Fluor-A-Day

Caries Prophylactic Agents
Fluoride Supplements
Fluoride Supplements (new)
Supplemental Dietary Agents

For storage information, see specific product information within the How Supplied section.

To reduce any unpleasant GI effects, fluoride can be taken with food that does not contain calcium.

Chewable tablets should be dissolved in the mouth or chewed before swallowing.
Administration at bedtime after brushing teeth is recommended.

Oral solution can be dropped directly into the mouth or mixed with cereal or fruit juice.

Sodium fluoride is applied to the teeth in the form of gels, mouthwashes, or toothpaste.
Children require supervision in the use of topical preparations.
Mouthwashes should not be swallowed.
The mouth should be rinsed after toothpaste use.
Avoid overuse or ingestion of any topical product.
After use of a fluoride rinsing solution, patients should not eat, drink or rinse with water for at least 30 minutes.

exfoliative dermatitis / Delayed / Incidence not known
GI bleeding / Delayed / Incidence not known
hematemesis / Delayed / Incidence not known

stomatitis / Delayed / Incidence not known
atopic dermatitis / Delayed / Incidence not known
anemia / Delayed / Incidence not known
dental fluorosis / Delayed / Incidence not known
synovitis / Delayed / Incidence not known

urticaria / Rapid / Incidence not known
weight loss / Delayed / Incidence not known
asthenia / Delayed / Incidence not known
abdominal pain / Early / Incidence not known
vomiting / Early / Incidence not known
hypersalivation / Early / Incidence not known
nausea / Early / Incidence not known

ACT Anti Cavity Flouride, ACT Dry Mouth Anti Cavity with Xylitol, biotene Dry Mouth, Denta 5000 Plus, Dentagel, Dental Resources Neutral, Duraflor, Epiflur, EtheDent, Fluor-A-Day, Fluorabon, Fluorinse, Fluorishield (Sodium Fluoride), Fluoritab, FluoroCare Neutral, Flura-Drops, Flura-Loz, Karigel, Karigel-N, Listerine Smart Rinse, Ludent, Luride, Morning Fresh, NaFrinse, Neutracare, Neutragard, Neutral, Neutral Floam, Neutral One Minute, Nice, Pediaflor, Perfect Choice Neutral, Pharmaflur, Phos-Flur, Plus Neutral, PreviDent, PreviDent 5000 Booster, PreviDent 5000 Booster Plus, PreviDent 5000 Dry Mouth, PreviDent 5000 ORTHO DEFENSE, PreviDent 5000 Plus, PreviDent Dental, Protect, ReNaf, SF 5000 Plus, SodiPhluor, Sultan/Topex Neutral Ph, Thera-Flur, Thera-Flur N, Wenthworth, Wentworth, Wentworth Sodium Fluoride, White Coral

OTC, Rx

Important mineral for bone and dental health; used in children for dental caries prophylaxis in areas of poor fluoridation of drinking water; topical rinses maintain healthy teeth; used orally as an alternative for osteoporosis and neoplastic bone disease.

3.1 mg PO per day for females; 3.8 mg PO per day for males. Medicinal supplementation is normally not needed in healthy adults.

2.9 mg PO per day for females; 3.2 mg PO per day for males. Medicinal supplementation of fluoride is normally not needed in healthy adolescents; fluoride supplementation may be needed for adolescents < 16 years of age for prevention of dental caries.

2 mg PO per day. Children may need fluoride supplementation for prevention of dental caries depending on the concentration of fluoride in municipal tap water.

1.1 mg PO per day. Children may need fluoride supplementation for prevention of dental caries depending on the concentration of fluoride in municipal tap water.

0.7 mg PO per day. Children may need fluoride supplementation for prevention of dental caries depending on the concentration of fluoride in municipal tap water.

0.5 mg PO per day. Children may need fluoride supplementation for prevention of dental caries depending on the concentration of fluoride in municipal tap water.

0.01 mg PO per day through human breast milk content; formula-fed infants usually ingest higher amounts if formula is prepared with fluoridated water. Because the fluoride intake of infants at this age does not appear to influence the development of dental caries, medicinal supplementation of fluoride is not necessary, even for breast-fed infants.

10 mL rinsed around the teeth for 1 minute, then expectorated. Use once daily after brushing and flossing.

Do not use; young children have a tendency to swallow the rinses.

10 mL rinsed around the teeth for 1 minute, then expectorated, use once per week after brushing and flossing.

