CALCIUM CHLORIDE 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 for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels. Calcium chloride is contraindicated for cardiac resuscitation in the presence of ventricular fibrillation or in patients with the risk of existing digitalis toxicity. Calcium chloride is not recommended in the treatment of asystole and electromechanical dissociation. 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.

Authorization status:

New Drug Application

Summary of Product characteristics

CALCIUM CHLORIDE- CALCIUM CHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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10% CALCIUM CHLORIDE 100 MG/ML INJECTION, USP 10 ML PREFILLED SYRINGE
DESCRIPTION
RX ONLY
1 GRAM (100 MG/ML)
REPRESENTS 27 MG (1.4 MEQ) CA++/ML
ANSYR PLASTIC 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.
ADMINISTER ONLY BY SLOW INJECTION (NOT TO EXCEED 1 ML/MINUTE)
10% Calcium Chloride Injection, USP is a sterile, nonpyrogenic,
hypertonic solution. Each
mL contains 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 contains no
bacteriostat,
antimicrobial agent or added buffer and is intended for use only as a
single-dose
injection. The pH of 10% Calcium Chloride Injection, USP is 6.3 (5.5
to 7.5) when diluted
with water for injection to make a 5% solution. 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) and is
described as white,
odorless fragments or granules freely soluble in water.
The plastic syringe is molded from a specially formulated
polypropylene. Water
permeates from inside the container at an extremely slow rate which
will have an
insignificant effect on solution concentration over the expected shelf
life. Solutions in
contact with the plastic container may leach out certain chemical
components from the
plastic in very small amounts; however, biological testing was
supportive of the safety of
the syringe material.
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
u