Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Chromic Chloride Injection, USP is supplied as follows: Unit of Sale Concentration NDC 72819-235-16 Carton of 25 Single-dose vials 40 mcg/10 mL (4 mcg/mL) Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature.] Distributed by: Archis Pharma LLC 15 Corporate Place South, Suite 108 Piscataway, NJ 08854 U.S.A. Rev.: 11/2024 PI-CRC-00 LEIA-327.00 10625; Principal Display Panel Text for Container Label: NDC 72819- 235 -06 Chromic Chloride Injection, USP 4 mg/mL 10 mL Single-dose Vials Rx only Principal Display Panel Text for Carton Label: NDC 72819- 235 -16 Chromic Chloride Injection, USP 4 mg/mL 10 mL Single-dose vials in package of 25 Rx only viallabel cartonlabel
- HOW SUPPLIED Chromic Chloride Injection, USP is supplied as follows: Unit of Sale Concentration NDC 72819-235-16 Carton of 25 Single-dose vials 40 mcg/10 mL (4 mcg/mL) Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature.] Distributed by: Archis Pharma LLC 15 Corporate Place South, Suite 108 Piscataway, NJ 08854 U.S.A. Rev.: 11/2024 PI-CRC-00 LEIA-327.00 10625
- Principal Display Panel Text for Container Label: NDC 72819- 235 -06 Chromic Chloride Injection, USP 4 mg/mL 10 mL Single-dose Vials Rx only Principal Display Panel Text for Carton Label: NDC 72819- 235 -16 Chromic Chloride Injection, USP 4 mg/mL 10 mL Single-dose vials in package of 25 Rx only viallabel cartonlabel
Overview
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 CrCl3•6H 2 O, a crystalline compound soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white, crystalline compound freely soluble in water.
Indications & Usage
Chromic Chloride Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration helps to maintain chromium serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
Dosage & Administration
Chromic Chloride Injection 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 .) Discard unused portion.
Warnings & Precautions
WARNINGS Direct intramuscular or intravenous injection of Chromic Chloride Injection 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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