Fluoride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = discontinued product

Cream, oral, as sodium [toothpaste]:

Denta 5000 Plus: 1.1% (51 g) [spearmint flavor; equivalent to fluoride 2.5 mg/dose]

PreviDent 5000 Plus: 1.1% (51 g) [contains sodium benzoate; fruitastic flavor; equivalent to fluoride 2.5 mg/dose]

PreviDent 5000 Plus: 1.1% (51 g) [contains sodium benzoate; spearmint flavor; equivalent to fluoride 2.5 mg/dose]

Gel, oral, as sodium [toothpaste]:

PreviDent 5000 Booster: 1.1% (100 mL [DSC]) [contains sodium benzoate; equivalent to fluoride 2.5 mg/dose]

PreviDent 5000 Booster Plus: 1.1% (100 mL) [contains sodium benzoate; fruitastic flavor; equivalent to fluoride 2.5 mg/dose]

PreviDent 5000 Booster Plus: 1.1% (100 mL) [contains sodium benzoate; spearmint flavor; equivalent to fluoride 2.5 mg/dose]

PreviDent 5000 Dry Mouth: 1.1% (100 mL) [mint flavor; equivalent to fluoride 2.5 mg/dose]

Gel, topical, as sodium:

DentaGel: 1.1% (56 g) [fresh mint flavor; neutral pH; equivalent to fluoride 2 mg/dose]

NeutraCare: 1.1% (60 g) [grape flavor; neutral pH]

NeutraCare: 1.1% (60 g) [mint flavor; neutral pH]

NeutraGard Advanced: 1.1% (60 g [DSC]) [mint flavor; neutral pH]

NeutraGard Advanced: 1.1% (60 g [DSC]) [mixed berry flavor; neutral pH]

Phos-Flur: 1.1% (51 g [DSC]) [contains propylene glycol, sodium benzoate; mint flavor; equivalent to fluoride 0.5%]

PreviDent: 1.1% (56 g) [mint flavor; neutral pH; equivalent to fluoride 2 mg/dose]

PreviDent: 1.1% (56 g) [very berry flavor; neutral pH; equivalent to fluoride 2 mg/dose]

Generic: 1.1% (56 g)

Gel, topical, as stannous fluoride:

Gel-Kam: 0.4% (122 g)

Just For Kids: 0.4% (122 g) [bubblegum flavor]

Just For Kids: 0.4% (122 g [DSC]) [fruit-punch flavor]

Just For Kids: 0.4% (122 g) [grapey grape flavor]

Omni Gel: 0.4% (122 g [DSC]) [cinnamon flavor]

Omni Gel: 0.4% (122 g [DSC]) [grape flavor]

Omni Gel: 0.4% (122 g) [mint flavor]

Omni Gel: 0.4% (122 g [DSC]) [natural flavor]

Omni Gel: 0.4% (122 g [DSC]) [raspberry flavor]

Lozenge, oral, as sodium:

Lozi-Flur: 2.21 mg (90s [DSC]) [sugar free; cherry flavor; equivalent to fluoride 1 mg]

Paste, oral, as sodium [toothpaste]:

Clinpro 5000: 1.1% (113 g) [vanilla-mint flavor]

ControlRx: 1.1% (57 g [DSC]) [vanilla-mint flavor]

Fluoridex: 1.1% (112 g)

Fluoridex Enhanced Whitening: 1.1% (112 g) [mint flavor]

Paste, oral, as stannous fluoride [toothpaste]:

parodontax: 0.454% (96.4 g) [mint flavor]

Sensodyne Complete Protection: 0.454% (96.4 g) [mint flavor]

Sensodyne Rapid Relief: 0.454% (23 g and 96.4 g) [mint flavor]

Sensodyne Repair & Protect: 0.454% (96.4 g) [mint flavor]

Solution, oral, as sodium [drops]:

Fluor-A-Day: 0.278 mg/drop (30 mL [DSC]) [equivalent to fluoride 0.125 mg/drop]

Fluorabon: 0.55 mg/0.6 mL (60 mL) [dye free, sugar free; equivalent to fluoride 0.25 mg/0.6 mL]

Fluoritab: 0.275 mg/drop (30 mL) [dye free; equivalent to fluoride 0.125 mg/drop]

Flura-Drops: 0.55 mg/drop (24 mL) [dye free, sugar free; contains natural rubber/natural latex in packaging; equivalent to fluoride 0.25 mg/drop]

Generic: 1.1 mg/mL (50 mL) [dye free, sugar free; equivalent to fluoride 0.5 mg/mL]

Solution, oral, as sodium [rinse]:

Act: 0.05% (532 mL) [contains benzyl alcohol, propylene glycol, sodium benzoate, tartrazine; cinnamon flavor; equivalent to fluoride 0.02%]

