Sod Fluoride 1.1 (.5mg)/ml Drp 50ml
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?
Sodium fluoride drops are a medicine that helps make your child's teeth stronger and more resistant to cavities. It works by adding fluoride to the tooth enamel, especially important if your drinking water doesn't have enough fluoride.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
Unless your doctor advises otherwise, take this medication before bedtime, after brushing your teeth.
When taking the liquid form of this medication, measure your dose carefully using the measuring device provided with the medication.
Some brands of this medication may need to be mixed with water or fruit juice. Check the specific instructions for your brand to ensure you're taking it correctly.
The frequency of taking this medication can vary, with some products taken daily and others taken 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. Consult with your doctor or pharmacist for guidance.
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, protected from light.
Keep all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it's 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 once or take extra doses to make up for a missed dose.
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
Unless your doctor advises otherwise, take this medication before bedtime, after brushing your teeth.
When taking the liquid form of this medication, measure your dose carefully using the measuring device provided with the medication.
Some brands of this medication may need to be mixed with water or fruit juice. Check the specific instructions for your brand to ensure you're taking it correctly.
The frequency of taking this medication can vary, with some products taken daily and others taken 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. Consult with your doctor or pharmacist for guidance.
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, protected from light.
Keep all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it's 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 once or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Administer drops directly into the mouth or mix with a small amount of juice or water (do NOT mix with milk or dairy products).
- Do not exceed the prescribed dose, as too much fluoride can cause white or brown spots on teeth (fluorosis).
- Ensure proper oral hygiene, including brushing twice daily with fluoride toothpaste (for age-appropriate children).
- Limit sugary snacks and drinks.
- Store out of reach of children to prevent accidental overdose.
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 adults in drop form; usually tablets or toothpaste for systemic fluoride supplementation if needed.
Pediatric Dosing
Neonatal:
Not established (generally not recommended for infants under 6 months unless specific risk factors and water fluoride levels warrant)
Infant:
Dosing based on water fluoride concentration (F-):
- Water F- < 0.3 ppm: 0.25 mg F- daily (0.5 mL of 1.1 mg/mL NaF solution) for ages 6 months to 3 years.
- Water F- 0.3-0.6 ppm: No supplementation needed for ages 6 months to 3 years.
- Water F- > 0.6 ppm: No supplementation needed for any age.
Child:
Dosing based on water fluoride concentration (F-):
- Water F- < 0.3 ppm: 0.5 mg F- daily (1 mL of 1.1 mg/mL NaF solution) for ages 3-6 years; 1.0 mg F- daily (2 mL of 1.1 mg/mL NaF solution) for ages 6-16 years.
- Water F- 0.3-0.6 ppm: 0.25 mg F- daily (0.5 mL of 1.1 mg/mL NaF solution) for ages 3-6 years; 0.5 mg F- daily (1 mL of 1.1 mg/mL NaF solution) for ages 6-16 years.
- Water F- > 0.6 ppm: No supplementation needed for any age.
Adolescent:
Dosing based on water fluoride concentration (F-):
- Water F- < 0.3 ppm: 1.0 mg F- daily (2 mL of 1.1 mg/mL NaF solution) for ages 6-16 years.
- Water F- 0.3-0.6 ppm: 0.5 mg F- daily (1 mL of 1.1 mg/mL NaF solution) for ages 6-16 years.
- Water F- > 0.6 ppm: No supplementation needed for any age.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution. Monitor for signs of fluorosis.
Moderate:
Use with caution. Consider reduced dose or alternative if water fluoride levels are not low. Monitor for signs of fluorosis.
Severe:
Contraindicated in severe renal impairment due to risk of fluoride accumulation and skeletal fluorosis.
Dialysis:
Contraindicated. Fluoride is primarily renally excreted, 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 demineralization than hydroxyapatite, thereby reducing the incidence of dental caries. Fluoride also inhibits bacterial enzymes, reducing acid production by oral bacteria, and promotes remineralization of early carious lesions.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90-95% (rapid and nearly complete from the GI tract)
Tmax:
30-60 minutes
FoodEffect:
Food, especially dairy products (calcium), aluminum- or magnesium-containing antacids, can chelate fluoride and significantly reduce absorption.
Distribution:
Vd:
Not readily quantifiable due to rapid uptake into calcified tissues.
ProteinBinding:
Minimal
CnssPenetration:
Limited
Elimination:
HalfLife:
2-9 hours (plasma); much longer in calcified tissues
Clearance:
Primarily renal clearance
ExcretionRoute:
Renal (urine), small amounts in feces and sweat
Unchanged:
Nearly 100% of absorbed fluoride is excreted unchanged or incorporated into calcified tissues.
Pharmacodynamics
OnsetOfAction:
Continuous exposure is required for prophylactic effect.
