|
|
blue |
23 mm |
54215 |
CAPSULE |
Packaging
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|
#
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Item Code
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Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:49349-064-02 |
30 in 1 BLISTER PACK |
|
|
Marketing Information
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|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
ANDA |
ANDA077728 |
2010-11-11 |
|
|
