Prevident Gel Mint 56.6gm

Manufacturer COLGATE ORAL PHARMACEUTICALS Active Ingredient Fluoride Gel(FLOR ide) Pronunciation PREV-ih-dent Gel Mint (FLOOR-ide)
This supplement is used to prevent cavities.
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Drug Class
Dental caries prophylactic; Remineralizing agent
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Pharmacologic Class
Ionic fluoride; Enamel remineralization agent
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Pregnancy Category
Category B
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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 Gel is a special toothpaste or gel that contains a high amount of fluoride. It helps make your teeth stronger and more resistant to cavities, especially if you are at high risk for tooth decay. It works by helping to repair and protect your tooth enamel.
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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 otherwise directed by your doctor, use this gel in place of your regular toothpaste. Apply a pea-sized amount to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute before spitting it out. It is essential not to swallow this medication.

After using the gel, refrain from eating, drinking, or rinsing your mouth for at least 30 minutes. This will help ensure the medication works as intended.

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 by your pharmacist. Instead, check with your pharmacist for guidance on the proper disposal method, as there may be drug take-back programs available in your area.

Missing a Dose

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. Do not use two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Brush your teeth thoroughly with the gel once daily, preferably at bedtime, for at least one minute.
  • Spit out the gel after brushing; do NOT swallow it.
  • Do NOT rinse your mouth, eat, or drink for at least 30 minutes after using the gel to allow the fluoride to work effectively.
  • Maintain good oral hygiene practices, including regular brushing and flossing.
  • Limit sugary foods and drinks.
  • Visit your dentist regularly for check-ups and cleanings.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin ribbon of gel to a toothbrush and brush thoroughly once daily for at least one minute, preferably at bedtime. Spit out excess. Do not rinse, eat, or drink for 30 minutes after use.

Condition-Specific Dosing:

highCariesRisk: Once daily, as directed by a dental professional.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Children 6 years of age and older: Apply a thin ribbon of gel to a toothbrush and brush thoroughly once daily for at least one minute, preferably at bedtime. Spit out excess. Supervise children to minimize swallowing. Not recommended for children under 6 years unless specifically directed by a dental professional due to risk of fluorosis.
Adolescent: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use. Caution if significant ingestion is anticipated.
Dialysis: No specific considerations for topical use. Systemic fluoride is renally cleared.

Hepatic Impairment:

Mild: No adjustment needed for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.

Pharmacology

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Mechanism of Action

Fluoride ions incorporate into the enamel structure, forming fluorapatite, which is more resistant to acid demineralization than hydroxyapatite. It also enhances remineralization of early carious lesions by attracting calcium and phosphate ions. Additionally, fluoride has antibacterial properties, inhibiting bacterial enzymes and reducing acid production by oral bacteria.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption from topical application when used as directed (spit out). Significant absorption if swallowed.
Tmax: Not applicable for topical action; systemic Tmax if ingested is variable.
FoodEffect: Not relevant for topical application; ingestion of calcium-rich foods/drinks immediately after use may reduce local fluoride availability.

Distribution:

Vd: Not applicable for topical action; systemically absorbed fluoride distributes to mineralized tissues (bones, teeth).
ProteinBinding: Not significant for topical action; systemically, minimal protein binding.
CnssPenetration: Limited (systemically absorbed fluoride can cross BBB, but not relevant for topical use).

Elimination:

HalfLife: Not applicable for topical action; systemically, plasma half-life is 2-9 hours.
Clearance: Not applicable for topical action; systemically, primarily renal clearance.
ExcretionRoute: Primarily renal (if systemically absorbed).
Unchanged: 100% (if systemically absorbed).
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Pharmacodynamics

OnsetOfAction: Immediate upon contact with tooth surface.
PeakEffect: Continuous effect as long as fluoride is present and incorporated into enamel.
DurationOfAction: Prolonged due to incorporation into enamel and residual fluoride in saliva/plaque.
Confidence: High

Safety & Warnings

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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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious allergic reaction:

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 upset stomach or vomiting

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although 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 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 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 can also provide guidance on managing side effects and offer medical advice.
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Seek Immediate Medical Attention If You Experience:

  • If swallowed, symptoms of overdose may include nausea, vomiting, stomach pain, and diarrhea. Seek immediate medical attention.
  • In children, excessive fluoride intake can lead to dental fluorosis, which appears as white flecks or streaks on the tooth enamel. If you notice this, consult your dentist.
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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.
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.

