sodium fluoride
ACT, Fluorigard, Fluorinse, Fluoritab, Flura-Drops, Flura-Loz, Karidium, Karigel, Karigel-N, Listermint with Fluoride, Luride, Luride Lozi-Tabs, Luride-SF Lozi-Tabs, Pediaflor, Phos-Flur, Point-Two, Prevident, Thera-Flur, Thera-Flur-N

Available forms
Available by prescription only
Drops: 0.125 mg/drop (30 ml), 0.125 mg/drop (60 ml, sugar-free), 0.25 mg/drop (19 ml), 0.25 mg/drop (24 ml, sugar-free), 0.5 mg/ml (50 ml)
Gel: 0.1% (65 g, 105 g, 122 g), 0.5% (24 g, 30 g, 60 g, 120 g, 130 g, 250 g), 1.23% (480 ml)
Gel drops: 0.5% (24 ml)
Lozenges: 1 mg
Rinse: 0.09% (240 ml, 480 ml), 0.09% (480 ml, sugar-free)
Tablets: 1 mg (sugar-free)
Tablets (chewable): 0.25 mg, 0.5 mg, 1 mg (sugar-free)
Available without a prescription
Gel: 0.1%
Rinse: 0.02%, 0.04%, 0.08%, 0.2%

Indications and dosages
 Aid in the prevention of dental caries.
Oral form. Children ages 6 to 16: 1 mg daily.
Children ages 3 to 5: 0.5 mg daily.
Children ages 6 months to 2 years: 0.25 mg daily.
≡ Dosage adjustment. If fluoride in the drinking water is less than 0.3 parts per million (ppm), use dosage listed; if fluoride content is 0.3 to 0.6 ppm, use one-half of dosage. Oral fluoride supplements aren’t needed in children younger than age 3 where the fluoride ion concentration in drinking water is 0.3 to 0.6 ppm; if fluoride content exceeds 0.6 ppm, don’t use.
Topical form. Adults and children older than age 12: 10 ml of 0.09% (0.2% fluoride ion) rinse. Use once daily after thoroughly brushing teeth and rinsing mouth. Rinse around and between teeth for 1 minute, then spit out.
Children ages 6 to 12: 5 ml of 0.09% (0.2% fluoride ion) solution.

Pharmacodynamics
Dental caries prophylactic action: Sodium fluoride acts systemically before tooth eruption and topically afterward by increasing tooth resistance to acid dissolution, by promoting remineralization, and by inhibiting the cariogenic microbial process. Acidulation provides greater topical fluoride uptake by dental enamel than neutral solutions. When topical fluoride is applied to hypersensitive exposed dentin, the formation of insoluble materials within the dentinal tubules blocks transmission of painful stimuli.

Pharmacokinetics
Absorption: Absorbed readily and almost completely from the GI tract. A large amount of an oral dose may be absorbed in the stomach; rate of absorption may depend on the gastric pH. Normal total plasma fluoride levels range from 0.14 to 0.19 mcg/ml.
Distribution: Stored in bones and developing teeth after absorption. Skeletal tissue also has a high storage capacity for fluoride ions. Because of the storage-mobilization mechanism in skeletal tissue, a constant fluoride supply may be provided. Fluoride has been found in all organs and tissues with a low accumulation in noncalcified tissues. Fluoride is distributed into sweat, tears, hair, and saliva. Fluoride crosses the placental barrier and is distributed into breast milk. Fluoride levels in milk range from about 0.05 to 0.13 ppm and remain fairly constant.
Metabolism: Not metabolized.
Excretion: Excreted rapidly, mainly in urine. About 90% of fluoride is filtered by the glomerulus and reabsorbed by the renal tubules.

Contraindications and precautions
Contraindicated in patients hypersensitive to fluoride. Also contraindicated when intake from drinking water exceeds 0.6 ppm.

Interactions
Drug-drug. Aluminum hydroxide or magnesium: May impair sodium fluoride absorption. Administer drugs at separate times.
Drug-food. Dairy foods: May cause incompatibility because of formation of calcium fluoride, which is poorly absorbed. Discourage use together.

Adverse reactions
CNS: headache, weakness.
GI: gastric distress.
Skin: hypersensitivity reactions (atopic dermatitis, eczema, urticaria).
Other: staining of teeth.

Effects on lab test results
None reported.

Overdose and treatment
In children, acute ingestion of 10 to 20 mg of sodium fluoride may cause excessive salivation and GI disturbances; 500 mg may be fatal. GI disturbances include salivation, nausea, abdominal pain, vomiting, and diarrhea. CNS disturbances include CNS irritability, paresthesia, tetany, hyperactive reflexes, seizures, and respiratory or cardiac failure (from the calcium-binding effect of fluoride). Hypoglycemia and hypocalcemia and delayed hyperkalemia are frequent laboratory findings.
 By using gastric lavage with 1% to 5% calcium chloride solution, the fluoride may be precipitated. Administer glucose I.V. in saline solution; parenteral calcium administration may be indicated for tetany. Maintain adequate urine output.

Special considerations
• Recommended doses are currently under study. Some evidence suggests that considerably less fluoride is needed for adequate supplementation.
• Tablets can be dissolved in the mouth, chewed, swallowed whole, added to drinking water or fruit juice, or added to water in infant formula or other foods.
• Drops may be administered orally undiluted or added to fluids or food.
• Sodium fluoride may be preferred to stannous fluoride to avoid staining tooth surfaces. Neutral sodium fluoride may also be preferred to acidulated fluoride to avoid dulling of porcelain and ceramic restorations.
• Prolonged intake of drinking water containing a fluoride ion concentration of 0.4 to 0.8 ppm may result in increased density of bone mineral and fluoride osteosclerosis.
• An oral sodium fluoride dose of 40 to 65 mg/day has resulted in adverse rheumatic effects.
• Drug is used investigationally to treat osteoporosis.
• Fluoride supplementation must be continuous from infancy to age 14 to be effective.
• Review dietary history with the family. A diet that includes large amounts of fish, mineral water, and tea provides about 5 mg/day of fluoride.
Breast-feeding patients
• Very little sodium fluoride appears in breast milk; it increases only when daily intake exceeds 1.5 mg.
Pediatric patients
• Young children usually can’t perform the rinse process needed with oral solutions. Because prolonged ingestion or improper techniques may result in dental fluorosis and osseous changes, the dose must be carefully adjusted according to the amount of fluoride ion in drinking water.

Patient education
• Tell patient that sodium fluoride tablets and drops should be taken with meals, but not with dairy products.
• Advise patient that rinse and gel are most effective if used immediately after brushing or flossing and when taken just before going to bed.
• Tell patient to expectorate (and not swallow) excess liquid or gel.
• Warn patient not to eat, drink, or rinse mouth for 15 to 30 minutes after application. Tell patient to use a plastic container-not glass-to dilute drops or rinse because the fluoride interacts with glass.
• Encourage patient to notify dentist if mottling of teeth occurs.
• Advise patient that if there is a change in water supply or if the patient moves to another area, a dentist should be contacted because excessive fluoride causes mottled tooth enamel. Tell patient that, if he uses a private well, to have the water tested for fluoride.
• Warn parents to treat fluoride tablets as a drug and to keep them away from children.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use