Prevident 5000plus Cream(spearmint)
This supplement is used to prevent cavities.
Drug Class
Dental caries prophylactic
Pharmacologic Class
Fluoride agent; Remineralizing agent
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Prevident 5000plus is a special toothpaste with a high amount of fluoride. It helps make your teeth stronger and protects them from getting cavities, especially if you are at high risk for tooth decay. You use it once a day, usually before bed, instead of your regular toothpaste.
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 medication. After using, 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 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. If you have questions about disposal, consult your pharmacist. You may also want to check if there are 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 the 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 medication. After using, 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 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. If you have questions about disposal, consult your pharmacist. You may also want to check if there are 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 the missed one.
Lifestyle & Tips
- Brush your teeth thoroughly for at least one minute, preferably at bedtime.
- After brushing, spit out the paste completely. Do NOT swallow it.
- Do NOT rinse your mouth with water immediately after brushing. This allows the fluoride to stay on your teeth longer.
- Avoid eating or drinking for at least 30 minutes after using the paste to maximize its effect.
- Maintain good overall oral hygiene, including regular flossing.
- Limit sugary foods and drinks, as these contribute to tooth decay.
- Visit your dentist regularly for check-ups and professional cleanings.
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 thin ribbon of paste to a toothbrush and brush thoroughly once daily for at least one minute, preferably at bedtime. After brushing, adults should expectorate (spit out) the paste. Do not rinse, eat, or drink for at least 30 minutes.
Condition-Specific Dosing:
high_caries_risk:
May be used more frequently as directed by a dental professional.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Children 6 years and older: Apply a pea-sized amount of paste to a toothbrush and brush thoroughly once daily for at least one minute, preferably at bedtime. Supervise children to ensure they expectorate and do not swallow the paste. Do not rinse, eat, or drink for at least 30 minutes.
Adolescent:
Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended for topical use with proper expectoration.
Moderate:
Use with caution. Systemic fluoride exposure should be minimized due to potential for accumulation.
Severe:
Contraindicated in patients with severe renal impairment due to risk of fluoride accumulation and toxicity.
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
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 interfere with bacterial adhesion and growth.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption when used topically as directed (spit out). If swallowed, rapid absorption (up to 90%) from the gastrointestinal tract.
Tmax:
Not applicable for topical action. If swallowed, plasma peak concentrations typically within 30-60 minutes.
FoodEffect:
Food (especially dairy products rich in calcium) can reduce systemic absorption of swallowed fluoride by forming insoluble complexes.
Distribution:
Vd:
Not applicable for topical action. If absorbed systemically, distributes widely, with high affinity for calcified tissues (bones, teeth).
ProteinBinding:
Low (approximately 10-20%).
CnssPenetration:
Limited, but can cross the blood-brain barrier at high concentrations.
Elimination:
HalfLife:
Systemic half-life is variable, typically 2-9 hours in adults with normal renal function. Longer in individuals with impaired renal function.
Clearance:
Primarily renal clearance.
ExcretionRoute:
Urine (approximately 50% within 24 hours), feces (unabsorbed portion), sweat.
Unchanged:
Nearly 100% of absorbed fluoride is excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Immediate local effect on tooth surface upon application.
PeakEffect:
Continuous protection with regular use.
DurationOfAction:
Local effect persists on tooth surface until removed by brushing or saliva. Systemic effects (if swallowed) are transient.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
Allergic reaction symptoms, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty 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. While many people may not experience any side effects or only have mild 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 do not go away, 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:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website at https://www.fda.gov/medwatch to report side effects online.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
Allergic reaction symptoms, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty 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. While many people may not experience any side effects or only have mild 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 do not go away, 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:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website at https://www.fda.gov/medwatch to report side effects online.
Seek Immediate Medical Attention If You Experience:
- Nausea, vomiting, or stomach upset (if swallowed)
- White or brown spots/streaks on your teeth (signs of fluorosis, especially in children)
- Any unusual or severe mouth irritation
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 allergic reaction you experienced, including any symptoms that occurred.
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.
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 allergic reaction you experienced, including any symptoms that occurred.
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.
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. To maintain good oral health, practice proper dental care and schedule regular dental check-ups.
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 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.
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 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.
