CUPRIC CHLORIDE injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Exela Pharma Sciences, LLC

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

Cupric Chloride Injection, USP 0.4 mg/mL is supplied in 10 mL plastic vials (NDC 51754-0103-1) available in a carton of 10 (NDC 51754-0103-3) and a carton of 25 (NDC 51754-0103-4). Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645  Revised: 11/2022

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CUPRIC CHLORIDE- CUPRIC CHLORIDE INJECTION, SOLUTION
EXELA PHARMA SCIENCES, LLC
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CUPRIC CHLORIDE INJECTION, USP – SOLUTION
EXELA PHARMA SCIENCES, LLC
CUPRIC CHLORIDE INJECTION, USP
0.4 MG/ML
FOR I.V. USE ONLY AFTER DILUTION
R only
DESCRIPTION
Cupric Chloride Injection, USP 0.4 mg/mL 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 vial is fabricated from cyclic olefin copolymer.
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
received no copper. The daily turnover of copper through ceruloplasmin
is
approximately 0.5 mg. Excretion of copper is through the bile (80%),
directly through
the intestinal wall (16%) and in urine (4%).
Plastic Vial
x
2
2
INDICATIONS AND USAGE
Cupric Chloride I