Cetylpyridinium chloride: Difference between revisions

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{{Chembox new
{{DrugProjectFormSinglePage
| ImageFile = cetylpyridinium_chloride.png
|authorTag={{RB}}
| ImageSize =  
|OTC=Yes
|genericName=Cetylpyridinium chloride
|aOrAn=a
|drugClass=[[antiseptic]]
|indicationType=treatment
|indication=[[gingivitis]]
|adverseReactions=staining of the [[teeth]] and [[tongue]]
 
 
 
<!--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====
* helps control [[plaque]] that leads to [[gingivitis]]
 
====Dosage====
[[File:Cetylp Dosage.png|None|400px]]
|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=====Indications====
* helps control plaque that leads to [[gingivitis]]
 
====Dosage====
[[File:Cetylp Dosage.png|None|400px]]
|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=* Keep out of reach of children under 6 years of age.
 
* If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
 
* Stop use and ask a dentist if
 
:* [[gingivitis]], [[bleeding]], or redness persists for more than 2 weeks
:* you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth
* These may be signs or symptoms of [[periodontitis]], a serious form of gum disease.
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
 
 
 
<!--Postmarketing Experience-->
|postmarketing=staining of the teeth and tongue
|drugInteractions=<!--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]]
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
 
 
<!--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={{chembox2
| verifiedrevid = 477000351
| ImageFile = Cetylp Wiki str.png
| ImageSize =
| IUPACName = 1-Hexadecylpyridinium chloride
| IUPACName = 1-Hexadecylpyridinium chloride
| OtherNames =  
| OtherNames = Acetoquat CPC; <br>Pyrisept
EXADECYL-PYRIDINIUM, CHLORIDE
| Section1 = {{Chembox Identifiers
| Section1 = {{Chembox Identifiers
|  CASNo = 123-03-5
|  Beilstein = 3578606
|  ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 28979
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 6BR7T22E2S
| InChI = 1/C21H38N.ClH/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-16-19-22-20-17-15-18-21-22;/h15,17-18,20-21H,2-14,16,19H2,1H3;1H/q+1;/p-1
| InChIKey = YMKDRGPMQRFJGP-REWHXWOFAU
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 34833
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI = 1S/C21H38N.ClH/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-16-19-22-20-17-15-18-21-22;/h15,17-18,20-21H,2-14,16,19H2,1H3;1H/q+1;/p-1
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = YMKDRGPMQRFJGP-UHFFFAOYSA-M
| CASNo_Ref = {{cascite|correct|CAS}}
| CASNo = 123-03-5
| CASNo1 = 6004-24-6
| CASNo1_Comment = (monohydrate)
| ATCCode_prefix = B05
| ATCCode_suffix = CA01
| ATC_Supplemental = &nbsp;{{ATC|D08|AJ03}},<br />{{ATC|D09|AA07}} (dressing), {{ATC|R02|AA06}}
|  PubChem = 31239
|  PubChem = 31239
|  SMILES = CCCCCCCCCCCCCCCC[n+]1ccccc1.[Cl-]
|  ChEBI_Ref = {{ebicite|correct|EBI}}
  }}
| ChEBI = 32915
| Section2 = {{Chembox Properties
| SMILES = Cl-.n+1(ccccc1)CCCCCCCCCCCCCCCC
|  Formula = C<sub>21</sub>H<sub>38</sub>NCl
}}
|  MolarMass = 339.986 g/mol
|   Appearance =
|   Density =
|  MeltingPtC = 77
|  BoilingPt =
|  Solubility =
  }}
| Section3 = {{Chembox Hazards
|   MainHazards =
|  FlashPt =
|  Autoignition =  
  }}
}}
}}
{{CMG}}


