Data from FDA - Curated by Toby Galbraith - Last updated 28 July 2017

Indication(s)

Indications and Usage 10% Calcium Chloride Injection, USP is indicated (1) for the treatment of hypocalcemia in those conditions requiring a prompt increase in blood plasma calcium levels, (2) in the treatment of magnesium intoxication due to overdosage of magnesium sulfate and (3) to combat the deleterious effects of hyperkalemia as measured by electrocardiographic (ECG), pending correction of the increased potassium level in the extracellular fluid. 10% Calcium Chloride Injection, USP also may be used in cardiac resuscitation when weak or inadequate contractions return following defibrillation or when epinephrine injection has failed to strengthen myocardial contractions.

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Advisory information

contraindications
Contraindications Calcium chloride is contraindicated for cardiac resuscitation in the presence of ventricular fibrillation or in patients with the risk of existing digitalis toxicity.
Special warnings and precautions
Precautions Do not administer unless solution is clear and seal is intact. Discard unused portion. Because of its additive effect, calcium should be administered very cautiously to a patient who is digitalized or who is taking effective doses of digitalis or digitalis-like preparations. Injections should be made slowly through a small needle into a large vein to minimize venous irritation and avoid undesirable reactions. It is particularly important to prevent a high concentration of calcium from reaching the heart because of the danger of cardiac syncope. If injected into the ventricular cavity in cardiac resuscitation, it must not be injected into the myocardial tissue. Pregnancy Category C. Animal reproduction studies have not been conducted with calcium chloride. It also is not known whether calcium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Calcium chloride should be given to a pregnant woman only if clearly needed.
Adverse reactions
Adverse Reactions Rapid injection may cause the patient to complain of tingling sensations, a calcium taste, a sense of oppression or “heat wave”. Injections of calcium chloride are accompanied by peripheral vasodilatation as well as a local “burning” sensation and there may be a moderate fall in blood pressure. Should perivascular infiltration occur, I.V. administration at that site should be discontinued at once. Local infiltration of the affected area with 1% procaine hydrochloride, to which hyaluronidase may be added, will often reduce venospasm and dilute the calcium remaining in the tissues locally. Local application of heat may also be helpful.

Usage information

Dosing and administration
Dosage and Administration 10% Calcium Chloride Injection, USP is administered only by slow intravenous injection (not to exceed 1 mL/min) and/or in cardiac resuscitation, by injection into the ventricular cavity. It must not be injected into the myocardium. The usual precautions for intravenous therapy should be observed. If time permits, the solution should be warmed to body temperature. The injection should be halted if the patient complains of any discomfort; it may be resumed when symptoms disappear. Following injection, the patient should remain recumbent for a short time. The usual adult dosage in hypocalcemic disorders ranges from 500 mg to 1 g (5 to 10 mL) at intervals of 1 to 3 days, depending on the response of the patient and/or results of serum calcium determinations. Repeated injections may be required because of rapid excretion of calcium. In magnesium intoxication, an initial adult dose of 500 mg (5 mL) should be administered promptly and the patient observed for signs of recovery before further doses are given. In hyperkalemic ECG disturbances of cardiac function, the dosage of calcium chloride injection should be titrated by constant monitoring of ECG changes during administration. In cardiac resuscitation, the usual adult dosage ranges from 500 mg to 1 g (5 to 10 mL) intravenously, or from 200 to 800 mg (2 to 8 mL) when injected into the ventricular cavity. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS. To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

More information

Category Value
Agency product number M4I0D6VV5M
Orphan designation No
Product NDC 52584-928
Date Last Revised 19-07-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder General Injectables & Vaccines, Inc.