Medication Guide App

Sodium Fluoride (Systemic)


VA CLASSIFICATION
Primary: TN407

Commonly used brand name(s): Flozenges; Fluor-A-Day; Fluoritab; Fluoritabs; Fluorodex; Fluorosol; Flura; Flura-Drops; Flura-Loz; Karidium; Luride; Luride Lozi-Tabs; Luride-SF Lozi-Tabs; PDF; Pedi-Dent; Pediaflor; Pharmaflur; Pharmaflur 1.1; Pharmaflur df; Phos-Flur; Solu-Flur.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Dental caries prophylactic—

nutritional supplement (mineral)—

Indications

Accepted

Dental caries (prophylaxis)—Sodium fluoride is indicated as a dietary supplement for prevention of dental caries in children in those areas where the level of naturally occurring fluoride in the drinking water is inadequate. In optimally fluoridated communities, {25} sodium fluoride supplementation may be necessary in {26} infants that are totally breast-fed or receive ready-to-use formulas {06} {11} or in children consuming nonfluoridated {29} bottled water rather than tap water. {16} {17} Sodium fluoride supplementation may also be indicated in those situations where home water filtration systems remove fluoride. This usually occurs with reverse osmosis or distillation units, but not with carbon charcoal filters. {23} {24}
—Evidence that oral systemic fluoride supplements reduce dental caries in adults is lacking.

Note: Sodium fluoride has been used to treat osteoporosis and otospongiosis in adults; {08} however, its use is controversial and further studies are needed. {27} {28} The doses used in osteoporosis and otospongiosis have potential for {04} toxicity, including skeletal fluorosis, osteomalacia, widening of unmineralized osteoid seams, and upper gastrointestinal ulceration {04}.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    41.99 {69}

Mechanism of action/Effect:

Fluoride ion becomes incorporated into and stabilizes the apatite crystal of bone and teeth. Fluoride acts primarily to promote remineralization of decalcified enamel and may interfere with growth and development of dental plaque bacteria. Deposition of fluoride ion in the enamel surface of teeth increases resistance to acid and to development of caries. {11} {13} {38}

Absorption:

Fluorides in solution or in the form of rapidly soluble salts are readily and almost completely absorbed from the gastrointestinal tract. {10}


Storage

In bone and developing teeth. {02}

Time to peak serum concentration

30 to 60 minutes. {02}

Elimination:
    Primarily renal (approximately 50%), with small amounts in feces and sweat. {02} {03}


Precautions to Consider

Carcinogenicity

Fluoride in the concentrations shown to be effective against tooth decay has not been shown to cause cancer in individuals who receive fluoride over prolonged periods. {19} {52}

Pregnancy/Reproduction

Problems in humans have not been documented with intake of normal daily recommended amounts. Fluoride readily crosses the placenta. {31}

There is conflicting evidence as to whether administration of fluoride supplements to women during pregnancy will help prevent caries in the child. {02} {09} {10}

Breast-feeding

Problems in humans have not been documented with intake of normal daily recommended amounts. Trace amounts of fluoride are distributed into breast milk, although the concentration is not high enough to provide benefits to the infant. {09} {34} {35}

Pediatrics

Problems in pediatrics have not been documented with intake of normal daily recommended amounts. Chronic overdose may cause fluorosis of the teeth (if given during the period of tooth-enamel formation) and osseous changes. {06}


Geriatrics


Problems in geriatrics have not been documented with intake of normal daily recommended amounts. Elderly patients are more likely to have age-related renal failure, which may require caution if patients are receiving large doses for osteoporosis or otospongiosis. The elderly are also more likely to develop stress fractures, gastrointestinal ulceration, and arthralgia from large doses of sodium fluoride. {27} {39}


Dental

Excessive doses of sodium fluoride may result in fluorosis of teeth if taken during tooth formation years. {09}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following, depending on the amount present, may also interact with this medication.

Aluminum hydroxide    (may decrease absorption and increase fecal excretion of fluoride; aluminium hydroxide–containing medications should be taken 2 hours before or after sodium fluoride {06} {37})


Calcium supplements{53}    (concurrent use with sodium fluoride may cause the calcium ions to complex with fluoride and inhibit absorption of both fluoride and calcium; {03} {06} {08} if sodium fluoride is used with calcium supplements to treat osteoporosis, a 1- to 2-hour interval should elapse between doses of the two)



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
Alkaline phosphatase concentrations, serum    (results may be elevated {46} {47})


Aspartate aminotransferase (AST [SGOT]) concentrations, serum    (may be falsely increased)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical conditions exist:
Arthralgia or{27}{39}
Gastrointestinal ulceration{08}{27}{40}    (conditions may be exacerbated, especially with high doses)


