Fluorides

Class: Cariostatic Agents
ATC Class: A12CD
VA Class: TN470
Molecular Formula: NaFNa3FPO4SnF2
CAS Number: 7681-49-4
Brands: APF , ACT, CaviRinse, CavityShield, ControlRX, DentinBloc, Duraphat, EtheDent, Fluorabon, Fluor-A-Day, Fluorinse, Fluoritab, FluoroFoam , Flura-Drops, Gel-Kam, Just for Kids, Minute-Foam, NeutraCare, Neutra-Foam, OMNI, OrthoWash, PerioMed, Phos-Flur, PreviDent, SF, Vanish

Introduction

Cariostatic agent; ionic form of fluorine.107 109 110 a d

Uses for Fluorides

Dental Caries

Prevent or reduce the incidence of dental caries; slow or reverse the progression of existing dental lesions.107 109 b d e i j s t v

Effect of fluoride is predominantly posteruptive; maintain consistent small amounts of fluoride in saliva and dental plaque.109 113 (See Actions.)

As a dietary supplement for the prevention of dental caries in children in areas where the concentration of fluoride ion in drinking water is less than optimal.109

American Dental Association (ADA) recommends that all patients, including those without dental caries and with no apparent increased risk of dental caries, receive adequate water fluoridation or oral fluoride supplementation, combined with daily use of fluoridated dentifrice and twice-yearly topical application of fluoride.128

In addition, ADA and others state that patients at low or slightly increased risk for dental caries (e.g., low socioeconomic status, low levels of parental education, no regular dental care, or without dental insurance or access to dental services) may require sodium fluoride 0.05% mouth rinse or 0.4% stannous fluoride gel.109 128

ADA and others recommend that patients at moderate-to-high risk for dental caries (e.g., active dental caries, history of high incidence of caries in older siblings or caregivers, root surfaces exposed by gingival recession, impaired ability to maintain oral hygiene, malformed enamel or dentin, low salivary buffering capacity, wearing of orthodontic appliances, or reduced salivary flow from medications, radiation treatment, or disease) receive additional exposure to fluorides (e.g., home or professionally applied products).109 128

CDC supports fluoridation of the public water supply as the most cost-effective means of providing optimal levels of fluoride to large segments of the population.109

Optimal concentration of fluoride ion in drinking water is approximately 1 ppm (range 0.7–1.2 ppm), depending on the annual mean maximum daily temperature of the area.106 109 b w In warm climates where more water is likely to be ingested, concentrations should be at the lower end of the range.106 109

In communities where the concentration of fluoride in the water supply is >2 ppm, use an alternative source of drinking water for children ≤8 years of age.109

Because consumption of commercially available beverages (including bottled water) in the US and Canada is displacing the consumption of tap or well water, the relative importance of fluoridation of local community water on fluoride intake may be affected.107 However, current recommendations in children continue to be based on the fluoride concentrations in local drinking water.106 107

ADA and others recommend that in areas where oral fluoride supplements are necessary, children 6 months to 16 years of age receive daily fluoride supplements to provide maximum benefit to both deciduous and permanent teeth.a

Efficacy of topically applied fluoride varies according to the concentration of fluoride ion in the preparation, method and frequency of application, and the duration of use.a

Acidulated phosphate fluoride gels (alone or in combination with a saliva substitute) have been used to control dental decay after xerostomia-producing radiation therapy of tumors of the head and neck.a

Stannous fluoride gels have been used to prevent decalcification in orthodontic patients.a

Stannous fluoride gels have been used to protect against postirradiation caries.a

Desensitizing Dentin

Topically to desensitize exposed root surfaces of teeth.f h

Bone Diseases

Has been used to increase bone density and relieve bone pain in the treatment of various metabolic and neoplastic bone diseases.a

Has been used in conjunction with calcium and vitamin D or calcium and estrogen to reduce skeletal fracture rates in osteoporosis; further study is needed.a

Has been used alone or in conjunction with calcium carbonate as an adjunct in the management of bone lesions in multiple myeloma.a

Has been used to reduce bone pain in metastatic prostatic carcinoma.a

Has been reported to stabilize the progression of hearing loss in a limited number of patients with otosclerosis.a

Has been used to increase spinal (but not femoral neck) bone mineral density (BMD) in corticosteroid-induced osteoporosis;108 however, further studies are needed and other therapies are preferred.108

Fluorides Dosage and Administration

Administration

Administer orally as a lozenge, solution, or chewable tablet or topically as a cream, dentifrice, foam, gel, rinsing solution, or solution.a e h l o p s v

Oral Administration

Administer sodium fluoride orally as a lozenge, chewable tablet, or as a solution undiluted or mixed with juice or water.b Dissolve chewable tablets in the mouth or chew before swallowing, preferably at bedtime after brushing the teeth.a b j

Administer oral fluoride supplements only when community fluoridation programs are not available or feasible and when the fluoride ion concentration in drinking water is ≤0.6 ppm (mg/L).a

Oral Topical Administration

Not for systemic treatment; do not swallow.119 121 a e f h i n o s t v

Rinsing solution may be swallowed only if directed to do so by a clinician to provide systemic fluoride supplementation.103

To minimize the amount of fluoride swallowed and absorbed systemically and the risk of fluorosis, instruct and/or supervise children <12 years of age regarding proper techniques for use of topical preparations.100 101 103 i (See Dental Fluorosis under Cautions.)

