Sod Fluoride 5000 1.1% Paste/fruit
This supplement is used to prevent cavities.
Drug Class
Dental Caries Prophylactic
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 that helps prevent cavities by making your tooth enamel stronger and more resistant to acid. It's used once a day, usually at bedtime, instead of your regular toothpaste.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication properly, follow your doctor's instructions and read all accompanying information carefully. 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 drug. After using the medication, 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 and all other medications in a secure location out of the reach of children and pets. Dispose of unused or expired medications appropriately. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you are unsure about the best disposal method, consult your pharmacist. You may also want to inquire about drug take-back programs available in your area.
Managing Missed Doses
If you miss a dose, use 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. Avoid using two doses at the same time or taking extra doses.
To use this medication properly, follow your doctor's instructions and read all accompanying information carefully. 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 drug. After using the medication, 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 and all other medications in a secure location out of the reach of children and pets. Dispose of unused or expired medications appropriately. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you are unsure about the best disposal method, consult your pharmacist. You may also want to inquire about drug take-back programs available in your area.
Managing Missed Doses
If you miss a dose, use 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. Avoid using two doses at the same time or taking extra doses.
Lifestyle & Tips
- Use exactly as directed by your dentist or doctor.
- Do not swallow the paste; spit it out thoroughly after brushing.
- Do not rinse your mouth, eat, or drink for at least 30 minutes after using the paste to allow the fluoride to work effectively.
- Maintain good oral hygiene practices, including regular brushing and flossing.
- Limit sugary foods and drinks.
- Attend regular dental check-ups.
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 soft-bristled toothbrush and brush thoroughly once daily, preferably at bedtime, after brushing with regular toothpaste. Spit out after use. Do not rinse, eat, or drink for at least 30 minutes.
Condition-Specific Dosing:
high_caries_risk:
Once daily application.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6 years of age and older: Apply a thin ribbon (pea-sized amount) to a soft-bristled toothbrush and brush thoroughly once daily, preferably at bedtime. Supervise use to minimize swallowing. Spit out after use. Do not rinse, eat, or drink for at least 30 minutes.
Adolescent:
Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for topical use, but caution advised with chronic use due to potential for systemic accumulation if swallowed.
Moderate:
Caution advised; monitor for signs of fluorosis or systemic toxicity if significant amounts are swallowed. Consult dentist/physician.
Severe:
Use with extreme caution or avoid if significant swallowing is likely, due to risk of systemic fluoride accumulation and toxicity. Consult dentist/physician.
Dialysis:
Use with extreme caution or avoid. Systemic fluoride accumulation is a significant risk.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Pharmacology
Mechanism of Action
Fluoride ions incorporate into the enamel structure of teeth, forming fluorapatite, which is more resistant to acid demineralization than hydroxyapatite. It also inhibits bacterial enzymes, reducing acid production by oral bacteria, and enhances remineralization of early carious lesions.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from topical application if not swallowed. If swallowed, rapidly absorbed from the gastrointestinal tract (up to 90%).
Tmax:
Not applicable for topical action. If swallowed, plasma peak concentrations typically within 30-60 minutes.
FoodEffect:
Food (especially dairy products rich in calcium) can reduce systemic absorption if swallowed.
Distribution:
Vd:
Not available (primarily local action)
ProteinBinding:
Minimal
CnssPenetration:
Limited (primarily deposited in calcified tissues like bone and teeth)
Elimination:
HalfLife:
Systemic half-life is variable, typically 2-9 hours for plasma, but much longer for fluoride incorporated into bone/teeth.
Clearance:
Primarily renal clearance.
ExcretionRoute:
Renal (urine), small amounts in feces and sweat.
Unchanged:
Nearly 100% of absorbed fluoride is excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Immediate local effect on enamel surface upon application.
PeakEffect:
Continuous effect with regular use, leading to cumulative strengthening of enamel.
DurationOfAction:
Local effect persists on tooth surface until removed by brushing/saliva; incorporated fluoride provides long-term protection.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
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. While many people may not experience any side effects or only mild ones, it's essential to monitor your body's response. If you notice 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 concerns or questions about side effects, consult your doctor.
Reporting Side Effects
To report any side effects, you can:
Call your doctor for medical guidance
Contact the FDA at 1-800-332-1088
* Submit a report online at https://www.fda.gov/medwatch
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
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. While many people may not experience any side effects or only mild ones, it's essential to monitor your body's response. If you notice 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 concerns or questions about side effects, consult your doctor.
