Sod Fluoride 0.2% Mint Solution

Manufacturer SHEFFIELD PHARMACEUTICALS Active Ingredient Fluoride Rinse(FLOR ide) Pronunciation FLOOR-ide
This supplement is used to prevent cavities.
đŸˇī¸
Drug Class
Dental caries prophylactic
đŸ§Ŧ
Pharmacologic Class
Fluoride agent
🤰
Pregnancy Category
Category B
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

This is a fluoride mouth rinse used to help prevent cavities. Fluoride strengthens your tooth enamel, making it more resistant to the acid that causes tooth decay. It's important to use it as directed and not swallow it.
📋

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. When using this drug, swish it in your mouth for the recommended amount of time, then spit it out. It is essential to note that you should not swallow this medication. After using the drug, avoid eating, drinking, or rinsing your mouth for at least 30 minutes.

Some products may require mixing before use. If your product needs to be mixed, only mix it when you are ready to use it, and use it immediately after mixing.

Storing and Disposing of Your Medication

Store this medication at room temperature, keeping it in a safe location that is out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to check if there are any drug take-back programs available 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 is 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 the same time or use extra doses to make up for a missed dose.
💡

Lifestyle & Tips

  • Use as part of a comprehensive oral hygiene routine including brushing twice daily with fluoride toothpaste and flossing daily.
  • Limit sugary foods and drinks.
  • Visit your dentist regularly for check-ups and professional cleanings.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Rinse with 10 mL (2 teaspoons) of solution for one minute once weekly, preferably at bedtime after brushing teeth. Do not swallow.

Condition-Specific Dosing:

dental_caries_prophylaxis: 10 mL once weekly
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6 years of age and older: Rinse with 10 mL (2 teaspoons) of solution for one minute once weekly, preferably at bedtime after brushing teeth. Supervise children to ensure they do not swallow the rinse. For children under 6 years, consult a dentist or physician.
Adolescent: Rinse with 10 mL (2 teaspoons) of solution for one minute once weekly, preferably at bedtime after brushing teeth. Do not swallow.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No specific considerations for topical use; consult dentist/nephrologist if concerns about systemic fluoride exposure.

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

Pharmacology

đŸ”Ŧ

Mechanism of Action

Fluoride acts primarily topically to prevent dental caries. It incorporates into the enamel structure, forming fluorapatite, which is more resistant to acid demineralization than hydroxyapatite. It also inhibits bacterial enzymes, reducing acid production by oral bacteria, and promotes remineralization of early carious lesions.
📊

Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption from topical rinse if not swallowed. Significant absorption occurs if ingested.
Tmax: Not applicable for topical action; if ingested, plasma peak levels typically within 30-60 minutes.
FoodEffect: Not applicable for topical rinse. If ingested, food (especially calcium-rich) can reduce absorption.

Distribution:

Vd: Not applicable for topical action. If absorbed systemically, fluoride distributes throughout the body, with high affinity for calcified tissues (bones, teeth).
ProteinBinding: Minimal
CnssPenetration: Limited (if absorbed systemically)

Elimination:

HalfLife: Not applicable for topical action. If absorbed systemically, plasma half-life is typically 2-9 hours, but fluoride is slowly released from bone.
Clearance: Primarily renal excretion if absorbed systemically.
ExcretionRoute: Renal (urine) if absorbed systemically; unabsorbed fluoride is excreted in feces.
Unchanged: 100% (if absorbed systemically)
âąī¸

Pharmacodynamics

OnsetOfAction: Immediate topical effect on enamel surface upon contact.
PeakEffect: Continuous protection with regular use.
DurationOfAction: Protective effects persist as long as regular use is maintained and fluoride is incorporated into enamel. The immediate topical effect lasts until rinse is cleared from oral cavity.
Confidence: Medium

Safety & Warnings

âš ī¸

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 immediately or seek emergency 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. However, many people do not experience any side effects or only have mild ones. If you have any side effects that concern you or persist, contact your doctor for advice.

