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{{DrugProjectFormSinglePage
|authorTag={{RB}}
|OTC=Yes
|genericName=Zinc gluconate
|aOrAn=a
|drugClass=lozenge
|indicationType=treatment
|indication= [[common cold]]. It reduces the severity of cold symptoms
|adverseReactions=stomach upset
<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
 
* Content
 
<!--Adult Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=====Indications====
* to reduce the duration of the [[common cold]]
* reduces the severity of cold symptoms: [[cough]], [[sore throat]], [[stuffy nose]], [[sneezing]], [[post nasal drip]] and/or [[hoarseness]]
 
====DIRECTIONS====
* adults and children 12 years and over
* for best results, begin treatment at start of symptoms (within 24-48 hours of onset)
* repeat every 2 - 4 hours as needed until all symptoms subside
* completely dissolve a COLD-EEZE® lozenge in mouth (do not chew)
* recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17
* children under 12 years of age should consult a health professional prior to use
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=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=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=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=<!--Warnings-->
|warnings=* Ask a doctor before use if you
 
:* are taking [[minocycline]], [[doxycycline]], [[tetracycline]] or are on [[coumadin]] therapy,
zinc treatment may inhibit the absorption of these medicines
* Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days.
 
* COLD-EEZE® Lozenges are formulated to reduce the duration of common cold symptoms and may be insufficient treatment for Influenza or Allergies.
 
* Diabetic Warning: sugar replacements may affect blood sugar levels.
 
* If pregnant or breast-feeding, ask a health professional before use.
 
* Keep out of reach of children.
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|drugInteractions=* Ask a doctor before use if you
 
:* are taking [[minocycline]], [[doxycycline]], [[tetracycline]] or are on coumadin therapy,
:* zinc treatment may inhibit the absorption of these medicines
 
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
|administration=* Oral
:* completely dissolve a COLD-EEZE® lozenge in mouth (do not chew)
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Description
 
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
|overdose=There is limited information regarding <i>Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox=: [[File:Zinc Gluconate Wiki str.png|thumb|none|500px|This image is taken from WikiPedia]]
 
 
 
<!--Mechanism of Action-->
|mechAction=*
 
<!--Structure-->
|structure=*
 
 
 
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->
|storage=* store in a cool dry place after opening
|packLabel======PRINCIPAL DISPLAY PANEL - 18 LOZENGE WILD CHERRY CARTON=====
GREAT
NEW TASTE
 
Cold-EEZE®
Zinc Gluconate Glycine
 
COLD REMEDY
 
SUGAR FREE
 
OTC Master's Circle
Achievement Award
#1
Pharmacist
Recommended
Brand!
Pharmacy
Times
 
Clinically proven to reduce the
duration of the common cold ®
#1 Pharmacist Recommended
Shortens your cold, works fast
18
Cold Remedy
Lozenges
 
Homeopathic
 
All Natural
Wild Cherry Flavor
with other natural flavors
 
: [[File:Zinc Gluconate PDP 18.png|none|500px]]
 
=====PRINCIPAL DISPLAY PANEL - 24 LOZENGE WILD CHERRY CARTON=====
 
GREAT
NEW TASTE
 
Cold-EEZE®
Zinc Gluconate Glycine
 
33%
MORE
FREE
 
COLD REMEDY
 
SUGAR FREE
 
OTC Master's Circle
Achievement Award
#1
Pharmacist
Recommended
Brand!
Pharmacy
Times
 
Clinically proven to reduce the
duration of the common cold ®
#1 Pharmacist Recommended
Shortens your cold, works fast
24
Cold Remedy
Lozenges
 
Homeopathic
 
All Natural
Wild Cherry Flavor
with other natural flavors
 
: [[File:Zinc Gluconate PDP 24.png|none|500px]]
 
=====Ingredients and Appearance=====
 
: [[File:Zinc Gluconate Ing and App.png|none|600px]]


{{Chembox new
| ImageFile = Zinc gluconate.png
| ImageSize =
| IUPACName =
| OtherNames =
| Section1 = {{Chembox Identifiers
|  CASNo = 4468-02-4
|  PubChem =
|  SMILES =
  }}
| Section2 = {{Chembox Properties
|  Formula = C<sub>12</sub>H<sub>22</sub>O<sub>14</sub>Zn
|  MolarMass = 455.685 g/mol
|  Appearance =
|  Density =
|  MeltingPt = 172-175 &deg;C
|  BoilingPt =
|  Solubility =
  }}
| Section3 = {{Chembox Hazards
|  MainHazards =
|  FlashPt =
|  Autoignition =
  }}
}}
{{SI}}
'''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.