Reporting Side Effects
To report any side effects, you can:
Call your doctor for medical guidance
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
- Diarrhea
- Headache
- Weakness
- Tremors
- Excessive salivation
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
Natural products and vitamins you are using
Any health problems you have
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
Natural products and vitamins you are using
Any health problems you have
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 it to your dentist. Regular dental check-ups and good oral hygiene practices are crucial to maintain healthy teeth.
In the event of accidental ingestion of a large amount of this medication, seek immediate medical attention by calling a doctor or a poison control center. 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 breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for 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 a poison control center. 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 breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose (swallowing large amounts): Nausea, vomiting, abdominal pain, diarrhea, salivation, headache, weakness, tremors, convulsions, cardiac arrest (severe cases).
- Chronic overdose (excessive systemic fluoride intake, especially during tooth development): Dental fluorosis (white flecks, streaks, or brown discoloration on teeth).
What to Do:
For acute overdose, immediately seek emergency medical attention or call Poison Control (1-800-222-1222). Induce vomiting if conscious and within minutes of ingestion. Administer calcium (e.g., milk, calcium gluconate) to bind fluoride. Hospitalization for supportive care may be required.
Drug Interactions
Moderate Interactions
- Calcium-containing products (e.g., antacids, milk): May reduce systemic absorption of swallowed fluoride. Advise patients not to eat or drink for 30 minutes after application.
Monitoring
Baseline Monitoring
Dental Caries Risk Assessment
Rationale: To determine the need for high-concentration fluoride and establish baseline oral health.
Timing: Prior to initiation of therapy.
Oral Examination for Fluorosis
Rationale: To assess existing fluorosis and prevent exacerbation, especially in children.
Timing: Prior to initiation of therapy.
Routine Monitoring
Oral Hygiene Compliance
Frequency: At each dental check-up (e.g., every 6-12 months)
Target: Consistent daily application as directed.
Action Threshold: Poor compliance may necessitate re-education or alternative strategies.
Signs of Dental Fluorosis
Frequency: At each dental check-up (e.g., every 6-12 months), especially in children.
Target: Absence of new or worsening fluorosis.
Action Threshold: Development of fluorosis may require discontinuation or reduction in fluoride exposure.
Caries Activity
Frequency: At each dental check-up (e.g., every 6-12 months)
Target: Reduction or arrest of caries progression.
Action Threshold: Continued caries activity may require re-evaluation of treatment plan or additional interventions.
Symptom Monitoring
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Salivation
- Headache
- Weakness
- Tremors
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy. Systemic absorption is minimal when used as directed.
Trimester-Specific Risks:
First Trimester:
No known specific risks with topical use.
Second Trimester:
No known specific risks with topical use.
Third Trimester:
No known specific risks with topical use.
Lactation
Considered safe for use during lactation. Minimal systemic absorption means negligible amounts are expected to pass into breast milk.
Infant Risk:
Low risk to breastfed infant.
Pediatric Use
Use in children under 6 years of age is generally not recommended for 5000 ppm fluoride products due to the increased risk of dental fluorosis if swallowed. For children 6 years and older, supervise use to ensure minimal swallowing and proper spitting. Assess caries risk and existing fluoride exposure from other sources (e.g., fluoridated water, supplements) before prescribing.
Geriatric Use
No specific dosage adjustments are typically needed. Older adults may benefit from high-concentration fluoride due to increased risk of root caries or xerostomia. Ensure ability to spit effectively.
Clinical Information
Clinical Pearls
- Emphasize the 'spit, don't swallow' instruction, especially for children, to minimize systemic fluoride exposure and prevent fluorosis.
- Advise patients not to rinse, eat, or drink for at least 30 minutes after application to maximize fluoride's contact time with enamel.
- This product is a therapeutic agent, not a cosmetic toothpaste. It should be used in addition to or in place of regular toothpaste as directed by a dental professional.
- Regular dental check-ups are crucial to monitor effectiveness and assess for any signs of fluorosis.
- Consider the patient's overall fluoride exposure (water, diet, other products) when prescribing high-concentration fluoride.
Alternative Therapies
- Lower concentration fluoride toothpastes (e.g., 1000-1500 ppm)
- Fluoride varnishes (professional application)
- Fluoride rinses (OTC or prescription)
- Dental sealants
- Xylitol-containing products
- Calcium phosphate technologies (e.g., amorphous calcium phosphate, casein phosphopeptide-amorphous calcium phosphate)
- Dietary counseling to reduce sugar intake
Cost & Coverage
Average Cost:
$15 - $40 per 50g tube
Generic Available:
Yes
Insurance Coverage:
Often covered by dental insurance plans, or available over-the-counter/prescription at a reasonable cash price.
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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.