Sodium monofluorophosphate: Difference between revisions

Jump to navigation Jump to search
VisualWikitext
m (Robot: Automated text replacement (-{{reflist}} +{{reflist|2}}, -<references /> +{{reflist|2}}, -{{WikiDoc Cardiology Network Infobox}} +))
m (Protected "Sodium monofluorophosphate": Bot: Protecting all pages from category Drug ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite)))
 
(10 intermediate revisions by 2 users not shown)
Line 1: Line 1:
{{DrugProjectFormSinglePage
|authorTag={{RB}}
|OTC=Yes
|genericName=Sodium monofluorophosphate
|aOrAn=a
|drugClass=OTC dental preaparation
|indicationType=treatment
|indication=cavities
|adverseReactions=[[flatulence]] and [[bloating|abdominal bloating]]
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>




<!--Adult Indications and Dosage-->


{{Chembox new
<!--FDA-Labeled Indications and Dosage (Adult)-->
|ImageFile=Sodium monofluorophosphate.PNG
|fdaLIADAdult=====Indications====
|ImageSize=
* helps protect against cavities
|IUPACName=disodium fluoro-dioxido-oxophosphorane
 
|OtherNames=
====Directions====
|Section1= {{Chembox Identifiers
 
| CASNo=
: [[File:Sodium monoflurophosphate Directions.png|none|500px]]
| PubChem=24266
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
| SMILES=[O-]P(=O)([O-])F.[Na+].[Na+]
 
  }}
<!--Non–Guideline-Supported Use (Adult)-->
|Section2= {{Chembox Properties
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
| Formula=FNa<sub>2</sub>O<sub>3</sub>P
 
| MolarMass=143.95
<!--Pediatric Indications and Dosage-->
| Appearance=
 
| Density=
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
| MeltingPt=
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
| BoilingPt=
 
| Solubility=
<!--Off-Label Use and Dosage (Pediatric)-->
  }}
 
|Section3= {{Chembox Hazards
<!--Guideline-Supported Use (Pediatric)-->
| MainHazards=
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
| FlashPt=
 
| Autoignition=
<!--Non–Guideline-Supported Use (Pediatric)-->
  }}
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
}}
 
{{SI}}
<!--Contraindications-->
'''Sodium monofluorophosphate''' (also '''disodium monofluorophosphate''' or '''MFP''') is a chemical with the formula Na<sub>2</sub>FPO<sub>3</sub>. Its molecular weight is 143.95 g/mol. Typical for a salt, MFP is odorless, colorless, and water-soluble. It melts at 625 ºC.
|contraindications=<!--Warnings-->
|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-->
|clinicalTrials=[[flatulence]] and [[bloating|abdominal bloating]]
 
<--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
<--Drug Interactions-->
|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=* If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox=: [[File:Sodium monoflurophosphate Wiki.png|thumb|none|500px|This image is provided by Wikipedia]]
 
 
 
<!--Mechanism of Action-->
|mechAction=
 
<!--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
 
 
 
<!--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=
|packLabel=====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
 
: [[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


==Uses of MFP==
: [[File:Sodium monoflurophosphate PDP 2.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


MFP is best known as an ingredient in [[toothpaste]]s for both humans and animals. It is claimed to protect tooth enamel from attack by bacteria that cause [[dental caries]] (cavities). Though developed by a chemist at Procter and Gamble, its use in toothpaste  Colgate toothpaste) was patented by Colgate-Palmolive, as Procter and Gamble was engaged in the marketing of Crest toothpaste (containing [[stannous fluoride]], marketed as "Fluoristan"). In the early 1980s, Crest was reformulated to use MFP, under the trademark "Fluoristat."
====Ingredients and Appearance====


MFP is also used in some medications for the treatment of [[osteoporosis]].
: [[File:Sodium monoflurophosphate Ing and App.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


In 1991, sodium monofluorophosphate was found by Calgon to inhibit the solubility of [[lead]] in drinking water when used in concentrations between 0.1 mg/L and 500 mg/L.<ref>Peter Meiers [http://www.fluoride-history.de/p-mfp.htm Monofluorophosphate History]</ref>
<!--Patient Counseling Information-->
|fdaPatientInfo=====QUESTIONS OR COMMENTS?====
* Call toll-free 1-800-468-6502


==Tooth decay==
<!--Precautions with Alcohol-->
Tooth decay is caused by bacteria normally present in one's mouth. These bacteria form a sticky, colorless soft film on the teeth called [[Dental plaque|plaque]]. When foods containing [[carbohydrate]]s, ([[starch|starches]], and [[sugar]]s) are eaten, the bacteria that form plaque use the sugar as a form of energy. They also turn it into a glue-like substance that helps them stick to the surface of the tooth. The plaque produces [[acid]] , which attacks the [[tooth enamel|enamel]].<ref>Healthy Teeth [http://www.healthyteeth.org]</ref>
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


===Chemistry of decay===
<!--Brand Names-->
Tooth enamel consists mostly of calcium hydroxyphosphate, Ca<sub>5</sub>(PO<sub>4</sub>)<sub>3</sub>OH, also known as the mineral [[apatite]]. Apatite is a hard, insoluble compound. Acid (H<sup>+</sup>), produced especially after a high-sugar meal, attack the apatite:
|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>
:Ca<sub>5</sub>(PO<sub>4</sub>)<sub>3</sub>OH<sub>(s)</sub>  +  H<sup>+</sup><sub>(aq)</sub>  →  Ca<sub>5</sub>(PO<sub>4</sub>)<sub>3</sub><sup>+</sup><sub>(aq)</sub>  +  H<sub>2</sub>O<sub>(l)</sub>