Renal insufficiency, severe{05}{08}    (condition may be exacerbated; may lead to higher blood levels of fluoride due to a decrease in excretion of fluoride; dosage reduction may be necessary {36})


Risk-benefit should be considered when the following medical problems exist
High dental fluorosis, or prevalence in other members of the immediate community{23}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Dental examination{01}    (recommended once or twice a year in most patients, and more frequently in those highly prone to developing caries)




Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Ulceration of oral mucous membranes (sores in mouth and on lips){06}





Overdose
For specific information on the agents used in the management of fluoride overdose, see    • Calcium Supplements (Systemic) monograph.


For more information on the management of overdose or unintentional ingestion contact a Poison Control Center (see Poison Control Center Listing) .

Clinical effects of overdose

Note: Stomach upset may occur with ingestion of 5 {04} to 20 mg of sodium fluoride. The lethal dose is not known, but has been estimated as 5 to 10 grams of sodium fluoride in untreated adults {02} {50} and 5 mg of fluoride ion per kilogram of body weight in children. {50}
Severe acute fluoride overdose {01} can cause hypocalcemia and tetany {03} and bone pain, especially in the feet and ankles, of uncertain cause; {04} electrolyte disturbances {49} and cardiac arrhythmias have been reported, progressing to cardiac failure or respiratory arrest in some cases. {10} {43}
Osseous changes, including skeletal fluorosis, osteomalacia, and osteosclerosis, may also result from excessive, chronic doses. {03} {04}

The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive
Chronic effects (fluorosis and osteosclerosis) {53}
    
Pain and aching of bones,{03} stiffness, or white, brown, or black discoloration of teeth{03} —occur only during periods of tooth development in children

Acute effects
    
Black, tarry stools
    
bloody vomit {03}
    
diarrhea {03}{48}
    
drowsiness
    
faintness
    
increased watering of mouth {51}
    
nausea or vomiting {03}{48}
    
shallow breathing{03}
    
stomach cramps or pain
    
tremors
    
unusual excitement
    
watery eyes
    
weakness



For treatment of acute overdose


Specific treatment:
Administration of intravenous dextrose. {03}

Gastric lavage with calcium chloride or calcium hydroxide solution {01} to precipitate fluoride. {03}

Intravenous calcium gluconate if hypocalcemia occurs. {03}



Monitoring:
Monitor respiration, blood pressure, and ECG. {03}



Supportive care:
Maintenance of high urine output.

Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Sodium Fluoride (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):


Importance of diet
Importance of proper nutrition; fluoride may be needed because of inadequate dietary intake

Dietary sources of fluoride; effects of processing

Recommended daily intake for fluoride

Remembering not to take more than recommended

Before using this medication
»   Conditions affecting use, especially:

Pregnancy—Fluoride crosses the placenta





Breast-feeding—Trace amount distributed into breast milk




Use in children—Chronic overdose may cause dental fluorosis and osseous changes






Use in the elderly—High doses used for osteoporosis or otospongiosis not recommended in elderly patients with arthralgia, gastrointestinal ulceration, or renal insufficiency





Dental—Excessive doses taken during tooth formation years may result in tooth fluorosis

Proper use of this medication
» Importance of not using more medication than the amount prescribed

» Proper dosing
Missed dose: Taking as soon as possible; not taking if almost time for next dose; not doubling doses

For individuals taking the chewable tablet dosage form
Chewing or crushing tablets before swallowing

Advisability of taking at bedtime after brushing teeth; not eating or drinking for at least 15 minutes after taking

For individuals taking the oral solution dosage form
Proper use of the dropper bottle

» Avoiding use of glass with fluoride-containing solutions since fluoride etches glass

May be dropped directly into the mouth or mixed with cereal, fruit juice, or other food (except calcium-containing foods or beverages)

» Proper storage

Precautions while using this medication
Checking with health care professional as soon as possible after moving to another geographic area to see if continued treatment at the same dosage is necessary, since fluoride levels of community drinking water vary; also checking if changing infant feeding habits, drinking water, or filtration {23}

Not taking calcium supplements or aluminum hydroxide-containing products and sodium fluoride at the same time; use should be separated by 2 hours

» Informing health care professional if teeth show signs of mottling


Side/adverse effects
Signs of potential side effects especially oral mucous membrane ulceration


General Dosing Information
Optimal benefit of fluorides must be established on an individual basis, taking into consideration the fluoride content of the water supply when determining the dose. {09} Some studies have found that systemic fluoride ingestion from toothpaste use in young children is significant. {56} {57}

The amount of fluoride from all sources should be taken into account when determining the therapeutic dose. {42} For example, infant formulas made with fluoridated water provide a significant amount. {09} Also, some schools in communities without water fluoridation have added up to 4.5 times the optimal fluoride level to the school"s water supply to ensure that children receive adequate fluoride. {10} {15}

Use of fluoride supplements is generally not recommended when community drinking water contains more than 0.6 parts per million (ppm) of fluoride.

