CALCIUM GLUCONATE INJECTION, USP 10%

Rx Only

STERILE, NONPYROGENIC

0.68 mOsmoI/mL 680 mOsmol/L

Ca⁺⁺ 0.465 mEq/mL pH (6.0-8.2)

CAUTION: For Intravenous Use. Not recommended for Intramuscular or Subcutaneous use.

Calcium Gluconate is the calcium salt of gluconic acid, an oxidation product of glucose, and contains 9.3% calcium, which is about one-third of the calcium in strength of calcium chloride USP. Since it is soluble to the extent of only one part in 30 parts of cold water, the 10% solution is supersaturated and is stabilized by the addition of calcium saccharate tetrahydrate 0.46% w/v (which supplies calcium 6.2%). Each mL contains 98 mg of calcium gluconate monohydrate, 4.6 mg of calcium saccharate tetrahydrate, and Water for Injection USP, q.s. Each mL provides 9.3 mg (0.465 milliequivalents) of calcium.

The 100 mL Pharmacy Bulk Package contains many single doses for use in a pharmacy admixture program in the preparation of parenteral fluids. See directions for dispensing from the 100 mL Pharmacy Bulk Package.

pH is adjusted with sodium hydroxide and/or hydrochloric acid.

The structural formula is:

Calcium is the fifth most abundant element in the body and is essential for maintenance of the functional integrity of nervous, muscular and skeletal systems and cell membrane and capillary permeability. It is also an important activator in many enzymatic reactions and is essential to a number of physiologic processes including transmission of nerve impulses; contraction of cardiac, smooth and skeletal muscles; renal function; respiration and blood coagulation. Calcium also plays regulatory roles in the release and storage of neurotransmitters and hormones, in the uptake and binding of amino acids, and in cyanocobalamin (vitamin B₁₂) absorption and gastrin secretion.

Calcium gluconate is used to treat conditions arising from calcium deficiencies such as hypocalcemic tetany, hypocalcemia related to hypoparathyroidism and hypocalcemia due to rapid growth or pregnancy. It is also used in the treatment of black widow spider bites to relieve muscle cramping and as an adjunct in the treatment of rickets, osteomalacia, lead colic and magnesium sulfate overdosage.

Calcium gluconate has also been employed to decrease capillary permeability in allergic conditions, nonthrombocytopenic purpura and exudative dermatoses such as dermatitis herpetiformis and for pruritus of eruptions caused by certain drugs. In hyperkalemia, calcium gluconate may aid in antagonizing the cardiac toxicity provided the patient is not receiving digitalis therapy.

Calcium salts are contraindicated in patients with ventricular fibrillation or hypercalcemia. Intravenous administration of calcium is contraindicated when serum calcium levels are above normal.

If neonates are required, or expected to require, treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition, ceftriaxone sodium injection is contraindicated because of the risk of precipitation of ceftriaxone-calcium.

A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving calcium containing fluids and ceftriaxone.  In some of these cases, the same intravenous infusion line was used for both calcium-containing fluids and ceftriaxone and in some a precipitate was observed in the intravenous infusion line. At least one fatality has been reported in a neonate in whom calcium-containing fluids and ceftriaxone were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate.  There have been no similar reports in patients other than neonates.

For intravenous use only. Subcutaneous or intramuscular injection may cause severe necrosis and sloughing.

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Patients may complain of tingling sensations, a sense of oppression or heat waves and a calcium or chalky taste following the intravenous administration of calcium gluconate.

Rapid intravenous injection of calcium salts may cause vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmias, syncope and cardiac arrest. Use in digitalized patients may precipitate arrhythmias.

Local necrosis and abscess formation may occur with intramuscular injection.

Calcium Gluconate should be administered intravenously either directly or by infusion. The dose is dependent upon the individual requirements of the patient. Calcium Gluconate may also be administered by intermittent infusion at a rate not exceeding 200 mg/min, or by continuous infusion.

DIRECTIONS FOR DISPENSING FROM 100 mL PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION.

The 100 mL Pharmacy Bulk Package is for use in a Pharmacy Admixture Service only. The 100 mL Pharmacy Bulk Package should be suspended (inverted) by its IV hang label in a laminar flow hood or biological safety cabinet. Prior to entering a Pharmacy Bulk Package remove the flip-off seal and cleanse the rubber closure with a suitable antiseptic agent. Entry into the Pharmacy Bulk Package must be made with a sterile transfer set or other sterile dispensing device and the contents dispensed in aliquots using aseptic technique. Use of a syringe needle is not recommended as it may cause leakage. ANY UNUSED PORTION MUST BE DISCARDED

WITHIN 4 HOURS AFTER INITIAL ENTRY. The date and the time initially opened should be recorded in the space provided on the Pharmacy Bulk Package label.

USUAL DOSAGE:

Adults: 500 mg - 2 grams (5-20 mL)

Children: 200-500 mg (2-5 mL)

Infants: not more than 200 mg (not more than 2 mL)

Calcium Gluconate Injection, USP 10%

NDC 0517-3910-25    10%    10 mL Single Dose Vials packed in boxes of 25
NDC 0517-3950-25    10%    50 mL Single Dose Vials packed in boxes of 25
NDC 0517-3900-25    10%    100 mL Pharmacy Bulk Package packed in boxes of 25

Supersaturated solutions are prone to precipitation.

NOTE: If crystallization has occurred, warming in a 60°C water bath for 15-30 minutes with occasional shaking, may dissolve the precipitate. Cool to body temperature before use. The injection must be clear at the time of use. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

No preservative added. Unused portion of vial should be discarded. Use only if solution is clear and seal intact.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN3910

Rev. 7/11

PRINCIPAL DISPLAY PANEL – 50 mL Container

NDC 0517-3950-25

CALCIUM GLUCONATE
INJECTION, USP

10%

23.25 mEq/50 mL Calcium

(0.465 mEq/mL)

50 mL SINGLE DOSE VIAL

FOR SLOW INTRAVENOUS USE

Rx Only

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Rev. 2/08

5178d569-figure-02

NDC 0517-3900-25

CALCIUM GLUCONATE
INJECTION, USP

10%

46.5 mEq/100 mL Calcium

(0.465 mEq/mL)

0.68 mOsmol/mL

pH (6.0-8.2)

Rx Only

100 mL PHARMACY BULK PACKAGE

NOT FOR DIRECT INFUSION

FOR INTRAVENOUS USE

Rev. 2/08

5178d569-figure-03