10 mL rinsed around the teeth for 1 minute, then expectorated, use once per week after brushing and flossing.

5 mL rinsed around the teeth for 1 minute, then expectorated, used once per week (after brushing and flossing).

Do not use; young children have a tendency to swallow the rinses.

Supplementation not necessary. Use of fluoride supplements is contraindicated in areas where fluoride water content is at least 0.7 ppm. If fluoride concentration in drinking water exceeds 0.6 ppm, do not take additional oral sodium fluoride for dental caries prophylaxis. An 8 fluid ounce glass of fluoridated drinking water (1 ppm or 1 mg/L) provides about 0.2 mg of fluoride.

0.5 mg PO per day.

0.25 mg PO per day.

Supplementation not necessary.

1 mg PO per day.

0.5 mg PO per day.

0.25 mg PO per day.

0.25 mg PO per day.

Supplementation not necessary.

After brushing and flossing the teeth, rinse 10 mL over the affected area for 1 minute, then expectorate; use once daily.

100 mg PO per day for the palliative management of bone pain.

100 to 200 mg PO per day for the palliative management of bone lesions.

25 to 60 mg PO per day.

30 to 100 mg PO per day.

25 mg PO of a sustained-release dosage form PO twice per day, for 12 months, followed by a 2-month drug-free period. This 14-month regimen was repeated over a 4-year period and lowered vertebral fracture rates compared to placebo in 1 study. Concomitant calcium citrate therapy was given continuously in both groups throughout the treatment period.

†Indicates off-label use

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears no dosage adjustments are needed.

CrCl 20—50 ml/min: Dosage reductions are necessary to avoid excessive serum concentrations, but specific guidelines for dose adjustments are not available.
CrCl < 20 ml/min: Systemic intake of supplemental fluoride is not normally recommended.
 
Intermittent hemodialysis:
Systemic intake of supplemental fluoride is not normally recommended.

Aluminum Hydroxide: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain aluminum. An interval of at least 2 hours is advisable between administration of sodium fluoride and aluminum hydroxide.
Aluminum Hydroxide; Magnesium Carbonate: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain aluminum. An interval of at least 2 hours is advisable between administration of sodium fluoride and aluminum hydroxide.
Aluminum Hydroxide; Magnesium Hydroxide: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain aluminum. An interval of at least 2 hours is advisable between administration of sodium fluoride and aluminum hydroxide.
Aluminum Hydroxide; Magnesium Hydroxide; Simethicone: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain aluminum. An interval of at least 2 hours is advisable between administration of sodium fluoride and aluminum hydroxide.
Aluminum Hydroxide; Magnesium Trisilicate: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain aluminum. An interval of at least 2 hours is advisable between administration of sodium fluoride and aluminum hydroxide.
Aspirin, ASA; Citric Acid; Sodium Bicarbonate: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Calcium Acetate: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain magnesium, aluminum, or calcium. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Calcium Carbonate: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain magnesium, aluminum, or calcium. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Calcium Carbonate; Famotidine; Magnesium Hydroxide: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain magnesium, aluminum, or calcium. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Calcium Carbonate; Magnesium Hydroxide: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain magnesium, aluminum, or calcium. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Calcium Carbonate; Magnesium Hydroxide; Simethicone: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain magnesium, aluminum, or calcium. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Calcium Carbonate; Simethicone: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain magnesium, aluminum, or calcium. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Calcium Chloride: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain magnesium, aluminum, or calcium. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Calcium Gluconate: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain magnesium, aluminum, or calcium. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Calcium: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain magnesium, aluminum, or calcium. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Calcium; Vitamin D: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain magnesium, aluminum, or calcium. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Chromium: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain magnesium, aluminum, or calcium. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Folic Acid, Vitamin B9: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain magnesium, aluminum, or calcium. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Food: (Major) Simultaneous oral administration of dairy foods along with sodium fluoride can produce calcium fluoride, which is poorly absorbed from the GI tract. Dairy products may also reduce fluoride absorption. While sodium fluoride may be administered with most foods to help reduce GI irritation, an interval of at least 2 hours is recommended between administration of sodium fluoride and dairy foods or other foods containing high levels of calcium.
Magnesium: (Major) Absorption of sodium fluoride may be reduced by concomitant use of magnesium supplements or antacids that contain magnesium. An interval of at least 2 hours is advisable between administration of sodium fluoride and magnesium salts.
Omeprazole; Sodium Bicarbonate: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Pyridoxine, Vitamin B6: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids that contain magnesium, aluminum, or calcium. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Sodium Bicarbonate: (Moderate) Absorption of sodium fluoride may be reduced by concomitant use of antacids. An interval of at least 2 hours is advisable between administration of sodium fluoride and antacids.
Trientine: (Major) In general, oral mineral supplements should not be given since they may block the oral absorption of trientine. However, iron deficiency may develop, especially in children and menstruating or pregnant women, or as a result of the low copper diet recommended for Wilson's disease. If necessary, iron may be given in short courses, but since iron and trientine each inhibit oral absorption of the other, 2 hours should elapse between administration of trientine and iron doses.