Act: 0.05% (532 mL) [contains propylene glycol, sodium benzoate, tartrazine; mint flavor; equivalent to fluoride 0.02%]

Act Kids: 0.05% (532 mL) [ethanol free; contains benzyl alcohol, propylene glycol, sodium benzoate; bubblegum flavor; equivalent to fluoride 0.02%]

Act Kids: 0.05% (500 mL) [ethanol free; contains benzyl alcohol, propylene glycol, sodium benzoate; ocean berry flavor; equivalent to fluoride 0.02%]

Act Restoring: 0.02% (1000 mL) [contains ethanol 11%, propylene glycol, sodium benzoate; Cool Splash mint flavor; equivalent to fluoride 0.009%]

Act Restoring: 0.02% (1000 mL) [contains ethanol 11%, propylene glycol, sodium benzoate; Cool Splash spearmint flavor; equivalent to fluoride 0.009%]

Act Restoring: 0.05% (532 mL) [contains ethanol 11%, propylene glycol, sodium benzoate; Cool Splash mint flavor; equivalent to fluoride 0.02%]

Act Restoring: 0.05% (532 mL) [contains ethanol 11%, propylene glycol, sodium benzoate; Cool Splash spearmint flavor; equivalent to fluoride 0.02%]

Act Restoring: 0.05% (532 mL) [contains ethanol 11%, propylene glycol, sodium benzoate; Cool Splash vanilla-mint flavor; equivalent to fluoride 0.02%]

Act Total Care: 0.05% (88 mL, 532 mL, 1000 mL) [contains ethanol 11%, propylene glycol, sodium benzoate; icy clean mint flavor; equivalent to fluoride 0.02%]

Act Total Care: 0.05% (88 mL, 532 mL, 1000 mL) [ethanol free; contains menthol, propylene glycol, sodium benzoate, tartrazine; fresh mint flavor; equivalent to fluoride 0.02%]

Act Total Care Dry Mouth: 0.02% (532 mL, 1000 mL) [ethanol free; contains propylene glycol, sodium benzoate; soothing mint flavor; equivalent to fluoride 0.009%]

Act Total Care Sensitive: 0.02% (532 mL, 1000 mL) [ethanol free; contains propylene glycol, sodium benzoate; mint flavor; equivalent to fluoride 0.009%]

CaviRinse: 0.2% (240 mL [DSC]) [mint flavor]

Fluorinse: 0.2% (480 mL) [ethanol free; cinnamon flavor]

Fluorinse: 0.2% (480 mL) [ethanol free; mint flavor]

OrthoWash: 0.044% (480 mL) [contains sodium benzoate; grape flavor]

OrthoWash: 0.044% (480 mL) [contains sodium benzoate; strawberry flavor]

Phos-Flur Rinse: 0.044% (473 mL) [ethanol free, sugar free; bubblegum flavor]

Phos-Flur Rinse: 0.044% (473 mL) [ethanol free, sugar free; gushing grape flavor]

Phos-Flur Rinse: 0.044% (500 mL) [sugar free; cool mint flavor]

PreviDent: 0.2% (473 mL [DSC]) [contains benzoic acid, ethanol 6%, sodium benzoate; cool mint flavor]

PreviDent: 0.2% (473 mL) [ethanol free; contains benzoic acid, propylene glycol, sodium benzoate; cool mint flavor]

Solution, oral, as stannous fluoride [concentrated rinse]:

Fluoridex Daily Renewal: 0.63% (248 mL) [mint flavor; equivalent to fluoride 7 mg/30 mL dose]

Gel-Kam Rinse: 0.63% (300 mL) [mint flavor; equivalent to fluoride 7 mg/30 mL dose]

PerioMed: 0.63% (284 mL) [ethanol free; cinnamon flavor; equivalent to fluoride 7 mg/30 mL dose]

PerioMed: 0.63% (284 mL) [ethanol free; mint flavor; equivalent to fluoride 7 mg/30 mL dose]

PerioMed: 0.63% (284 mL) [ethanol free; tropical fruit flavor; equivalent to fluoride 7 mg/30 mL dose]

StanGard Perio: 0.63% (284 mL) [mint flavor]

Tablet, chewable, oral, as sodium:

Fluor-A-Day: 0.55 mg [raspberry flavor; equivalent to fluoride 0.25 mg] [DSC]

Fluor-A-Day: 1.1 mg [raspberry flavor; equivalent to fluoride 0.5 mg] [DSC]

Fluor-A-Day: 2.2 mg [raspberry flavor; equivalent to fluoride 1 mg] [DSC]

Fluoritab: 2.2 mg [cherry flavor; equivalent to fluoride 1 mg]

Fluoritab: 1.1 mg [dye free; cherry flavor; equivalent to fluoride 0.5 mg]