PeakEffect:
Continuous exposure is required for prophylactic effect.
DurationOfAction:
Effect persists as long as adequate fluoride levels are maintained in the oral cavity and incorporated into enamel.
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 have side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
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. 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 on managing side effects.
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 have side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
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. 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 on managing side effects.
Seek Immediate Medical Attention If You Experience:
- White or brown spots on teeth (dental fluorosis)
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
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 and its symptoms.
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, this is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your:
Medications (prescription and over-the-counter)
Natural products
Vitamins
* Health problems
with your doctor and pharmacist to ensure safe use. Always consult your doctor before starting, stopping, or changing the dose of any medication to verify that it is safe for you to take this medication with your other medications and health conditions.
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 and its symptoms.
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, this is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your:
Medications (prescription and over-the-counter)
Natural products
Vitamins
* Health problems
with your doctor and pharmacist to ensure safe use. Always consult your doctor before starting, stopping, or changing the dose of any medication to verify that it is safe for you to take this medication with your other medications and health conditions.
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 breast-feeding, 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 breast-feeding, 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: Nausea, vomiting, abdominal pain, diarrhea, salivation, lacrimation, sweating, muscle weakness, tremors, convulsions, cardiac arrhythmias, hypotension, respiratory depression, coma.
- Chronic (fluorosis): Dental fluorosis (mild to severe enamel discoloration/pitting), skeletal fluorosis (joint pain, stiffness, bone changes).
What to Do:
For acute overdose, immediately seek emergency medical attention. Induce vomiting if conscious and within 30 minutes of ingestion. Administer calcium (e.g., milk, calcium gluconate/lactate solution) to bind fluoride. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Moderate Interactions
- Aluminum-containing antacids (e.g., aluminum hydroxide)
- Calcium-containing products (e.g., dairy products, calcium supplements)
- Magnesium-containing antacids (e.g., magnesium hydroxide)
Monitoring
Baseline Monitoring
Local water fluoride concentration
Rationale: Essential for determining appropriate fluoride supplementation dosage to prevent both caries and fluorosis.
Timing: Before initiating therapy and periodically if water source changes.
Routine Monitoring
Dental examinations
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 fluorosis indicates excessive fluoride exposure, requiring dose reduction or discontinuation.
Assessment of fluoride intake from all sources (water, toothpaste, other supplements)
Frequency: Annually or as needed
Target: Total daily fluoride intake within recommended limits for age.
Action Threshold: Excessive total intake requires adjustment of supplementation.
Symptom Monitoring
- Signs of dental fluorosis (e.g., white flecks, streaks, or brown discoloration on tooth enamel)
- Gastrointestinal upset (nausea, vomiting, abdominal pain) - rare with therapeutic doses, but possible with acute overdose.
Special Patient Groups
Pregnancy
Category B. Studies in animals have shown no evidence of harm to the fetus. Human studies are limited but generally suggest no increased risk of birth defects with recommended doses. Use only if clearly needed and benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
No known increased risk.
Second Trimester:
No known increased risk.
Third Trimester:
No known increased risk.
Lactation
L2 - Likely compatible. Fluoride is excreted into breast milk in small amounts, but the concentration is generally low and not considered harmful to the breastfed infant at therapeutic maternal doses. The amount transferred is usually insufficient to provide adequate systemic fluoride for the infant.
Infant Risk:
Low risk of adverse effects to the infant.
Pediatric Use
Primary patient population. Dosing is critical and must be based on the child's age and the fluoride concentration of the primary drinking water source to prevent both dental caries and dental fluorosis. Contraindicated in infants under 6 months unless specifically indicated by a healthcare professional.
Geriatric Use
Not typically indicated for geriatric patients in drop form. If systemic fluoride is needed, tablets or other forms may be considered, but generally, fluoride supplementation is for developing teeth.
Clinical Information
Clinical Pearls
- Always determine the fluoride concentration of the patient's primary drinking water source before prescribing fluoride supplements.
- Educate parents/caregivers on the importance of accurate dosing and the risks of over-supplementation (dental fluorosis).
- Do not mix fluoride drops with milk, dairy products, or antacids, as this can reduce absorption.
- Emphasize that fluoride supplementation is an adjunct to, not a replacement for, good oral hygiene practices.
- Store fluoride supplements safely out of reach of children to prevent accidental overdose.
Alternative Therapies
- Fluoride tablets (chewable or dissolvable)
- Fluoride toothpaste (over-the-counter and prescription strength)
- Fluoride mouth rinses (over-the-counter and prescription strength)
- Topical fluoride varnishes or gels (applied by dental professionals)
- Community water fluoridation
Cost & Coverage
Average Cost:
Varies widely by manufacturer and pharmacy per 50ml bottle
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans, but may require prior authorization or be considered an OTC product depending on the plan.
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 this 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.