Flurodent

Approved Indications:

• Dental Caries Prevention: Topical or systemic use for prevention and reduction of dental caries in children and adults, especially in areas with non-fluoridated water supplies.
• Treatment of Dental Hypersensitivity: Reduces sensitivity in exposed dentin by occluding dentinal tubules.
• Osteoporosis (Off-label use): As adjunct therapy to stimulate new bone formation in postmenopausal osteoporosis, though not a first-line treatment.
• Dental Fluorosis (for diagnostic use): Used in evaluating fluoride exposure and toxicity.
• Tooth Remineralization: Promotes enamel remineralization in early-stage caries.

Dosage Forms Available: Tablets, mouth rinses, toothpaste, gels, lozenges, drops.

Dental Caries Prophylaxis (Systemic) – Oral Tablets/Drops:

• Children (6 months–16 years) (dose depends on age and water fluoride content):
• <0.3 ppm fluoride in water:
• 6 mo–3 yrs: 0.25 mg/day
• 3–6 yrs: 0.5 mg/day
• 6–16 yrs: 1 mg/day
• 0.3–0.6 ppm:
• 3–6 yrs: 0.25 mg/day
• 6–16 yrs: 0.5 mg/day
• 0.6 ppm: No supplementation needed

Topical Dental Caries Prevention – Toothpaste/Gel/Rinse:

• Children over 2 years and adults:
• Use toothpaste containing 1000–1500 ppm fluoride twice daily.
• Fluoride mouth rinses (0.05% NaF daily or 0.2% NaF weekly).
• Professional use:
• 2% sodium fluoride gel or varnish applied every 3–6 months by dental professionals.

Dental Hypersensitivity:

• Sodium fluoride varnish or toothpaste applied twice daily or as per dental recommendation.

Osteoporosis (Off-label):

• 25–50 mg elemental fluoride daily, in divided doses, often combined with calcium and vitamin D supplements.

Special Populations:

• Renal impairment: Caution advised; fluoride is excreted renally—dose adjustment may be necessary.
• Elderly: Use standard adult doses but monitor bone health and renal function.
• Pregnancy: Supplementation generally not needed if dietary intake is adequate.

Sodium fluoride exerts its anti-caries effect through topical and systemic actions. Topically, it promotes remineralization of demineralized enamel by forming fluorapatite, a more acid-resistant crystalline structure. It also inhibits bacterial metabolism by interfering with enzyme activity in cariogenic organisms like Streptococcus mutans. Systemically, fluoride becomes incorporated into developing dental enamel during tooth formation, making the enamel more resistant to decay. In bone, fluoride stimulates osteoblast activity and enhances bone matrix mineralization, although high doses may impair bone quality.

• Absorption: Rapidly absorbed from the gastrointestinal tract (90% bioavailability).
• Distribution: Distributes throughout the body; 99% found in bones and teeth.
• Metabolism: Not metabolized; exists as free fluoride ion in plasma.
• Half-life: Approximately 3–10 hours depending on renal function.
• Excretion: Primarily via kidneys through glomerular filtration; small amounts in feces and sweat.
• Onset of Action: Preventive effects on teeth are gradual and cumulative with long-term use.

• Pregnancy: Not assigned a specific FDA category. Supplementation is not routinely recommended during pregnancy unless fluoride intake is deficient.
• Lactation: Sodium fluoride is excreted in small amounts into breast milk. Considered safe in recommended doses. No adverse effects expected in nursing infants at therapeutic levels.
• Caution: Avoid excessive intake during pregnancy and lactation to prevent fluorosis.

• Primary Class: Anti-caries agent
• Subclass: Inorganic fluoride compound
• Other Use: Bone metabolism modifier (off-label)

• Known hypersensitivity to sodium fluoride or any component of the formulation
• Children unable to expectorate (for rinses/gels)
• Patients in areas with high natural fluoride content in drinking water (>0.6 ppm for children)
• Severe renal impairment (risk of accumulation)

• Fluorosis Risk: Prolonged high intake in children may cause dental or skeletal fluorosis.
• Pediatric Use: Use age-appropriate doses and supervise young children to avoid swallowing topical products.
• Renal Impairment: Reduced clearance may increase fluoride accumulation and toxicity.
• Accidental Ingestion: Ingestion of large quantities (especially from toothpaste or rinses) may cause acute toxicity.
• Monitoring: Evaluate total fluoride exposure from all sources before supplementing.

Common (Mild):

• Gastrointestinal upset (nausea, vomiting)
• Chalky white spots on teeth (mild fluorosis in children)
• Mild irritation of oral mucosa with topical forms

Serious (Rare, usually with overdose):

• Dental fluorosis (in children with excessive intake)
• Skeletal fluorosis (chronic overuse)
• Hypocalcemia, tetany (in severe acute toxicity)
• Neurological effects: headache, tremors (high doses)

Acute Toxicity Signs (usually from ingestion >5 mg/kg):

• Nausea, abdominal pain, diarrhea
• Hypotension, seizures, cardiac arrhythmias (in severe overdose)

• Calcium, Magnesium, Aluminum-containing products: Reduce fluoride absorption—avoid taking together.
• Antacids or dairy: Delay fluoride dosing by 2 hours if co-administered.
• Tetracyclines (in vitro): May form complexes, though not clinically significant.
• Enzyme Systems: Not metabolized via CYP450; no enzyme-mediated interactions.

• CDC and WHO continue to recommend fluoride use for caries prevention, with emphasis on correct dosing and supervision in children.
• Some recent international guidelines have refined dosage thresholds for pediatric fluoride supplementation based on updated water fluoride levels.
• Fluoride varnish remains the preferred form for in-office topical prevention in high-risk pediatric populations.

• Tablets, Rinses, Gels, Toothpaste:
• Store at 20°C to 25°C (68°F to 77°F)
• Protect from excessive heat and moisture
• Do not freeze liquid formulations
• Keep tightly closed and out of reach of children
• Fluoride Varnish:
• Store below 30°C; protect from light
• Shake well before use