Sodium Fluoride Topical

Sodium fluoride topical is used to prevent dental caries (cavities).

Sodium fluoride topical is available under the following different brand names: PreviDent, Phos-Flur Rinse, Phos-Flur Gel, and PreviDent 5000.

Dosages of Sodium Fluoride Topical:

Dosage Forms and 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)

Dosage Considerations – Should be Given as Follows:

Dental Caries Prevention

Dental Gel/Cream

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

Dental Rinse

• 5-10 mL orally once daily 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 once daily

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

Side effects of sodium fluoride topical include:

• Drooling
• Mouth/gum irritation
• Nausea, vomiting, stomach pain, diarrhea, headache, muscle tremor (if accidentally swallowed)
• Discoloration of teeth (rare)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Sodium fluoride topical has no listed severe interactions with other drugs.
• Sodium fluoride topical has no listed serious interactions with other drugs.
• Sodium fluoride topical has no listed moderate interactions with other drugs.
• Sodium fluoride topical has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains a sodium fluoride topical. Do not take PreviDent, Phos-Flur Rinse, Phos-Flur Gel, or PreviDent 5000 if you are allergic to sodium fluoride topical or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity
• 1 mg/5mL rinse in children under 6 years
• Low sodium or sodium-free diets
• Drinking water fluoride content 0.7 ppm or greater

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Sodium Fluoride Topical?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Sodium Fluoride Topical?”

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 a low-sodium diet
• Supervise use in children; do not use in children unable to expectorate content
• Some products may contain tartrazine

Pregnancy and Lactation

• Sodium fluoride topical may be acceptable for use during pregnancy. Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk. Heavy in-utero exposure to fluoride may cause skeletal fluorosis.
• Sodium fluoride topical is distributed in breast milk. Consult your doctor before breastfeeding.