Zinc

None known.

• Direct intramuscular or intravenous injection of Zinc 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) 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.
• Copper Deficiency Several post-marketing cases have reported that zinc products taken over extended periods of time (i.e., months to years) may result in copper deficiency.
• The cases reported the following complications of copper deficiency:
• anemia, granulocytopenia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and myeloneuropathy.
• If a patient develops signs and/or symptoms of copper deficiency during treatment with zinc chloride, interrupt zinc treatment and check zinc and copper levels.
• Consider supplemental copper administration to treat copper deficiency and monitor zinc levels.
• Aluminum Toxicity 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.
• General Use only if the solution is clear and the seal is intact.
• Zinc 1 mg/mL (Zinc Chloride Injection, USP) 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.
• Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of zinc from a bolus injection.
• Administration of zinc in the absence of copper may cause a decrease in serum copper levels.
• Laboratory Tests Periodic determinations of serum copper as well as zinc are suggested as a guideline for subsequent zinc administration.
• Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies to evaluate the carcinogenic potential of Zinc 1 mg/mL (Zinc Chloride Injection, USP) 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.
• Pediatric Use See DOSAGE and ADMINISTRATION section.
• Pregnancy Animal reproduction studies have not been conducted with zinc chloride.
• Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients.
• General Use only if the solution is clear and the seal is intact.
• Zinc 1 mg/mL (Zinc Chloride Injection, USP) 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.
• Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of zinc from a bolus injection.
• Administration of zinc in the absence of copper may cause a decrease in serum copper levels.

• Animal reproduction studies have not been conducted with zinc chloride.
• It is also not known whether zinc chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• Zinc chloride should be given to a pregnant woman only if clearly needed.
• 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 Zinc 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

• Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations.
• However, acute toxicity was reported in an adult when 10 mg zinc was infused over a period of one hour on each of four consecutive days.
• Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum zinc concentration of 207 mcg/dl.
• Symptoms abated within three hours.
• Hyperamylasemia may be a sign of impending zinc overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of total parenteral nutrition solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal:
• 130 to 310).
• Death resulted from an overdosage in which 1683 mg zinc was delivered intravenously over the course of 60 hours to a 72-year-old patient.
• Symptoms of zinc toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum zinc level of 4184 mcg/dl.
• Calcium supplements may confer a protective effect against zinc toxicity.