Yes

Nutritional Supplement

Prevention of dental caries

C

Hypersensitivity to fluoride, tartrazine, or any component; when fluoride content of drinking water exceeds 0.7 ppm; low sodium or sodium-free diets; do not use 1 mg tablets in children <3 years of age or when drinking water fluoride content is greater than or equal to 0.3 ppm; do not use 1 mg/5 mL rinse (as supplement) in children <6 years of age

Prolonged ingestion with excessive doses may result in dental fluorosis and osseous changes; do not exceed recommended dosage; some products contain tartrazine

<1%: Rash, nausea, vomiting, products containing stannous fluoride may stain the teeth

Symptoms of overdose include hypersalivation, salty or soapy taste, epigastric pain, nausea, vomiting, diarrhea, rash muscle weakness, tremor, seizures, cardiac failure, respiratory arrest, shock, death

Fatal dose not known. Children: 500 mg; Adults: 7-140 mg/kg

Treatment of overdose: Gastric lavage with CaCl₂ or Ca(OH)₂ solution; administer large quantity of milk at frequent intervals; Al(OH)₃ may also bind the fluoride ion

Decreased effect/absorption with magnesium-, aluminum-, and calcium-containing products

Store in tight plastic containers (not glass)

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

Absorption: Absorbed in GI tract, lungs, and skin; calcium, iron, or magnesium may delay absorption

Distribution: 50% of fluoride is deposited in teeth and bone after ingestion; topical application works superficially on enamel and plaque; crosses placenta; appears in breast milk

Elimination: In urine and feces

Oral:

<0.3 ppm

Birth to 6 months: 0 mg

6 months to 3 years: 0.25 mg

3-6 years: 0.5 mg

6-16 years: 1 mg

0.3-0.6 ppm:

Birth to 3 years: 0 mg

3-6 years: 0.25 mg

6-16 years: 0.5 mg

>0.6 ppm:

All ages: 0 mg

*Adapted from AAP News, 1995, 11(2):18

Dental rinse or gel:

Children 6-12 years: 5-10 mL rinse or apply to teeth and spit daily after brushing

Adults: 10 mL rinse or apply to teeth and spit daily after brushing

Do not administer with milk; do not allow eating or drinking for 30 minutes after use

No information available to require special precautions

No effects or complications reported

Take with food (but not milk) to eliminate GI upset; with dental rinse or dental gel do not swallow, do not eat or drink for 30 minutes after use

Avoid giving with milk or dairy products

Fluoride ion content listed in brackets

Fluoritab®, Flura-Drops®: 0.55 mg/drop [0.25 mg/drop] (22.8 mL, 24 mL)

Karidium®, Luride®: 0.275 mg/drop [0.125 mg/drop] (30 mL, 60 mL)

Pediaflor®: 1.1 mg/mL [0.5 mg/mL] (50 mL)

Gel, topical:

Acidulated phosphate fluoride (Minute-Gel®): 1.23% (480 mL)

Sodium fluoride (Karigel®, Karigel®-N, PreviDent®): 1.1% [0.5%] (24 g, 30 g, 60 g, 120 g, 130 g, 250 g)

Stannous fluoride (Gel Kam®, Gel-Tin®, Stop®): 0.4% [0.1%] (60 g, 65 g, 105 g, 120 g)

Lozenge, as sodium (Flura-Loz®) (raspberry flavor): 2.2 mg [1 mg]

Rinse, topical, as sodium:

ACT®, Fluorigard®: 0.05% [0.02%] (90 mL, 180 mL, 300 mL, 360 mL, 480 mL)

Fluorinse®, Point-Two®: 0.2% [0.09%] (240 mL, 480 mL, 3780 mL)

Listermint® with Fluoride: 0.02% [0.01%] (180 mL, 300 mL, 360 mL, 480 mL, 540 mL, 720 mL, 960 mL, 1740 mL)

Solution, oral, as sodium (Phos-Flur®): 0.44 mg/mL [0.2 mg/mL] (250 mL, 500 mL, 3780 mL)

Tablet, as sodium:

Chewable:

Fluoritab®, Luride® Lozi-Tab®, Pharmaflur®: 1.1 mg [0.5 mg]

Fluoritab®, Karidium®, Luride® Lozi-Tab®, Luride®-SF Lozi-Tab®, Pharmaflur®: 2.2 mg [1 mg]

Oral: Flura®, Karidium®: 2.2 mg [1 mg]

Berman L, Taves D, Mitra S, et al, "Inorganic Fluoride Poisoning: Treatment by Hemodialysis," N Engl J Med, 1973, 289(17):922.

Cummings CC and McIvor ME, "Fluoride-Induced Hyperkalemia: The Role of Ca(2+)-Dependent K⁺ Channels," Am J Emerg Med, 1988, 6(1):1-3.

McIvor ME, "Acute Fluoride Toxicity. Pathophysiology and Management," Drug Saf, 1990, 5(2):79-85.

Pak CYS, Sakhaee K, Adams-Huet B, et al, "Treatment of Postmenopausal Osteoporosis With Slow-Release Sodium Fluoride: Final Report of a Randomized Controlled Trial," Ann Intern Med, 1995, 123(6):401-8.

Pitt P and Berry H, "Fluoride Treatment in Osteoporosis," Postgrad Med J, 1991, 67(786):323-6.

Riggs BL, Hodgson SF, O'Fallon WM, et al, "Effect of Fluoride Treatment on the Fracture Rate in Postmenopausal Women With Osteoporosis," N Engl J Med, 1990, 322(12):802-9.

Schuman AJ, "How Much Fluoride Is Too Much? The New Guidelines," Contemp Pediatr, 1995, 12(6):65-74.

U.S. Department of Health and Human Services, "Toxicological Profile for Fluorides, Hydrogen Fluoride, and Fluorine (F) TP-91/17," Agency for Toxic Substances and Diseases Registry, 1993.