Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Chromium (Chromic Chloride Injection, USP) is supplied as follows: Unit of Sale Concentration NDC 0409-4093-10 40 mcg/10 mL Tray of 25 Single-dose plastic vials (4 mcg/mL) Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Novaplus is a registered trademark of Vizient, Inc. LAB-1066-3.0 Revised: 4/2021 Novaplus Logo; PRINCIPAL DISPLAY PANEL - 10 mL Vial Label 10 mL Single-dose Vial CHROMIUM Chromic Chloride Inj., USP 40 mcg/10 mL (4 mcg/mL) novaplus ™ Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 10 mL Vial Label; PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray 10 mL Single-dose Vial NDC 0409-4093-10 Contains 25 of NDC 0409-4093-09 CHROMIUM Chromic Chloride Injection, USP 40 mcg/10 mL (4 mcg/mL) CAUTION: FOR INTRAVENOUS USE ONLY AFTER DILUTION. Rx only PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray
- HOW SUPPLIED Chromium (Chromic Chloride Injection, USP) is supplied as follows: Unit of Sale Concentration NDC 0409-4093-10 40 mcg/10 mL Tray of 25 Single-dose plastic vials (4 mcg/mL) Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Novaplus is a registered trademark of Vizient, Inc. LAB-1066-3.0 Revised: 4/2021 Novaplus Logo
- PRINCIPAL DISPLAY PANEL - 10 mL Vial Label 10 mL Single-dose Vial CHROMIUM Chromic Chloride Inj., USP 40 mcg/10 mL (4 mcg/mL) novaplus ™ Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 10 mL Vial Label
- PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray 10 mL Single-dose Vial NDC 0409-4093-10 Contains 25 of NDC 0409-4093-09 CHROMIUM Chromic Chloride Injection, USP 40 mcg/10 mL (4 mcg/mL) CAUTION: FOR INTRAVENOUS USE ONLY AFTER DILUTION. Rx only PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray
Overview
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 3 • 6H 2 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.
Indications & Usage
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.
Dosage & Administration
Chromium 4 mcg/mL (Chromic Chloride Injection, USP) contains 4 mcg chromium/mL and is administered intravenously only after dilution. The additive should be administered in a volume of fluid not less than 100 mL. For the adult receiving TPN, the suggested additive dosage is 10 to 15 mcg chromium/day (2.5 to 3.75 mL/day). The metabolically stable adult with intestinal fluid loss may require 20 mcg chromium/day (5 mL/day), with frequent monitoring of blood levels as a guideline for subsequent administration. For pediatric patients, the suggested additive dosage is 0.14 to 0.20 mcg/kg/day (0.035 to 0.05 mL/kg/day). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .
Warnings & Precautions
WARNINGS Direct intramuscular or intravenous injection of Chromium 4 mcg/mL (Chromic Chloride Injection, USP) is contraindicated, as the acidic pH of the solution may cause considerable tissue irritation. Severe kidney disease may make it necessary to reduce or omit chromium and zinc doses because these elements are primarily eliminated in the urine. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Contraindications
None known.
Adverse Reactions
None known.
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