pharmacopeia
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/api/v1/drug/zinc-acetate

Mechanism of action

Sourced from openFDA

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

Indications

Sourced from openFDA
  • Zinc acetate therapy is indicated for maintenance treatment of patients with Wilson’s disease who have been initially treated with a chelating agent (See PRECAUTIONS: Monitoring Patients ).

Contraindications

Sourced from openFDA
  • Zinc Acetate Capsules are contraindicated in patients with known hypersensitivity to any of the components of the formulation.contraindicated

Dosage & administration

Sourced from openFDA

The recommended adult dose is 50 mg as zinc three times daily (See CLINICAL TRIALS ). Since 25 mg t.i.d. is also an effective dose in children 10 years of age or older or in women who are pregnant, it may be advisable to use a dose of zinc to 25 mg three times a day, as long as the patient is compliant with therapy. The dose can be raised to 50 mg t.i.d. if monitoring indicates a lessening of control (see PRECAUTIONS: Monitoring Patients ). Patients should take zinc acetate on an empty stomach, at least one hour before or two to three hours after meals. For additional information, see PRECAUTIONS .

Warnings & precautions

Sourced from openFDA

Copper Deficiency Several post-marketing cases reported that zinc acetate taken over extended periods of time (i.e., months to years) may result in decreased enteral copper absorption and copper deficiency. The cases reported the following complications of copper deficiency: anemia, granulocytopenia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and myeloneuropathy. If a patient develops signs and/or symptoms of copper deficiency during treatment with zinc acetate, interrupt zinc treatment and measure zinc, 24-hr urinary copper, and non-ceruloplasmin bound copper (NCC) levels. Consider restarting zinc acetate treatment based on periodic monitoring of 24-hr urinary copper and NCC levels. Gastric Ulcer There have been postmarketing reports of gastric ulcers with long-term use of zinc acetate. The cases reported the complications of anemia and gastric ulcer perforation with peritonitis. In some cases, ulcers persisted after treatment until zinc acetate was discontinued. If a patient develops signs and/or symptoms of gastric ulcer during treatment with zinc acetate, discontinue zinc treatment. Most patients showed improvement after cessation of zinc treatment.

Adverse reactions

Sourced from openFDA

The following adverse reactions associated with the use of zinc acetate were identified from postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disorders: gastric irritation Investigations: elevations of serum alkaline phosphatase, amylase, and lipase lasting from weeks to months suggesting pancreatitis; the levels usually return to high normal within the first one or two years of zinc therapy.

Use in specific populations

Sourced from openFDA

Pregnancy: Teratogenic Effects. Studies in pregnant women have not shown that zinc acetate or zinc sulfate increases the risk of fetal abnormalities if administered during all trimesters of pregnancy. If this drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, zinc acetate should be used during pregnancy only if clearly needed. While zinc acetate should be used during pregnancy only if clearly needed, copper toxicosis can develop during pregnancy if anti-copper therapy is stopped. Oral teratology studies have been performed with zinc sulfate in pregnant rats at doses up to 42.5 mg/Kg/day (2 times the recommended human dose based on body surface area), mice at doses up to 30 mg/Kg/day (1 time the recommended human dose based on body surface area), rabbits at doses up to 60 mg/Kg/day (6 times the recommended human dose based on body surface area) and hamsters at doses up to 88 mg/Kg/day (5 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to zinc sulfate. (See CLINICAL TRIALS ).

Overdosage

Sourced from openFDA

Acute oral overdosage with inorganic salts of zinc in humans is reported rarely. In the event of overdosage, the unabsorbed zinc salt should be removed from the stomach by lavage as quickly as possible. The plasma level of zinc should be measured, and heavy metal chelation therapy should be considered if the plasma level of zinc is elevated markedly (>1000 μg/dL). In addition, any signs or symptoms of toxicity should be treated as medically indicated. One fatality associated with overdosage of zinc sulfate has been reported. The death of this adult woman followed the accidental ingestion of approximately 28 g of zinc sulfate. Death occurred on the fifth day after ingestion and was attributed to renal failure. Hemorrhagic pancreatitis and hyperglycemic coma resulted from the overdose. The amount ingested was 500 mg/Kg of zinc sulfate, a value that is in the same order of magnitude as that found to be lethal in animals.

Approval history

Sourced from openFDA
  • Jan 28, 1997NDANDA020458Eton

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.
1,911 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. 1Anosmia33317%
  2. 2Ageusia23312%
  3. 3Fatigue1146.0%
  4. 4Nausea1005.2%
  5. 5Pain955.0%
  6. 6Diarrhoea934.9%
  7. 7Headache854.4%
  8. 8Rash854.4%
  9. 9Off Label Use814.2%
  10. 10Pruritus683.6%
  11. 11Vomiting683.6%
  12. 12Dyspnoea663.5%
  13. 13Pneumonia643.3%
  14. 14Product Dose Omission Issue643.3%
  15. 15Covid-19613.2%

Literature

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Recent PubMed references pinned to Zinc Acetate 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 Acetate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Zinc Acetate work?
Mechanism-of-action classes: Acid-Base Activity; Electrolyte Activity; Enzyme Interactions.
What is Zinc Acetate used for?
According to FDA labeling, Zinc Acetate carries indications including: Zinc acetate therapy is indicated for maintenance treatment of patients with Wilson’s disease who have been initially treated with a chelating agent (See PRECAUTIONS: Monitoring Patients ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Zinc Acetate?
Zinc Acetate is classified as Various alimentary tract and metabolism products, Acid-Base Activity, Electrolyte Activity, Enzyme Interactions.
What are the brand names for Zinc Acetate?
Zinc Acetate is marketed under brand names including Banophen Cream, Benadryl Itch Stopping, Calaclear, Caladryl Clear, Calagel, Callergy Clear, Derma Gran Spray, Galzin.
What are the contraindications for Zinc Acetate?
Zinc Acetate labeling lists contraindications including: Zinc Acetate Capsules are contraindicated in patients with known hypersensitivity to any of the components of the formulation.. Always consult the full prescribing information and a clinician.
Note. Data for zinc-acetate 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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