ACT Anti Cavity Flouride/ACT Dry Mouth Anti Cavity with Xylitol/Fluorinse/Listerine Smart Rinse/NaFrinse/Perfect Choice Neutral/Phos-Flur/PreviDent/PreviDent Dental/Sodium Fluoride/Wenthworth Dental Sol: 0.02%, 0.05%, 0.2%, 2%
biotene Dry Mouth/Denta 5000 Plus/EtheDent/Morning Fresh/PreviDent 5000 Booster/PreviDent 5000 Booster Plus/PreviDent 5000 Dry Mouth/PreviDent 5000 ORTHO DEFENSE/PreviDent 5000 Plus/SF 5000 Plus/Sodium Fluoride/Wentworth/Wentworth Sodium Fluoride/White Coral Dental Paste: 0.15%, 0.76%, 1.1%, 1.23%
Denta 5000 Plus/EtheDent/PreviDent 5000 Booster/PreviDent 5000 Booster Plus/PreviDent 5000 Dry Mouth/PreviDent 5000 ORTHO DEFENSE/PreviDent 5000 Plus/SF 5000 Plus/Sodium Fluoride/Wentworth/Wentworth Sodium Fluoride Oral Paste: 1.1%
Dentagel/Dental Resources Neutral/EtheDent/Fluorishield (Sodium Fluoride)/FluoroCare Neutral/Karigel/Karigel-N/Neutracare/Neutragard/Neutral/Neutral One Minute/Perfect Choice Neutral/Phos-Flur/Plus Neutral/PreviDent/PreviDent 5000 Booster/PreviDent 5000 Booster Plus/PreviDent 5000 Dry Mouth/Sodium Fluoride/Sultan/Topex Neutral Ph/Thera-Flur/Thera-Flur N Dental Gel: 1%, 1.1%, 1.12%, 2%, 1.1-0.1molar
Dental Resources Neutral/FluoroCare Neutral/Neutracare/Neutral/Neutral One Minute/Perfect Choice Neutral/Sodium Fluoride/Sultan/Topex Neutral Ph Oral Gel: 2%
Duraflor/Fluorinse/NaFrinse/Phos-Flur/PreviDent/PreviDent Dental/Sodium Fluoride/Wenthworth Dental Liq: 0.1%, 0.2%, 4.4mg, 5%, 10mL
Epiflur/EtheDent/Fluorabon/Fluor-A-Day/Fluoritab/Flura-Loz/Ludent/Luride/NaFrinse/Pharmaflur/ReNaf/Sodium Fluoride Oral Tab Chew: 0.55mg, 1.1mg, 2.2mg, 2.21mg
Fluorabon/Flura-Drops/Luride/Pediaflor/SodiPhluor/Sodium Fluoride Oral Drops: 0.55mg, 0.6mL, 1drop, 1mL, 1.1mg
Fluor-A-Day/Sodium Fluoride Oral Sol: 1mL, 1.1mg, 2.2mg, 5.56mg
NaFrinse Dental Pwd F/Recon: 0.05%, 0.2%
NaFrinse Oral Tab: 0.55mg
Neutral Floam/Nice/Protect/Sodium Fluoride Dental Foam: 2%

Dependent upon indication and route of administration.

Dependent upon indication and route of administration.

Dependent upon indication and route of administration.

Dependent upon indication and route of administration.

>= 6 months: Dependent upon indication and route of administration.
< 6 months: Safe and effective use has not been established.

