Cetylpyridinium chloride: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{RB}}
|OTC=Yes
|genericName=Cetylpyridinium chloride
|aOrAn=a
|aOrAn=a
|drugClass=antiseptic
|indicationType=treatment
|indicationType=treatment
|hasBlackBoxWarning=Yes
|indication=gingivitis
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=staining of the teeth and tongue
 
 
 
<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
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|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=====Indications====
 
helps control plaque that leads to gingivitis
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information


:* Dosage
====Dosage====
 
[[File:Cetylp Dosage.png|None|40px]]
=====Condition4=====
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
* Dosing Information
 
:* Dosage
 
<!--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)-->
<!--Non–Guideline-Supported Use (Adult)-->
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* 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-->
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed=====Indications====
 
helps control plaque that leads to gingivitis
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
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
 
:* Dosage


=====Condition2=====
====Dosage====
 
[[File:Cetylp Dosage.png|None|40px]]
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=


<!--Warnings-->
<!--Warnings-->
|warnings=* Description
|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.


====Precautions====
Stop use and ask a dentist if


* Description
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-->
<!--Adverse Reactions-->
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<!--Postmarketing Experience-->
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=staining of the teeth and tongue
 
|drugInteractions=
=====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-->
|drugInteractions=* Drug
:* Description


<!--Use in Specific Populations-->
<!--Use in Specific Populations-->
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|administration=* Oral
|administration=* Oral


* Intravenous
 
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Description
 


<!--IV Compatibility-->
<!--IV Compatibility-->
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<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=There is limited information regarding <i>Overdose</i> of {{PAGENAME}} in the drug label.
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->
<!--Pharmacology-->
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<!--Structure-->
<!--Structure-->
|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
 


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
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<!--How Supplied-->
<!--How Supplied-->
|howSupplied=*
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|storage=* store at controlled room temperature 20-25° C (68-77° F)
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
* 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.]]


<!--Precautions with Alcohol-->
====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.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
|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-->
<!--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>
|lookAlike=There is limited information regarding the look alike drug names
 
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}

Revision as of 13:10, 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

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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

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

helps control plaque that leads to gingivitis

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

helps control plaque that leads to gingivitis

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.

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

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

  • Oral

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

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

Mechanism of Action

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

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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