Rx Only

100 mg/mL (13.6 mEq Calcium/10 mL)

FOR INTRAVENOUS USE ONLY

Osmolarity 2.04 mOsmol/mL

DESCRIPTION

Each mL contains: Calcium Chloride Dihydrate 100 mg in Water for Injection q.s. pH (range 5.5-7.5) adjust with Hydrochloric Acid and/or Sodium Hydroxide. Each 10 mL contains 13.6 mEq Calcium and 13.6 mEq Chloride. The molecular weight is 147.02 and the molecular formula is CaCl2*2H2O. Sterile, nonpyrogenic.

CLINICAL PHARMACOLOGY

Calcium is the fifth most abundant element in the body; the major fraction is in bone. It is essential for the functional integrity of the nervous and muscular systems, for normal cardiac contractility and the coagulation of blood. It also functions as an enzyme cofactor and affects the secretory activity of endocrine and exocrine glands.

INDICATIONS AND USAGE

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 has been used when epinephrine has failed to improve weak or ineffective myocardial contractions.

CONTRAINDICATIONS

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

WARNINGS

This solution is suitable only for intravenous use. 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, the rate of injection should not exceed 0.5 mL to 1 mL per 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 calcium compound unless the indications are clearly defined.

USE IN PREGNANCY

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

ADMINISTRATION AND DOSAGE

The usual adult dose of this preparation varies from 5 to 10 mL at 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.

TREATMENT OF OVERDOSE

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

HOW SUPPLIED

Calcium Chloride Injection, USP 10% (No preservative added).

NDC 0517-2710-25 10mL single dose vial packed in a box of 25

American Regent, Inc.

Shirley, NY 11967

IN2710

Rev. 01/09

MG #14274

PRINCIPAL DISPLAY PANEL

Calcium Chloride Injection, USP

10% (100 mg/mL) (13.6 mEq Calcium/10 mL)

5 x 10 ml Single Dose Vials