Zinc chloride

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Zinc chloride
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

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Overview

Zinc chloride is an nutritional agent that is FDA approved for the {{{indicationType}}} of zinc deficiency. Common adverse reactions include none known.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hypozincemia in TPN
  • Zinc 1 mg/mL (Zinc Chloride Injection, USP) 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.
  • 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 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Zinc chloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Zinc chloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Zinc chloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Zinc chloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Zinc chloride in pediatric patients.

Contraindications

  • None

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.
  • 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.

Precautions

  • Do not use unless 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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Zinc chloride in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Zinc chloride in the drug label.

Drug Interactions

There is limited information regarding Zinc chloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category C
  • 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.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Zinc chloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Zinc chloride during labor and delivery.

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 Zinc 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

There is no FDA guidance on the use of Zinc chloride with respect to pediatric patients.

Geriatic 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.

Gender

There is no FDA guidance on the use of Zinc chloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Zinc chloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Zinc chloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Zinc chloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Zinc chloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Zinc chloride in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Intravenous

Monitoring

There is limited information regarding Monitoring of Zinc chloride in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Zinc chloride in the drug label.

Overdosage

Acute Overdose

  • 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 TPN 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.
  • Calcium supplements may confer a protective effect against zinc toxicity.

Chronic Overdose

There is limited information regarding Chronic Overdose of Zinc chloride in the drug label.

Pharmacology

There is limited information regarding Zinc chloride Pharmacology in the drug label.

Mechanism of Action

  • Zinc is an essential nutritional requirement and serves as a cofactor for more than 70 different enzymes including carbonic anhydrase, alkaline phosphatase, lactic dehydrogenase, and both RNA and DNA polymerase. Zinc facilitates wound healing, helps maintain normal growth rates, normal skin hydration, and the senses of taste and smell.

Structure

  • 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 (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 m0smoL/mL (calc.).
  • Zinc Chloride, USP is chemically designated ZnCl2, 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.

Pharmacodynamics

Pharmacokinetics

  • Zinc resides in muscle, bone, skin, kidney, liver, pancreas, retina, prostate and particularly in the red and white blood cells. Zinc binds to plasma albumin, α2-macroglobulin, and some plasma amino acids including histidine, cysteine, threonine, glycine, and asparagine. Ingested zinc is excreted mainly in the stool (approximately 90%), and to a lesser extent in the urine and in perspiration.

Nonclinical Toxicology

  • 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.

Clinical Studies

There is limited information regarding Clinical Studies of Zinc chloride in the drug label.

How Supplied

  • Zinc 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).
  • Store at 20 to 25°C (68 to 77°F).

Storage

There is limited information regarding Zinc chloride Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Zinc chloride in the drug label.

Precautions with Alcohol

  • Alcohol-Zinc chloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

There is limited information regarding Zinc chloride Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "ZINC zinc chloride injection, solution".


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