For maximum benefit, do not eat or drink for ≥30 minutes after administration; adults, do not rinse mouth for 30 minutes after administration.119 121 a d e m n o s t v

Oral Topical Administration (Sodium Fluoride)

1.1% cream: Apply a thin ribbon to toothbrush; brush thoroughly for 2 minutes.121 d e Expectorate after use; children, expectorate and rinse mouth thoroughly.121 d e

2% foam: Dental personnel may apply topically to teeth using trays or mouthpiece applicators.120 128

1.1% gel: Rinse thoroughly after brushing teeth normally.119 s Apply a ribbon of gel to teeth with toothbrush or mouth tray for ≥1 minute; expectorate.119 s Children, rinse mouth thoroughly.119 s

0.044, 0.05, and 0.2% rinsing solutions: After thoroughly brushing teeth, rinse solution vigorously around and between teeth for 1 minute.115 116 a m n Expectorate.115 116 a m n

5% solution: May be applied by dental personnel to moist teeth.h Apply to teeth with cotton swabs, brush, or probe.h Do not dry.h Patient should not eat hard foods or brush for ≥2 hours after application.h Avoid other fluoride preparations on the day of application.h Suspend use of fluoride tablets for several days after treatment.h

Oral Topical Administration (Sodium Fluoride Combinations)

Solution: Dental personnel may apply saturated foam applicator to the tooth surface with constant light pressure for 1 minute; have patient expectorate.f

Oral Topical Administration (Acidulated Phosphate Fluoride)

Do not place in porcelain or glass containers.f o v (See Teeth Surface and Restoration Staining under Cautions and also see Storage under Stability.)

1.1% gel: Rinse thoroughly after brushing teeth normally.v Apply a thin ribbon of gel to teeth with toothbrush or mouth trays for ≥1 minute; expectorate.v Children, rinse mouth thoroughly.v

Foam or 1.23% gel: Dental personnel may apply after prophylaxis.o t Prior to filling mouth trays, shake foam bottle vigorously for 3–4 seconds.o Have patient bite down lightly on mouth tray(s) for 1–4 minutes.o t Remove tray(s) and have patient expectorate excess.o t Gel may also be applied by swab.t

For desensitizing exposed root surfaces, use gel after brushing and flossing at bedtime.a

Oral Topical Administration (Stannous Fluoride)

0.4% gel: After brushing teeth normally, shake toothbrush to remove excess water; apply the gel to cover the bristles.l Brush teeth thoroughly; allow the gel to remain on the teeth for 1 minute, then expectorate.124 125 l For sensitivity relief, use a toothbrush or cotton swab to ensure that all sensitive areas are covered with the gel.124 125 l

0.1% rinsing solution: Dilute before use.i Use after regular brushing and flossing.117 118 i Swish vigorously around and between teeth for 1 minute; expectorate.117 118 i Repeat.117 118 i

Reconstitution

Reconstitute fluoride powders as directed by the manufacturer.103

Dilution

Prepare 0.1% rinsing solution from concentrate prior to use.117 118 i Add 3.75 mL concentrated rinse to the mixing vial (or fill to 1/8 oz mark); add 26.25 mL water (or fill to 1 oz mark) and mix to provide a 0.1% rinsing solution.117 118 i Use immediately;117 118 i solutions may decompose within a few hours to stannous hydroxides, forming a white precipitate.a

For home irrigators, pour 30 mL of the diluted 0.1% solution into the irrigator reservoir; add 120 mL of water and mix thoroughly to provide a 0.02% stannous fluoride rinse.i Consult the manufacturer’s prescribing information for additional information on preparation and use of the concentrated solution with home irrigators.117 118 i

Dosage

Available as sodium fluoride, acidulated phosphate fluoride, sodium monofluorophosphate, or stannous fluoride; dosage expressed in terms of the fluoride ion.a c i j n o p

Dosage of oral fluoride supplements varies according to the age of the child and the concentration of fluoride in the drinking water.109 110 Adjust dosage in proportion to the amount of fluoride provided from all possible sources (e.g., childcare settings, school, bottled water, dentifrice, multivitamins, mouth rinse).a 109 110 Do not exceed recommended dosages.a (See Dental Fluorosis and also see Pediatric Use under Cautions.)

CDC recommends that patients at increased risk for dental caries receive fluoride applications by dental personnel twice a year.109

Pediatric Patients

Dental Caries Prophylaxis
Fluoride-containing Dentifrices
Oral Topical

Children 2–6 years of age: Apply only a pea-sized amount (approximately 0.25 g) to the toothbrush no more often than twice daily.100 101 109

Adequate Dietary Intake
Oral

For tolerable upper intake levels, see Prescribing Limits under Dosage and Administration.

