COPPER- cupric chloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CUPRIC CHLORIDE (UNII: S2QG84156O) (CUPRIC CATION - UNII:8CBV67279L)

Available from:

Hospira, Inc.

INN (International Name):

CUPRIC CHLORIDE

Composition:

CUPRIC CATION 0.4 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Copper 0.4 mg/mL (Cupric Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms. None known. None known.

Product summary:

Copper 0.4 mg/mL (Cupric Chloride Injection, USP) is supplied as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1067-2.0 Revised: 04/2021

Authorization status:

New Drug Application

Summary of Product characteristics

COPPER- CUPRIC CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
----------
COPPER
0.4 MG/ML
Cupric Chloride
Injection, USP
FOR I.V. USE ONLY AFTER DILUTION
Plastic Vial
R only
DESCRIPTION
Copper 0.4 mg/mL (Cupric Chloride Injection, USP) is a sterile,
nonpyrogenic solution
intended for use as an additive to intravenous solutions for total
parenteral nutrition
(TPN). Each mL of solution contains 1.07 mg cupric chloride, dihydrate
and 9 mg sodium
chloride.
The solution contains no bacteriostat, antimicrobial agent or added
buffer. The pH is 2.0
(1.5 to 2.5); product may contain hydrochloric acid and sodium
hydroxide for pH
adjustment. The osmolarity is 0.327 mOsmol/mL (calc.).
Cupric chloride, USP is chemically designated cupric chloride,
dihydrate (CuCl
• 2H O), a
crystalline compound freely soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline compound freely
soluble in water.
The semi-rigid vial is fabricated from a specially formulated
polyolefin. It is a copolymer of
ethylene and propylene. The safety of the plastic has been confirmed
by tests in animals
according to USP biological standards for plastic containers. The
small amount of water
vapor that can pass through the plastic container wall will not
significantly alter the drug
concentration.
CLINICAL PHARMACOLOGY
Copper is an essential nutrient which serves as a cofactor for serum
ceruloplasmin, an
oxidase necessary for proper formation of the iron carrier protein,
transferrin. Copper
also helps maintain normal rates of red and white blood cell
formation.
Providing copper during TPN helps prevent development of the following
deficiency
symptoms: Leukopenia, neutropenia, anemia, depressed ceruloplasmin
levels, impaired
transferrin formation, secondary iron deficiency and osteoporosis.
Normal serum copper values range from 80 to 163 mcg/dl (mean,
approximately 110
mcg/dl). The serum copper level at which deficiency symptoms appear is
not precisely
defined. A serum value of 9 mcg copper/dl was reported for one TPN
patient who