Zinc sulfate

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Zinc sulfate
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: Deepika Beereddy, MBBS [2]

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Overview

Zinc sulfate is a parenteral mineral- trace mineral that is FDA approved for the prophylaxis of prophylaxis of zinc deficiency. Common adverse reactions include indigestion, nausea, vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Zinc deficiency; Prophylaxis
  • Zinc Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain plasma levels and to prevent depletion of endogenous stores.
  • Dosing Information
  • Zinc Sulfate Injection, USP provides 1 mg zinc/mL. For metabolically stable adults receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day. An additional 2 mg zinc/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, or an additional 17.1 mg zinc/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 is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day is suggested.
  • Aseptic addition of Zinc Sulfate Injection, USP to the TPN solution under a laminar flow hood is recommended. Zinc is physically compatible with the electrolytes and vitamins usually present in the amino acid/dextrose solution used for TPN.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration, 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 sulfate in adult patients.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Zinc sulfate Contraindications in the drug label.

Warnings

There is limited information regarding Zinc sulfate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

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

Labor and Delivery

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

Nursing Mothers

  • There is no FDA guidance on the use of Zinc sulfate with respect to nursing mothers.

Pediatric Use

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

Geriatic Use

  • There is no FDA guidance on the use of Zinc sulfate with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Zinc Sulfate Injection, USP provides 1 mg zinc/mL. For metabolically stable adults receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day. An additional 2 mg zinc/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, or an additional 17.1 mg zinc/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 is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day is suggested.
  • Aseptic addition of Zinc Sulfate Injection, USP to the TPN solution under a laminar flow hood is recommended. Zinc is physically compatible with the electrolytes and vitamins usually present in the amino acid/dextrose solution used for TPN.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

Monitoring

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

IV Compatibility

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

Overdosage

  • Symptoms of zinc overdosage resulting from oral ingestion of zinc sulfate in large amounts (30 and 44 grams, respectively) have resulted in death. Symptoms include nausea, vomiting, dehydration, electrolyte imbalances, dizziness, abdominal pain, lethargy and incoordination. Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. Normal plasma levels for zinc vary from approximately 88 to 112 mcg/100 mL. Plasma levels sufficient to produce symptoms of toxic manifestations in humans are not known. Calcium supplements may confer a protective effect against zinc toxicity.

Pharmacology

Mechanism of Action

  • Zinc has been identified as a cofactor for over 70 different enzymes, including 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.
  • Providing zinc during TPN prevents development of the following deficiency symptoms: Parakeratosis, hypogeusia, anorexia, dysosmia, geophagia, hypogonadism, growth retardation and hepatosplenomegaly. At plasma levels below 20 mcg zinc/100 mL, dermatitis followed by alopecia has been reported for TPN patients.

Structure

  • Zinc Sulfate Injection, USP is a sterile, nonpyrogenic solution intended for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains Zinc Sulfate (Anhydrous) 2.46 mg, Water for Injection q.s. pH adjusted with Sulfuric Acid. It contains no preservatives. Discard any unused portion.

Pharmacodynamics

  • There is limited information regarding Pharmacodynamics of Zinc sulfate in the drug label.

Pharmacokinetics

  • There is limited information regarding Pharmacokinetics of Zinc sulfate in the drug label.

Nonclinical Toxicology

  • There is limited information regarding Nonclinical Toxicology of Zinc sulfate in the drug label.

Clinical Studies

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

How Supplied

  • Zinc Sulfate Injection, USP 1 mg/mL
  • NDC 0517-6110-25- 10 mL SDV- packed in a box of 25

Storage

  • Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

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 sulfate in the drug label.

Precautions with Alcohol

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

Brand Names

M2 Zinc 50, Zn Plus Protein.

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ "http://www.ismp.org". External link in |title= (help)

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