Table 1. Adequate Daily Dietary Intake of Fluoride in Infants, Children, and Adolescents107

Age

Adequate Daily Dietary Intake of Fluoride

0– 6 months

0.01 mg

7–12 months

0.5 mg

1–3 years

0.7 mg

4–8 years

1.1 mg

9–13 years

2 mg

14–18 years

2.9–3.2 mg

Fluoride Supplementation in Areas with Insufficient Fluoride in Drinking Water
Oral
Table 2. Oral Daily Dosage of Supplemental Fluoride (as Lozenge, Chewable Tablet, or Solution) for Children Living in Areas with Insufficient Fluoride in Drinking Water (Expressed in Terms of Fluoride Ion)106107109jw

Fluoride Ion Concentration in Drinking Water

Age

<0.3 ppm

0.3–0.6 ppm

>0.6 ppm

0 to <6 months

None

None

None

6 months to <3 years

0.25 mg

None

None

3 to <6 years

0.5 mg

0.25 mg

None

6–16 years

1 mg

0.5 mg

None

Sodium Fluoride
Oral Topical

1.1% cream in children ≥6 years of age: Brush for 2 minutes once daily, preferably at bedtime.121 d e

1.1% gel in children ≥6 years of age: Once daily, preferably at bedtime.119 s

0.044 or 0.05% rinsing solution in children ≥6 years of age: 10 mL once daily at bedtime.116 n p

0.2% rinsing solution in children ≥6 years of age: 10 mL once weekly, preferably at bedtime.115 m

Acidulated Phosphate Fluoride
Oral Topical

1.1% gel in children ≥6 years of age: Once daily, preferably at bedtime.v

1.2 or 1.23% foam or 1.23% gel in children ≥6 years of age: Apply once every 6–12 months.a o In patients with rampant or active caries, may repeat 1–2 times every 6 months.a o

Stannous Fluoride
Oral Topical

0.4% gel in children ≥12 years of age: Once daily.124 125 l

0.1% rinsing solution in children ≥12 years of age: Dilute before use to a 0.1% solution.i (See Dilution under Dosage and Administration.) Use 15 mL once daily.117 118 i Repeat with an additional 15 mL.117 118 i May use more frequently as directed by clinician.i

Desensitizing Dentin
Stannous Fluoride
Oral Topical

0.4% gel in children ≥12 years of age: Twice daily.124 125

Adults

Dental Caries Prophylaxis
Adequate Daily Dietary Intake of Fluoride
Oral

Adults ≥19 years of age: 3.1–3.8 mg daily.a

Sodium Fluoride
Oral Topical

1.1% cream: Brush for 2 minutes once daily, preferably at bedtime.121 d

2% foam: Some clinicians recommend applying 5 mL to teeth by means of trays or mouthpiece applicators.120 128

1.1% gel: Once daily, preferably at bedtime.s

0.044 or 0.05% rinsing solution: 10 mL once daily, preferably at bedtime.n p

0.2% rinsing solution: 10 mL once weekly, preferably at bedtime.m

Acidulated Phosphate Fluoride
Oral Topical

1.1% gel: Once daily, preferably at bedtime.v

1.2 or 1.23% foam or 1.23% gel: Apply once every 6–12 months.a o May repeat 1–2 times every 6 months in patients with rampant or active caries.a o

Stannous Fluoride
Oral Topical

0.4% gel: Once daily.124 125

0.1% rinsing solution: Dilute before use to a 0.1% solution.i (See Dilution under Dosage and Administration.) Use 15 mL once daily.117 118 i Repeat with an additional 15 mL.117 118 i May use more frequently, as directed by clinician.i

Desensitizing Dentin
Sodium Fluoride
Oral Topical

0.2% rinsing solution: Once daily at bedtime.a

Sodium Fluoride, Stannous Fluoride, and Hydrogen Fluoride
Oral Topical

Solution: Apply to the tooth surface for 1 minute.f May require sequential 1-minute treatments.f

Acidulated Phosphate Fluoride
Oral Topical

1.2% gel: Apply a few drops to a toothbrush and brush the affected area(s) each night at bedtime.a Relief from sensitivity usually occurs within a few weeks.a

Stannous Fluoride
Oral Topical

0.4% gel: Use twice daily (morning and evening).124 125 l

Bone Diseases
Hearing Loss in Otosclerosis: Sodium Fluoride
Oral

25–60 mg daily has been used.a

Prescribing Limits

Pediatric Patients

Fluoride Tolerable Daily Upper Intake Levels in Infants and Children107
Table 3.

