FDA label 4af3c41a-611e-524f-e054-00144ff8d46c

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.

WARNINGS 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 administration of calcium should be avoided in patients receiving cardiac glycosides; if necessary, calcium should be given slowly in small amounts. Calcium complexes 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. Transient elevations of plasma 11-hydroxycorticosteroid levels (Glenn-Nelson technique) may occur when intravenous calcium is administered but levels return to control values after one hour. In addition, intravenous calcium gluconate can produce false-negative values for serum and urinary magnesium. Teratogenic Effects: Pregnancy Category C — Animal reproduction studies have not been conducted with calcium gluconate. It is also not known whether calcium gluconate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Calcium gluconate should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when calcium gluconate is administered to a nursing woman.

ADVERSE REACTIONS 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.