Prevident 5000 Plus Cream (fruit)
This supplement is used to prevent cavities.
Drug Class
Dental caries prophylactic
Pharmacologic Class
Fluoride agent
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Prevident 5000 Plus is a special toothpaste with a high concentration of fluoride. It's used to help prevent cavities, especially if you're at high risk for them. The fluoride works by making your tooth enamel stronger and more resistant to acid, which causes cavities.
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. Replace your regular toothpaste with this medication unless your doctor advises otherwise. Brush your teeth as directed, then spit out the medication. It is essential not to swallow this drug. After using the medication, wait at least 30 minutes before eating, drinking, or rinsing your mouth.
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 properly. 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 best disposal method, consult your pharmacist, who may be aware of drug take-back programs 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.
To use this medication effectively, 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. It is essential not to swallow this drug. After using the medication, wait at least 30 minutes before eating, drinking, or rinsing your mouth.
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 properly. 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 best disposal method, consult your pharmacist, who may be aware of drug take-back programs 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.
Lifestyle & Tips
- Brush your teeth thoroughly with the cream once daily, preferably at bedtime.
- Use only a pea-sized amount.
- Spit out the cream after brushing; do NOT swallow it.
- Do not rinse your mouth, eat, or drink for at least 30 minutes after brushing to allow the fluoride to work effectively.
- Maintain good overall oral hygiene, including regular flossing and dental check-ups.
- Limit sugary foods and drinks.
Available Forms & Alternatives
Available Strengths:
- Prevident Gel Mint 56.6gm
- Prevident 1.1% Gel Berry 56.6gm
- Prevident 5000plus Cream(spearmint)
- Prevident 5000 Plus Cream (fruit)
- Prevident 5000 Sensitive Paste Mint
- Prevident 5000 Dry Mouthmint Paste
- Prevident 5000 Enamel Mint Paste
- Prevident 5000 Bstr Plus Paste/mint
- Prevident 5000 Bst Plus Paste/fruit
- Prevident 0.2% Solution 473ml
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a pea-sized amount (approximately 1 gram) to a soft-bristled toothbrush and brush thoroughly once daily, preferably at bedtime, for at least one minute. Expectorate after use. Do not rinse, eat, or drink for 30 minutes after use.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Children 6 years and older: Apply a pea-sized amount (approximately 1 gram) to a soft-bristled toothbrush and brush thoroughly once daily, preferably at bedtime, for at least one minute. Expectorate after use. Do not rinse, eat, or drink for 30 minutes after use. Supervise children to minimize swallowing.
Adolescent:
Same as adult dosing.
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
Mechanism of Action
Fluoride acts topically to prevent dental caries by several mechanisms: 1) It enhances remineralization of demineralized enamel and inhibits demineralization by forming fluorapatite, which is more resistant to acid dissolution than hydroxyapatite. 2) It inhibits bacterial enzymes, thereby reducing acid production by oral bacteria. 3) It can also interfere with bacterial adhesion and growth.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from topical application to teeth; primarily local effect.
Tmax:
Not applicable for topical dental cream (systemic Tmax not relevant).
FoodEffect:
Food/drink immediately after application can reduce local efficacy by washing away fluoride.
Distribution:
Vd:
Not applicable (primarily local action).
ProteinBinding:
Not applicable (primarily local action).
CnssPenetration:
Limited (only if significant systemic absorption occurs, which is not expected with proper use).
Elimination:
HalfLife:
Not applicable for topical dental cream (systemic half-life not relevant for therapeutic effect).
Clearance:
Not applicable (primarily local action).
ExcretionRoute:
If systemically absorbed (e.g., from ingestion), primarily renal excretion.
Unchanged:
Not applicable (primarily local action).
Pharmacodynamics
OnsetOfAction:
Immediate local effect on enamel surface upon application.
PeakEffect:
Sustained local effect with regular use.
DurationOfAction:
Local effect persists on tooth surface until washed away; benefits accumulate with consistent daily use.
