Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Zinc Chloride Injection, USP, 1 mg/mL is supplied in 10 mL plastic vials. NDC Number Strength Packaged NDC 51754-0102-1 10 mg/10 mL (1 mg/mL) 10 mL vial NDC 51754-0102-4 10 mg/10 mL (1 mg/mL) 25 vials per carton Store at 20 to 25°C (6 8 to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: 1245 Blowing Rock Blvd Lenoir, NC 28645 Revised 05/2021 exela logo; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-10 mL Vial Label Rx Only NDC 51754-0102-1 Zinc Chloride Injection, USP 10 mg/10 mL (1mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION Discard Unused Portion 10 mL Single-dose Vial vial label; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-25 ct Carton NDC 51754-0102-4 Rx Only Zinc Chloride Injection, USP 10 mg/10 mL (1 mg/mL) CAUTION: FOR INTRAVENOUS USE ONLY AFTER DILUTION Discrd Unused Portion 25 x 10 mL Single-dose Vials carton label
- HOW SUPPLIED Zinc Chloride Injection, USP, 1 mg/mL is supplied in 10 mL plastic vials. NDC Number Strength Packaged NDC 51754-0102-1 10 mg/10 mL (1 mg/mL) 10 mL vial NDC 51754-0102-4 10 mg/10 mL (1 mg/mL) 25 vials per carton Store at 20 to 25°C (6 8 to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: 1245 Blowing Rock Blvd Lenoir, NC 28645 Revised 05/2021 exela logo
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-10 mL Vial Label Rx Only NDC 51754-0102-1 Zinc Chloride Injection, USP 10 mg/10 mL (1mg/mL) FOR INTRAVENOUS USE ONLY AFTER DILUTION Discard Unused Portion 10 mL Single-dose Vial vial label
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-25 ct Carton NDC 51754-0102-4 Rx Only Zinc Chloride Injection, USP 10 mg/10 mL (1 mg/mL) CAUTION: FOR INTRAVENOUS USE ONLY AFTER DILUTION Discrd Unused Portion 25 x 10 mL Single-dose Vials carton label
Overview
Zinc Chloride Injection, USP, 1 mg/mL is a sterile, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition (TPN). 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 Chloride Injection, USP, 1 mg/mL is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain zinc serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.
Dosage & Administration
Zinc Chloride Injection, USP contains 1 mg/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 TPN, 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 Chloride Injection, USP, 1 mg/mL 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. 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
None known.
Adverse Reactions
None known.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.