Sodium Fluoride 1.1mg (0.5mg)chew T
This supplement is used to prevent cavities.
Drug Class
Dental caries prophylactic agent
Pharmacologic Class
Fluoride supplement
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Sodium Fluoride chewable tablets are a medicine that helps make your child's teeth stronger and protects them from getting cavities. It works by making the tooth enamel more resistant to the acids that cause tooth decay.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food. Unless your doctor advises otherwise, take this medication before bedtime, after brushing your teeth.
Chew the medication thoroughly before swallowing. Some brands of this medication can also be dissolved in your mouth - check with your doctor or pharmacist to see if this applies to your medication. The frequency of taking this medication varies depending on the product, so be sure to follow your doctor's instructions. Some products are taken daily, while others are taken only once a week.
Important Interactions to Avoid
Do not take antacids containing magnesium or aluminum at the same time as this medication. If you have any questions, consult your doctor or pharmacist. Additionally, avoid taking this medication within 2 hours of consuming dairy products or other calcium-containing products.
Storing and Disposing of Your Medication
Store your medication at room temperature, keeping it in a safe place out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about the best way to dispose of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food. Unless your doctor advises otherwise, take this medication before bedtime, after brushing your teeth.
Chew the medication thoroughly before swallowing. Some brands of this medication can also be dissolved in your mouth - check with your doctor or pharmacist to see if this applies to your medication. The frequency of taking this medication varies depending on the product, so be sure to follow your doctor's instructions. Some products are taken daily, while others are taken only once a week.
Important Interactions to Avoid
Do not take antacids containing magnesium or aluminum at the same time as this medication. If you have any questions, consult your doctor or pharmacist. Additionally, avoid taking this medication within 2 hours of consuming dairy products or other calcium-containing products.
Storing and Disposing of Your Medication
Store your medication at room temperature, keeping it in a safe place out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about the best way to dispose of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take exactly as prescribed by your doctor or dentist.
- Chew or dissolve the tablet in the mouth before swallowing; do not swallow whole.
- Do not take with milk or other dairy products, or with calcium, magnesium, or aluminum-containing antacids/supplements. Wait at least 1 hour before or after taking these products.
- Maintain good oral hygiene, including regular brushing with fluoride toothpaste and flossing.
- Ensure regular dental check-ups for your child.
- Store out of reach of children to prevent accidental overdose.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Not typically indicated for systemic fluoride supplementation in adults via chewable tablets; primarily pediatric use.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (Fluoride drops or lower strengths may be used for infants based on water fluoride levels)
Child:
Dosing is based on age and the fluoride concentration in the community drinking water. For 0.5 mg fluoride (1.1 mg Sodium Fluoride) chewable tablets: Children 3-6 years of age: 0.5 mg fluoride daily if drinking water contains less than 0.3 ppm fluoride. Children 6-16 years of age: 0.5 mg fluoride daily if drinking water contains 0.3-0.6 ppm fluoride.
Adolescent:
Adolescents 6-16 years of age: 0.5 mg fluoride daily if drinking water contains 0.3-0.6 ppm fluoride.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for signs of fluorosis.
Moderate:
Use with caution; consider dose reduction or avoidance due to risk of fluoride accumulation and fluorosis.
Severe:
Contraindicated due to significant risk of fluoride accumulation and toxicity.
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Pharmacology
Mechanism of Action
Fluoride ions replace hydroxyl ions in the hydroxyapatite crystal lattice of tooth enamel, forming fluorapatite. Fluorapatite is more resistant to acid dissolution, thereby enhancing remineralization and inhibiting demineralization of tooth enamel. Fluoride also inhibits bacterial enzymes, reducing acid production by oral bacteria, and can have direct antibacterial effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80-90% (rapidly absorbed from the gastrointestinal tract)
Tmax:
30-60 minutes
FoodEffect:
Food, especially dairy products or calcium/magnesium/aluminum-containing antacids, can significantly reduce absorption by forming insoluble fluoride complexes.
Distribution:
Vd:
Not readily quantifiable due to rapid uptake into calcified tissues; distributes widely, concentrating in bones and teeth.
ProteinBinding:
Low (<10%)
CnssPenetration:
Limited, but can cross the blood-brain barrier.
Elimination:
HalfLife:
Variable; typically 2-9 hours in plasma, but much longer in calcified tissues (days to years).
Clearance:
Primarily renal clearance.
ExcretionRoute:
Renal (urine)
Unchanged:
>90%
Pharmacodynamics
OnsetOfAction:
Systemic effect is continuous with daily administration; local effect on enamel is ongoing.
PeakEffect:
Not applicable for prophylactic effect; plasma levels peak within 30-60 minutes.
DurationOfAction:
Continuous with daily dosing; fluoride incorporated into enamel provides long-term protection.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe stomach upset or vomiting
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or persist, contact your doctor for advice.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe stomach upset or vomiting
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or persist, contact your doctor for advice.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- White, yellow, or brown spots or streaks on teeth (dental fluorosis) - contact your dentist.
- Nausea, vomiting, stomach pain, diarrhea (signs of acute overdose) - seek immediate medical attention.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bone problems
+ Joint problems
+ Kidney problems
+ Ulcers
The level of fluoride in your drinking water, particularly if it is greater than or equal to 0.6 parts per million.