Age

Tolerable Daily Upper Intake Levels of Fluoride

Infants 0– 6 months of age

0.7 mg

Infants 7–12 months of age

0.9 mg

Children 1–3 years of age

1.3 mg

Children 4–8 years of age

2.2 mg

Children 9–18 years of age

10 mg

Adults

Prevention of Dental Caries
Oral Topical

Sodium fluoride 2% foam: Maximum 10 mL daily.128

Stannous fluoride 0.4% gel (self-care): Maximum twice daily for 4 weeks for sensitive teeth.l

Tolerable Daily Upper Intake Level
Oral

Maximum 10 mg daily.107

Pregnant women: Maximum 10 mg daily.107

Lactating women: Maximum 10 mg daily.107

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.a

Renal Impairment

No specific dosage recommendations at this time; however, see Renal Impairment in Cautions.f m o

Geriatric Patients

Select dosage with caution because of age-related decreases in renal function.f m o

Cautions for Fluorides

Contraindications

  • Known hypersensitivity to fluoride or any ingredient in the formulation.a h

  • Sodium fluoride 5% suspension: Known sensitivity to colophony (kolophonium).h

  • Fluoride dietary supplements: Drinking water fluoride ion concentration ≥0.6 ppm (mg/L).a b j

  • Sodium fluoride 1-mg chewable tablets: Drinking water fluoride ion concentration ≥0.3 ppm (mg/L).j

  • Sodium fluoride 5% topical solution: Ulcerative gingivitis or stomatitis.h

  • Sodium fluoride 0.2% rinsing solution: Dysphagia.m

  • Stannous fluoride oral rinsing solutions and sodium fluoride 5% topical solution: Not for systemic treatment.h i Do not ingest.h i

Warnings/Precautions

Warnings

Dental Fluorosis

Excessive amounts may produce dose-related dental fluorosis (hypocalcification and hypoplasia) and osseous changes in children <8 years of age, especially where water fluoridation >0.6 ppm.107 a b d e f i j m o s v

Follow proper techniques for applying topical preparations to minimize the amount ingested and systemically absorbed.100 101 103 e i

Mild fluorosis has no effect on tooth function; may render the enamel more resistant to caries.107 May cause white opaque patches on the incisal edges of anterior teeth or cusp tips of posterior teeth (“snow capping”).107

Risk of stained and pitted teeth in moderate-to-severe fluorosis; effect primarily cosmetic.107 t

Skeletal Fluorosis

Prolonged intake of high fluoride ion concentrations (i.e., 4–8 ppm [mg/L]) in drinking water may result in an increase in bone mineral density and apparent fluoride osteosclerosis.107 Risk of developing fluorosis directly related to the extent and duration of fluoride exposure; crippling skeletal fluorosis is extremely rare in the US.107

Teeth Surface and Restoration Staining

Staining or pigmentation (e.g., yellow, brown, brown-black) of the teeth may result from topical application of concentrated solutions or gels of stannous fluoride, particularly in patients with poor oral hygiene.a i Good oral hygiene (e.g., adequate brushing) minimizes risk of staining; staining is not harmful or permanent and can be removed by dentist.103 i

Acidulated phosphate fluoride preparations may cause dulling of porcelain and ceramic restorations unless protected from contact.a c f o t v

Sodium-Free Diet

Some fluoride products (e.g., Fluor-A-Day) are not recommended by manufacturer for use in patients receiving a sodium-free diet.b

Sensitivity Reactions

Allergic Reactions

Allergic rash and other idiosyncratic reactions rarely reported.a d f h i j m o s t v

Urticaria, exfoliative dermatitis, atopic dermatitis, stomatitis, and GI and respiratory allergic reactions have occurred rarely following the use of dentifrices or multivitamin preparations containing fluoride.a h

Patients with mucositis or with abraded or sensitive gingival tissue may be hypersensitive to alcohol or other ingredients contained in some oral or topical fluoride preparations.a f m o v

Sodium fluoride 5% topical solution: Dyspnea has occurred rarely in asthmatic children.h Edematous swelling reported rarely after application to extensive surfaces.h If intolerance occurs, remove solution layer by brushing and rinsing.h

General Precautions

Use of Fixed Combinations

When fluoride is used in fixed combination with other preparations, consider the cautions, precautions, and contraindications associated with the concomitant agent(s).a (See Pediatric Use under Cautions.)

Specific Populations

Pregnancy

Category B.f i j m o v

The ADA currently does not recommend fluoride supplements during pregnancy.a

Lactation

Distributed into milk in small amounts.a Use with caution in nursing women.f i j m o s v

Pediatric Use

ADA, American Academy of Pediatric Dentistry (AAPD), and AAP currently do not recommend oral fluoride supplements in infants <6 months of age.106 107 j

In children <2 years of age, consider other sources of fluoride when weighing the risks and benefits of using fluoridated dentifrice.109

Instruct and/or supervise children 2–12 years of age carefully regarding the proper use of topical fluoride-containing products to minimize repeated swallowing and the risk of dental fluorosis.100 101 103 e i m s v

Efficacy of oral fluoride supplements in controlling dental caries in children >16 years of age not established.109

Sodium fluoride, stannous fluoride, and hydrogen fluoride fixed-combination solution: Safety and efficacy not established.f

Sodium fluoride chewable tablets: Safety and efficacy not established in children <6 months of age.j

Sodium fluoride 1.1% topical cream, gel, and rinsing solution: Safety and efficacy not established in children <6 years of age.d e m n s

Acidulated phosphate fluoride topical foam and gel: Safety and efficacy not established in children <6 years of age.o v

Stannous fluoride oral rinsing solutions and topical gels: Safety and efficacy not established in children <12 years of age.117 118 124 125 i

May be difficult to appropriately adjust the amount of fluoride required from fixed-combination multivitamin or multivitamin/iron preparations used as oral fluoride supplements.a (See Dosage in Dosage and Administration.)

