Calcium Chloride 10%

Calcium Chloride (calcium chloride) Injection, USP10%. (No preservative added).

NDC 0517-2710-2510 mLsingle dose vialpacked in a box of 25

Rev. 2/00. American Regent Laboratories Inc., Shirley, NY 11967. FDA revision date: 3/18/2003

Calcium chloride (calcium chloride) is indicated in the immediate treatment of hypocalcemic tetany. Other therapy, such as parathyroid hormone or vitamin D, may be indicated according to the etiology of the tetany. It is also important to institute oral calcium therapy as soon as practicable. Calcium salts have been used as adjunctive therapy in a number of conditions, including the following:

Insect bites or stings, such as Black Widow Spider bites.

Sensitivity reactions, particularly when characterized by urticaria.

As an aid in the treatment of depression due to overdosage of magnesium sulfate.

As an aid in the management of the acute symptoms in lead colic.

In cardiac resuscitation, particularly after open heart surgery, calcium chloride (calcium chloride) has been used when epinephrine has failed to improve weak or ineffective myocardial contractions.

The usual adult dose of this preparation varies from 5 to 10 mLat intervals of 1 to 3 days.

In cardiac resuscitation, the usual dose is 2 to 4 mL injected into the ventricular cavity. Care should be taken to avoid injection into the cardiac muscle.

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

In cardiac resuscitation, the use of calcium chloride (calcium chloride) is contraindicated in the presence of ventricular fibrillation.

WARNINGS

This solution is suitable only for intravenous use. Calcium chloride (calcium chloride) solution injection into muscle or into subcutaneous or perivascular tissue may cause severe necrosis and sloughing. Intravenous injections of this drug must be made with great care to avoid leakage into the perivascular tissue.

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.

PRECAUTIONS

To avoid undesirable reactions that may follow intravenous administration of calcium chloride (calcium chloride) , the rate of injection should not exceed 0.5 mLto 1 mLper minute.

Because of the danger involved in the 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 the indications are clearly defined.

Use In Pregnancy

Safety for use in pregnancy has not been established. Use of calcium chloride (calcium chloride) in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.

SIDE EFFECTS

No information provided.

DRUG INTERACTIONS

No information provided.

No information provided.

Inadvertent systemic overloading with calcium ion can produce an acute hypercalcemic syndrome. The syndrome is characterized by weakness, lethargy, intractable nausea and vomiting, coma, and sudden death, and a markedly elevated plasma calcium level. It is suggested that details of treatment of this problem be obtained by reference to Harrison's Principles of Internal Medicine Sixth Edition, pg. 475, column 2, “Acute Hypercalcemic Syndrome”.

Store at controlled room temperature 15°-30°C (59°-86°F) (See USP).