Prevident 0.2% Solution 473ml

Manufacturer COLGATE ORAL PHARMACEUTICALS Active Ingredient Fluoride Rinse(FLOR ide) Pronunciation FLOR-ide
This supplement is used to prevent cavities.
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Drug Class
Dental Caries Prophylactic
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Pharmacologic Class
Fluoride Agent
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Pregnancy Category
Category B (for systemic fluoride; topical application has minimal systemic absorption)
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Prevident 0.2% Solution is a fluoride mouth rinse used once a week to help prevent cavities. It works by strengthening your tooth enamel, making it more resistant to the acids that cause tooth decay.
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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. Do not swallow the medication. After using, wait at least 30 minutes before eating, drinking, or rinsing your mouth.

Some products may require mixing before use. If your product needs to be mixed, do not mix it until you are ready to use it, and use it immediately after mixing.

Storing and Disposing of Your Medication

Store this medication at room temperature, 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 disposing of your medication, consult your pharmacist. You may also want to check if there are 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Use exactly as directed by your dentist or the product label.
  • Do not swallow the rinse. Spit it out completely after use.
  • Do not eat, drink, or rinse your mouth for at least 30 minutes after using the rinse to allow the fluoride to work effectively.
  • Maintain good oral hygiene practices, including brushing twice daily with fluoride toothpaste and flossing regularly.
  • Limit sugary foods and drinks.
  • Keep out of reach of children, especially those under 6 years old, to prevent accidental swallowing.

Dosing & Administration

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Adult Dosing

Standard Dose: Rinse once a week, preferably at bedtime, after thoroughly brushing teeth. Pour 10 mL (2 teaspoons) into a cup, rinse vigorously around and between teeth for one minute, then spit out. Do not swallow. Do not eat, drink, or rinse for at least 30 minutes after use.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Children 6 years of age and older: Rinse once a week, preferably at bedtime, after thoroughly brushing teeth. Pour 10 mL (2 teaspoons) into a cup, rinse vigorously around and between teeth for one minute, then spit out. Do not swallow. Supervise children to ensure they spit out completely. Not recommended for children under 6 years of age due to risk of swallowing.
Adolescent: Same as adult dosing.
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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; systemic fluoride is primarily renally excreted, but topical absorption is negligible.

Hepatic Impairment:

Mild: No adjustment needed (not metabolized by liver)
Moderate: No adjustment needed (not metabolized by liver)
Severe: No adjustment needed (not metabolized by liver)

Pharmacology

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Mechanism of Action

Fluoride works primarily by topical action on tooth enamel. It promotes remineralization of demineralized enamel, inhibits demineralization, and can inhibit bacterial enzymes, thereby reducing acid production by oral bacteria. It incorporates into the enamel structure, forming fluorapatite, which is more resistant to acid dissolution than hydroxyapatite.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible systemic absorption from topical rinse if used as directed (spit out). If swallowed, systemic bioavailability is high.
Tmax: Not applicable for topical action. If swallowed, peak plasma levels occur within 30-60 minutes.
FoodEffect: Not applicable for topical action. If swallowed, food (especially dairy/calcium) can reduce absorption.

Distribution:

Vd: Not applicable for topical action. If absorbed systemically, distributes widely, with high affinity for calcified tissues (bones, teeth).
ProteinBinding: Not applicable for topical action. If absorbed systemically, minimal protein binding.
CnssPenetration: Limited (if absorbed systemically, does not readily cross intact blood-brain barrier)

Elimination:

HalfLife: Not applicable for topical action. If absorbed systemically, plasma half-life is typically 2-9 hours, but terminal half-life from bone can be much longer.
Clearance: Not applicable for topical action. If absorbed systemically, primarily renal clearance.
ExcretionRoute: Primarily renal (if absorbed systemically); unabsorbed fluoride is eliminated in feces.
Unchanged: 100% (not metabolized)
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Pharmacodynamics

OnsetOfAction: Immediate (topical effect on enamel surface)
PeakEffect: Continuous with regular use, building up resistance over time.
DurationOfAction: Topical effect persists on enamel surface; systemic effects (if swallowed) are transient, but fluoride incorporated into enamel provides long-term protection.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, including:
+ 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 bother you or do not go away, contact your doctor for advice.

