Stannous fluoride

Stannous 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: Alberto Plate [2]

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Overview

Stannous fluoride is an anticavity, antigingivitis, antihypersensitivity mouthrinse that is FDA approved for the prophylaxis of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. Common adverse reactions include surface staining of the teeth.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Adults and children 6 years of age and older:

• Do not use before mixing with water. Use immediately after preparing the rinse.
• Remove cap and replace with pump.
• Rotate spout container clockwise to extend.
• Depress pump until rinse comes to the tip of the pump.
• Depress pump twice into cup provided (1/8oz). Add water to line (1oz) on cup. Mix well.
• Vigorously swish rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
• Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Adults and children 6 years of age and older:

• Do not use before mixing with water. Use immediately after preparing the rinse.
• Remove cap and replace with pump.
• Rotate spout container clockwise to extend.
• Depress pump until rinse comes to the tip of the pump.
• Depress pump twice into cup provided (1/8oz). Add water to line (1oz) on cup. Mix well.
• Vigorously swish rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
• Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

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 Stannous fluoride in pediatric patients.

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

• Keep out of reach of children.
• Do not swallow. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison *Control Center right away.
• Do not use until diluted.
• This product may produce surface staining of the teeth.
• Adequate tooth-brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Stannous fluoride Clinical Trials Experience in the drug label.

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Stannous fluoride in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Stannous fluoride in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Stannous fluoride in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

There is limited information regarding Stannous fluoride Administration in the drug label.

Monitoring

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

IV Compatibility

There is limited information regarding the compatibility of Stannous fluoride and IV administrations.

Overdosage

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

Pharmacology

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

• Store at controlled room temperature 59° - 86°F (15°-30°C). Protect from freezing.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

There is limited information regarding Stannous fluoride Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Stannous 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.