A fluoride level of approximately 1 ppm (0.6 to 1.2 ppm) in water is generally considered optimal {03} for development of decay-resistant teeth without causing fluorosis, the actual value depending on the annual mean maximum daily temperature of the geographic area.

2.2 mg of sodium fluoride is equivalent to 1 mg of fluoride ion. {43}

Since therapy with oral, systemic fluoride supplements is most effective on unerupted teeth, {02} it is recommended that children receive oral fluoride supplementation until the age of 13 (or when the second molars have erupted) to provide maximum benefit to both deciduous and permanent teeth. {02} {11} Subsequent periodic topical application of fluoride for life may be advisable to prolong the cariostatic benefits, since beneficial effects, particularly in caries-prone individuals, appear to be lost a year or two after topical use is discontinued.

The recommended dose should not be exceeded, since prolonged overdosage may cause dental fluorosis in children and osseous changes in children and adults. {43}

Mottling of tooth enamel (dental fluorosis) occurs with excessive ingestion of fluoride (e.g., continual use of drinking water containing greater than 2 ppm of fluoride) during the period of tooth development in children. {06}

Stiffness (skeletal fluorosis) occurs with chronic ingestion of water containing 4 {03} to 14 ppm of fluoride.

Generalized effects (renal damage, albuminuria, goiter) occur only after chronic ingestion of large amounts of fluoride over 10 to 20 years. {43}

It is recommended that fluoride preparations (especially the chewable tablets) taken on a once-a-day basis be taken at bedtime after the teeth have been thoroughly brushed (to also provide some topical benefit from the fluoride).

Sodium fluoride (25 to 60 mg a day) may stabilize the progression of hearing loss in some patients with otospongiosis. {54} {55}

Diet/Nutrition
Nausea (although rare with doses of fluoride taken for dental caries) may be reduced by taking sodium fluoride with or just after meals, provided that the foods do not contain calcium, since calcium may interfere with fluoride absorption. {30}

The oral solution may be administered undiluted or mixed with cereal, fluids, or other food. However, absorption of sodium fluoride may be reduced when taken with calcium-rich foods or beverages. {23} {25}

Recommended dietary intakes for fluoride are defined differently worldwide.


For U.S.:
The Recommended Dietary Allowances (RDAs) for vitamins and minerals are determined by the Food and Nutrition Board of the National Research Council and are intended to provide adequate nutrition in most healthy persons under usual environmental stresses. In addition, a different designation may be used by the FDA for food and dietary supplement labeling purposes, as with Daily Value (DV). DVs replace the previous labeling terminology United States Recommended Daily Allowances (USRDAs). {44} {70}



For Canada:
Recommended Nutrient Intakes (RNIs) for vitamins, minerals, and protein are determined by Health and Welfare Canada and provide recommended amounts of a specific nutrient while minimizing the risk of chronic diseases. {71}

There is no RDA or RNI established for fluoride. Daily recommended intakes for fluoride are generally defined as follows {44}


Infants and children—
Birth to 3 years: 0.1 to 1.5 mg.

4 to 6 years: 1 to 2.5 mg.

7 to 10 years: 1.5 to 2.5 mg.



Adolescents and adults—
1.5 to 4 mg.


Sources of fluoride other than fluoridated drinking water include fish that are consumed with their bones and tea. {44} Cooking foods in fluorinated water can increase their fluoride content as can cooking with Teflon- (a fluoride-containing polymer) coated utensils and pans. However, cooking foods in utensils and pans with an aluminum surface can decrease their fluoride content. {44} {45}



Oral Dosage Forms

SODIUM FLUORIDE LOZENGES

Usual pediatric dose
Dental caries prophylactic or
Nutritional supplement
Dosage of fluoride recommended by the American Dental Association, the American Academy of Pediatrics, and the American Academy of Pediatric Dentistry for communities where the level of fluoride in drinking water is 0.6 ppm or less {01}

Water Fluoride (ppm)
Age (yr)
Dose of Fluoride Ion (mg per day)
<0.3
Birth to 0.5
0
  0.5 to 3
0.25
  3 to 6
0.5
  6 to 16
1
0.3–0.6
Birth to 3
0
  3 to 6
0.25
  6 to 16
0.5
>0.6
Birth to 16
0


Note: In Canada a different dosing schedule may be used. The Canadian Dental Association recommendations differ from that of the American Dental Association.



