Sod Fluoride 5000 1.1% Pste/sprmint
This supplement is used to prevent cavities.
Drug Class
Dental caries prophylactic agent
Pharmacologic Class
Fluoride
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This is a high-strength fluoride toothpaste or gel prescribed by your dentist to help prevent cavities and strengthen your tooth enamel. It works by making your teeth more resistant to acid attacks from bacteria and foods.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication properly, follow your doctor's instructions and read all the information provided. Replace your regular toothpaste with this medication, unless your doctor advises otherwise. Brush your teeth as directed, then spit out the medication. It is essential not to swallow this medication. After using, wait at least 30 minutes before eating, drinking, or rinsing your mouth.
Storing and Disposing of Your Medication
Store this medication at room temperature, keeping it in a safe location out of the reach of children and pets. Dispose of unused or expired medication appropriately. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you are unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, use 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 schedule. Do not use two doses at the same time or take extra doses to make up for the missed one.
To use this medication properly, follow your doctor's instructions and read all the information provided. Replace your regular toothpaste with this medication, unless your doctor advises otherwise. Brush your teeth as directed, then spit out the medication. It is essential not to swallow this medication. After using, wait at least 30 minutes before eating, drinking, or rinsing your mouth.
Storing and Disposing of Your Medication
Store this medication at room temperature, keeping it in a safe location out of the reach of children and pets. Dispose of unused or expired medication appropriately. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you are unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, use 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 schedule. Do not use two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Maintain good oral hygiene practices, including regular brushing and flossing.
- Limit consumption of sugary foods and drinks.
- Visit your dentist regularly for check-ups and cleanings.
- Do not swallow the toothpaste/gel; spit it out thoroughly after brushing.
- Do not rinse your mouth, eat, or drink for at least 30 minutes after using the product to allow the fluoride to work effectively.
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:
Apply a thin ribbon (pea-sized amount) to a toothbrush and brush thoroughly once daily, preferably at bedtime, for at least one minute. Spit out after use. Do not rinse, eat, or drink for 30 minutes.
Condition-Specific Dosing:
highCariesRisk:
Once daily application.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Children 6 years and older: Apply a pea-sized amount to a toothbrush and brush thoroughly once daily, preferably at bedtime. Supervise brushing to minimize swallowing. Spit out after use. Do not rinse, eat, or drink for 30 minutes.
Adolescent:
Same as adult.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for topical use.
Moderate:
No specific adjustment for topical use.
Severe:
No specific adjustment for topical use. Caution advised if significant amounts are swallowed due to renal excretion of fluoride.
Dialysis:
No specific adjustment for topical use. Caution advised if significant amounts are swallowed.
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 inhibiting demineralization and enhancing remineralization of early carious lesions. Fluoride also inhibits bacterial enzymes in plaque, reducing acid production.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from topical application if not swallowed. If swallowed, rapidly absorbed from the gastrointestinal tract.
Tmax:
Not applicable for topical use. If swallowed, plasma peak concentrations typically within 30-60 minutes.
FoodEffect:
Not relevant for topical use. If swallowed, food (especially dairy/calcium-rich) can reduce absorption.
Distribution:
Vd:
Not typically reported for topical fluoride. Systemically, distributes to calcified tissues (bones, teeth).
ProteinBinding:
Low (<10%)
CnssPenetration:
Limited
Elimination:
HalfLife:
Plasma half-life is short (2-9 hours), but fluoride is retained in calcified tissues for longer periods.
Clearance:
Primarily renal clearance.
ExcretionRoute:
Urine (approximately 50% within 24 hours, higher in children).
Unchanged:
Nearly 100% excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Immediate topical effect on enamel surface.
PeakEffect:
Continuous with regular, consistent use.
DurationOfAction:
Protective effects persist as long as regular application is maintained and fluoride is incorporated into enamel.
Confidence:
Medium
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
+ 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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for advice:
Note: 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.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Submit a report 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
+ 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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for advice:
Note: 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.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Submit a report online at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- Nausea, vomiting, stomach pain, or diarrhea (if swallowed in large amounts)
- White or brown spots on teeth (signs of fluorosis, especially in children)
- Oral irritation or allergic reaction (rare)
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 your safety, it is crucial to discuss all of your medications, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
* Vitamins
As well as any health problems you are experiencing. This will enable your doctor to assess potential interactions and determine the safest course of treatment for you. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 your safety, it is crucial to discuss all of your medications, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
* Vitamins
As well as any health problems you are experiencing. This will enable your doctor to assess potential interactions and determine the safest course of treatment for you. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 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: Nausea, vomiting, abdominal pain, diarrhea, salivation, headache, weakness, muscle cramps, tetany, convulsions, cardiac arrhythmias (severe cases).
