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NDC 63304-0241-59

CALCITRIOL 1 ug/mL SOLUTION

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NDC
63304-0241-59
Generic Name
CALCITRIOL
Brand Name
CALCITRIOL
Strength
1 ug/mL
Dosage Form
SOLUTION
Route
ORAL
Package Size
—
Labeler
Sun Pharmaceutical Industries, Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Predialysis Patients Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients Calcitriol is indicated in the…

Important Warnings

WARNINGS Overdosage of any form of vitamin D is dangerous (see OVERDOSAGE ). Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. Chronic hypercalcemia can lead to generalized vascular calcification, nephrocalcinosis and other soft-tissue calcification. The serum calcium times phosphate (Ca x P) product should not be allow…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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