Prevident 5000 Sensitive Paste Mint

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 (remineralization agent); Potassium Nitrate (nerve desensitizer)
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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 toothpaste that helps prevent cavities and reduces tooth sensitivity. Sodium fluoride strengthens your tooth enamel to fight cavities, and 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 have questions about disposal, consult your pharmacist, who may be aware of local drug take-back programs.

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

  • Brush your teeth thoroughly at least twice a day, or after every meal, for at least one minute.
  • Use a soft-bristled toothbrush.
  • Do not swallow the toothpaste; spit it out after brushing.
  • 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 at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Children 6-12 years: Use a pea-sized amount and supervise brushing to minimize swallowing. Children under 6 years: Consult a dentist or physician.
Adolescent: Same as adult, apply at least a 1-inch strip.
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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 (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (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 inhibiting bacterial acid production. Potassium Nitrate: Desensitizes nerve endings in the dentin by blocking the transmission of pain signals from the tooth surface to the nerve.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible systemic absorption from topical use
Tmax: Not applicable (local action)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (local action)
ProteinBinding: Not applicable (local action)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (local action)
Clearance: Not applicable (local action)
ExcretionRoute: Not applicable (minimal systemic absorption)
Unchanged: Not applicable (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Fluoride: Immediate local effect on enamel; Potassium Nitrate: Typically 2-4 weeks for noticeable desensitization.
PeakEffect: Not applicable (local action)
DurationOfAction: Local effect until rinsed; sustained remineralization and desensitization with continued use.

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. If you notice any of the following symptoms, contact your doctor or seek immediate 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 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, talk to 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:

  • Increased tooth sensitivity or pain
  • Oral irritation, redness, or swelling
  • Rash or allergic reaction
  • Nausea, vomiting, or stomach upset (if swallowed in large amounts)
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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 (OTC) drugs, natural products, and vitamins.
* Any health problems you have.

It is crucial to verify that it is safe to take this medication with all 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, 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 fluoride toxicity (if large amounts are swallowed): nausea, vomiting, abdominal pain, diarrhea, salivation, thirst, headache, weakness, convulsions, cardiac arrest.
  • Chronic fluoride toxicity (fluorosis, especially in children): white or brown discoloration of tooth enamel, pitting of enamel.

What to Do:

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

Drug Interactions

Monitoring

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Baseline Monitoring

Dental examination

Rationale: To assess oral health, identify underlying causes of sensitivity, and determine suitability for product use.

Timing: Prior to initiation of therapy

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Routine Monitoring

Oral hygiene practices

Frequency: Daily

Target: Consistent brushing twice daily with proper technique

Action Threshold: Inconsistent use or improper technique may reduce efficacy.

Tooth sensitivity

Frequency: Ongoing

Target: Reduction or elimination of sensitivity

Action Threshold: Persistent or worsening sensitivity may indicate an underlying issue requiring dental evaluation.

Dental check-ups

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

Target: Maintenance of oral health, absence of new caries

Action Threshold: New caries or other oral health issues require dental intervention.

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Symptom Monitoring

  • Persistent tooth sensitivity
  • Oral irritation or discomfort
  • Allergic reactions (e.g., rash, swelling)
  • Signs of fluorosis (e.g., white or brown spots on teeth, especially in children)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Low risk
Second Trimester: Low risk
Third Trimester: Low risk
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Lactation

Generally considered safe for use during lactation due to minimal systemic absorption and negligible transfer into breast milk. Consult with a healthcare provider.

Infant Risk: Low risk
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Pediatric Use

Children under 6 years should use a pea-sized amount and be supervised during brushing to minimize swallowing, as excessive fluoride ingestion can lead to dental fluorosis. For children under 6, consult a dentist or physician.

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Geriatric Use

No specific dosage adjustments or precautions are generally needed for geriatric patients. Use as directed for adults.

Clinical Information

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Clinical Pearls

  • This product is intended for topical use only; do not swallow.
  • For best results in reducing sensitivity, use consistently twice daily.
  • Sensitivity relief may take several weeks to become noticeable.
  • If tooth sensitivity persists or worsens after 4 weeks of use, consult a dentist as it may indicate a more serious dental problem.
  • Ensure children are supervised to prevent excessive swallowing, which can lead to fluorosis.
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Alternative Therapies

  • Other fluoride toothpastes (e.g., prescription strength 5000 ppm fluoride toothpastes without desensitizer)
  • Other desensitizing toothpastes (e.g., those containing strontium chloride or stannous fluoride)
  • In-office fluoride treatments
  • Dental sealants
  • Dental procedures for sensitivity (e.g., bonding, gum grafts)
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Cost & Coverage

Average Cost: $15 - $30 per 112g tube
Generic Available: Yes
Insurance Coverage: Typically OTC, not covered by medical insurance; may be covered by some dental plans or FSA/HSA.
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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 evaluation and guidance. To ensure your safety and the effectiveness of your 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 for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification. 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, the amount consumed, and the time it occurred.