Zinc Chloride 1 mg/mL
Zinc Chloride · INJECTION · Exela Pharma Sciences,LLC
Zinc Chloride is an intravenous injection used to provide zinc supplementation for patients who cannot get adequate nutrition through eating, such as those receiving long-term intravenous feeding. It helps maintain normal body functions including immune system support and wound healing.
Key Facts
- Brand Name
- Zinc Chloride
- Generic Name
- Zinc Chloride
- NDC Code (Product)
51754-0102- Manufacturer
- Exela Pharma Sciences,LLC
- Strength
- 1 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA212007
- Marketing Start
- 08/27/2021
Recall History
McDaniel Life-Line LLC
Unapproved new drug
Tri-Coast Pharmacy
Lack of Assurance of Sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Medaus, Inc.
Lack of Assurance of Sterility
Hi-Tech Pharmacal Co., Inc.
Subpotent; Cetylpyridinum Chloride
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Lack of Assurance of Sterility
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
GenoGenix LLC
Lack of Assurance of Sterility
Olympia Compounding Pharmacy dba Olympia Pharmacy
Lack of assurance of sterility.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND 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
DOSAGE AND 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 administratio…
Warnings
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
CONTRAINDICATIONS None known.
Adverse Reactions
ADVERSE REACTIONS None known.
Frequently Asked Questions
What is Zinc Chloride used for?
Zinc Chloride is an intravenous injection used to provide zinc supplementation for patients who cannot get adequate nutrition through eating, such as those receiving long-term intravenous feeding. It helps maintain normal body functions including immune system support and wound healing.
Is Zinc Chloride a controlled substance?
Zinc Chloride is not classified as a controlled substance by the DEA.
What is the generic name for Zinc Chloride?
The generic name for Zinc Chloride is Zinc Chloride. There are 3 other brand versions of Zinc Chloride.
What is the NDC code for Zinc Chloride 1 mg/mL?
The NDC (National Drug Code) for Zinc Chloride 1 mg/mL is 51754-0102, listed by Exela Pharma Sciences,LLC.