Generic: 0.55 mg [equivalent to fluoride 0.25 mg], 1.1 mg [equivalent to fluoride 0.5 mg], 2.2 mg [equivalent to fluoride 1 mg]

Pharmacology

Mechanism of Action

Promotes remineralization of decalcified enamel; inhibits the cariogenic microbial process in dental plaque; increases tooth resistance to acid dissolution

Pharmacokinetics/Pharmacodynamics

Absorption

Oral: ~50% absorbed from GI tract (IOM, 1997; dairy products may delay absorption)

Distribution

99% in calcified tissue (IOM, 1997)

Excretion

Urine (IOM, 1997)

Use: Labeled Indications

Prevention of dental caries

Contraindications

Fluor-A-Day: When fluoride content of drinking water exceeds 0.6 ppm; patients with arthralgia, GI ulceration, chronic renal insufficiency and failure, or osteomalacia

Fluorabon: When fluoride content of drinking water exceeds 0.6 ppm

Fluoritab: Patients with dental fluorosis

Flura-Drops, Loziflur: When fluoride content of drinking water is ≥0.3 ppm

Dosage and Administration

Dosing: Adult

Cream or paste:

Clinpro 5000 paste, Control Rx 1.1%, Denta 5000 Plus: Once daily, in place of conventional toothpaste, brush teeth with a thin ribbon or pea-sized amount of paste for at least 2 minutes. Brush teeth with cream or paste once daily regardless of fluoride content of drinking water

Prevident 5000 Sensitive: Twice daily, brush teeth with a 1 inch strip of toothpaste for at least 1 minute. After brushing, expectorate and rinse mouth thoroughly. Brush teeth twice daily regardless of fluoride content of drinking water

Dental rinse or gel:

ACT Restoring 0.02% rinse, ACT Total Care 0.02% rinse: Twice daily after brushing, rinse 10 mL around and between teeth for 1 minute, then spit. Do not eat, drink, or rinse mouth for at least 30 minutes after treatment; do not swallow

ACT 0.05% rinse, Phos-Flur Rinse: Once daily after brushing, rinse 10 mL around and between teeth for 1 minute, then spit. Do not eat, drink, or rinse mouth for at least 30 minutes after treatment; do not swallow

Cavirinse, PreviDent rinse: Once weekly, rinse 10 mL vigorously around and between teeth for 1 minute, then spit; this should be done preferably at bedtime, after thoroughly brushing teeth; do not swallow. For maximum benefit with PreviDent rinse, do not eat, drink, or rinse mouth for at least 30 minutes after treatment.

Gel-Kam rinse: After diluting solution as directed, rinse with 15 mL for 1 minute at least daily, then spit. Repeat with remaining solution.

Lozenge: Lozi-FlurOne lozenge daily regardless of fluoride content of drinking water

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Adequate Intake (AI): (IOM, 1997): Infants, Children, and Adolescents: Oral:

1 to 6 months: 0.01 mg/day; additional supplementation is not recommended in infants <6 months of age

7 to 12 months: 0.5 mg/day

1 to 3 years: 0.7 mg/day

4 to 8 years: 1 mg/day

9 to 13 years: 2 mg/day

14 to 18 years: 3 mg/day

Dental caries, prevention:

Systemic therapy:

Drops/tablets (Fluorabon, Fluor-A-Day, Fluoritab, Flura-drops): Oral: The recommended oral daily dose of fluoride is adjusted in proportion to the fluoride content of available drinking water:

Birth to 6 months: No supplement required regardless of fluoride content of drinking water

6 months to 3 years:

<0.3 ppm: 0.25 mg once daily

≥0.3 ppm: No supplement required

3 to 6 years:

<0.3 ppm: 0.5 mg once daily

0.3 to 0.6 ppm: 0.25 mg once daily

>0.6 ppm: No supplement required

6 to 16 years:

<0.3 ppm: 1 mg once daily

0.3 to 0.6 ppm: 0.5 mg once daily

>0.6 ppm: No supplement required

Lozenges (Lozi-Flur): Children ≥6 years and Adolescents: Oral: 1 lozenge daily; allow lozenge to dissolve slowly in the mouth and swallow with saliva. Note: For use in areas where the fluoride content of drinking water is <0.3 ppm.

Topical therapy:

Dental rinse: Note: Do not eat, drink, or rinse mouth for at least 30 minutes after treatment; do not swallow.

Acidulated phosphate fluoride rinse (Phos-Flur): Children ≥6 years and Adolescents: Topical: 10 mL once daily after brushing; swish between teeth for 1 minute, then spit.