Geriatric Use

No overall differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.f m o Substantially eliminated by the kidneys; geriatric patients more likely to have decreased renal function; monitor renal function and adjust dosage accordingly.f m o

Renal Impairment

Excreted by the kidney; therefore, risk of toxic reactions may be greater in patients with impaired renal function.f m o

Interactions for Fluorides

Specific Drugs

Drug

Interaction

Comments

Aluminum hydroxide

Concomitant ingestion may decrease oral absorption of fluoridea

Calcium

May cause formation of calcium fluoride and may decrease fluoride absorption by 10–25%107 b j

Simultaneous ingestion of dairy products containing calcium probably has little effect on absorption of the low concentrations of fluoride present in drinking watera

Avoid dairy products within 1 hour after oral fluoride systemic administrationj

Magnesium hydroxide

Concomitant ingestion may decrease oral absorption of fluoridea

Fluorides Pharmacokinetics

Absorption

Bioavailability

Sodium fluoride and other soluble fluoride salts: Readily and almost completely absorbed from the GI tract.107 a b

≥80% of soluble fluoride probably absorbed from the GI tract in the absence of high dietary concentrations of calcium or certain other cations.107 (See Interactions.)

Food

Milk, infant formula, or certain foods (e.g., with high concentrations of calcium or certain other divalent or trivalent cations that form insoluble fluoride salts) may decrease absorption of fluoride by 10–25%.107

Distribution

Extent

Crosses the placenta and is distributed in small amounts into milk, sweat, tears, and hair.a

Stored in bones, developing teeth, and skeletal tissue.a b

Elimination

Elimination Route

Rapidly excreted principally in urine, and in small amounts in feces, sweat, and saliva.a b

Special Populations

Hemodialysis may remove fluoride in patients with severe intoxication or with impaired renal function.a

Stability

Storage

Oral

Solution

Sodium fluoride: Tight, plastic containers at <40°C (maintain between 15–30°C), especially if the pH of the solution is <7.5.a May decompose and become alkaline when stored in ordinary pharmaceutical glass.a b Store and dispense in plastic, paraffin-lined flasks or USP type 1 borosilicate glass containers.b

Tablets

Sodium fluoride: 20–25°C.j

Topical

Cream

Sodium fluoride 1.1%: 20–25°C.e

Foam

Acidulated phosphate fluoride 1.2%: 20–25°C.o Do not store at >48°C (120° F).o Do not freeze.o Do not puncture or incinerate.o

Gel

Acidulated phosphate fluoride: Tight, plastic containersa at 20–25°C.t v Do not freeze.t

Sodium fluoride 1.1%: 20–25°C.s

Rinsing Solution

Sodium fluoride 0.2% 20–25°C.m

Stannous fluoride: Tightly closed containers at 20–25°C.i Decomposes to stannous hydroxides within a few hours, forming a white precipitate; prepare just prior to use.a

Solution

Sodium fluoride 5%: 20–25°C.h

Sodium fluoride, stannous fluoride, and hydrogen fluoride: 20–25°C.f

Drug Compatibility

Sodium fluoride is incompatible with calcium and magnesium salts.a

Stannous fluoride is incompatible with alkaline substances and oxidizing agents.a

Actions

  • Mechanism of action in reducing tooth decay not fully understood;a however, research now indicates predominant effect is posteruptive, not preeruptive as previously hypothesized.109 113

  • Increases tooth resistance to acid dissolution, promotes remineralization, and inhibits the cariogenic microbial process.109 a b e i j m o s w v

  • Prior to tooth eruption, fluoride is incorporated into tooth enamel during formation.a

  • Cariostatic effects on teeth after eruption result from combined effects of bacterial metabolism in plaque and on the dynamics of enamel demineralization and remineralization during an acidogenic challenge.107

  • Obturates dentin tubule orifices; reduces patency of the tooth pulp and decreases hypersensitivity.f h

  • Increases skeletal density and bone mass; however, large doses can cause skeletal fluorosis and osteomalacia.a

Advice to Patients

  • Advise patients receiving fluoride powders or concentrated rinsing solutions that the preparation must be reconstituted and/or diluted as directed prior to use.103 i

  • Advise patients receiving fluoride treatment gels or rinsing solutions for self-administration that these preparations are to be used as directed and not as dentifrices or mouthwashes or gargles, respectively.103 i

  • Advise individuals receiving stannous fluoride-containing preparations of the importance of good oral hygiene (e.g., adequate brushing) to minimize the risk of staining.103 i Inform patients that such staining is not harmful or permanent and can be removed by a dentist or dental hygienist.103 i

  • Instruct and/or supervise children <12 years of age during use of topical fluoride preparations (e.g., rinsing solutions, gels, dentifrices) to minimize the risk of fluorosis and the amount of fluoride swallowed and absorbed systemically.100 101 103 i Instruct children, especially those 2–6 years of age, not to swallow topical fluoride products.100 101 109 Inform individuals with children that ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth.w

