Chromic Chloride
FDA Drug Information • Also known as: Chromic Chloride, Chromium
- Brand Names
- Chromic Chloride, Chromium
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION 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
What Is Chromic Chloride Used For?
INDICATIONS AND 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 and Administration
DOSAGE AND 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.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS None known.
Warnings and 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
CONTRAINDICATIONS None known.
Overdosage
OVERDOSAGE Trivalent chromium administered intravenously to TPN patients has been shown to be nontoxic when given at dosage levels of up to 250 mcg/day for two consecutive weeks. Reported toxic reactions to chromium include nausea, vomiting, ulcers of the gastrointestinal tract, renal and hepatic damage, convulsions and coma. The acute LD50 for intravenous trivalent chromium in rats was reported as 10 to 18 mg/kg.
How Supplied
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
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.