Chromic Chloride - Chromic Chloride injection, Solution prescribing information
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
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.
CONTRAINDICATIONS
None known.
ADVERSE REACTIONS
None known.
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•6H 2 O, a crystalline compound soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white, crystalline compound freely soluble in water.
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 result in normalization of the glucose tolerance curve from the diabetic-like curve typical of chromium deficiency. This response is viewed as a more meaningful indicator of chromium nutriture than serum chromium levels.
Excretion of chromium is via the kidneys, ranging from 3 to 50 mcg/day. Biliary excretion via the small intestine may be an ancillary route, but only small amounts of chromium are believed to be excreted in this manner.
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
