Sodium fluoride

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Sodium fluoride
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Sodium fluoride is a dental agent that is FDA approved for the prophylaxis of dental caries. Common adverse reactions include dental fluorosis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • Aids in the prevention of dental cavities

Dosage

  • Use once a day after brushing your teeth with a toothpaste
  • Hold bottle upright and squeeze. Fill to FILL LINE pour out. Only the correct 10 milliliters dose will pour out.
  • Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sodium fluoride in adult patients.

Non–Guideline-Supported Use

Indications

  • Sensitive dentin

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

  • Aids in the prevention of dental cavities

Dosing

Children 6 years of age and older

  • Use once a day after brushing your teeth with a toothpaste
  • Hold bottle upright and squeeze. Fill to FILL LINE pour out. Only the correct 10 milliliters dose will pour out.

Children under 6 years of age: consult a dentist or doctor

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sodium flouride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium fluoride in pediatric patients.

Contraindications

There is limited information regarding Sodium fluoride Contraindications in the drug label.

Warnings

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Sodium fluoride in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Sodium fluoride in the drug label.

Drug Interactions

There is limited information regarding Sodium fluoride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Sodium fluoride in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sodium fluoride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sodium fluoride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sodium fluoride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Sodium fluoride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Sodium fluoride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Sodium fluoride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sodium fluoride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sodium fluoride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sodium fluoride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sodium fluoride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sodium fluoride in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Monitoring of Sodium fluoride in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Sodium fluoride in the drug label.

Overdosage

There is limited information regarding Sodium fluoride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

This image is provided by the National Library of Medicine.

Mechanism of Action

There is limited information regarding Sodium fluoride Mechanism of Action in the drug label.

Structure

There is limited information regarding Sodium fluoride Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Sodium fluoride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Sodium fluoride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Sodium fluoride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Sodium fluoride in the drug label.

How Supplied

There is limited information regarding Sodium fluoride How Supplied in the drug label.

Storage

There is limited information regarding Sodium fluoride Storage in the drug label.

Images

Drug Images

Package and Label Display Panel

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Sodium fluoride in the drug label.

Precautions with Alcohol

  • Alcohol-Sodium fluoride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

ACT ANTICAVITY FLUORIDE CINNAMON

Look-Alike Drug Names

There is limited information regarding Sodium fluoride Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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