Pentetate Zinc Trisodium
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Black Box Warning
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See full prescribing information for complete Boxed Warning.
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Overview
Pentetate Zinc Trisodium is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Pentetate Zinc Trisodium FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pentetate Zinc Trisodium in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pentetate Zinc Trisodium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Pentetate Zinc Trisodium in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pentetate Zinc Trisodium in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pentetate Zinc Trisodium in pediatric patients.
Contraindications
- Condition1
Warnings
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See full prescribing information for complete Boxed Warning.
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- Description
Precautions
- Treatment over several months with Zn-DTPA could lead to depletion of body stores of endogenous metals (e.g., magnesium, manganese). These elements should be monitored routinely and, if appropriate, mineral or vitamin plus mineral supplements should be provided.
Adverse Reactions
Clinical Trials Experience
- In the U.S. Registry, a total of 646 individuals received at least one dose of either Ca-DTPA or Zn-DTPA. Of these, 62 received Zn-DTPA by one or more routes of administration. Forty-eight individuals were dosed by intravenous administration, 18 by inhalation and 8 by other or unknown routes of administration.
- Of the individuals that received Zn-DTPA, 23/62 (37%) received one dose and 8 (13%) received two doses. The remaining 31 individuals received three or more doses. The largest number of Zn-DTPA doses to a single individual was 574 doses delivered over 3.5 years.
- Overall, the presence or absence of adverse events was recorded in 310/646 individuals. Of these 19 (6.1%) individuals reported at least one adverse event. The total number of recorded adverse events was 20. Of the 20 adverse events, 1 individual treated with Zn-DTPA reported headache, lightheadedness, and pelvic pain.
- Two individuals experienced cough and/or wheezing with nebulized Ca-DTPA therapy however there was no report of such events with nebulized Zn-DTPA.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Pentetate Zinc Trisodium in the drug label.
Drug Interactions
- Adequate and well-controlled drug-drug interaction studies in humans were not identified in the literature. When an individual is contaminated with multiple radiocontaminants, or when the radiocontaminants are unknown, additional therapies may be needed (e.g., Prussian blue, potassium iodide).
Use in Specific Populations
Pregnancy
- Pregnancy Category B
- There are no human pregnancy outcome data from which to assess the risk of Zn-DTPA exposure on fetal development. Reproduction studies have been performed in pregnant mice at doses up to 11.5 mmol/kg (31 times the recommended daily dose of 1 gram based on body surface area [BSA] adjusted dose) and have revealed no evidence of impaired fertility or harm to the fetus. There was a slight reduction in the average birth weight.
- Treatment of pregnant women should begin and continue with Zn-DTPA. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. The risk of toxicity from untreated internal radioactive contamination should be weighed against the risk of Zn-DTPA treatment.
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pentetate Zinc Trisodium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Pentetate Zinc Trisodium during labor and delivery.
Nursing Mothers
- Studies to determine if Zn-DTPA is excreted in breast milk have not been conducted.
- Radiocontaminants are known to be excreted in breast milk. Women with known or suspected internal contamination with radiocontaminants should not breast feed, whether or not they are receiving chelation therapy. Precautions should be taken when discarding breast milk
Pediatric Use
- The safety and effectiveness of Zn-DTPA was established in the adult population and efficacy was extrapolated to the pediatric population for the intravenous route based on the comparability of pathophysiologic mechanisms. The dose is based on body size adjustment for an intravenous drug that is renally cleared. The safety and effectiveness of the nebulized route of administration has not been established in the pediatric population.
Geriatic Use
There is no FDA guidance on the use of Pentetate Zinc Trisodium with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Pentetate Zinc Trisodium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Pentetate Zinc Trisodium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Pentetate Zinc Trisodium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Pentetate Zinc Trisodium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Pentetate Zinc Trisodium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Pentetate Zinc Trisodium in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
- Serum electrolytes and essential metals should be closely monitored during Zn-DTPA treatment. Mineral or vitamin plus mineral supplements may be given as appropriate.
IV Compatibility
There is limited information regarding IV Compatibility of Pentetate Zinc Trisodium in the drug label.
Overdosage
- Overdose with Zn-DTPA has not been reported.
Pharmacology
There is limited information regarding Pentetate Zinc Trisodium Pharmacology in the drug label.
Mechanism of Action
Structure
This image is provided by the National Library of Medicine.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Pentetate Zinc Trisodium in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Pentetate Zinc Trisodium in the drug label.
Nonclinical Toxicology
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Studies with Zn-DTPA to evaluate carcinogenesis, mutagenesis and impairment of fertility have not been performed. Data for Zn-DTPA effects on spermatogenesis are not available
Clinical Studies
There is limited information regarding Clinical Studies of Pentetate Zinc Trisodium in the drug label.
How Supplied
- Zn-DTPA is supplied as a sterile solution in 5 mL single-use clear glass ampoules at a concentration of 200 mg/mL for intravenous use. Each ampoule contains the equivalent of 1000 mg of pentetate zinc trisodium.
- NDC 52919-002-03, 5 mL single-use ampoules, package of 10.
- Storage
- Store between 15 - 30°C (59 - 86°F).
Storage
There is limited information regarding Pentetate Zinc Trisodium 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 Pentetate Zinc Trisodium in the drug label.
Precautions with Alcohol
- Alcohol-Pentetate Zinc Trisodium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Pentetate Zinc Trisodium Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Pentetate Zinc Trisodium 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.
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