Additionally, to ensure safe use, it is crucial to disclose all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
as well as any existing health problems to your doctor and pharmacist. This will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bone problems
+ Joint problems
+ Kidney problems
+ Ulcers
The level of fluoride in your drinking water, particularly if it is greater than or equal to 0.6 parts per million.
Additionally, to ensure safe use, it is crucial to disclose all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
as well as any existing health problems to your doctor and pharmacist. This will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you notice any staining or spotting on your teeth, be sure to notify your dentist. Regular dental care is crucial, so schedule frequent dental check-ups to maintain good oral health.
In the event of accidental ingestion of a large amount of this medication, seek immediate medical attention by calling a doctor or poison control center right away, as it can cause harm. Note that different brands of this medication may be suitable for children of various ages, so it is crucial to consult with your doctor before administering this drug to a child.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
In the event of accidental ingestion of a large amount of this medication, seek immediate medical attention by calling a doctor or poison control center right away, as it can cause harm. Note that different brands of this medication may be suitable for children of various ages, so it is crucial to consult with your doctor before administering this drug to a child.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose: Nausea, vomiting, abdominal pain, diarrhea, excessive salivation, muscle weakness, tremors, seizures, cardiac arrhythmias, hypotension, respiratory depression, coma.
- Chronic overdose: Dental fluorosis (mottling of tooth enamel), skeletal fluorosis (bone pain, stiffness, joint deformities - rare with typical supplementation).
What to Do:
For acute overdose, immediately seek emergency medical attention. Call 911 or Poison Control (1-800-222-1222). Induce vomiting if conscious and within minutes of ingestion. Administer milk or calcium-containing liquids to bind fluoride. Hospital management may include gastric lavage, IV calcium, and supportive care.
Drug Interactions
Moderate Interactions
- Calcium-containing products (e.g., milk, dairy products, calcium supplements, calcium-containing antacids)
- Magnesium-containing products (e.g., magnesium supplements, magnesium-containing antacids)
- Aluminum-containing products (e.g., aluminum hydroxide antacids)
Monitoring
Baseline Monitoring
Fluoride concentration in primary drinking water source
Rationale: To determine appropriate fluoride supplementation dosage and prevent over-supplementation and fluorosis.
Timing: Prior to initiation of therapy and periodically if water source changes.
Dental examination
Rationale: To assess baseline dental health and identify any existing fluorosis or caries.
Timing: Prior to initiation of therapy.
Routine Monitoring
Dental examination for signs of fluorosis
Frequency: Annually or as recommended by dentist
Target: Absence of dental fluorosis (white or brown mottling)
Action Threshold: Presence of mild to severe fluorosis may indicate over-supplementation and require dose adjustment or discontinuation.
Overall oral hygiene and caries status
Frequency: Regular dental check-ups (e.g., every 6-12 months)
Target: Good oral hygiene, reduction in caries incidence
Action Threshold: Increased caries despite supplementation may indicate need for re-evaluation of oral hygiene practices or other interventions.
Symptom Monitoring
- Dental fluorosis (white, yellow, or brown discoloration/mottling of tooth enamel)
- Gastrointestinal upset (nausea, vomiting, abdominal pain) - rare with therapeutic doses, but a sign of acute overdose.
Special Patient Groups
Pregnancy
Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Generally considered safe when used at recommended doses.
Trimester-Specific Risks:
First Trimester:
Low risk.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
L2 - Likely compatible. Fluoride is excreted in breast milk in small amounts. The amount is generally considered too low to provide significant systemic fluoride to the infant, but caution is advised.
Infant Risk:
Low risk of adverse effects to the breastfed infant at therapeutic maternal doses. Consider total fluoride exposure from all sources for the infant.
Pediatric Use
This is the primary target population. Dosing is critical and must be based on the child's age and the fluoride concentration in the primary drinking water source to prevent dental fluorosis and ensure effective caries prevention. Over-supplementation can lead to dental fluorosis.
Geriatric Use
Not typically indicated for systemic fluoride supplementation in geriatric patients via chewable tablets. Fluoride needs in this population are usually met through fluoridated water, toothpaste, or topical applications.
Clinical Information
Clinical Pearls
- Always determine the fluoride concentration of the patient's primary drinking water source before prescribing systemic fluoride supplements to avoid over-supplementation and dental fluorosis.
- Educate parents/caregivers on the importance of proper dosing and storage to prevent accidental overdose, which can be serious.
- Advise patients to avoid taking fluoride tablets with milk, dairy products, or calcium/magnesium/aluminum-containing antacids/supplements, as these can significantly reduce fluoride absorption. Separate administration by at least 1 hour.
- Chewable tablets should be chewed or dissolved in the mouth, not swallowed whole, to allow for some topical fluoride exposure to the teeth.
- Dental fluorosis is a sign of chronic over-exposure to fluoride during tooth development and can range from barely noticeable white flecks to severe brown staining and pitting.
Alternative Therapies
- Fluoridated drinking water
- Fluoride varnish (professional application)
- Fluoride gels (prescription or OTC)
- Fluoride rinses (OTC or prescription)
- Fluoride toothpaste (OTC)
- Sodium fluoride oral solution/drops (for younger children)
Cost & Coverage
Average Cost:
$10 - $30 per 120 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often covered by most insurance plans)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.