<!--Mechanism of Action-->
|mechAction=


'''Cetylpyridinium chloride''' ('''CPC''') is a [[cationic]] [[quaternary ammonium]] compound in some types of [[mouthwash]]es, [[toothpaste]]s, [[lozenge]]s, throat sprays, anti-snore throat sprays, breath sprays, and nasal sprays. It is an [[antiseptic]] that kills bacteria and other microorganisms. It has been shown to be effective in preventing dental [[Dental plaque|plaque]] and reducing [[gingivitis]]. It has also been used  as an ingredient in certain [[pesticide]]s. However, this ingredient has also been shown (according to WebMD,<ref name="uslc-1">{{cite web|title=Tooth Discoloration: Causes and Treatments|url=http://www.webmd.com/content/article/66/79599.htm}}</ref> eMedicine,<ref name="uslc-2">{{cite web|title=Tooth Discoloration : Article by Jonathan A Ship, DMD|url=http://www.emedicine.com/derm/topic646.htm}}</ref> and Amazon.com<ref name="amazon">{{cite web|title=Amazon Product Page|url=http://www.amazon.com/gp/product/customer-reviews/B000BS6VWC/ref=cm_cr_dp_2_1/102-5647531-6773768?ie=UTF8&customer-reviews.sort%5Fby=-SubmissionDate&n=3760901}}</ref> and Drugstore.com reviews of Crest Pro-Health® rinse product) to cause brown stains between the teeth.
<!--Structure-->
|structure=* ACTIVE INGREDIENT (IN EACH 20 ML)
:* cetylpyridinium chloride (0.05% w/w)
* INACTIVE INGREDIENTS
:* water, glycerin, propylene glycol, sorbitol, polysorbate 20, sodium benzoate, flavor, phosphoric acid, menthol, sodium saccharin, FD&C blue no. 1


==Synonyms==
Cetylpyridinium chloride is called or is present in commercial products such as n as 1-palmitylpyridinium chloride, C16-alkylpyridinium chloride, 1-hexadecylpyridinium chloride, acetoquat CPC, aktivex, ammonyx CPC, cecure, ceepryn chloride, cepacol, ceprim, cepacol chloride, cetafilm, cetamium, dobendan, halset, ipanol, medilave, mercocet, merothol, pionin B, pristacin, pyrisept and asept.


==Physical and chemical properties==
Cetylpyridinium chloride has the molecular formula C<sub>21</sub>H<sub>38</sub>NCl and at its pure form is in a solid state at [[room temperature]]. It has a melting point of 77 °C when [[anhydrous]] or 80–83 °C in its [[monohydrate]] form. It is insoluble in [[acetone]], [[acetic acid]], or [[ethanol]]. It has a [[pyridine]]-like odor. It is combustible. Concentrated solutions are destructive to [[mucous membrane]]s. It is very toxic when inhaled.


The CAS number for the monohydrate is {{CASREF|CAS=6004-24-6}}.
<!--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-->
|howSupplied=
|storage=* store at controlled room temperature 20-25° C (68-77° F)
* this rinse is not intended to replace brushing or flossing
|packLabel=====PRINCIPAL DISPLAY PANEL - 30 ML BOTTLE LABEL====
: [[File:Cetylp PDP.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
====Ingredients and Appearance====
: [[File:Cetylp Ing and App.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Patient Counseling Information-->
|fdaPatientInfo=* QUESTIONS OR COMMENTS?
* Call toll-free 1-800-468-6502
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
<!--Brand Names-->
|brandNames=* COLGATE TOTAL PEPPERMINT®<ref>{{Cite web | title = Cetylpyridinium chloride | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1773c295-2434-4370-8795-81b55ff1b75e}}</ref>
 
<!--Look-Alike Drug Names-->
|lookAlike=There is limited information regarding the look alike drug names
|drugShortage=
}}


In some products, '''cetylpyridinium bromide''' is used instead. Its properties are virtually identical.


==Toxicology and Pharmacology==
The [[LD50]] in rats is 200 mg/kg.