Reporting Side Effects

This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Signs of acute fluoride toxicity (if swallowed in large amounts): nausea, vomiting, abdominal pain, diarrhea, excessive salivation, headache, weakness, tremors, tetany, convulsions.
  • Signs of dental fluorosis (in children): white flecks, streaks, or brown stains on teeth (indicates excessive fluoride intake over time).
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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 as a result of the allergy.
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, it is crucial to discuss all of your medications, including:
Prescription drugs
Over-the-counter (OTC) medications
Natural products
* Vitamins

As well as any existing health problems with your doctor and pharmacist to ensure safe use. 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.
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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 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 poison control center. Note that different formulations of this drug may be suitable for children of various ages, so it is crucial to consult with your doctor before administering this medication 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.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Abdominal pain
  • Diarrhea
  • Excessive salivation
  • Headache
  • Weakness
  • Tremors
  • Tetany
  • Convulsions
  • Cardiac arrhythmias
  • Hypocalcemia

What to Do:

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

Drug Interactions

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Minor Interactions

  • Calcium-containing products (e.g., milk, antacids): If swallowed, calcium can bind with fluoride, reducing its systemic absorption. This is generally not a concern for topical rinse use where swallowing is avoided.

Monitoring

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Routine Monitoring

Oral hygiene practices

Frequency: Ongoing

Target: Consistent brushing, flossing, and regular dental check-ups

Action Threshold: Poor oral hygiene may indicate need for re-education or alternative fluoride delivery methods.

Signs of dental fluorosis (in children)

Frequency: During routine dental check-ups

Target: Absence of white flecks or brown stains on teeth

Action Threshold: Presence of fluorosis may indicate excessive fluoride intake from all sources; reassess total fluoride exposure.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Salivation
  • Headache
  • Weakness
  • Tremors
  • Tetany
  • Convulsions
  • Cardiac arrhythmias

Special Patient Groups

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Pregnancy

Topical fluoride rinses are generally considered safe for use during pregnancy as systemic absorption is minimal when used as directed. Consult with a healthcare provider or dentist.

Trimester-Specific Risks:

First Trimester: Low risk due to minimal systemic absorption.
Second Trimester: Low risk due to minimal systemic absorption.
Third Trimester: Low risk due to minimal systemic absorption.
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Lactation

Topical fluoride rinses are generally considered safe for use during lactation as systemic absorption is minimal and fluoride is poorly transferred into breast milk from topical application.

Infant Risk: Low risk to infant.
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Pediatric Use

Not recommended for children under 6 years of age due to the risk of swallowing the rinse, which can lead to dental fluorosis (discoloration of developing teeth) or acute toxicity. Children 6 years and older should be supervised to ensure they spit out the rinse completely.

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Geriatric Use

No specific dose adjustments are necessary. Use as directed for adults. May be beneficial for older adults experiencing root caries or dry mouth.

Clinical Information

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Clinical Pearls

  • This 0.2% fluoride solution is designed for weekly use, not daily. Ensure patients understand the correct frequency to avoid excessive fluoride exposure.
  • Emphasize the importance of spitting out the rinse completely and not swallowing it, especially for children.
  • Advise patients to avoid eating, drinking, or rinsing for at least 30 minutes after use to maximize fluoride's topical effect.
  • This rinse is an adjunct to, not a replacement for, daily brushing with fluoride toothpaste and regular dental check-ups.
  • For patients with high caries risk, a daily 0.05% fluoride rinse or other higher-concentration fluoride products (e.g., varnish, gel) may be considered by a dental professional.
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Alternative Therapies

  • Daily 0.05% sodium fluoride rinses (e.g., ACT Fluoride Rinse)
  • Fluoride toothpastes (e.g., prescription-strength 5000 ppm fluoride toothpaste)
  • Fluoride varnishes (applied by dental professional)
  • Fluoride gels (prescription-strength, often used with trays)
  • Community water fluoridation
  • Dietary fluoride supplements (for children in non-fluoridated areas, by prescription)
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Cost & Coverage

Average Cost: $15 - $30 per 473ml bottle
Generic Available: Yes
Insurance Coverage: Often OTC, may be covered by some dental insurance plans or FSA/HSA accounts. Not typically covered by medical insurance.
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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 seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.