CHROMIC CHLORIDE 4 ug/mL Injection, Solution — NDC 72819-235-16 (Billing 72819-0235-16)

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.

ADVERSE REACTIONS None known.

PRECAUTIONS General Do not use unless solution is clear and seal is intact. Chromic Chloride Injection should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

In assessing the contribution of chromium supplements to maintenance of glucose homeostasis, consideration should be given to the possibility that the patient may be diabetic. Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Laboratory Tests Because chromium is present in the bloodstream in microgram quantities, routine measurement is impractical.

If necessary, samples can be sent to a reference laboratory for assay. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies to evaluate the carcinogenic potential of Chromic Chloride Injection have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility. Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when Chromic Chloride Injection is administered to a nursing woman. Pediatric Use See DOSAGE and ADMINISTRATION section. Safety and effectiveness in children have not been established.

Pregnancy Animal reproduction studies have not been conducted with chromic chloride. It is also not known whether chromic chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Chromic chloride should be given to a pregnant woman only if clearly indicated.

DRUG ABUSE AND DEPENDENCE None known.