Calcium Gluconate Injection 10ml /10% 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
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 formual 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, cell membranes 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; in cyanocobalamin (vitamin B12) absorption;
and gastrin secretion.
Indications and 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
blackwidow 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 prurifus of eruptions caused by
certain drugs. In hyperkalemia, calcium gluconate may aid in
antgonizing the cardiac toxicity, provided the patient is not
receiving digitalis therapy.
Calcium slats are contraindicated in patients with ventricular
fibrillation or hypercalcemia. Intravenous administration of
calcium is contraindicated when serum calcium levels are above
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.
To avoid undesirable reactions that may follow rapid intravenous
administration of calcium gluconate, the drug should be given
slowly, e.g., approximately 1.5 mL over a period of one minute.
When injected intravenously, calcium gluconate should be injected
through a small needle into a large vein in order to avoid too
rapid an increase in serum calcium and extravasation of calcium
solution into the surrounding tissue with resultant necrosis.
Rapid injection of calcium gluconate may cause vasodilation,
decreased blood pressure, bradycardia, cardiac arrhythmias, syncope
and cardiac arrest.
Because of the danger involved in simultaneous use of calcium salts
and drugs of the digitalis group, a digitalized patient should not
receive an intravenous injection of a calcium compound unless
indications are clearly defined.
The inotropic and toxic effects of cardiac glycosides and calcium
are synergistic, and arrhythmias may occur if these drugs are given
together (particularly when calcium is given intravenously).
Intravenous administrationn of calcium should be avoided in
patients receiving cardiac glycosides; if necessary, calcium should
be given slowly in small amounts.
Calciumcomplexes tetracycline antibiotics rendering them inactive.
The two drugs should not be given at the same time orally nor
should they be mixed for parenteral administration.
Calcium Gluconate Injection has been reported to be incompatible
with intravenous solutions containing various drugs. Published data
are too varied and/or limited to permit generalizations, and
specialized reference should be consulted for specific information.
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 neocrosis and abscess formation may occur with intramuscular
Dosage and Administration
The dose is dependent on the requirements of the individual
patient. Intravenous Calcium Gluconate Injection must be
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 discorloration prior to adminsitration,
whenever solution and container permit.
Certificate of analysis
|Name of Drug||Calcium Gluconate Injection||Batch No.||201609|
|Mfg. Date:||09/2016||Exp. Date||09/2019|
|Sampling date||02/10/2016||Report date||16/10/2016|
|Characteristic:||Should be colorless liquid||Complies|
|Identification:||Should Positive reaction||Positive reaction|
|Color||Not more than Y6 standard color||Complies|
|Uniformity of volume||Not less than 10ml||10.2ml|
|Visible foreign matter:||Meet the requirement||Complies|
|Insoluble particles||Meet the requirement||Complies|
|Bacterial endotoxins:||Meet the requirement||Complies|
|Related substance:||Meet the requirement||Complies|
|Bacterial endotoxins:||Meet the requirement||Complies|
|Sterility:||Meet the requirement||Complies|
|ASSAY :||C12H22CaO14.H2O 93.0%~107.0%||100.85|
|CONCLUSION||The above product confirms to CP2005 Standards|