Sod Fluoride 0.55mg (0.25mg)chew T
This supplement is used to prevent cavities.
Drug Class
Dental Caries Prophylactic
Pharmacologic Class
Mineral Supplement; Anticaries Agent
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluoride chewable tablets are a medicine that helps make your child's teeth stronger and more resistant to cavities. It works by becoming part of the tooth enamel and also by helping to repair early damage to teeth.
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 depending on the product, so follow your doctor's guidance on whether to take it daily or once a week.
Important Interactions to Avoid
Do not take antacids containing magnesium or aluminum at the same time as this medication. Consult with your doctor or pharmacist if you have any questions. 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. Dispose of unused or expired medication properly. 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 with 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's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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 depending on the product, so follow your doctor's guidance on whether to take it daily or once a week.
Important Interactions to Avoid
Do not take antacids containing magnesium or aluminum at the same time as this medication. Consult with your doctor or pharmacist if you have any questions. 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. Dispose of unused or expired medication properly. 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 with 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's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take exactly as prescribed by your doctor or dentist.
- Chew or dissolve the tablet in the mouth before swallowing, preferably at bedtime after brushing teeth.
- Do not eat or drink for at least 15-30 minutes after taking the tablet to allow maximum topical effect.
- Avoid taking with milk, dairy products, or antacids, as these can reduce fluoride absorption. Separate by at least 1-2 hours.
- Continue good oral hygiene practices, including brushing twice daily with fluoride toothpaste and regular dental check-ups.
- Ensure your doctor or dentist knows the fluoride level in your child's drinking water.
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 systemic caries prevention in adults via chewable tablets; topical fluoride is preferred.
Pediatric Dosing
Neonatal:
Not established
Infant:
For infants 6 months to 3 years: 0.25 mg elemental fluoride once daily, if drinking water fluoride concentration is less than 0.3 ppm.
Child:
For children 3 to 6 years: 0.5 mg elemental fluoride once daily, if drinking water fluoride concentration is less than 0.3 ppm. Or 0.25 mg elemental fluoride once daily, if drinking water fluoride concentration is between 0.3 and 0.6 ppm. For children 6 to 16 years: 1.0 mg elemental fluoride once daily, if drinking water fluoride concentration is less than 0.3 ppm. Or 0.5 mg elemental fluoride once daily, if drinking water fluoride concentration is between 0.3 and 0.6 ppm.
Adolescent:
For adolescents 6 to 16 years: 1.0 mg elemental fluoride once daily, if drinking water fluoride concentration is less than 0.3 ppm. Or 0.5 mg elemental fluoride once daily, if drinking water fluoride concentration is between 0.3 and 0.6 ppm.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment guidelines; use with caution.
Moderate:
Use with caution; consider lower doses or avoid due to risk of fluoride accumulation and fluorosis.
Severe:
Contraindicated or use with extreme caution; significant risk of fluoride accumulation and skeletal fluorosis.
Dialysis:
Contraindicated due to risk of fluoride accumulation and toxicity.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Pharmacology
Mechanism of Action
Fluoride acts systemically and topically to prevent dental caries. Systemically, it is incorporated into the developing enamel structure during tooth formation, forming fluorapatite, which is more resistant to acid demineralization than hydroxyapatite. Topically, it promotes remineralization of early carious lesions, inhibits bacterial acid production by interfering with enzyme systems, and inhibits bacterial adherence to tooth surfaces.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90-95% (from soluble salts)
Tmax:
30-60 minutes
FoodEffect:
Food, especially dairy products or calcium/magnesium/aluminum-containing antacids, can significantly reduce absorption by forming insoluble complexes.
Distribution:
Vd:
Not readily quantifiable, but distributes widely throughout the body water.
ProteinBinding:
Low
CnssPenetration:
Limited
Elimination:
HalfLife:
2-9 hours (plasma); much longer in bone/teeth
Clearance:
Primarily renal clearance
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 50% of absorbed fluoride is excreted unchanged in urine within 24 hours; the remainder is rapidly taken up by calcified tissues.
Pharmacodynamics
OnsetOfAction:
Systemic effect: During tooth development. Topical effect: Immediate upon contact with tooth surface.
PeakEffect:
Systemic effect: Continuous incorporation during tooth development. Topical effect: Sustained remineralization and antibacterial activity with regular use.
DurationOfAction:
Systemic effect: Lifelong protection from incorporated fluoride. Topical effect: Continues as long as fluoride is present in the oral cavity and with regular exposure.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
+ Trouble 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. Although many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you have side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
This list is not exhaustive, and you may have questions about other potential side effects. If you do, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice and help you manage any side effects.
While rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
+ Trouble 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. Although many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you have side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
This list is not exhaustive, and you may have questions about other potential side effects. If you do, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice and help you manage any side effects.