==References==
<div class="references-small">
<references/>
</div>


==External links==
<!--Category-->
* [http://physchem.ox.ac.uk/MSDS/CE/cetylpyridinium_chloride.html Material Safety Data Sheet]
* [http://www.cas.astate.edu/draganjac/cetylpyridiniumchloride.html Page on its use in mouthwash]
* [http://www.chemicalland21.com/lifescience/phar/CETYLPYRIDINIUM%20CHLORIDE.htm Chemical Information]
* [http://www.nature.com/bdj/journal/v194/n4/full/4809913a.html ''An in vitro evaluation of the availability of cetylpyridinium chloride and chlorhexidine in some commercially available mouthrinse products'' by S. Sheen and M. Addy in ''British Dental Journal'']


{{Throat preparations}}
[[Category:Drug]]
[[Category:Quaternary ammonium compounds]]
[[Category:Antiseptics]]
<br>
[[es:cloruro de cetilpiridinio]]
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Latest revision as of 13:46, 21 April 2015

Cetylpyridinium chloride
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

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
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

Cetylpyridinium chloride is a antiseptic that is FDA approved for the treatment of gingivitis. Common adverse reactions include staining of the teeth and tongue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Dosage

None

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

Dosage

None

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Cetylpyridinium chloride Contraindications in the drug label.

Warnings

  • Keep out of reach of children under 6 years of age.
  • If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
  • Stop use and ask a dentist if
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth
  • These may be signs or symptoms of periodontitis, a serious form of gum disease.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Cetylpyridinium chloride in the drug label.

Postmarketing Experience

staining of the teeth and tongue

Drug Interactions

There is limited information regarding Cetylpyridinium chloride Drug Interactions in the drug label.

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 Cetylpyridinium chloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cetylpyridinium chloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cetylpyridinium chloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Cetylpyridinium chloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Cetylpyridinium chloride with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

There is no FDA guidance on the use of Cetylpyridinium chloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cetylpyridinium chloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

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

Immunocompromised Patients

There is no FDA guidance one the use of Cetylpyridinium chloride in patients who are immunocompromised.

Administration and Monitoring

Administration

Monitoring

There is limited information regarding Monitoring of Cetylpyridinium chloride in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Cetylpyridinium chloride in the drug label.

Overdosage

There is limited information regarding Overdose of Cetylpyridinium chloride in the drug label.

Pharmacology

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Template:Chembox header2 | Cetylpyridinium chloride
Identifiers
3D model (JSmol)
ChEBI
ChEMBL
ChemSpider
ECHA InfoCard Lua error in Module:Wikidata at line 879: attempt to index field 'wikibase' (a nil value). Lua error in Module:Wikidata at line 879: attempt to index field 'wikibase' (a nil value).
UNII
Template:Chembox header2 | Except where noted otherwise, data are given for
materials in their standard state
(at 25 °C, 100 kPa)
Infobox disclaimer and references

Mechanism of Action

There is limited information regarding Cetylpyridinium chloride Mechanism of Action in the drug label.

Structure

  • ACTIVE INGREDIENT (IN EACH 20 ML)
  • cetylpyridinium chloride (0.05% w/w)
  • INACTIVE INGREDIENTS
  • water, glycerin, propylene glycol, sorbitol, polysorbate 20, sodium benzoate, flavor, phosphoric acid, menthol, sodium saccharin, FD&C blue no. 1

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Cetylpyridinium chloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Cetylpyridinium chloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Cetylpyridinium chloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Cetylpyridinium chloride in the drug label.

How Supplied

There is limited information regarding Cetylpyridinium chloride How Supplied in the drug label.

Storage

  • store at controlled room temperature 20-25° C (68-77° F)
  • this rinse is not intended to replace brushing or flossing

Images

Drug Images

{{#ask: Page Name::Cetylpyridinium chloride |?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 - 30 ML BOTTLE LABEL

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

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

Patient Counseling Information

  • QUESTIONS OR COMMENTS?
  • Call toll-free 1-800-468-6502

Precautions with Alcohol

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

Brand Names

  • COLGATE TOTAL PEPPERMINT®[1]

Look-Alike Drug Names

There is limited information regarding the look alike drug names

Drug Shortage Status

Price

References

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

  1. ↑ "Cetylpyridinium chloride".
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