sodium fluoride topical (Rx, OTC)

Brand and Other Names:PreviDent, Phos-Flur Rinse, more...Phos-Flur Gel, PreviDent 5000
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

dental cream

  • 1.1% as sodium

dental gel

  • 1.1% as sodium
  • 0.4% as stannous fluoride

dental paste

  • 1.1% as sodium

liquid, base

  • 0.125 mg/drop

solution

  • 0.02% as fluoride
  • 0.2% as sodium

drops

  • 1.1 mg/mL as sodium (equivalent to fluoride 0.5 mg/mL)

lozenge

  • 2.21 mg (equivalent to 1 mg fluoride)
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Dental Caries Prevention

Dental Gel/Cream

  • Apply thin ribbon to toothbrush; brush thoroughly qDay at bedtime for 2 minutes
  • Expectorate after brushing; for best results do not eat, drink, or rinse mouth for 30 minutes

Dental Rinse

  • 5-10 mL PO qDay or q12hr; swish for 1 minute, then expectorate
  • Use immediately after brushing/flossing teeth
  • Avoid eating, drinking, or rinsing your mouth for at least 30 minutes after using this to enable the medication to have contact with the teeth

Lozenge

  • 1 lozenge qDay

Dosage Forms & Strengths

dental cream

  • 1.1%

dental gel

  • 1.1% as sodium
  • 0.4% as stannous fluoride

solution

  • 0.02% as fluoride
  • 0.2% as sodium
more...

Dental Caries Prevention

Infants and young children <6 years: Safety and efficacy not established

May be prescribed for older children and adolescents undergoing orthodontia

Dental Gel/Cream

  • Apply thin ribbon to toothbrush; brush thoroughly qDay at bedtime for 2 minutes
  • Pediatric patients aged 6-16 years: Expectorate after brushing, and rinse mouth thoroughly; for best results do not eat or drink for 30 minutes

Dental Rinse

  • 5-10 mL PO qDay or q12hr; swish for 1 minute, then expectorate
  • Use immediately after brushing/flossing teeth
  • Do not swallow rinse unless directed by your doctor or dentist
  • Avoid eating, drinking, or rinsing your mouth for at least 30 minutes after using this to enable the medication to have contact with the teeth
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Adverse Effects

Frequency Not Defined

Sialorrhea

Mouth/gum irritation

Nausea, vomiting, stomach pain, diarrhea, headache, muscle tremor (if accidentally swallowed)

Discoloration of teeth (rare)

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Warnings

Contraindications

Hypersensitivity

1 mg/5mL rinse in children < 6 years

Low sodium or sodium free diets

Drinking water fluoride content ≥ 0.7 ppm

Cautions

Not for systemic use; do not swallow

Continuous ingestion may result in fluoride toxicity; particularly in young children and if water fluoridation exceeds 0.6 ppm (dental fluorosis or osseous changes may occur)

Caution with kidney disease, peptic ulcer disease, severe joint pain, or low-sodium diet

Supervise use in children; do not use in children unable to expectorate content

Some products may contain tartrazine

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Pregnancy & Lactation

Pregnancy Category: B; heavy in utero exposure to fluoride may cause skeletal fluorosis

Lactation: Distributed in breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Provides fluorosis; frequent topical applications of high fluoride content to the teeth increases tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel

Pharmacokinetics

Absorption: Rapid and complete

Distribution: 50% deposited in teeth and bone after ingestion

Excretion: Urine and feces

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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