  • Importance of long-term compliance on a daily basis in patients who require oral fluoride supplements.w

  • Advise patients not to brush or eat hard foods for 2 hours after application of topical solution.h

  • Advise patients to contact a poison control center or other qualified clinician immediately if they swallow more fluoride than the amount used for brushing or rinsing.l n

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.b c d e f i j l m n o p s t w v h

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b c d e f i j l m n o p s t w v h

  • Importance of informing patients of other important precautionary information.b c d e f i j l m n o p s t w v h (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Sodium Fluoride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Lozenge

2.21 mg (1 mg of fluoride ion)

Fluor-A-Day

Pharmascience

Solution

0.55 mg/mL (0.42 mg of fluoride ion per mL)

Fluorabon Drops

Kirkman

5.56 mg/mL (2.5 mg of fluoride ion per mL

Fluor-A-Day

Pharmascience

11 mg/mL (5 mg of fluoride ion per mL)

Fluoritab

Fluoritab

Flura-Drops

Kirkman

Tablets, chewable

0.55 mg (0.25 mg of fluoride ion)*

EtheDent

Ethex

Fluor-A-Day

Pharmascience

Fluoritab

Fluoritab

Sodium Fluoride Chewable Tablets

1.1 mg (0.5 mg of fluoride ion)*

EtheDent

Ethex

Fluor-A-Day

Pharmascience

Fluoritab

Fluoritab

Sodium Fluoride Chewable Tablets

2.2 mg (1 mg of fluoride ion)*

EtheDent

Ethex

Fluor-A-Day

Pharmascience

Fluoritab

Fluoritab

Sodium Fluoride Chewable Tablets

Oral (Topical Use Only)

Cream

1.1% (0.5% fluoride ion)

ControlRx

3M ESPE

EtheDent

Ethex

PreviDent 5000 Plus

Colgate Oral

SF 5000 Plus

Cypress

Foam

2% (0.9% fluoride ion)

Neutra-Foam

Oral-B

Gel

1.1% (0.5% fluoride ion)

EtheDent

Ethex

NeutraCare

Oral-B

PreviDent

Colgate Oral

SF

Cypress

Rinsing Solution

0.044% (0.02% fluoride ion)

OrthoWash

3M ESPE

Phos-Flur

Colgate Oral

0.05% (0.02% fluoride ion)

ACT

Chattem

0.2% (0.09% fluoride ion)

CaviRinse

3M ESPE

Fluorinse

Oral-B

PreviDent

Colgate Oral

Solution

5%

CavityShield

3M ESPE

Duraphat Varnish

Colgate Oral

PreviDent Varnish

Colgate Oral

Vanish Varnish

3M ESPE

Sodium fluoride is also commercially available in multivitamin and multivitamin/iron preparations for oral use and in dentifrices.

Sodium Fluoride Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral (Topical Use Only)

Solution

1.09% with Hydrogen Fluoride 0.14% and Stannous Fluoride 0.4% (0.717% fluoride ion and tin 0.303%)

Gel-Kam DentinBloc

Colgate Oral

Acidulated Phosphate Fluoride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral (Topical Use Only)

Foam

Sodium Fluoride 1.2% (0.5% fluoride ion)

Fluorofoam

Colgate Oral

Sodium Fluoride and Hydrogen Fluoride (1.23% fluoride ion)

Minute-Foam

Oral-B

Gel

Sodium Fluoride 1.1% (0.5% fluoride ion)

Phos-Flur

Colgate Oral

Sodium Fluoride 0.79% and Hydrogen Fluoride 0.44% (1.23% fluoride ion)

APF

Biotrol

Sodium Monofluorophosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Sodium monofluorophosphate is commercially available only in dentifrices.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Stannous Fluoride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral (Topical Use Only)

Gel

0.4% (0.15% fluoride ion)

Gel-Kam

Colgate Oral

OMNI

3M ESPE

Stop

Oral-B

Just for Kids

3M ESPE

Powder*

Rinsing solution, concentrate

0.63%

Gel-Kam

Colgate Oral

PerioMed

3M ESPE

Stannous fluoride is also commercially available in dentifrices.

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Denta 5000 Plus 1.1% Cream (RISING PHARMACEUTICALS): 51/$15.99 or 102/$20.98

DentaGel 1.1% Gel (RISING PHARMACEUTICALS): 56/$14.99 or 168/$23.97

Fluoridex Daily Defense 1.1% Gel (DISCUS DENTAL): 112/$21.99 or 336/$42.97

Neutral Sodium Fluoride 0.2% Solution (CYPRESS PHARMACEUTICAL): 473/$17.99 or 1419/$44.97

Phos-Flur 1.1% Gel (COLGATE ORAL PHARMACEUTICALS): 51/$22.99 or 153/$50.97

PreviDent 0.2% Solution (COLGATE ORAL PHARMACEUTICALS): 473/$21.99 or 946/$32.97

PreviDent 1.1% Gel (COLGATE ORAL PHARMACEUTICALS): 56/$21.99 or 112/$32.97

PreviDent 5000 Booster 1.1% Paste (COLGATE ORAL PHARMACEUTICALS): 100/$21.99 or 200/$32.97