Mechanism of Action: Fluoride replaces the hydroxyl group in the calcium phosphorus salts of teeth and bones to form fluoroapatite. Fluoride enters the systemic circulation by way of food or drink and is essential in formation of strong bones and teeth. Tooth development begins before birth and fluoride is effective in conferring caries-resistant properties in the pre- and postnatal period. Although changes can occur in the surface enamel of teeth, there is little change in their basic composition during life. A study investigated the addition of oral fluoride (1 mg/day) to pregnant women who drank fluoridated water. The resultant children were caries-free at ages 5 and 6 years. However, at this time the FDA does not recommend additional fluoride intake during pregnancy.Fluoride available in the oral cavity also plays a part in prevention of tooth decay. Fluoride in saliva has a small bactericidal action. Saliva provides a buffering action that neutralizes plaque acids. If plaque acids are not neutralized demineralization of the tooth occurs. Once the buffering action restores plaque pH, remineralization can take place. This is the critical point at which fluoride is essential. Minerals deposited as fluoroapatite in surface tooth enamel are more resistant to erosion than hydroxyapatite. These new surfaces contain few pits and fissures, further reducing likely spots for decay.When dentin is exposed, possibly as a result of receding gums, it is sensitive to external stimuli. Application of topical sodium fluoride allows for insoluble material to be deposited in the dental tubules, blocking the transmission of unpleasant stimuli.Systemic administration of large doses of sodium fluoride produces dramatic increases in bone mass. The mechanism whereby fluoride is incorporated into bone is the same as for teeth. However, replacing hydroxyl groups with fluoride changes the size and structure of crystal formation. Chronic ingestion of fluoride can produce a hyperostosis, with dense bone, ligament ossification, and neurologic complications caused by bony overgrowth. In treating osteoporosis, sodium fluoride increases bone mass of the spine. This increase is offset, however, by development of non-load bearing bone in the hips, knees, feet and ankles. Although there may be a decrease in spinal fractures, there is an increased risk of fracture at these other sites, often seen as microfractures accompanied by pain. The recent study by Pak et al showed that a 2 month drug-free interval overcame the attenuated osteoblastic activity seen with continuous fluoride therapy. A continuous supplementation of calcium citrate was also given, which may inhibit parathyroid hormone secretion and reduce bone resorption. Conjunctive use of calcium and vitamin D during sodium fluoride supplementation are essential in prevention of bone mineralization defects. Calcium carbonate has been implicated in decreasing radial shaft bone density in postmenopausal osteoporosis, but the Pak study found that calcium citrate stabilized it.

Sodium fluoride is administered systemically via the oral route or applied topically to the teeth. Ionic fluoride is the pharmacologically active form and 15—20% of plasma fluoride is ionized. Once absorbed, fluoride is distributed widely and stored in bones and teeth. Fluoride can be detected in all tissues and organs throughout the body, but does not accumulate in non-calcified tissue. Saliva contains fluoride, with small amounts found in tears, sweat, and hair. Fluoride crosses the placenta and is essential to bone and tooth formation in the neonate. Fluoride is distributed into breast milk, but the concentration in milk is low (i.e., ranges from 0.007—0.011 mg/L). Skeletal tissue has a high capacity for storage of fluoride ions, and is responsible for maintaining a low concentration of fluoride in the body. Serum fluoride concentrations of 5—10 micro-mol/l are believed to be therapeutic. Teeth represent a small repository of fluoride because of their relatively small mass. Most of the fluoride in teeth is concentrated in dental enamel, and secondly at the dentinoenamel junction. Fluoride in teeth is not readily released. Excretion of fluoride is mainly renal with small amounts excreted in the feces. About 90% is filtered by the glomerulus, with reabsorption by the renal tubules.

Absorption of sodium fluoride from the GI tract is rapid and almost complete.

Systemic absorption of fluoride from improperly used toothpaste or other topical preparation can be significant.

Topical stannous and sodium fluoride preparations (e.g., gels, toothpastes, foams, and mouthwashes) as well as oral preparations are considered safe to use during pregnancy as directed and when needed. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Infants of mothers that are breast-feeding and use topical sodium fluoride should not receive much, if any, fluoride from the breast milk, as topical use by the mother should not result in increased maternal systemic fluoride concentrations. Use of oral sodium fluoride within the recommended daily dietary intake for lactating women is generally recognized as safe. An upper intake concentration for fluoride of 10 mg/day has been established for lactation, because an extremely small proportion of fluoride in drinking water is transferred to the breast milk. Reduced milk production was reported in farm-raised fox when fed a diet containing a high concentration of fluoride (98 to 137 mg/kg of body weight); no adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weigh, a dose at least 200 times greater than the recommended daily dose in humans. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.