severity of the hypocalcemia and/or secondary hyperparathyroidism, is 1 mcg (0.02 mcg/kg) to 2 mcg administered three times weekly, approximately every other day. Doses as small as 0.5 mcg and as large as 4 mcg three times weekly have been used as an initial dose. If a satisfactory response is not observed, the dose may be increased by 0.5 to 1 mcg at two to four week intervals. During this titration period, serum calcium and phosphorus levels should be obtained at least twice weekly. If hypercalcemia or a serum calcium times phosphate product greater than 70 is noted, the drug should be immediately discontinued until these parameters are appropriate. Then, the Calcijex dose should be reinitiated at a lower dose. Doses may need to be reduced as the PTH levels decrease in response to the therapy. Thus, incremental dosing must be individualized and commensurate with PTH, serum calcium and phosphorus levels. The following is a suggested approach in dose titration:
PTH Levels Calcijex Dose
the same or increasing increase
decreasing by < 30% increase
decreasing by > 30%, < 60% maintain
decreasing by > 60% decrease
one and one-half to three times
the upper limit of normal maintain
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Discard unused portion.
HOW SUPPLIED
Calcijex (calcitriol injection) is supplied as follows:
List Container Concentration Fill
8110 Ampul 1 mcg/mL 1 mL
Protect from light.
Store at controlled room temperature 15° to 30°C (59° to 86°F).
Patent Pending.
Mfd. by:
Hospira, Inc.
Lake Forest, IL 60045 USA
For:
Abbott Laboratories
North Chicago, IL 60064 USA
©Abbott 2004
Printed in USA
NDC 0074-8110-31
1 mL Single-dose 5 Ampuls
CALCIJEX® Calcitriol Injection (1 mcg/mL)
For I.V. use. Protect from light. Keep ampuls in package until time of use.
Each mL contains calcitriol, 1 mcg; polysorbate 20, 4 mg; sodium ascorbate 2.5 mg added. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH is 6.5 (5.9 to 7.0). Contains no more than 1 mcg/mL of aluminum. Usual dosage: See insert. Store at controlled room temperature 15° to 30°C (59° to 86°F).
©Abbott 2004
Mfd. by: Hospira, Inc., Lake Forest, IL 60045 USA For: Abbott Laboratories, North Chicago, IL 60064 USA
Rx only
CALCIJEX
calcitriol injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0074-8110
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCITRIOL (CALCITRIOL) CALCITRIOL 1 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 20
SODIUM ASCORBATE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0074-8110-31 5 AMPULE In 1 CARTON contains a AMPULE
1 1 mL In 1 AM
