Sodium monofluorophosphate: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->
|authorTag={{RB}}
|aOrAn=a
|OTC=Yes
|hasBlackBoxWarning=Yes
|genericName=Sodium monofluorophosphate
|adverseReactions=<!--Black Box Warning-->
|indicationType=treatment
|indication=cavities
|adverseReactions=
* 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.
 
<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
 


<!--Adult Indications and Dosage-->
<!--Adult Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=====Indications====
 
* helps protect against cavities
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:


* Class of Recommendation:
====Directions====


* Strength of Evidence:  
: [[File:Sodium monoflurophosphate Directions.png|none|500px]]


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


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
* 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 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 the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
 
====Precautions====
 
* Description


<!--Adverse Reactions-->
<!--Adverse Reactions-->
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|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.


=====Body as a Whole=====
<--Postmarketing Experience-->
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.


=====Body as a Whole=====
<--Drug Interactions-->
 
|drugInteractions=*  
 
 
=====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-->
Line 266: Line 78:
|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.


Line 275: Line 87:


<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=* If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
 
====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-->
Line 296: Line 96:


<!--Structure-->
<!--Structure-->
|structure=*
|structure======ACTIVE INGREDIENT=====
Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)
 
====INACTIVE INGREDIENTS====
dicalcium phosphate dihydrate, water, glycerin, sodium lauryl sulfate, cellulose gum, flavor, tetrasodium pyrophosphate, sodium saccharin
 


: [[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-->
|packLabel=====PRINCIPAL DISPLAY PANEL - 85 GRAM TUBE====
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
Colgate®
Fluoride Toothpaste
 
ADA
Accepted
American
Dental
Association®
 
NET WT 3.0 OZ (85 g)
 
Cavity
Protection
 
Strengthens Teeth
with Active Fluoride
 
Great Regular Flavor
 
: [[File:Sodium monoflurophosphate PDP.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
====PRINCIPAL DISPLAY PANEL - 85 GRAM TUBE CARTON====
Colgate®
Fluoride Toothpaste
 
ADA
Accepted
American
Dental
Association®
 
NET WT 3.0 OZ (85 g)
 
Cavity
Protection
 
Strengthens Teeth
with Active Fluoride
 
Great Regular Flavor
 
: [[File:Sodium monoflurophosphate PDP 2.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
====Ingredients and Appearance====
 
: [[File:Sodium monoflurophosphate 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


<!--Precautions with Alcohol-->
<!--Precautions with Alcohol-->
Line 321: Line 174:


<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>
|brandNames=* COLGATE TOOTHPASTE  GREAT REGULAR FLAVOR®<ref>{{Cite web | title = sodium monofluorophosphate | url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ce5c6085-718d-409b-8d0f-e2e8419016c4 }}</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=


<!--Drug Shortage Status-->
<!--Drug Shortage Status-->

Revision as of 16:10, 30 January 2015

Sodium monofluorophosphate
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

Sodium monofluorophosphate is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of cavities. Common adverse reactions include * 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..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • helps protect against cavities

Directions

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Sodium monofluorophosphate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Sodium monofluorophosphate Contraindications in the drug label.

Warnings

  • Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Sodium monofluorophosphate in the drug label.

<--Postmarketing Experience-->

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Sodium monofluorophosphate in the drug label.

<--Drug Interactions-->

Drug Interactions

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 Sodium monofluorophosphate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sodium monofluorophosphate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sodium monofluorophosphate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Sodium monofluorophosphate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Sodium monofluorophosphate with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

There is no FDA guidance on the use of Sodium monofluorophosphate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sodium monofluorophosphate in patients with hepatic impairment.

Females of Reproductive Potential and Males

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

Immunocompromised Patients

There is no FDA guidance one the use of Sodium monofluorophosphate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Monitoring of Sodium monofluorophosphate in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Sodium monofluorophosphate in the drug label.

Overdosage

  • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Pharmacology

There is limited information regarding Sodium monofluorophosphate Pharmacology in the drug label.

Mechanism of Action

Structure

ACTIVE INGREDIENT

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

INACTIVE INGREDIENTS

dicalcium phosphate dihydrate, water, glycerin, sodium lauryl sulfate, cellulose gum, flavor, tetrasodium pyrophosphate, sodium saccharin

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Sodium monofluorophosphate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Sodium monofluorophosphate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Sodium monofluorophosphate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Sodium monofluorophosphate in the drug label.

How Supplied

Storage

There is limited information regarding Sodium monofluorophosphate Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Sodium monofluorophosphate |?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 - 85 GRAM TUBE

Colgate® Fluoride Toothpaste

ADA Accepted American Dental Association®

NET WT 3.0 OZ (85 g)

Cavity Protection

Strengthens Teeth with Active Fluoride

Great Regular Flavor

This image is provided by the National Library of Medicine.

PRINCIPAL DISPLAY PANEL - 85 GRAM TUBE CARTON

Colgate® Fluoride Toothpaste

ADA Accepted American Dental Association®

NET WT 3.0 OZ (85 g)

Cavity Protection

Strengthens Teeth with Active Fluoride

Great Regular Flavor

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::Sodium monofluorophosphate |?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-Sodium monofluorophosphate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • COLGATE TOOTHPASTE GREAT REGULAR FLAVOR®[1]

Look-Alike Drug Names

There is limited information regarding Sodium monofluorophosphate 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. ↑ "sodium monofluorophosphate".

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