Sodium Fluoride 1.0mg Chewable Tabs
This supplement is used to prevent cavities.
Drug Class
Dental caries prophylactic
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 teeth stronger and more resistant to cavities. It works by adding fluoride to your tooth enamel, which is the hard outer layer of your teeth. This is especially important for children who don't get enough fluoride from their drinking water.
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 with your prescription 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, so be sure to check with your doctor or pharmacist for specific instructions. The frequency of taking this medication varies, with some products taken daily and others taken only once a week. Be sure to follow the schedule recommended by your doctor.
Important Interactions to Avoid
Do not take antacids containing magnesium or aluminum at the same time as this medication. If you have questions, consult your doctor or pharmacist. Additionally, avoid taking this medication within 2 hours of consuming dairy products or other calcium-rich foods.
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. Instead, check with your pharmacist for guidance on the best disposal method, which may include participating in a local drug take-back program.
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 scheduled 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 with your prescription 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, so be sure to check with your doctor or pharmacist for specific instructions. The frequency of taking this medication varies, with some products taken daily and others taken only once a week. Be sure to follow the schedule recommended by your doctor.
Important Interactions to Avoid
Do not take antacids containing magnesium or aluminum at the same time as this medication. If you have questions, consult your doctor or pharmacist. Additionally, avoid taking this medication within 2 hours of consuming dairy products or other calcium-rich foods.
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. Instead, check with your pharmacist for guidance on the best disposal method, which may include participating in a local drug take-back program.
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 scheduled 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
- Chew or dissolve the tablet in the mouth completely before swallowing, preferably at bedtime after brushing teeth.
- Do not eat, drink, or rinse for at least 30 minutes after taking the tablet to allow maximum topical effect.
- Take consistently every day as prescribed.
- Do not take with milk, dairy products, or antacids; separate by at least 2 hours.
- Continue good oral hygiene practices, including brushing twice daily with fluoridated toothpaste and flossing.
- Regular dental check-ups are essential.
Available Forms & Alternatives
Available Strengths:
- Sod Fluoride 1.1 (.5mg)/ml Drp 50ml
- Sodium Fluoride 1.1mg (0.5mg)chew T
- Sodium Fluoride 1.0mg Chewable Tabs
- Sod Fluoride 0.55mg (0.25mg)chew T
- Sod Fluoride 5000 1.1% Pste/sprmint
- Sod Fluoride 5000 1.1% Paste/fruit
- Sod Fluor 5000 1.1% Pst (dry Mouth)
- Sod Fluoride 5000 Ppm Ena Pro Pst
- Sod Fluoride 0.2% Mint Solution
- Sod Fluoride/pot Nit Sen 1.1-5% Pst
Dosing & Administration
Adult Dosing
Standard Dose:
Not typically indicated for routine systemic prophylaxis in adults with fluoridated water. If water fluoride is <0.3 ppm, 1.0 mg fluoride daily may be considered, but topical fluoride is usually preferred.
Condition-Specific Dosing:
low_water_fluoridation:
1.0 mg fluoride (1 tablet) daily if drinking water contains <0.3 ppm fluoride.
Pediatric Dosing
Neonatal:
Not established (generally not recommended for infants under 6 months)
Infant:
Based on fluoride concentration in drinking water:
- If <0.3 ppm F-: 0.25 mg F- (1/4 tablet) daily for ages 6 months to 3 years.
- If 0.3-0.6 ppm F-: Not recommended for this age group.
- If >0.6 ppm F-: Not recommended for supplementation.
Child:
Based on fluoride concentration in drinking water:
- If <0.3 ppm F-: 0.5 mg F- (1/2 tablet) daily for ages 3 to 6 years; 1.0 mg F- (1 tablet) daily for ages 6 to 16 years.
- If 0.3-0.6 ppm F-: 0.25 mg F- (1/4 tablet) daily for ages 3 to 6 years; 0.5 mg F- (1/2 tablet) daily for ages 6 to 16 years.
- If >0.6 ppm F-: Not recommended for supplementation.
Adolescent:
Based on fluoride concentration in drinking water:
- If <0.3 ppm F-: 1.0 mg F- (1 tablet) daily for ages 6 to 16 years.
- If 0.3-0.6 ppm F-: 0.5 mg F- (1/2 tablet) daily for ages 6 to 16 years.
- If >0.6 ppm F-: Not recommended for supplementation.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for fluorosis.
Moderate:
Use with caution; consider dose reduction or avoidance due to impaired excretion and increased risk of fluorosis.
Severe:
Contraindicated due to significant risk of fluoride accumulation and toxicity (skeletal fluorosis).
Dialysis:
Contraindicated; fluoride is not effectively removed by dialysis and accumulation can occur.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific 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 inhibiting demineralization and enhancing remineralization of early carious lesions. Fluoride also inhibits bacterial enzymes, reducing acid production by oral bacteria.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90-95% (rapid and nearly complete from GI tract, especially on an empty stomach).
Tmax:
30-60 minutes
FoodEffect:
Food, especially dairy products or calcium/magnesium/aluminum-containing antacids, can significantly reduce absorption by forming insoluble fluoride complexes. Administer at least 2 hours apart.
Distribution:
Vd:
Not readily quantifiable, distributes throughout total body water.
ProteinBinding:
Minimal
CnssPenetration:
Limited (crosses blood-brain barrier to a small extent)
Elimination:
HalfLife:
2-9 hours (plasma); much longer in calcified tissues (days to years)
Clearance:
Primarily renal clearance.
ExcretionRoute:
Primarily renal (50-90% excreted in urine within 24 hours); small amounts in feces and sweat.
