pharmacopeia
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/api/v1/drug/zinc-chloride

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Acid-Base Activity; Electrolyte Activity; Enzyme Interactions.

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • None known.contraindicated

Dosage & administration

Sourced from openFDA

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

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

None known.

Use in specific populations

Sourced from openFDA

Pregnancy 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.

Overdosage

Sourced from openFDA

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. Symptoms of zinc toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum zinc level of 4184 mcg/dl. Calcium supplements may confer a protective effect against zinc toxicity.

Approval history

Sourced from openFDA
  • Jun 26, 1986NDANDA018959Hospira
  • May 21, 2021ANDAANDA212007Exela Pharma
  • Oct 16, 2024ANDAANDA216152Somerset

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
23,969 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue2,55711%
  2. 2Pain1,9318.1%
  3. 3Nausea1,8897.9%
  4. 4Diarrhoea1,8357.7%
  5. 5Headache1,8097.5%
  6. 6Off Label Use1,7807.4%
  7. 7Drug Ineffective1,5316.4%
  8. 8Dyspnoea1,4205.9%
  9. 9Dizziness1,2915.4%
  10. 10Arthralgia1,2865.4%
  11. 11Fall1,2315.1%
  12. 12Asthenia1,2125.1%
  13. 13Constipation1,1134.6%
  14. 14Rash1,0594.4%
  15. 15Covid-199574.0%

Literature

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Recent PubMed references pinned to Zinc Chloride as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 46 ClinicalTrials.gov registrations naming Zinc Chloride as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Zinc Chloride work?
Mechanism-of-action classes: Acid-Base Activity; Electrolyte Activity; Enzyme Interactions.
What is Zinc Chloride used for?
According to FDA labeling, Zinc Chloride carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Zinc Chloride?
Zinc Chloride is classified as Electrolyte solutions, Acid-Base Activity, Electrolyte Activity, Enzyme Interactions, Astringent Activity.
What are the brand names for Zinc Chloride?
Zinc Chloride is marketed under brand names including Bucalsep.
What are the contraindications for Zinc Chloride?
Zinc Chloride labeling lists contraindications including: None known.. Always consult the full prescribing information and a clinician.
Note. Data for zinc-chloride is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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