calcium gluconate 10 % per 10 ML Injection
WARNINGS
For intravenous use only.
Subcutaneous or intramuscular injection may cause severe necrosis and sloughing.
WARNING: 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.
DESCRIPTION
Calcium Gluconate Injection, USP is a sterile, nonpyrogenic, supersaturated solution of calcium gluconate for intravenous use only.
Each mL contains: Calcium gluconate 94 mg; calcium saccharate (tetrahydrate) 4.5 mg; Water for Injection q.s.
Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (6.0-8.2).
Calcium saccharate provides 6% of the total calcium and stabilizes the supersaturated solution of calcium gluconate.
Each 10 mL of the injection provides 93 mg elemental calcium (Ca ++ ) equivalent to 1 g of calcium gluconate.
The structural formula is: MM1
HOW SUPPLIED
Product No.
NDC No.
Calcium Ion (mEq/mL) Volume/ Vial Size (mL) 31110 63323-311-10 0.465 10 31150 63323-311-50 0.465 50 Packaged in 25 vials per tray.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Do not permit to freeze.
Preservative Free.
Discard unused portion.Use only if solution is clear and seal intact.
Vial stoppers do not contain natural rubber latex.
NOTE: Supersaturated solutions are prone to precipitation.
The precipitate, if present, may be dissolved by warming the vial to 60° to 80°C, with occasional agitation, until the solution becomes clear.
Shake vigorously.
Allow to cool to room temperature before dispensing.
Use injection only if clear immediately prior to use.
INDICATIONS AND USAGE
INDICATIONS & USAGE Calcium Gluconate Injection, USP 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.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION The dose is dependent on the requirements of the individual patient.
Intravenous calcium gluconate injection must be administered slowly.
Adults —500 mg to 2 g (5 to 20 mL) Pediatric patients —200 to 500 mg (2 to 5 mL) Infants —Not more than 200 mg (not more than 2 mL) Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.