Confidence:
High
Safety & Warnings
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. Although many people may not experience any side effects or only minor ones, it's essential to monitor your response to the medication. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have concerns or questions about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Submit a report online at https://www.fda.gov/medwatch
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. Although many people may not experience any side effects or only minor ones, it's essential to monitor your response to the medication. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have concerns or questions about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Submit a report online at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- Nausea
- Vomiting
- Stomach upset
- Diarrhea
- Headache
- Weakness
- Any unusual white spots or brown stains on teeth (especially in children, indicating fluorosis)
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, this is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems
with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication and your individual health profile.
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, this is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems
with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication and your individual health profile.
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 check-ups and good oral hygiene practices are crucial while using this drug.
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, it is vital to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for both you and your baby.
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, it is vital to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Acute fluoride toxicity symptoms (if significant amount swallowed): nausea, vomiting, abdominal pain, diarrhea, excessive salivation, headache, weakness, muscle cramps, tremors, convulsions. Severe cases can lead to hypocalcemia, cardiac arrhythmias, and respiratory depression.
What to Do:
If a large amount is swallowed, immediately seek emergency medical attention or call Poison Control (1-800-222-1222). Induce vomiting if advised by medical professional. Administer milk or calcium-containing antacids to bind fluoride.
Drug Interactions
Monitoring
Baseline Monitoring
Dental examination
Rationale: To assess oral health, identify existing caries, and determine the need for high-concentration fluoride.
Timing: Prior to initiation of therapy.
Routine Monitoring
Oral hygiene assessment
Frequency: At regular dental check-ups (e.g., every 6-12 months)
Target: Good oral hygiene practices
Action Threshold: Poor compliance or continued caries activity may require re-evaluation of treatment plan.
Dental fluorosis assessment (especially in children)
Frequency: At regular dental check-ups
Target: Absence of fluorosis or very mild fluorosis
Action Threshold: Signs of moderate to severe fluorosis may indicate excessive fluoride intake and require discontinuation or reduction of fluoride sources.
Symptom Monitoring
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Headache
- Weakness
- Signs of dental fluorosis (white flecks, streaks, or brown stains on teeth)
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy. Minimal systemic absorption is expected with proper use.
Trimester-Specific Risks:
First Trimester:
Low risk with proper topical use.
Second Trimester:
Low risk with proper topical use.
Third Trimester:
Low risk with proper topical use.
Lactation
Considered safe for use during lactation. Minimal systemic absorption means negligible transfer into breast milk.
Infant Risk:
Low risk to breastfed infant.
Pediatric Use
Use in children under 6 years is generally not recommended due to the risk of swallowing and subsequent dental fluorosis. For children 6 years and older, supervise use to ensure proper brushing and expectoration to minimize swallowing.
Geriatric Use
No specific dose adjustments are necessary. May be beneficial for older adults at high risk for root caries or xerostomia-related caries.
Clinical Information
Clinical Pearls
- Emphasize the 'do not swallow' instruction, especially for children, to prevent systemic fluoride exposure and potential fluorosis.
- Advise patients not to rinse, eat, or drink for at least 30 minutes after application to maximize fluoride's topical effect.
- This product is a prescription-strength fluoride and should not be used as a regular toothpaste unless directed by a dental professional.
- Patients with dry mouth (xerostomia) may particularly benefit from high-concentration fluoride products due to increased caries risk.
Alternative Therapies
- Over-the-counter fluoride toothpastes (e.g., 1000-1500 ppm fluoride)
- Fluoride varnishes (applied by dental professional)
- Fluoride rinses (e.g., ACT Fluoride Rinse)
- Silver Diamine Fluoride (SDF) for arresting caries
- Dental sealants
Cost & Coverage
Average Cost:
$20 - $40 per 51g tube
Generic Available:
Yes
Insurance Coverage:
Often covered by dental insurance plans; may be covered by some medical plans if prescribed for a specific condition.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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'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 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 details about the medication taken, the amount, and the time it happened.