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, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Nausea, vomiting, stomach pain, or diarrhea (signs of accidental ingestion)
  • White or brown spots on teeth (signs of fluorosis, especially in children)
  • Oral irritation or rash
📋

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 symptoms you experienced.
Certain health conditions, including:
+ Bone problems
+ Joint problems
+ Kidney problems
+ Ulcers
* If the fluoride level in your drinking water is 0.6 parts per million or higher.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
âš ī¸

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 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. 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, 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
  • Headache
  • Weakness
  • Tremors
  • In severe cases: muscle spasms, convulsions, cardiac arrhythmias, respiratory depression, coma

What to Do:

If a large amount is accidentally swallowed, immediately seek medical attention or contact a Poison Control Center. Give milk or calcium-containing antacids to bind fluoride. Induce vomiting only if advised by medical professional. Call 1-800-222-1222 (Poison Control).

Drug Interactions

Monitoring

đŸ”Ŧ

Baseline Monitoring

Dental examination

Rationale: To assess oral health, identify existing caries, and determine need for fluoride therapy.

Timing: Prior to initiating therapy

📊

Routine Monitoring

Regular dental check-ups

Frequency: Every 6-12 months, or as recommended by dentist

Target: Not applicable

Action Threshold: New caries, signs of fluorosis, or other oral health concerns

Oral hygiene assessment

Frequency: At dental check-ups

Target: Good oral hygiene practices

Action Threshold: Poor plaque control, gingivitis

đŸ‘ī¸

Symptom Monitoring

  • Signs of dental fluorosis (white or brown spots on teeth, pitting) - especially in children under 6 if used inappropriately or if other fluoride sources are high
  • Oral irritation or allergic reaction (rare)
  • Symptoms of acute fluoride toxicity if accidentally ingested (nausea, vomiting, abdominal pain, diarrhea, salivation, headache, weakness, tremors)

Special Patient Groups

🤰

Pregnancy

Generally considered safe for topical use during pregnancy as systemic absorption is minimal. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: No known specific risks for topical use.
Second Trimester: No known specific risks for topical use.
Third Trimester: No known specific risks for topical use.
🤱

Lactation

Considered safe for use during lactation as systemic absorption is minimal and fluoride is naturally present in breast milk at very low levels. Risk to infant is negligible.

Infant Risk: Low
đŸ‘ļ

Pediatric Use

Not recommended for children under 6 years of age unless specifically directed by a dentist or physician, due to the risk of accidental ingestion and potential for dental fluorosis. Supervise children 6-12 years of age during use to ensure proper rinsing and spitting.

👴

Geriatric Use

No specific dose adjustments or precautions are generally needed for geriatric patients. Ensure ability to rinse and spit effectively.

Clinical Information

💎

Clinical Pearls

  • Emphasize 'do not swallow' to patients, especially children, to prevent systemic fluoride exposure and potential toxicity.
  • For optimal benefit, use the rinse at a different time than brushing with fluoride toothpaste (e.g., rinse at night, brush in the morning and evening).
  • Advise patients not to eat, drink, or rinse for at least 30 minutes after using the fluoride rinse to allow maximum topical effect.
  • Regular dental check-ups are crucial to monitor oral health and assess the effectiveness of fluoride therapy.
🔄

Alternative Therapies

  • Fluoride toothpaste (e.g., 1100-1450 ppm fluoride)
  • Prescription fluoride toothpaste (e.g., 5000 ppm fluoride)
  • Fluoride varnish (applied by dental professional)
  • Fluoride gels (prescription or OTC)
  • Community water fluoridation
  • Dietary fluoride supplements (for children in non-fluoridated areas, by prescription)
💰

Cost & Coverage

Average Cost: $5 - $20 per 500 mL bottle
Generic Available: Yes
Insurance Coverage: Over-the-counter (OTC) product, generally not covered by medical insurance. May be covered by some dental plans or FSA/HSA.
📚

General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, 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 to confirm. If you have any questions or concerns about your 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 reporting the incident, be prepared to provide detailed information about the medication taken, including the dosage, time of ingestion, and any other relevant details.