Seek Immediate Medical Attention If You Experience:
- White, chalky spots or streaks on teeth (early sign of fluorosis)
- Brown stains or pitting on teeth (more severe fluorosis)
- Nausea, vomiting, stomach pain, diarrhea (signs of acute overdose)
- Excessive salivation, tearing, sweating (signs of acute overdose)
- Muscle weakness, tremors, seizures (severe acute overdose)
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 treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your overall health problems
This information will help your doctor determine if it is safe for you to take this medication with your other drugs 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 treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your overall health problems
This information will help your doctor determine if it is safe for you to take this medication with your other drugs 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 mention this to 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 medical attention immediately by calling a doctor or a poison control center. Be aware 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 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 to make an informed decision.
In the event of accidental ingestion of a large amount of this medication, seek medical attention immediately by calling a doctor or a poison control center. Be aware 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 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 to make an informed decision.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Excessive salivation
- Tearing
- Sweating
- Headache
- Weakness
- Tetany
- Paresthesia
- Muscle weakness
- Tremors
- Seizures
- Cardiac arrhythmias
- Hypocalcemia
- Hypomagnesemia
- Respiratory paralysis
What to Do:
Immediately seek emergency medical attention. For acute overdose, induce vomiting if conscious and within minutes of ingestion, then administer milk or calcium-containing antacids to bind fluoride. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Moderate Interactions
- Aluminum-containing antacids
- Calcium supplements
- Magnesium-containing laxatives/antacids
- Dairy products
Monitoring
Baseline Monitoring
Drinking water fluoride concentration
Rationale: To determine appropriate fluoride supplementation dosage and prevent fluorosis.
Timing: Before initiating therapy and periodically if water source changes.
Routine Monitoring
Dental examination for signs of fluorosis
Frequency: Annually or as recommended by dentist
Target: Absence of fluorosis or very mild, barely noticeable fluorosis.
Action Threshold: Presence of moderate to severe fluorosis warrants re-evaluation of fluoride intake.
Overall oral hygiene and caries status
Frequency: Regular dental check-ups (e.g., every 6-12 months)
Target: Healthy teeth, minimal or no new caries.
Action Threshold: Increased caries rate may indicate need for re-evaluation of oral hygiene, diet, or fluoride regimen.
Symptom Monitoring
- White flecks or streaks on tooth enamel (mild fluorosis)
- Brown stains or pitting on tooth enamel (moderate to severe fluorosis)
- Nausea, vomiting, abdominal pain (acute overdose)
- Muscle weakness, tremors, seizures (severe acute overdose)
Special Patient Groups
Pregnancy
Fluoride is classified as Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. Human studies are limited but do not suggest an increased risk of birth defects. Systemic fluoride supplementation during pregnancy is generally not recommended for caries prevention in the offspring, as the evidence for benefit is weak, and the primary benefit of fluoride is post-eruptive.
Trimester-Specific Risks:
First Trimester:
No known increased risk.
Second Trimester:
No known increased risk.
Third Trimester:
No known increased risk.
Lactation
Fluoride is excreted in breast milk in very small amounts, generally considered safe for the nursing infant. The amount transferred is typically too low to provide significant systemic fluoride to the infant.
Infant Risk:
L1 (Safest) - No known risk to the infant.
Pediatric Use
This medication is primarily indicated for pediatric use to prevent dental caries in children residing in areas with suboptimal drinking water fluoride concentrations. Dosage must be carefully determined based on age and the fluoride concentration of the primary drinking water source to prevent dental fluorosis.
Geriatric Use
Not typically indicated for systemic caries prevention in the elderly via chewable tablets. Topical fluoride applications (e.g., rinses, varnishes, toothpastes) are more commonly used for caries prevention in this population, especially for root caries.
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 fluorosis.
- Dental fluorosis is a dose-dependent effect of excessive fluoride intake during tooth development (up to age 8). Counsel parents on proper dosing and storage.
- Chewable tablets should be chewed or dissolved in the mouth, preferably at bedtime after brushing, to maximize topical contact with tooth surfaces.
- Advise patients to avoid eating or drinking for at least 15-30 minutes after taking the tablet to allow for optimal topical effect.
- Do not administer with milk, dairy products, or antacids containing calcium, magnesium, or aluminum, as these can significantly reduce fluoride absorption. Separate administration by at least 1-2 hours.
Alternative Therapies
- Fluoridated toothpaste
- Fluoride rinses (prescription or OTC)
- Fluoride varnishes (professionally applied)
- Fluoride gels (professionally applied or home use)
- Community water fluoridation
- Dietary counseling (reducing sugar intake)
- Dental sealants
Cost & Coverage
Average Cost:
$10 - $30 per 100 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often covered by dental or medical 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 happened.