CALCIUM CHLORIDE injection, solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)
Available from:
American Regent, Inc.
INN (International Name):
CALCIUM CHLORIDE
Composition:
CALCIUM CHLORIDE 100 mg in 1 mL
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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. 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 overdo
Product summary:
Calcium Chloride Injection, USP 10%. (No preservative added). NDC 0517-2710-25             10 mL single dose vial                packed in a box of 25 AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN2710 Rev. 7/11
Authorization status:
Unapproved drug for use in drug shortage
Authorization number:
0517-2710-25

CALCIUM CHLORIDE- calcium chloride injection, solution

American Regent, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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CALCIUM CHLORIDE INJECTION, USP 10%

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)

adjusted 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 CaCl

2H O. 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.

If neonates are required, or expected to require, treatment with calcium-containing IV solutions,

including continuous calcium-containing infusions such as parenteral nutrition, ceftriaxone

sodium injection is contraindicated because of the risk of precipitation of ceftriaxone-calcium.

A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and

kidneys at autopsy have been reported in neonates receiving calcium containing fluids and ceftriaxone.

In some of these cases, the same intravenous infusion line was used for both calcium-containing fluids

and ceftriaxone and in some a precipitate was observed in the intravenous infusion line. At least one

fatality has been reported in a neonate in whom calcium-containing fluids and ceftriaxone were

administered at different time points via different intravenous lines; no crystalline material was observed

at autopsy in this neonate. There have been no similar reports in patients other than neonates.

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 a calcium compound unless

the indications are clearly defined.

Interaction with Calcium-Containing Products:

Do not use diluents containing calcium to reconstitute ceftriaxone vials or to further dilute a

reconstituted vial for IV administration because a precipitate can form. Precipitation of

ceftriaxone-calcium can also occur when calcium-containing solutions are mixed with ceftriaxone

in the same IV administration line. Calcium-containing IV solutions, including continuous

calcium-containing infusions such as parenteral nutrition must not be administered

simultaneously with ceftriaxone via a Y-site. However, in patients other than neonates, calcium-

containing solutions and ceftriaxone may be administered sequentially of one another if the

infusion lines are thoroughly flushed between infusions with a compatible fluid. In vitro studies

using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an

increased risk of precipitation of ceftriaxone-calcium.

There have been no reports of an interaction between oral calcium-containing products and ceftriaxone

or interaction between calcium-containing products (IV or oral) and intramuscular ceftriaxone.

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.

DOSAGE AND ADMINISTRATION

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 OVERDOSAGE

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°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled

Room Temperature).

HOW SUPPLIED

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

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

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

IN2710

Rev. 7/11

HEALTH CARE PROVIDER LETTER SECTION

Not available at this time.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mL Container Label

NDC 0517-2710-25

CALCIUM CHLORIDE INJECTION, USP

10% (100 mg/mL)

(13.6 mEq Calcium/10 mL)

10 mL SINGLE DOSE VIAL

FOR IV USE ONLY

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Rev. 10/10

PRINCIPAL DISPLAY PANEL - 10 mL Carton Labeling

CALCIUM CHLORIDE INJECTION, USP

10% (100 mg/mL)

(13.6 mEq Calcium/10 mL)

NDC 0517-2710-25

25 x 10 mL

SINGLE DOSE VIALS

FOR INTRAVENOUS USE ONLY

Rx Only

Each mL contains: Calcium Chloride (Dihydrate) 100 mg, Water for Injection q.s.

pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide. 2.04 mOsmol/mL

WARNING: DISCARD UNUSED PORTION. Sterile, nonpyrogenic.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F)

(See USP Controlled Room Temperature).

Directions for Use: See Package Insert.

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Rev. 9/06

CALCIUM CHLORIDE

calcium chloride injection, solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 517-2710

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

CALCIUM CHLO RIDE (UNII: M4I0 D6 VV5M) (CALCIUM CATION - UNII:2M8 3C4R6 ZB, CHLORIDE

ION - UNII:Q32ZN48 6 9 8 )

CALCIUM

CHLORIDE

10 0 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 517-2710 -

25 in 1 TRAY

0 7/0 5/20 17

1

10 mL in 1 VIAL, SINGLE-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

American Regent, Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph

Cita tio n

Marke ting Start

Date

Marke ting End

Date

UNAPPROVED DRUG FOR USE IN DRUG

SHORTAGE

0 7/0 5/20 17

Labeler -

American Regent, Inc. (002033710)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

American Regent, Inc.

0 0 20 33710

ANALYSIS(0 517-2710 ) , MANUFACTURE(0 517-2710 )

Revised: 12/2019

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