Zinc gluconate is a popular form for the delivery of zinc as a [[dietary supplement]].


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
<!--Patient Counseling Information-->
  | author = Sumitra Ramachandran, Pierre Fontanille, Ashok Pandey and Christian Larroche
|fdaPatientInfo=* avoid minor stomach upset - Do not dissolve COLD-EEZE® lozenges on an empty stomach
  | title = Gluconic Acid: A Review
* avoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking COLD-EEZE® lozenges as they may diminish product effectiveness, otherwise, drink plenty of fluids
  | journal =Food Technology and Biotechnology
* store in a cool dry place after opening
  | volume = 44
* gluten-free
  | issue = 2
* product may produce a laxative effect
  | pages = 185–195
<!--Precautions with Alcohol-->
  | date = 2006
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
  | 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=* Cold-EEZE®<ref>{{Cite web | title = Zinc gluconate | url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=58123f25-56d8-4b29-83fd-ca4981a38c08 }}</ref>


==Zinc gluconate glycine==
<!--Look-Alike Drug Names-->
|lookAlike=<!--Drug Shortage Status-->
|drugShortage=
}}
<!--Pill Image-->


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]].


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.
<!--Label Display Image-->


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). 


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==
<!--Category-->
* {{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:Drug]]
<references />
{{SIB}}
{{Dietary supplement}}
{{Mineral supplements}}
[[Category:Zinc|Gluconate]]
[[Category:Dietary supplements]]
[[Category:Endocrinology]]
{{WikiDoc Help Menu}}
{{WikiDoc Sources}}

Latest revision as of 21:45, 24 February 2015

Zinc gluconate
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: Rabin Bista, M.B.B.S. [2]

Disclaimer

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Zinc gluconate is a lozenge that is FDA approved for the treatment of common cold. It reduces the severity of cold symptoms. Common adverse reactions include stomach upset.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

DIRECTIONS

  • adults and children 12 years and over
  • for best results, begin treatment at start of symptoms (within 24-48 hours of onset)
  • repeat every 2 - 4 hours as needed until all symptoms subside
  • completely dissolve a COLD-EEZE® lozenge in mouth (do not chew)
  • recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17
  • children under 12 years of age should consult a health professional prior to use

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

  • Ask a doctor before use if you

zinc treatment may inhibit the absorption of these medicines

  • Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days.
  • COLD-EEZE® Lozenges are formulated to reduce the duration of common cold symptoms and may be insufficient treatment for Influenza or Allergies.
  • Diabetic Warning: sugar replacements may affect blood sugar levels.
  • If pregnant or breast-feeding, ask a health professional before use.
  • Keep out of reach of children.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

  • Ask a doctor before use if you

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
  • completely dissolve a COLD-EEZE® lozenge in mouth (do not chew)

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

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

Pharmacology

This image is taken from WikiPedia

Mechanism of Action

Structure

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

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

Storage

  • store in a cool dry place after opening

Images

Drug Images

{{#ask: Page Name::Zinc gluconate |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL - 18 LOZENGE WILD CHERRY CARTON

GREAT NEW TASTE

Cold-EEZE® Zinc Gluconate Glycine

COLD REMEDY

SUGAR FREE

OTC Master's Circle Achievement Award

  1. 1

Pharmacist Recommended Brand! Pharmacy Times

Clinically proven to reduce the duration of the common cold ®

  1. 1 Pharmacist Recommended

Shortens your cold, works fast 18 Cold Remedy Lozenges

Homeopathic

All Natural Wild Cherry Flavor with other natural flavors

PRINCIPAL DISPLAY PANEL - 24 LOZENGE WILD CHERRY CARTON

GREAT NEW TASTE

Cold-EEZE® Zinc Gluconate Glycine

33% MORE FREE

COLD REMEDY

SUGAR FREE

OTC Master's Circle Achievement Award

  1. 1

Pharmacist Recommended Brand! Pharmacy Times

Clinically proven to reduce the duration of the common cold ®

  1. 1 Pharmacist Recommended

Shortens your cold, works fast 24 Cold Remedy Lozenges

Homeopathic

All Natural Wild Cherry Flavor with other natural flavors

Ingredients and Appearance

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

Patient Counseling Information

  • avoid minor stomach upset - Do not dissolve COLD-EEZE® lozenges on an empty stomach
  • avoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking COLD-EEZE® lozenges as they may diminish product effectiveness, otherwise, drink plenty of fluids
  • store in a cool dry place after opening
  • gluten-free
  • product may produce a laxative effect

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

There is limited information regarding Zinc gluconate 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.

  1. "Zinc gluconate".