Overdose Information
Overdose Symptoms:
- Acute toxicity (if large amounts are swallowed): Nausea, vomiting, abdominal pain, diarrhea, salivation, headache, weakness, muscle spasms, tremors, seizures, cardiac arrhythmias, and potentially death.
- Chronic toxicity (excessive long-term intake): Dental fluorosis (discoloration and pitting of tooth enamel), skeletal fluorosis (bone pain, stiffness, increased bone density).
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
Moderate Interactions
- Calcium-containing products (e.g., dairy products, antacids, calcium supplements): If swallowed, these can bind fluoride and reduce its systemic absorption. Advise patients not to eat or drink dairy products immediately after using fluoride toothpaste.
Monitoring
Baseline Monitoring
Dental examination and caries risk assessment
Rationale: To determine the need for high-concentration fluoride and establish baseline oral health.
Timing: Prior to initiation of therapy.
Routine Monitoring
Oral hygiene practices and compliance
Frequency: At each dental visit (typically every 6-12 months).
Target: Consistent daily use as directed, proper brushing and expectoration.
Action Threshold: Poor compliance or improper use may necessitate re-education or alternative strategies.
Assessment for dental fluorosis
Frequency: At each dental visit, especially in children.
Target: Absence of fluorosis or very mild, barely noticeable fluorosis.
Action Threshold: Moderate to severe fluorosis may indicate excessive fluoride intake and require discontinuation or reduction of fluoride exposure from all sources.
Caries activity
Frequency: At each dental visit.
Target: Reduction or arrest of new carious lesions.
Action Threshold: Continued high caries activity may require re-evaluation of treatment plan, dietary habits, and oral hygiene.
Symptom Monitoring
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Salivation
- Headache
- Weakness
- Signs of dental fluorosis (white or brown spots/streaks on teeth)
Special Patient Groups
Pregnancy
Fluoride is classified as Pregnancy Category B. Topical use of fluoride toothpaste, with proper expectoration, is generally considered safe during pregnancy as systemic absorption is minimal. Benefits of preventing maternal caries outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
No known increased risk.
Second Trimester:
No known increased risk.
Third Trimester:
No known increased risk.
Lactation
Fluoride is classified as L2 (likely compatible). Minimal amounts of fluoride are excreted into breast milk, and the amount transferred from topical toothpaste use is negligible. Considered safe for use by breastfeeding mothers.
Infant Risk:
Low risk to infant.
Pediatric Use
Not recommended for children under 6 years of age due to the increased risk of dental fluorosis from accidental swallowing. For children 6 years and older, use a pea-sized amount and supervise closely to ensure they spit out the paste and do not swallow it. The risk of fluorosis is highest during tooth development (up to age 8).
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. Use with caution in elderly patients with severe renal impairment due to potential for fluoride accumulation if swallowed.
Clinical Information
Clinical Pearls
- Emphasize the 'spit, don't rinse' instruction to patients, as rinsing immediately after brushing significantly reduces the fluoride's efficacy.
- This product is a prescription-strength fluoride toothpaste, not a regular over-the-counter toothpaste. It should be used as directed by a dental professional.
- For patients with dry mouth (xerostomia), high-concentration fluoride toothpastes are particularly beneficial due to reduced salivary flow and increased caries risk.
- Educate parents about the importance of supervising children to prevent swallowing, especially in areas with fluoridated water, to minimize the risk of fluorosis.
- Advise patients to store the product out of reach of children to prevent accidental ingestion.
Alternative Therapies
- Other high-concentration fluoride toothpastes (e.g., Clinpro 5000, SF 5000 Plus)
- Fluoride varnishes (applied professionally by a dentist)
- Fluoride gels (prescription or OTC)
- Fluoride rinses (prescription or OTC)
- Non-fluoride remineralizing agents (e.g., products containing amorphous calcium phosphate (ACP) or casein phosphopeptide-amorphous calcium phosphate (CPP-ACP))
- Silver diamine fluoride (SDF) for arresting caries
Cost & Coverage
Average Cost:
$15 - $30 per 112g tube
Generic Available:
Yes
Insurance Coverage:
Often covered by dental insurance plans, or may be an out-of-pocket expense. Some medical plans may cover it if prescribed for a specific medical condition (e.g., xerostomia).
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 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.