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 medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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 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 immediate medical attention by calling a doctor or a poison control center. Be aware 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.
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Overdose Information

Overdose Symptoms:

  • Acute (large ingestion): Nausea, vomiting, abdominal pain, diarrhea, salivation, weakness, tremors, convulsions, cardiac arrest.
  • Chronic (excessive long-term exposure): Dental fluorosis (white, yellow, or brown discoloration and pitting of enamel), skeletal fluorosis (rare).

What to Do:

For acute ingestion, immediately seek emergency medical attention or call Poison Control (1-800-222-1222). Induce vomiting if advised by medical professional. Administer calcium (e.g., milk, calcium supplements) to bind fluoride. For chronic fluorosis, management involves cosmetic dental procedures and reducing fluoride exposure.

Drug Interactions

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Moderate Interactions

  • Calcium, Magnesium, Aluminum-containing products (e.g., antacids, dairy products): May bind fluoride if ingested immediately after use, reducing its effectiveness. Advise patients not to eat, drink, or rinse for 30 minutes after use.

Monitoring

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Baseline Monitoring

Dental examination and caries risk assessment

Rationale: To determine the need for prescription-strength fluoride and establish baseline oral health.

Timing: Prior to initiation of therapy.

Assessment of fluoride exposure from other sources (e.g., water, supplements)

Rationale: To prevent excessive fluoride intake and risk of fluorosis, especially in children.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Regular dental check-ups

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

Target: Not applicable

Action Threshold: Increased caries activity, signs of fluorosis (especially in children).

Oral hygiene assessment

Frequency: At each dental visit.

Target: Good oral hygiene.

Action Threshold: Poor plaque control, gingivitis.

Monitoring for dental fluorosis (in children)

Frequency: At each dental visit.

Target: No signs of fluorosis.

Action Threshold: Presence of white flecks or streaks on enamel, indicating excessive fluoride intake.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Abdominal pain
  • Diarrhea
  • Salivation
  • Weakness
  • Tremors
  • Convulsions (in cases of acute overdose)
  • White flecks or streaks on tooth enamel (dental fluorosis, chronic exposure)

Special Patient Groups

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Pregnancy

Generally considered safe for topical use during pregnancy (Pregnancy Category B). Minimal systemic absorption is expected when used as directed.

Trimester-Specific Risks:

First Trimester: No known increased risk.
Second Trimester: No known increased risk.
Third Trimester: No known increased risk.
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Lactation

Considered safe for use during lactation (L1 - Safest). Minimal transfer into breast milk is expected from topical application.

Infant Risk: Low risk to infant due to minimal systemic absorption and excretion into breast milk.
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Pediatric Use

Use in children under 6 years of age is generally not recommended for routine use due to the risk of dental fluorosis if swallowed. If prescribed for high-risk children, strict supervision is required to ensure the gel is spit out and not swallowed. Dosing must be carefully controlled.

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Geriatric Use

Safe and beneficial for geriatric patients, especially those with root caries, xerostomia, or increased caries risk due to medications or systemic conditions. No specific dose adjustments are typically needed.

Clinical Information

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Clinical Pearls

  • Emphasize the 'spit, don't swallow' instruction, especially for children, to minimize systemic absorption and prevent fluorosis.
  • Advise patients not to rinse, eat, or drink for at least 30 minutes after use to maximize fluoride's contact time with enamel.
  • This is a prescription-strength fluoride product, typically used for patients with moderate to high caries risk, exposed root surfaces, or xerostomia.
  • Regular dental check-ups are crucial to monitor effectiveness and detect any signs of fluorosis, particularly in pediatric patients.
  • Ensure patients understand that this gel is a supplement to, not a replacement for, regular fluoride toothpaste and good oral hygiene.
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Alternative Therapies

  • Fluoride varnishes (applied professionally by dentist)
  • Fluoride rinses (OTC or prescription strength)
  • Over-the-counter fluoride toothpastes
  • Dental sealants
  • Xylitol-containing products
  • Chlorhexidine rinses (for specific bacterial control)
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Cost & Coverage

Average Cost: Varies, typically $15-$30 per 56.6gm tube
Generic Available: Yes
Insurance Coverage: Often covered by dental insurance plans or available as an out-of-pocket purchase. May be covered under prescription drug plans depending on the specific plan and formulation.
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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 medication, including the amount taken and the time it happened, to ensure you receive the best possible care.