Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Zinc 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL single-dose plastic vials. Unit of Sale Concentration Each NDC 0409-4090-01 10 mg/10 mL NDC 0409-4090-11 Tray of 25 single-dose vials (1 mg/mL) 10 mg single-dose vial Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1069-4.0 Revised: 8/2024 Logo; PRINCIPAL DISPLAY PANEL - 10 mL Vial Label 10 mL Single-dose Vial NDC 0409-4090-11 ZINC Zinc Chloride Injection, USP 10 mg/10 mL (1 mg/mL) Rx only FOR INTRAVENOUS USE ONLY AFTER DILUTION. Hospira Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 10 mL Vial Label; PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray 10 mL Single-dose Vial NDC 0409-4090-01 Contains 25 of NDC 0409-4090-11 ZINC Rx only 10 mg/10 mL (1 mg/mL) CAUTION: FOR INTRAVENOUS USE ONLY AFTER DILUTION. Zinc Chloride Injection, USP Hospira PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray
- HOW SUPPLIED Zinc 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL single-dose plastic vials. Unit of Sale Concentration Each NDC 0409-4090-01 10 mg/10 mL NDC 0409-4090-11 Tray of 25 single-dose vials (1 mg/mL) 10 mg single-dose vial Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1069-4.0 Revised: 8/2024 Logo
- PRINCIPAL DISPLAY PANEL - 10 mL Vial Label 10 mL Single-dose Vial NDC 0409-4090-11 ZINC Zinc Chloride Injection, USP 10 mg/10 mL (1 mg/mL) Rx only FOR INTRAVENOUS USE ONLY AFTER DILUTION. Hospira Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 10 mL Vial Label
- PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray 10 mL Single-dose Vial NDC 0409-4090-01 Contains 25 of NDC 0409-4090-11 ZINC Rx only 10 mg/10 mL (1 mg/mL) CAUTION: FOR INTRAVENOUS USE ONLY AFTER DILUTION. Zinc Chloride Injection, USP Hospira PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray
Overview
Zinc 1 mg/mL (Zinc Chloride Injection, USP) is a sterile, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition. Each mL of solution contains 2.09 mg zinc chloride 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 sodium hydroxide for pH adjustment. The osmolarity is 0.354 mOsmoL/mL (calc.). Zinc Chloride, USP is chemically designated ZnCl 2 , a white crystalline compound freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration.
Indications & Usage
Zinc 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition. Administration helps to maintain zinc serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.
Dosage & Administration
Zinc 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving total parenteral nutrition, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of zinc blood levels is suggested for patients receiving more than the usual maintenance dosage level of zinc. For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (See PRECAUTIONS ).
Warnings & Precautions
WARNINGS 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.
Contraindications
None known.
Adverse Reactions
None known.
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