CHROMIUM- chromic chloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHROMIC CHLORIDE (UNII: KB1PCR9DMW) (CHROMIC CATION - UNII:X1N4508KF1)

Available from:

Hospira, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chromium 4 mcg/mL (Chromic Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain chromium serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms. None known. None known.

Product summary:

Chromium (Chromic Chloride Injection, USP) is supplied as follows: Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1065-3.0 Revised: 4/2021

Authorization status:

New Drug Application

Summary of Product characteristics

CHROMIUM- CHROMIC CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
----------
CHROMIUM
CHROMIC CHLORIDE
INJECTION, USP
40 MCG/10 ML (4 MCG/ML)
FOR I.V. USE ONLY AFTER DILUTION
Plastic Vial
Rx Only
DESCRIPTION
Chromium 4 mcg/mL (Chromic 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 20.5 mcg chromic chloride,
hexahydrate 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/or sodium
hydroxide for pH adjustment. The osmolarity is 0.308 mOsm/mL (calc.).
Chromic Chloride, USP is chemically designated chromic chloride,
hexahydrate CrCl
•
6H O, a crystalline compound 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
Trivalent chromium is part of glucose tolerance factor, an essential
activator of insulin-
mediated reactions. Chromium helps to maintain normal glucose
metabolism and
peripheral nerve function.
Providing chromium during TPN helps prevent deficiency symptoms
including impaired
glucose tolerance, ataxia, peripheral neuropathy and a confusional
state similar to
mild/moderate hepatic encephalopathy.
Serum chromium is bound to transferrin (siderophilin) in the beta
globulin fraction.
Typical blood levels for chromium range from 1 to 5 mcg/liter, but
blood levels are not
considered a meaningful index of tissue stores. Administration of
chromium
supplements to chromium-deficient patients can resu