===Chemistry of enamel fluoridation===
<!--Look-Alike Drug Names-->
The degradation of apatite by loss of OH<sup>-</sup> causes the enamel to dissolve.  The process is reversible as saliva supplies back OH<sup>-</sup>  to reform apatite. If fluoride, F<sup>-</sup>, ions are present in saliva, fluorapatite, Ca<sub>5</sub>(PO<sub>4</sub>)<sub>3</sub>F, also forms.
|lookAlike=<!--Drug Shortage Status-->
:Ca<sub>5</sub>(PO<sub>4</sub>)<sub>3</sub><sup>+</sup><sub>(aq)</sub>  +  F<sup>-</sup><sub>(aq)</sub>  →  Ca<sub>5</sub>(PO<sub>4</sub>)<sub>3</sub>F<sub>(s)</sub>  
|drugShortage=
}}
<!--Pill Image-->


Fluorapatite resists attacks by acids better than apatite itself, so the tooth enamel resists decay better than enamel containing no fluoride.<ref>Davis, R. E., Ph.D., Metcalfe, H. C., Williams, J. E., Castka, J. F. (1999). ''Modern Chemistry''. Austin, TX: Harcourt Brace & Company.</ref>


==Preparation==
MFP is prepared by heating a difluorophosphate solution in dilute [[sodium hydroxide]].


:PO<sub>2</sub>F<sub>2</sub><sup>2-</sup><sub>(aq)</sub>  +  2 NaOH<sub>(aq)</sub>  →  Na<sub>2</sub>PO<sub>3</sub>F<sub>(aq)</sub>  +  2 HF<sub>(aq)</sub>
<!--Label Display Image-->


==Discovery and development==
Sodium monofluorophosphate was first described in 1929 by the German chemist Dr. Willy Lange, who was then with the University of Berlin. His fruitless attempts to prepare the free monofluorophosphoric acid led him to check the stability of its esters. Together with Gerda von Krueger, one of his students, Lange thus synthesized diethyl fluorophosphate and some analogs, which proved to be quite toxic; the first nerve agents were discovered. In the 1930's, Gerhard Schrader, working for the German company IG Farben, tried to develop synthetic insecticide. His work focused on esters of phosphoric acid and resulted in an accidental discovery of some other nerve agents such as DFP (= di-isopropyl fluorophosphate), [[Tabun (nerve agent)|Tabun]], Soman, and Sarin. In the meantime, Lange -who was married to a Jewish woman- emigrated from Germany to the United States and started work for Procter and Gamble Company. In 1947, he and Ralph Livingston of Monsanto Company published
reports on the preparation of the free fluorophosphoric acids and mentioned the use of some toxic esters of monofluorophosphoric acid (like DFP) in the treatment of [[glaucoma]] and [[myasthenia gravis]]. The well known toxicity of these esters led to fears that the simple salts might also be toxic, and such fears precluded any large scale commercial use of the salts. In 1950, under sponsorship of the manufacturer of the compounds, Ozark Chemical Company, the toxicity of sodium monofluorophosphate was studied by Harold C. Hodge at the University of Rochester who included anti-cavity testing. In 1967 Colgate-Palmolive filed several patents on the use of sodium monofluorophosphate in toothpaste.<ref>Peter Meiers [http://www.fluoride-history.de/p-mfp.htm Monofluorophosphate History]</ref>


==Content and toxicity==
The usual content of MFP in toothpaste is 0.76%. It is not used for water fluoridation. Currently accepted research indicates that by using such toothpaste, cavities may be reduced 17-38%.


The compound is not very toxic. ([[LD50|LD<sub>50</sub>]] in rats = 0.9 g/kg).


==Structure of fluorophosphate==
The structure of the fluorophosphate anion consists of [[phosphorus]] at the center of a tetrahedron defined by three [[oxygen]] atoms and one [[fluorine]]. Formal representations depict a double bond between one oxygen atom and phosphorus, with single bonds for the other two oxygen atoms and the fluorine. In this very formal depiction, negative charge is localized on the O atoms of the single P-O bonds. MFP is similar to and [[isoelectronic]] with Na<sub>2</sub>SO<sub>4</sub>.


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


{{Stomatological preparations}}
[[Category:Drug]]
{{Mineral supplements}}
[[Category:Endocrinology]]
[[Category:Phosphates]]
[[Category:Fluorides]]
[[Category:Sodium compounds]]
{{WikiDoc Help Menu}}
{{WikiDoc Sources}}

Latest revision as of 17:09, 20 August 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 a OTC dental preaparation that is FDA approved for the treatment of cavities. Common adverse reactions include flatulence and abdominal bloating.

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

flatulence and abdominal bloating

<--Postmarketing Experience-->

Postmarketing Experience

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

<--Drug Interactions-->

Drug Interactions

There is limited information regarding Sodium monofluorophosphate 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 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.

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

This image is provided by Wikipedia

Mechanism of Action

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

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

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

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".
Retrieved from "https://www.wikidoc.org/index.php?title=Sodium_monofluorophosphate&oldid=1137556"