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{{Chembox new
<!--Adult Indications and Dosage-->
| ImageFile = Zinc gluconate.png
 
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* Dosing Information
|   CASNo = 4468-02-4
 
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:* Dosage
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=====Condition2=====
| Section2 = {{Chembox Properties
 
|   Formula = C<sub>12</sub>H<sub>22</sub>O<sub>14</sub>Zn
* Dosing Information
|   MolarMass = 455.685 g/mol
 
|   Appearance =  
:* Dosage
|   Density =  
 
|   MeltingPt = 172-175 &deg;C
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'''Zinc gluconate''' is the [[salt (chemistry)|salt]] of [[gluconic acid|gluconate]] and [[zinc]] II. It is an [[ionic bond|ionic]] [[chemical compound|compound]] consisting of two moles of gluconate for each mole of zinc.
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
* Dosing Information
 
:* Dosage
 
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There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
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* Dosing Information
 
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* Intravenous
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Zinc gluconate is a popular form for the delivery of zinc as a [[dietary supplement]].
<!--How Supplied-->
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


It is found naturally, and is industrially manufactured by the [[fermentation (biochemistry)|fermentation]] of [[glucose]], typically by ''[[Aspergillus niger]]'', but also by other [[fungus|fungi]], e.g. ''[[Penicillium]]'', or by [[bacteria]], e.g. ''[[Acetobacter]]'', ''[[Pseudomonas]]'' and ''Gluconobacter''.<ref>{{cite journal
<!--Precautions with Alcohol-->
  | author = Sumitra Ramachandran, Pierre Fontanille, Ashok Pandey and Christian Larroche
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
  | title = Gluconic Acid: A Review
  | journal =Food Technology and Biotechnology
  | volume = 44
  | issue = 2
  | pages = 185–195
  | date = 2006
  | url = http://jagor.srce.hr/ftbrfd/44-185.pdf
  | accessdate = December 6, 2006 }}</ref>  In its pure form, it is a white to off-white powder. It can also be manufactured by electrolytic oxidation<ref>{{cite journal
  | author = Henk G.J. de Wilt
  | title = Part I: The oxidation of Glucose to Gluconic Acid
  | journal = Ind. Eng. Chem. Prod. Res. Develop.
  | volume = 11
  | issue = 4
  | pages = 370 -
  | date = 1972
  | url = http://pubs.acs.org/cgi-bin/abstract.cgi/iepra6/1972/11/i04/f-pdf/f_i360044a002.pdf
  | accessdate = December 6, 2006 }}</ref>, although this is a more expensive process. The advantages are a lower microbiological profile, and a more complete reaction, yielding a product with a longer shelf life.


Zinc gluconate may interfere with the absorption of [[antibiotic]]s, so combinations may be unsafe.
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>


==Zinc gluconate glycine==
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


Zinc gluconate glycine is a formulation containing '''zinc gluconate''' and the [[amino acid]] [[glycine]]. It is available as an over-the-counter remedy for the [[common cold]].
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Zinc gluconate, when made into a [[throat lozenge|lozenge]] by itself, has a mildly [[acid]]ic taste, which will turn into a  bitter taste over a period of time. The addition of large amounts of glycine to the lozenge produces a much milder and more stable taste. The resulting commercial products have a nearly unlimited shelf life. 


This compound was patented in 1985 by John C. Godfrey of Godfrey Science & Design. The Quigley Corporation has trademarked the name '''ZIGG'''™ for the compound.  The company is also the only major supplier of zinc gluconate glycine, distributed under the brand name '''Cold-Eeze'''. All [[clinical trial]]s of the compound to date have involved the lozenges in this product family.


Like zinc gluconate, zinc gluconate glycine has been shown in clinical trials to shorten the mean and median duration of symptoms of the common cold<ref>{{cite journal|author=Godfrey JC, Godfrey NJ, Novick SG. |title=Zinc for treating the common cold: Review of all clinical trials since 1984.|year=1996| id= PMID 8942045}}</ref> The amount of glycine added can range anywhere from two to twenty [[Mole (unit)|mole]]s of glycine for each mole of zinc gluconate (US Patent 4,684,528, Claim 1). 
<!--Label Display Image-->


The manufacturer claims that their product reduces the duration of common cold symptoms by 42%, compared to the natural duration.  However, the actual benefits gained from the product depend heavily on how quickly the treatment is started after the first appearance of symptoms.  Repeated clinical trials of the compound have generally shown a measurable, but varied, benefit relative to a [[placebo]], typically on the order of a one to four day reduction in symptom duration.<ref>{{cite journal|author=D. Hulisz |title=Efficacy of zinc against common cold viruses: an overview.|year=2004| id= PMID 15496046}}</ref><ref>{{cite journal|author=BH McElroy |title=An open-label, single-center, phase IV clinical study of the effectiveness of zinc gluconate glycine lozenges (Cold-Eeze) in reducing the duration and symptoms of the common cold in school-aged subjects.|year=2003| id = PMID 12975716}}</ref>


==Safety Concerns==
<!-- This section, [[Zinc gluconate#Safety Concerns]], is direct-linked to by the [[Homeopathy]] article in a discussion of Zicam. Please do not change the section title without fixing the link-->
In September 2003, Zicam, a brand of homeopathic zinc cold remedy, faced lawsuits from users who claimed that the product negatively affected their sense of smell, and sometimes taste.  In January 2006, 340 lawsuits were settled for $12 million.[http://zicam.vanosteen.com/] In early 2004, at the height of the controversy, Matrixx Industries, the maker of Zicam, claimed that only a small number of people had experienced problems and that [[anosmia]] (loss of smell) can, amongst others, also be caused by the common cold itself. Matrixx Industries also claimed that zinc gluconate dissolves into zinc ions and gluconate, and that both are naturally occurring compounds which are found in all human tissues. They also claim that Zicam is a buffered gel that is formulated to have a neutral [[pH]].  Others countered Matrixx Industries, claiming that many of the patients had experienced a strong and very painful burning sensation when they used the product, indicating damage to the nasal tissue. Nonetheless the nasal gel continues to be sold.


The U.S. [[Food and Drug Administration]] (FDA) considers zinc gluconate to be [[generally recognized as safe]] (GRAS) when used in accordance with good manufacturing practice, although this does not constitute a finding by the FDA that the substance is a useful dietary supplement.<ref>{{cite web
  | title      = Title 21, Part 182 Substances Generally Recognized as Safe (21CFR182)
  | work        = United States [[Code of Federal Regulations]]
  | publisher  = [[Food and Drug Administration]], [[Department of Health and Human Services]]
  | url        = http://www.access.gpo.gov/nara/cfr/waisidx_03/21cfr182_03.html
  | accessdate  = 2007-07-09
}}</ref>


==External links==
* {{US patent|4758439}} - Flavor of zinc supplements for oral use
* {{US patent|4684528}} - Flavor of zinc supplements for oral use
* [http://coldcure.com/html/common-cold.pdf Review of multiple zinc-based cold treatments]
* [http://www.coldeeze.com/clinical_info/index.html Clinical information from manufacturer]
* {{ATC|A12|CB02}}


==References==
<!--Category-->
{{reflist|2}}


{{Dietary supplement}}
[[Category:Drug]]
{{Mineral supplements}}
[[Category:Zinc|Gluconate]]
[[Category:Dietary supplements]]
[[Category:Endocrinology]]
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Revision as of 19:57, 23 January 2015

Zinc gluconate
Black Box Warning
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];

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Black Box Warning

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Zinc gluconate is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. 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)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

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

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

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

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

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 gluconate in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Zinc gluconate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Zinc gluconate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

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

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