Sodium fluoride: Topical:

0.02% Sodium fluoride (ACT Restoring, ACT Total Care): Children ≥6 years and Adolescents: 10 mL swish and spit twice daily after brushing

0.05% Sodium fluoride (ACT Anticavity Rinse, ACT Kids): Children ≥6 years and Adolescents: 10 mL swish and spit once daily after brushing

0.2% Neutral sodium fluoride (CaviRinse, PreviDent Rinse): Children ≥6 years and Adolescents: 10 mL swish and spit once weekly, preferably at bedtime after brushing. Note: CaviRinse labeling recommends children and adolescents 6 to 16 years rinse with water immediately following treatment.

Stannous fluoride 0.63% (Gel-Kam): Children ≥12 years and Adolescents: Topical: After diluting solution as directed, rinse with 15 mL for 1 minute, then spit; repeat with remaining solution. Use at least once daily.

Gel: Stannous fluoride 0.4% (Just for Kids): Children ≥6 years and Adolescents: Topical: Once daily after brushing, apply a pea-sized amount of gel to teeth and brush thoroughly. Allow gel to remain on teeth for 1 minute prior to spitting out. Do not eat or drink for 30 minutes after using.

Paste: Sodium fluoride 1.1%: Topical:

Clinpro 5000, Control Rx, Denta 5000 Plus :Children ≥6 years and Adolescents: Once daily, preferably at bedtime, in place of conventional toothpaste; brush teeth with a thin ribbon or pea-sized amount of toothpaste for at least 2 minutes; after brushing expectorate and rinse mouth thoroughly with water.

PreviDent 5000 Sensitive: Children ≥12 years and Adolescents: Twice daily, brush teeth with a 1-inch strip of toothpaste for at least 1 minute. After brushing, expectorate and rinse mouth thoroughly.

Dental varnish: 5% Sodium Fluoride (2.26% Fluoride ion): Infants (after primary tooth eruption), Children and Adolescents: Topical: Apply a thin layer of varnish to surfaces of teeth at least every 3 to 6 months (ADA [Weyant], 2013). Note: Must be professionally applied; USPSTF recommends dental varnish may be applied by primary care practitioners to the primary teeth of all infants and children starting at the age of primary tooth eruption through 5 years of age (USPSTF, 2014):

Reconstitution

Concentrated Oral Rinse (stannous fluoride 0.63%): Must be diluted with water to stannous fluoride 0.1% prior to use

Administration

Once daily products are generally used at bedtime. Rinses are generally used after routine teeth brushing and should not be swallowed. Consult specific product labeling for details.

Clinpro 5000 paste, Control Rx 1.1%, Denta 5000 Plus: After brushing expectorate.

Fluor-A-Day: Tablets should be dissolved in mouth or chewed prior to swallowing. Drops may be administered in juice or water. Dairy products should be avoided within 1 hour of administration.

Fluorabon: Drops may be administered directly into the mouth or in a non-dairy food that will be totally consumed

Flura-Drops: Drops may be administered undiluted or in fruit juice or water. Dairy products should be avoided within 1 hour of administration.

Lozi-Flur: Lozenge should be dissolved in mouth and swallowed with saliva

Prevident 5000 Sensitive: After brushing for at least 1 minute, expectorate and rinse mouth thoroughly with water.

Dietary Considerations

Do not administer with dairy products.

Storage

Store at room temperature.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not defined.

Dermatologic: Skin rash

Gastrointestinal: Dental discoloration (with products containing stannous fluoride; temporary), nausea

Hypersensitivity: Hypersensitivity reaction

Warnings/Precautions

Concerns related to adverse effects:

• Dental fluorosis/osseous: Prolonged ingestion with excessive doses may result in dental fluorosis and osseous changes, especially if the water fluoridation exceeds 0.6 ppm; do not exceed recommended dosage.

Special populations:

• OTC products: Swallowing should be minimized with topical products (eg, creams, gels, rinses). OTC products are generally not recommended for use in children <6 years of age unless as directed by a health care provider.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.
• Latex: Packaging of some products may contain natural latex/natural rubber.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer’s labeling.
• Tartrazine: Some products contain tartrazine.

Other warnings/precautions:

• Appropriate use: Dietary fluoride supplements are recommended for children at high risk of developing dental caries. They are not recommended for use in children <6 months of age, or any child at low risk. All sources of fluoride should be considered prior to preventive intervention (Rozier, 2010).

Pregnancy

Pregnancy Risk Factor

B

Pregnancy Considerations

Fluoride crosses the placenta and can be found in the fetal circulation (IOM, 1997). Adverse events have not been observed in animal reproduction studies; epidemiological studies in areas with high levels of fluorinated water have not shown an increase in adverse effects. Heavy exposure in utero may be linked to skeletal fluorosis seen later in childhood.

Patient Education

What is this drug used for?

• This supplement is used to prevent cavities.
• It is used to help sensitive teeth.

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Severe nausea
• Severe vomiting
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.