Strength(s) usually available
U.S.—


2.2 mg (1 mg of fluoride ion) (Rx) [Flura-Loz{58}]

Canada—


1.1 mg (OTC) [Flozenges{62}]


2.2 mg (OTC) [Flozenges{62}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.


SODIUM FLUORIDE ORAL SOLUTION USP

Usual pediatric dose
See Sodium Fluoride Lozenges.

Strength(s) usually available
U.S.—
{06}

0.275 mg (0.125 mg of fluoride ion) per drop (Rx) [Karidium{58}] [Luride{58}][Generic]{58}{59}


0.44 mg (0.2 mg of fluoride ion) per mL (Rx) [Phos-Flur{58}]


0.55 mg (0.25 mg of fluoride ion) per drop (Rx) [Fluoritab{58}] [Flura-Drops{58}]


1.1 mg (0.5 mg of fluoride ion) per mL (Rx) [Pediaflor (alcohol less than 0.5%)]

Canada—
{07}

2 mg (0.905 mg of fluoride ion) per mL (OTC) [PDF{65}]


2.2 mg (1 mg of fluoride ion) per 4 drops (Rx) [Solu-Flur]


2.21 mg (1 mg of fluoride ion) per 8 drops (0.5 mL) (OTC) [Karidium{63}]


5.56 mg (1 mg of fluoride ion) per mL (OTC){62}{64} [Fluor-A-Day{20}]


6.9 mg (3.12 mg of fluoride ion) per mL (OTC){62}{67} [Fluorosol{62}] [Pedi-Dent][Generic]{62}{21}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, plastic container. Protect from freezing.

Auxiliary labeling:
   • Keep out of reach of children.

Note: To reduce the risk associated with accidental ingestion and overdosage, it is recommended that no more than 264 mg of sodium fluoride be dispensed at one time. {02} The American Dental Association Council on Dental Therapeutics considers a limit of 300 mg acceptable when sodium fluoride is dispensed to children in prepackaged containers.
Since size of drop dispensed and strength vary among commercial preparations, always dispense the same brand for refills on a prescription.



SODIUM FLUORIDE TABLETS USP

Usual pediatric dose
See Sodium Fluoride Lozenges.

Strength(s) usually available
U.S.—


1.1 mg (0.5 mg of fluoride ion) (Rx)[Generic]{58}


2.2 mg (1 mg of fluoride ion) (Rx) [Flura] [Karidium][Generic]

Canada—


2.2 mg (1 mg fluoride ion) (OTC){62}{63} [Fluorosol{62}] [Karidium][Generic]{62}{66}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Keep out of reach of children.

Note: To reduce the risk associated with accidental ingestion and overdosage, it is recommended that no more than 264 mg of sodium fluoride be dispensed at one time. {02} The American Dental Association Council on Dental Therapeutics considers a limit of 300 mg acceptable when sodium fluoride is dispensed to children in prepackaged containers.



SODIUM FLUORIDE CHEWABLE TABLETS USP

Usual pediatric dose
See Sodium Fluoride Lozenges.

Strength(s) usually available
U.S.—


0.55 mg (0.25 mg of fluoride ion) (Rx) [Luride Lozi-Tabs{60}]


1.1 mg (0.5 mg of fluoride ion) (Rx) [Fluoritab (scored){58}{61}] [Fluorodex] [Luride Lozi-Tabs{58}] [Pharmaflur 1.1{58}{68}][Generic]{58}


2.2 mg (1 mg of fluoride ion) (Rx) [Fluoritab] [Fluorodex] [Karidium{58}] [Luride Lozi-Tabs{58}] [Luride-SF Lozi-Tabs{58}] [Pharmaflur{58}{68}] [Pharmaflur df{58}{68}][Generic]

Canada—


2.2 mg (1 mg of fluoride ion) (OTC){62}{64}{67} [Fluor-A-Day] [Fluoritabs] [Pedi-Dent] [Solu-Flur][Generic]{62}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Keep out of reach of children.

Note: To reduce the risk associated with accidental ingestion and overdosage, it is recommended that no more than 264 mg of sodium fluoride be dispensed at one time. The American Dental Association Council on Dental Therapeutics considers a limit of 300 mg acceptable when sodium fluoride is dispensed to children in prepackaged containers.




Revised: 08/07/1995



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