Unchanged:
Nearly 100%
Pharmacodynamics
OnsetOfAction:
Immediate (systemic absorption); long-term (incorporation into enamel over time)
PeakEffect:
Not applicable for therapeutic effect on enamel; peak plasma levels within 30-60 minutes.
DurationOfAction:
Long-lasting (due to incorporation into tooth structure and bone); daily administration maintains optimal systemic levels for continuous benefit.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, including:
+ 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.
Note: This is not an exhaustive list of all possible side effects. 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, including:
+ 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.
Note: This is not an exhaustive list of all possible side effects. 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/streaks on teeth (dental fluorosis) - contact dentist/doctor.
- Nausea, vomiting, stomach pain, diarrhea (signs of acute overdose) - seek immediate medical attention.
- Muscle weakness, tremors, seizures (signs of severe 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 symptoms you experienced.
Certain health conditions, including:
+ Bone problems
+ Joint problems
+ Kidney problems
+ Ulcers
* If the fluoride level in your drinking water is 0.6 parts per million or higher.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. Never start, stop, or adjust 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 symptoms you experienced.
Certain health conditions, including:
+ Bone problems
+ Joint problems
+ Kidney problems
+ Ulcers
* If the fluoride level in your drinking water is 0.6 parts per million or higher.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. Never start, stop, or adjust 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. To maintain good oral health, practice proper dental care and schedule regular dental check-ups.
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. Note that different brands of this medication may be suitable for children of varying 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 breastfeeding, inform your doctor. You and your doctor 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. Note that different brands of this medication may be suitable for children of varying 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 breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Acute toxicity: Nausea, vomiting, abdominal pain, diarrhea, salivation, headache, weakness, muscle cramps, tetany, paresthesia, convulsions, cardiac arrhythmias, hypotension, respiratory depression. Severe cases can lead to shock and death.
- Chronic toxicity (Fluorosis): Dental fluorosis (enamel mottling, discoloration, pitting), skeletal fluorosis (joint pain, stiffness, bone changes, osteosclerosis).
What to Do:
For acute overdose, immediately seek emergency medical attention. Induce vomiting if conscious and within minutes of ingestion. Administer calcium (e.g., milk, calcium gluconate, calcium carbonate) to bind fluoride. Hospitalization for fluid and electrolyte management, cardiac monitoring, and supportive care. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Antacids (calcium, aluminum, magnesium-containing)
- Dairy products (milk, yogurt, cheese)
- Calcium supplements
Monitoring
Baseline Monitoring
Fluoride concentration in drinking water
Rationale: Essential for determining appropriate fluoride supplementation dosage to prevent under-dosing or over-dosing (fluorosis).
Timing: Prior to initiating therapy and periodically if water source changes.
Dental examination
Rationale: To assess baseline oral health and identify any existing dental fluorosis.
Timing: Before starting treatment.
Routine Monitoring
Dental check-ups
Frequency: Every 6-12 months
Target: Absence of dental caries; absence of moderate to severe dental fluorosis.
Action Threshold: Presence of new caries may indicate inadequate fluoride exposure or poor oral hygiene; presence of mild fluorosis may warrant dose reduction; moderate/severe fluorosis requires immediate cessation.
Assessment of fluoride intake from all sources
Frequency: Annually or as needed
Target: Total fluoride intake within recommended limits for age.
Action Threshold: Excessive intake from multiple sources (e.g., fluoridated toothpaste, other supplements, diet) may necessitate dose adjustment or cessation of chewable tablets.
Symptom Monitoring
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Headache
- Weakness
- Dental fluorosis (white flecks, streaks, or brown stains on teeth)
- Skeletal fluorosis (joint pain, stiffness, bone changes - rare with therapeutic doses)
Special Patient Groups
Pregnancy
Generally considered safe for use during pregnancy at recommended doses. Fluoride crosses the placenta, but no evidence of harm to the fetus has been demonstrated in human studies at therapeutic doses. Category B.
Trimester-Specific Risks:
First Trimester:
No increased risk of congenital malformations.
Second Trimester:
No known specific risks.
Third Trimester:
No known specific risks.
Lactation
Considered safe for use during breastfeeding. Fluoride is excreted into breast milk in small amounts, but the concentration is generally low and not considered harmful to the infant at therapeutic maternal doses. L1 (Safest).
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Primary indication for systemic fluoride supplementation. 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. Not recommended for infants under 6 months.
Geriatric Use
Generally not indicated for systemic dental caries prophylaxis in the elderly unless specific risk factors (e.g., xerostomia, high caries risk) and low water fluoridation are present. Renal function should be assessed due to fluoride's renal excretion.
Clinical Information
Clinical Pearls
- Always determine the fluoride concentration of the patient's primary drinking water source before prescribing systemic fluoride supplements.
- Emphasize the importance of proper administration: chew or dissolve completely, preferably at bedtime, and avoid food/drink for 30 minutes afterward.
- Educate parents about the signs of dental fluorosis and the need to contact their dentist if observed.
- Systemic fluoride supplements are typically discontinued once a child reaches 16 years of age, as tooth enamel development is largely complete.
- Ensure patients are not receiving fluoride from multiple systemic sources (e.g., drops, chewables, highly fluoridated water) to prevent overdose.
Alternative Therapies
- Fluoride drops (for infants and young children who cannot chew tablets)
- Fluoridated toothpaste
- Fluoride mouth rinses (for children over 6 years and adults)
- Professionally applied topical fluoride varnishes or gels
- Community water fluoridation
Cost & Coverage
Average Cost:
Varies, typically $10-$30 per 100 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.