Sod Fluor 5000 1.1% Pst (dry Mouth)
This supplement is used to prevent cavities.
Drug Class
Dental Caries Prophylactic; Remineralizing Agent
Pharmacologic Class
Fluoride Agent
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This is a special toothpaste or gel with a high concentration of fluoride. It's prescribed by your dentist to help strengthen your teeth, prevent cavities, and repair early tooth decay, especially if you have dry mouth or are at high risk for cavities.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Unless your doctor advises otherwise, use this gel in place of your regular toothpaste.
To apply:
- Use a pea-sized amount of the gel.
- Brush your teeth thoroughly.
- Allow the gel to remain on your teeth for 1 minute before spitting it out.
- Do not swallow the medication.
- After using the gel, wait at least 30 minutes before eating, drinking, or rinsing your mouth.
Storing and Disposing of Your Medication
- Store the medication at room temperature.
- Keep all medications in a safe location, out of the reach of children and pets.
- Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about the disposal, 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, 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 continue with your regular dosing schedule. Avoid taking two doses at the same time or using extra doses.
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Unless your doctor advises otherwise, use this gel in place of your regular toothpaste.
To apply:
- Use a pea-sized amount of the gel.
- Brush your teeth thoroughly.
- Allow the gel to remain on your teeth for 1 minute before spitting it out.
- Do not swallow the medication.
- After using the gel, wait at least 30 minutes before eating, drinking, or rinsing your mouth.
Storing and Disposing of Your Medication
- Store the medication at room temperature.
- Keep all medications in a safe location, out of the reach of children and pets.
- Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about the disposal, 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, 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 continue with your regular dosing schedule. Avoid taking two doses at the same time or using extra doses.
Lifestyle & Tips
- Brush your teeth thoroughly with the prescribed fluoride paste/gel once daily, preferably at bedtime.
- Use only a pea-sized amount on your toothbrush.
- After brushing, spit out the paste. DO NOT RINSE your mouth with water or mouthwash immediately after use. This allows the fluoride to stay on your teeth longer and work more effectively.
- Avoid eating or drinking for at least 30 minutes after using the fluoride paste/gel.
- Maintain good overall oral hygiene, including regular brushing and flossing.
- Limit sugary foods and drinks, which contribute to tooth decay.
- Attend regular dental check-ups and cleanings as recommended by your dentist.
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 at least 30 minutes.
Condition-Specific Dosing:
dryMouth:
Use as directed by a dental professional, typically once daily at bedtime to maximize contact time with tooth surfaces.
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 toothbrush and brush thoroughly once daily, preferably at bedtime, for at least one minute. Supervise children to ensure they spit out after use and do not swallow. Do not rinse, eat, or drink for at least 30 minutes.
Adolescent:
Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed for topical use due to minimal systemic absorption.
Moderate:
No adjustment typically needed for topical use due to minimal systemic absorption.
Severe:
Use with caution. While systemic absorption from topical use is minimal, chronic ingestion (e.g., swallowing) in severe renal impairment could lead to fluoride accumulation. Consult with a healthcare professional.
Dialysis:
Use with caution. While systemic absorption from topical use is minimal, chronic ingestion (e.g., swallowing) could lead to fluoride accumulation. Consult with a healthcare professional.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Pharmacology
Mechanism of Action
Fluoride acts primarily by enhancing the remineralization of demineralized enamel and inhibiting the demineralization process. It incorporates into the hydroxyapatite crystal structure of enamel, forming fluorapatite, which is more resistant to acid dissolution. Fluoride also inhibits bacterial enzymes involved in carbohydrate metabolism, thereby reducing acid production by cariogenic bacteria, and can have a direct antibacterial effect.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic bioavailability from topical application if not swallowed. If swallowed, rapidly absorbed from the gastrointestinal tract (up to 90%).
Tmax:
Not applicable for topical action. If ingested, peak plasma concentrations typically within 30-60 minutes.
FoodEffect:
Food (especially dairy products rich in calcium) can reduce systemic absorption of ingested fluoride by forming insoluble complexes.
Distribution:
Vd:
Not applicable for topical action. If ingested, distributes widely, primarily to mineralized tissues (bones, teeth).
ProteinBinding:
Minimal protein binding.
CnssPenetration:
Limited
Elimination:
HalfLife:
Plasma half-life is typically 2-9 hours (longer in renal impairment).
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 tooth surface upon application.
PeakEffect:
Continuous remineralization and caries protection with consistent use.
DurationOfAction:
Local effect persists on tooth surface until removed by brushing/saliva. Systemic effects (if ingested) are transient.
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 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 do not go away, 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 contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also available to provide guidance on managing side effects and answering any questions you may have.
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 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 do not go away, 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 contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also available to provide guidance on managing side effects and answering any questions you may have.
Seek Immediate Medical Attention If You Experience:
- If you accidentally swallow a large amount, especially in children, watch for symptoms like nausea, vomiting, stomach pain, or diarrhea. Seek immediate medical attention or call Poison Control.
- In children, excessive fluoride intake can lead to dental fluorosis (white spots or streaks on the teeth). Ensure children are supervised to prevent swallowing.