- Chronic (in children during tooth development): Dental fluorosis (enamel discoloration, pitting).
What to Do:
For acute ingestion: Immediately seek emergency medical attention or call Poison Control (1-800-222-1222). If conscious, induce vomiting (if recent ingestion) and administer calcium (e.g., milk, calcium gluconate/chloride) to bind fluoride. For chronic fluorosis: Discontinue fluoride use and consult a dentist for cosmetic treatment options.
Drug Interactions
Minor Interactions
- Calcium-containing products (e.g., milk, antacids, calcium supplements)
- Aluminum-containing products (e.g., antacids)
- Magnesium-containing products (e.g., antacids)
Monitoring
Baseline Monitoring
Dental examination and caries risk assessment
Rationale: To determine the need for high-concentration fluoride and establish baseline oral health.
Timing: Prior to initiation of therapy.
Assessment for signs of fluorosis
Rationale: Especially in children, to identify pre-existing fluorosis or risk factors.
Timing: Prior to initiation of therapy.
Routine Monitoring
Regular dental check-ups
Frequency: Every 6-12 months, or as recommended by dentist.
Target: Maintenance of oral hygiene, reduction in caries incidence.
Action Threshold: Increased caries activity, signs of fluorosis, or poor oral hygiene may require re-evaluation of treatment plan.
Assessment of oral hygiene and brushing technique
Frequency: At dental visits.
Target: Effective plaque removal, proper application of fluoride.
Action Threshold: Poor technique or compliance may reduce efficacy.
Monitoring for signs of fluorosis (especially in children)
Frequency: At dental visits.
Target: Absence of new or worsening fluorosis.
Action Threshold: Development of fluorosis may indicate excessive fluoride intake and require dose adjustment or discontinuation.
Symptom Monitoring
- Signs of dental fluorosis (e.g., white flecks, streaks, or brown stains on tooth enamel)
- Oral irritation or discomfort
- Symptoms of acute fluoride toxicity if swallowed in large amounts (e.g., nausea, vomiting, abdominal pain, diarrhea, salivation, headache, weakness, muscle cramps, tetany, convulsions)
Special Patient Groups
Pregnancy
Category B. Topical fluoride is generally considered safe for use during pregnancy as systemic absorption is minimal when used as directed.
Trimester-Specific Risks:
First Trimester:
No known increased risk.
Second Trimester:
No known increased risk.
Third Trimester:
No known increased risk.
Lactation
L1 (Safest). Topical fluoride is considered safe for use during lactation as systemic absorption is minimal and fluoride is naturally present in breast milk at very low concentrations.
Infant Risk:
Minimal to no risk to the breastfed infant when used topically by the mother.
Pediatric Use
Not recommended for children under 6 years of age due to the risk of dental fluorosis if swallowed during tooth development. For children 6 years and older, use a pea-sized amount and supervise brushing to minimize swallowing.
Geriatric Use
No specific dose adjustments are necessary. Use as directed for adults. May be particularly beneficial for managing root caries or xerostomia-related caries.
Clinical Information
Clinical Pearls
- This is a prescription-strength fluoride product intended for patients with a high risk of dental caries.
- It is not a substitute for regular fluoride toothpaste; it is an additional therapeutic agent.
- Emphasize the 'spit, don't rinse' instruction to maximize fluoride retention on tooth surfaces.
- Advise patients not to eat or drink for at least 30 minutes after use to allow for optimal fluoride uptake.
- Educate parents about the risk of dental fluorosis in young children if the product is swallowed, and the importance of supervision.
Alternative Therapies
- Dental sealants
- Chlorhexidine rinses (for specific bacterial control)
- Xylitol-containing products
- Dietary counseling for caries prevention
Cost & Coverage
Average Cost:
Varies, typically $15-$40 per 50g-100g tube
Generic Available:
Yes
Insurance Coverage:
Often covered by dental insurance plans, sometimes by medical insurance if prescribed for specific conditions.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.