PreviDent 5000 Booster 1.1% Paste (COLGATE ORAL PHARMACEUTICALS): 100/$22.00 or 200/$33.00

PreviDent 5000 Dry Mouth 1.1% Paste (COLGATE ORAL PHARMACEUTICALS): 100/$22.00 or 200/$32.97

PreviDent 5000 Plus 1.1% Cream (COLGATE ORAL PHARMACEUTICALS): 51/$22.00 or 102/$32.46

PreviDent 5000 Plus 1.1% Cream (COLGATE ORAL PHARMACEUTICALS): 102/$29.99 or 204/$48.98

Sodium Fluoride 0.55 (0.25 F)MG Chewable Tablets (CYPRESS PHARMACEUTICAL): 120/$15.99 or 240/$20.97

Sodium Fluoride 1.1 (0.5 F)MG Chewable Tablets (CYPRESS PHARMACEUTICAL): 100/$14.99 or 200/$18.97

Sodium Fluoride 1.1 (0.5 F)MG/ML Solution (SANCILIO): 50/$16.99 or 100/$25.98

Sodium Fluoride 2.2 (1 F)MG Chewable Tablets (CYPRESS PHARMACEUTICAL): 120/$18.99 or 240/$26.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 1, 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

100. American Dental Association Council on Dental Therapeutics. Accepted dental therapeutics. 40th ed. Chicago: American Dental Association; 1984 Oct:395-420.

101. American Academy of Pediatrics Committee on Nutrition. Fluoride supplementation. Pediatrics. 1986; 77:758-61. [IDIS 215201] [PubMed 3703642]

102. American Academy of Pediatrics Committee on Nutrition. Pediatric nutrition handbook, 2nd ed. Elk Grove Village, IL: American Academy of Pediatrics; 1985:169-173.

103. Food and Drug Administration. Anticaries drug products for over-the-counter human use; tentative final monograph. [21 CFR Part 355] Fed Regist. 1985; 50:39854-73.

104. National Research Council Food and Nutrition Board Subcommittee on the Tenth Edition of the RDAs. Recommended dietary allowances. 10th ed. Washington, DC: National Academy Press; 1989:235-40,284.

105. Centers for Disease Control and Prevention. Engineering and administrative recommendations for water fluoridation. MMWR Morb Mortal Wkly Rep. 1995; 44(RR-13):1-40. [PubMed 7799912]

106. American Academy of Pediatrics. Fluoride supplementation for children: interim policy recommendations. Pediatrics. 1995; 95:777. [IDIS 346414] [PubMed 7724324]

107. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences. Dietary reference intakes for calcium, phosphorus, magnesium, vitamin D, and fluoride. Washington, DC: National Academy Press; 1997. (Uncorrected proofs.)

108. American College of Rheumatology Task Force on Osteoporosis Guidelines. Recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheumatism. 1996; 39:1791-801. [IDIS 375200] [PubMed 8912500]

109. Centers for Disease Control and Prevention. Recommendations for using fluoride to prevent and control dental caries in the United States. MMWR Morb Mortal Wkly Rep. 2001; 50(No. RR-14):1-42. [PubMed 11215787]

110. American Dental Association. Facts About Fluoride. 2001, Jul. From: www.ada.org/public/topics/fluoride/artcl-01.html.

111. Margolis HC, Moreno EC. Physiochemical perspectives on the cariostatic mechanisms of systemic and topical fluorides. J Dent Res. 1990 69(special issue):606-13.

112. ten Cate JM, van Loveren C. Fluoride mechanisms. Dent Clin North Amer. 1999; 43:713-42.

113. Clarkson BH, Fejerskov O, Ekstrand, J et al. Rational use of fluoride in caries control. In: Fejerskov O, Ekstrand J, Burt BA, eds. Fluoride in Dentistry. 2nd ed. Copenhagen: Munksgaard, 1996:347–57.

114. Colgate Oral Pharmaceuticals. Phos-Flur Rinse (sodium fluoride 0.44% rinse) prescribing information. Canton, MA; 2001. From Colgate website.

115. Colgate Oral Pharmaceuticals. PreviDent Dental Rinse (neutral sodium fluoride 0.2% rinse) prescribing information. Canton, MA; 2001. From Colgate website.

116. Colgate Oral Pharmaceuticals. Fluorigard (sodium fluoride 0.05%) prescribing information. Canton, MA; 2001. From Colgate website..

117. Cypress Pharmaceutical. Stannous Fluoride 0.63% Concentrate Oral Rinse prescribing information. Madison, MS; 2000 Mar.

118. Colgate Oral Pharmaceuticals. Gel-Kam Oral Care Rinse (sodium fluoride 0.63% concentrate) prescribing information. Canton, MA; 2001. From Colgate website.

119. Colgate Oral Pharmaceuticals. PreviDent Gel (sodium fluoride 1.1% gel) prescribing information. Canton, MA; 2001. From Colgate website.