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, please 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 complete medical history, including any health problems you are experiencing
It is crucial to verify that this medication is safe to take with all your other medications 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 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, please 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 complete medical history, including any health problems you are experiencing
It is crucial to verify that this medication is safe to take with all your other medications 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 right away, as it can cause harm. 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 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 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 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 fluoride toxicity (if large amounts are ingested): nausea, vomiting, abdominal pain, salivation, diarrhea, weakness, tremors, convulsions, cardiac arrhythmias, and in severe cases, cardiac arrest.
What to Do:
If a large amount is swallowed, immediately seek emergency medical attention. Call Poison Control (1-800-222-1222). Induce vomiting if recent ingestion and patient is conscious (only if advised by Poison Control or medical professional). Administer calcium (e.g., milk, calcium gluconate) to bind fluoride. Gastric lavage may be performed in a medical setting.
Drug Interactions
Moderate Interactions
- Calcium, magnesium, or aluminum-containing products (e.g., antacids, milk, dairy products): If ingested, these can bind fluoride and reduce its systemic absorption. This is less relevant for topical application where ingestion is minimized.
Monitoring
Baseline Monitoring
Comprehensive Dental Examination
Rationale: To assess current oral health status, identify existing caries, evaluate caries risk, and determine the need for high-concentration fluoride.
Timing: Prior to initiation of therapy.
Medical and Dental History Review
Rationale: To identify any contraindications, allergies, or systemic conditions (e.g., renal impairment) that might influence fluoride use.
Timing: Prior to initiation of therapy.
Routine Monitoring
Oral Hygiene Compliance
Frequency: At each dental recall visit (typically every 3-6 months).
Target: Consistent daily use as prescribed.
Action Threshold: Poor compliance may necessitate re-education or alternative strategies.
Caries Progression/Remineralization
Frequency: At each dental recall visit (typically every 3-6 months) via clinical examination and radiographs as indicated.
Target: Reduction in new carious lesions; arrest or remineralization of existing lesions.
Action Threshold: Continued caries progression may indicate need for re-evaluation of fluoride regimen, oral hygiene, or other risk factors.
Signs of Fluorosis (in children)
Frequency: At each dental recall visit (typically every 6-12 months) until permanent dentition is fully erupted.
Target: Absence of white spots or enamel discoloration.
Action Threshold: Presence of fluorosis may indicate excessive fluoride intake and necessitate adjustment of fluoride regimen (e.g., supervision of brushing, evaluation of other fluoride sources).
Symptom Monitoring
- Signs of acute fluoride toxicity (if accidentally ingested in large amounts): nausea, vomiting, abdominal pain, salivation, diarrhea, weakness, tremors, convulsions.
- Signs of dental fluorosis (in children): white flecks, streaks, or brown discoloration on tooth enamel.
- Oral discomfort or irritation (rare with proper use).
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:
Low risk with topical use.
Second Trimester:
Low risk with topical use.
Third Trimester:
Low risk with topical use.
Lactation
Considered safe for use during lactation. Minimal systemic absorption means negligible amounts would be excreted in breast milk.
Infant Risk:
L1 (Safest) - No known risk to the breastfed infant with topical maternal use.
Pediatric Use
Use in children under 6 years of age is generally not recommended for high-concentration fluoride toothpastes due to the increased risk of dental fluorosis if swallowed. For children 6 years and older, strict supervision is required to ensure the product is spit out and not swallowed. The amount used should be a pea-sized portion.
Geriatric Use
Generally safe and often beneficial for geriatric patients, who may have increased caries risk due to root exposure, xerostomia (dry mouth), or reduced manual dexterity for oral hygiene. No specific dose adjustments are typically needed.
Clinical Information
Clinical Pearls
- Emphasize the 'spit, don't rinse' instruction to patients, as rinsing immediately after use significantly reduces the fluoride's efficacy.
- For patients with severe dry mouth, using this product at bedtime allows for prolonged contact of fluoride with tooth surfaces, maximizing its remineralizing benefits.
- Educate parents on the importance of supervising children (especially those under 12) to ensure proper brushing technique and to prevent swallowing, which can lead to dental fluorosis.
- This product is a prescription-strength fluoride and should be used under the guidance of a dental professional as part of a comprehensive caries management plan.
- Patients should be advised that this product is not a substitute for regular dental check-ups and professional cleanings.
Alternative Therapies
- Lower concentration (OTC) fluoride toothpastes (e.g., 0.24% sodium fluoride or 0.15% stannous fluoride)
- Fluoride varnishes (professional application)
- Fluoride rinses (OTC or prescription strength)
- Xylitol-containing products (gums, lozenges, toothpaste)
- Saliva substitutes/stimulants for dry mouth (e.g., Biotene, Oasis)
- Chlorhexidine gluconate rinse (for specific bacterial control, not direct remineralization)
Cost & Coverage
Average Cost:
Varies widely, typically $20-$60 per 100-120g tube
Generic Available:
Yes
Insurance Coverage:
Often covered by dental insurance plans or some medical plans if prescribed. May be out-of-pocket for some patients.
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.