CALCIUM CHLORIDE- 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:

Cardinal Health

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: NDC No. Container Size Needle 0409-1631-10 Ansyr™ Plastic Syringe 10 mL None 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
CARDINAL HEALTH
----------
10% CALCIUM CHLORIDE INJECTION, USP
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)
Rx only
DESCRIPTION
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 CaCl
• 2H O (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
understood. It is essential for
the functional integrit