Prevident 5000 Enamel Mint Paste

Manufacturer COLGATE Active Ingredient Sodium Fluoride and Potassium Nitrate(SOW dee um FLOR ide & po TAS ee um NYE trate) Pronunciation SOW-dee-um FLOR-ide & po-TAS-ee-um NYE-trate
This supplement is used to prevent cavities.It is used to help sensitive teeth.
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Drug Class
Dental Caries Prophylactic; Desensitizing Agent
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Pharmacologic Class
Fluoride; Nerve Depolarizing Agent
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Pregnancy Category
Category C
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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?

This is a prescription-strength toothpaste that helps prevent cavities and reduce tooth sensitivity. The fluoride strengthens your tooth enamel, making it more resistant to decay, while the potassium nitrate calms the nerves inside your teeth to lessen pain from hot, cold, or sweet foods.
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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 accompanying information carefully. Replace your regular toothpaste with this medication unless your doctor advises otherwise. Brush your teeth as directed, then spit out the medication. Do not swallow it. Rinse your mouth thoroughly and spit out the rinse water.

Storing and Disposing of Your Medication

Store this medication at room temperature, keeping it in a secure location that is out of reach of children and pets. Dispose of unused or expired medication responsibly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.

Managing Missed Doses

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. Avoid taking two doses at once or using extra doses to make up for a missed one.
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Lifestyle & Tips

  • Use once daily, preferably at bedtime, in place of your regular toothpaste.
  • Brush thoroughly for two minutes.
  • Do not rinse, eat, or drink for at least 30 minutes after brushing to allow the fluoride to work effectively.
  • Do not swallow the paste; spit out thoroughly after brushing.
  • Maintain good oral hygiene practices, including regular flossing and dental check-ups.
  • Limit sugary foods and drinks.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin ribbon of paste to a toothbrush and brush thoroughly once daily for two minutes, preferably at bedtime, in place of your regular toothpaste.

Condition-Specific Dosing:

caries_prevention: Once daily application
dentin_hypersensitivity: Once daily application
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Children 6-16 years: Apply a thin ribbon of paste to a toothbrush and brush thoroughly once daily for two minutes, preferably at bedtime. Supervise to minimize swallowing.
Adolescent: Adolescents 16 years and older: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption.
Moderate: No specific adjustment needed due to minimal systemic absorption.
Severe: No specific adjustment needed due to minimal systemic absorption. Use with caution in patients with severe renal impairment due to potential for fluoride accumulation if ingested.
Dialysis: Considerations: Minimal systemic absorption, but caution if significant ingestion occurs.

Hepatic Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption.
Moderate: No specific adjustment needed due to minimal systemic absorption.
Severe: No specific adjustment needed due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Sodium Fluoride: Increases the resistance of tooth enamel to acid demineralization by promoting remineralization and forming fluorapatite. It also inhibits bacterial enzymes, reducing acid production by oral bacteria. Potassium Nitrate: Desensitizes nerves in the dental pulp by depolarizing nerve fibers, thereby reducing the transmission of pain signals from the tooth surface to the brain.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (primarily local action)
Tmax: Not applicable (for systemic effects)
FoodEffect: Not applicable (for systemic effects)

Distribution:

Vd: Not applicable (for systemic effects)
ProteinBinding: Not applicable (for systemic effects)
CnssPenetration: No (systemically significant)

Elimination:

HalfLife: Not applicable (for systemic effects)
Clearance: Not applicable (for systemic effects)
ExcretionRoute: Not applicable (for systemic effects)
Unchanged: Not applicable (for systemic effects)
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Pharmacodynamics

OnsetOfAction: Immediate local effect for fluoride; desensitizing effect of potassium nitrate may take 2-4 weeks of consistent use.
PeakEffect: Not applicable (for systemic effects)
DurationOfAction: Local effect persists until removed by brushing/saliva; fluoride benefits are cumulative with regular use.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
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 medical help right away:
- 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 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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Signs of fluorosis (white, yellow, or brown spots on teeth, especially in children)
  • Oral irritation or rash
  • Swelling of the mouth or face (rare, allergic reaction)
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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.

Additionally, to ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
* Any health problems you have

This will help your doctor determine if it is safe for you 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 notify your dentist. Regular dental check-ups and good oral hygiene practices are crucial to maintaining 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. Be aware that different brands of this medication may have varying dosage recommendations for children, 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, it is vital to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Salivation
  • Headache
  • Weakness
  • Tremors
  • Tetany
  • Cardiac arrhythmias (severe cases)
  • Hypocalcemia (severe cases)

What to Do:

If a large amount is accidentally swallowed, seek immediate 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

Monitoring

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Baseline Monitoring

Oral examination by dentist

Rationale: To assess dental health, identify existing caries, and determine suitability for prescription fluoride toothpaste.

Timing: Prior to initiation of therapy

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Routine Monitoring

Dental check-ups

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

Target: Healthy teeth and gums, absence of new caries

Action Threshold: Presence of new caries, increased sensitivity, or signs of fluorosis

Patient compliance with brushing instructions

Frequency: At each dental visit

Target: Consistent daily use as prescribed

Action Threshold: Poor compliance may lead to reduced efficacy

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Symptom Monitoring

  • Reduction in tooth sensitivity
  • Absence of new dental caries
  • Signs of dental fluorosis (white or brown spots on teeth, especially in children)
  • Oral irritation or discomfort

Special Patient Groups

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Pregnancy

Pregnancy Category C. While systemic absorption is minimal, animal studies with high doses of fluoride have shown adverse effects. Use only if the potential benefit justifies the potential risk to the fetus. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Minimal systemic exposure, but caution advised.
Second Trimester: Minimal systemic exposure, but caution advised.
Third Trimester: Minimal systemic exposure, but caution advised.
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Lactation

Lactation Risk L2 (Safer). Sodium fluoride is minimally excreted into breast milk following topical application due to minimal systemic absorption. Potassium nitrate is also minimally absorbed. Considered compatible with breastfeeding when used as directed.

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

Children under 6 years of age should not use this product due to the risk of dental fluorosis from swallowing. Children 6-16 years should be supervised during brushing to minimize swallowing. Risk of fluorosis increases with total fluoride intake from all sources.

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Geriatric Use

No specific dosage adjustments are necessary for geriatric patients. Use as directed for adults.

Clinical Information

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Clinical Pearls

  • This product is a prescription-strength fluoride toothpaste and should not be used as a regular over-the-counter toothpaste.
  • Emphasize the 'spit, don't rinse' instruction to maximize fluoride retention on tooth surfaces.
  • Advise patients to avoid eating or drinking for at least 30 minutes after brushing to allow optimal fluoride uptake.
  • For patients with severe dry mouth, the effectiveness of fluoride may be reduced; consider additional fluoride varnish applications.
  • Educate parents about the risk of dental fluorosis in young children if the paste is swallowed.
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Alternative Therapies

  • Over-the-counter fluoride toothpastes (0.24% sodium fluoride or 0.15% stannous fluoride)
  • Fluoride varnishes or gels applied by a dental professional
  • Dental sealants for caries prevention
  • Other desensitizing agents (e.g., strontium chloride, arginine-calcium carbonate)
  • Restorative dental procedures for sensitivity (e.g., bonding, crowns)
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Cost & Coverage

Average Cost: $15 - $30 per 110g tube
Generic Available: Yes
Insurance Coverage: Often covered by dental insurance plans or eligible for FSA/HSA. May require prescription.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.