120. Oral-B Laboratories. Neutra-Foam (neutral sodium fluoride 2% foam). South Boston, MA; 2000. From Oral-B website.

121. Colgate Oral Pharmaceuticals. PreviDent 5000 Plus (sodium fluoride 1/1%) dental cream prescribing information. Canton, MA; 2001. From Colgate website.

122. Colgate Oral Pharmaceuticals. Thera Flur-N Gel-Drops (neutral sodium fluoride 1.1% gel) prescribing information. Canton, MA; 2001 Jun. From Colgate website.

123. Cyress Pharmaceutical. APF Gel (sodium fluoride 1.1% and acidulated phosphate gel) prescribing information. Madison, MS; Undated.

124. Colgate Oral Pharmaceuticals. Gel-Kam Gel (stannous fluoride 0.4% gel) prescribing information. Canton, MA; 2001. From Colgate website.

125. Cyress Pharmaceutical. Stannous Fluoride 0.4% Gel prescribing information. Madison MS; 1999 Oct.

126. Consumer Product Safety Commission. Requirements for child-resistant packaging; household products with more than 50 mg of elemental fluoride and more than 0.5 percent elemental fluoride; and modification of exemption for oral prescription drugs with sodium fluoride. Final rule. (16 CFR Part 1700). Fed Regist1998; 63:29949-53.

127. Fluorides. In: Ellenhorn MJ, Schonwald S, Ordog G et al, eds. Ellenhorn's medical toxicology: diagnosis and treatment of human poisoning. 2nd ed. Baltimore: Williams & Wilkins; 1997:1003–6.

128. Burrell KH, Chan JT. Systemic and topical fluorides. In: Cianco SG, ed. ADA guide to dental therapeutics. Chicago, ADA Publishing; 2000:230-41.

129. Department of Health and Human Services, Food and Drug Administration. Anticaries drug products for over-the-counter human use. Professional labeling. (21 *CFR* Chapter I, Part 335, Supart C, Section 335.60). 2001; 289. From:

a. AHFS Drug Information 2009. McEvoy GK, ed. Fluorides. Bethesda, MD: American Society of Health-System Pharmacists; 2009:3671.

b. Pharmascience Inc. Fluor-a-day (sodium fluoride chewable tablets, lozenges, and oral solution) prescribing information. Montreal, CA; 1999 Nov 1.

c. Oral-B Laboratories. Neutra-Foam (neutral sodium fluoride 2% foam). South Boston, MA; 2006. From:

d. 3M ESPE. ControlRx(sodium fluoride 1.1%) dentifrice prescribing information. St. Paul, MN; 2007.

e. Colgate. PreviDent 5000 Plus (1.1% sodium fluoride) dental creamprescribing information. Canton, MA; 2009. From website. Accessed 2009 Feb 8.

f. Colgate Oral Pharmaceuticals. Gel-Kam DentinBloc Dentin Densensitizer (1.09% sodium fluoride, 0.4% stannous fluoride and 0.14% hydrogen fluoride) prescribing information. New York, NY; 2009. From website. Accessed 2009 Feb 8.

h. Colgate Oral Pharmaceuticals. Duraphat sodium fluoride 5% varnish prescribing information. New York, NY; 2009. From website. Accessed 2009 Feb 15.

i. Colgate Oral Pharmaceuticals.Gel-Kam oral care rinse (0.63% stannous fluoride concentrate) prescribing information. New York, NY; 2009. From website. Accessed 2009 Feb 9.

j. Ethex Corporation. EtheDent (sodium fluoride) chewable tablets prescribing information. St. Louis, MO; 2002 Oct.

l. Colgate Oral Pharmaceuticals. Gel-Kam treament gel (stannous fluoride 0.4%) prescribing information. New York, NY; 2009. From website. Accessed 2009 Feb 15.

m. Colgate Oral Pharmaceuticals. PreviDent dental rinse (neutral sodium fluoride 0.2%) prescribing information. New York, NY; 2009. From website

n. Chattem, Inc. ACT Restoring (sodium fluoride 0.05%) anticavity mouthrinse product information. Chattanooga, TN; 2007.

o. Colgate Oral Pharmaceuticals. Fluoro-Foam (acidulated phosphate fluoride 1.2%) prescribing information. New York, NY; 2009. From website. Accessed 2009 Feb 15.

p. Colgate Oral Pharmaceuticals. Phos-Flur fluoride rinse (sodium fluoride 0.044%) product information. New York, NY; 2009. From website. Accessed 2009 Feb 15.

s. Colgate oral pahrmaceuticals. PreviDent brush-on (1.1% sodium fluoride) gel prescribing information. New York, NY; 2009.

t. Biotrol. Earth City, MO: Personal communication.

w. American Dental Association. Facts About Fluoride. 1994. From website.

v. Colgate Oral Pharmaceuticals. Phos-Flur gel (1.1% sodium fluoride and acidulated phosphate gel) pprescribing information. New York, NY; 2009. From website. Accessed 2009 Feb 15.

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