CALCIUM CHLORIDE- calcium choride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Calcium Chloride (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

General Injectables & Vaccines, Inc.

INN (International Name):

Calcium Chloride

Composition:

Calcium Chloride 100 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Calcium chloride is contraindicated for cardiac resuscitation in the presence of ventricular fibrillation or in patients with the risk of existing digitalis toxicity. None known.

Product summary:

10% Calcium Chloride Injection, USP is supplied in single-dose containers as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Abboject® is a trademark of the Abbott group of companies LIFESHIELD® is the trademark of ICU Medical, Inc. and is used under license. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1241-2.0 Revised: 04/2018

Authorization status:

unapproved drug other

Summary of Product characteristics

CALCIUM CHLORIDE- CALCIUM CHORIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, 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 10% 10ML ABBOJECT SYRINGE
100 mg/mL Rx only
Represents 27 mg (1.4 mEq) Ca++/mL
ABBOJECT® Syringe
A HYPERTONIC SOLUTION IN A 10 ML
UNIT OF USE SYRINGE FOR PROMPT
INTRAVENOUS INJECTION.
CAUTION: This solution must not be injected
intramuscularly or subcutaneously.
DESCRIPTION
10% Calcium Chloride Injection, USP is a sterile, nonpyrogenic,
hypertonic solution
containing 100 mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4 mEq
each of Ca++
and Cl¯) in water for injection. It is provided in a 10 mL Unit of
Use Syringe to facilitate
prompt intravenous injection. The solution is administered only by
intravenous or
intraventricular cavity injection as a calcium replenisher.
The solution contains no bacteriostat, antimicrobial agent or added
buffer and is
intended only for use as a single-dose injection. As per USP testing,
when diluted with
water for injection to make a 5% solution, the pH of calcium chloride
injection is 6.3 (5.5
to 7.5). May contain hydrochloric acid and/or sodium hydroxide for pH
adjustment. The
osmolar concentration is 2.04 mOsmol/mL (calc.). 10% Calcium Chloride
Injection, USP is
oxygen sensitive.
Calcium Chloride, USP dihydrate is chemically designated CaCl2 · 2H2O
(dihydrate) white,
odorless fragments or granules freely soluble in water.
CLINICAL PHARMACOLOGY
Calcium is the fifth most abundant element in the body and the major
fraction is in the
bony structure. Calcium plays important physiological roles, many of
which are poorly
understood. It is essential for the functional integrity of the
nervous and muscular
systems. It is necessary for normal cardiac function and is one of the
factors that
operates in the mechanisms involved in the coagulation of blood.
Calcium chloride in water disso