Prevident 5000 Bstr Plus Paste/mint
This supplement is used to prevent cavities.
Drug Class
Dental caries prophylactic
Pharmacologic Class
Fluoride agent
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Prevident 5000 is a high-strength fluoride toothpaste prescribed by your dentist to help prevent cavities and strengthen your tooth enamel. It works by making your teeth more resistant to the acid attacks that cause decay.
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. 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 and all other medications in a secure location out of the reach of children and pets. Dispose of unused or expired medications appropriately. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you are unsure about the proper disposal method, consult your pharmacist. You may also want to inquire about drug take-back programs available in your area.
Managing Missed Doses
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 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. 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 and all other medications in a secure location out of the reach of children and pets. Dispose of unused or expired medications appropriately. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you are unsure about the proper disposal method, consult your pharmacist. You may also want to inquire about drug take-back programs available in your area.
Managing Missed Doses
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
- Use once daily, preferably at bedtime, in place of your regular toothpaste.
- Brush thoroughly for at least one minute.
- After brushing, spit out the paste completely. Do NOT rinse your mouth with water immediately after brushing.
- Avoid eating or drinking for at least 30 minutes after brushing to allow the fluoride to work effectively.
- Keep out of reach of children, especially those under 6 years old, to prevent accidental ingestion.
- Maintain good oral hygiene practices, including regular flossing and limiting 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 thin ribbon of paste to a soft-bristled toothbrush. Brush thoroughly once daily for at least one minute, preferably at bedtime, replacing regular toothpaste. After brushing, spit out the paste. Do not rinse, eat, or drink for at least 30 minutes.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 6 years of age due to risk of fluorosis from swallowing. For children 6-16 years, use a pea-sized amount once daily under adult supervision, ensuring they spit out the paste and do not swallow.
Adolescent:
Same as adult dosing, once daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
Use with caution in patients with severe renal impairment due to potential for fluoride accumulation if significant amounts are ingested. Consult a dentist or physician.
Dialysis:
Use with caution; consult a dentist or physician.
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 incorporates into the enamel structure, forming fluorapatite, which is more resistant to acid demineralization than hydroxyapatite. 2) It enhances remineralization of early carious lesions by attracting calcium and phosphate ions. 3) It inhibits bacterial enzymes involved in carbohydrate metabolism, thereby reducing acid production by oral bacteria.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from topical application to teeth. If ingested, rapidly and almost completely absorbed from the gastrointestinal tract.
Tmax:
If ingested, approximately 30-60 minutes.
FoodEffect:
Food (especially dairy products rich in calcium) can reduce systemic absorption if ingested.
Distribution:
Vd:
Approximately 0.5-0.7 L/kg (if systemically absorbed).
ProteinBinding:
Low (less than 10%).
CnssPenetration:
Limited.
Elimination:
HalfLife:
Variable, typically 2-9 hours (influenced by age, renal function, and bone uptake).
Clearance:
Primarily renal clearance.
ExcretionRoute:
Primarily renal (urine); small amounts excreted in feces and sweat.
Unchanged:
Approximately 90% of absorbed fluoride is excreted unchanged in urine within 24 hours.
Pharmacodynamics
OnsetOfAction:
Immediate topical effect on enamel surface.
PeakEffect:
Continuous topical exposure provides ongoing benefit.
DurationOfAction:
Local effect persists on tooth surface; systemic effects are transient if ingested.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, some individuals may be at risk of life-threatening reactions when taking this medication. Be aware of the following symptoms that may indicate a serious side effect:
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
+ 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
As with all medications, side effects can occur. While 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 questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can contact your doctor for medical advice or reach out to the FDA directly:
Call the FDA at 1-800-332-1088
Visit the FDA's MedWatch website at https://www.fda.gov/medwatch
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, some individuals may be at risk of life-threatening reactions when taking this medication. Be aware of the following symptoms that may indicate a serious side effect:
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
+ 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
As with all medications, side effects can occur. While 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 questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can contact your doctor for medical advice or reach out to the FDA directly:
Call the FDA at 1-800-332-1088
Visit the FDA's MedWatch website at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- White, yellow, or brown spots or streaks on your teeth (signs of fluorosis, especially in children)
- Stomach upset, nausea, or vomiting (if accidentally swallowed in large amounts)
- Oral irritation or allergic reaction (rare)
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 and its symptoms.
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 prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
Any existing health problems
This information 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.
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 and its symptoms.
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 prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
Any existing health problems
This information 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.
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 varying 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 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.
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 varying 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 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.
Overdose Information
Overdose Symptoms:
- Acute overdose (ingestion of large amounts): Nausea, vomiting, abdominal pain, diarrhea, salivation, headache, weakness, tremors. Severe cases can lead to hypocalcemia, cardiac arrhythmias, convulsions, and respiratory paralysis.
- Chronic overdose (excessive long-term intake): Dental fluorosis (mottling of tooth enamel), skeletal fluorosis (bone pain, stiffness, increased bone density).
What to Do:
For accidental ingestion, immediately seek medical attention or call a Poison Control Center (1-800-222-1222). Induce vomiting if advised by medical personnel. Administer calcium (e.g., milk, calcium supplements) to bind fluoride.
Drug Interactions
Moderate Interactions
- Calcium-containing products (e.g., antacids, milk, dairy) if ingested concurrently, as they can bind fluoride and reduce systemic absorption. This is less relevant for topical dental use where ingestion is minimized.
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
Frequency: At each dental visit (e.g., every 6-12 months)
Target: Effective brushing and spitting techniques
Action Threshold: Poor technique or swallowing of paste requires re-education.
Signs of dental fluorosis (especially in children)
Frequency: At each dental visit
Target: Absence of white/brown mottling on tooth enamel
Action Threshold: Presence of fluorosis may indicate excessive fluoride intake and necessitate re-evaluation of fluoride sources.
Symptom Monitoring
- Signs of dental fluorosis (white, yellow, or brown spots/streaks on teeth)
- Oral irritation or discomfort
- Nausea, vomiting, or stomach upset (if accidentally ingested)
Special Patient Groups
Pregnancy
Category C. While systemic fluoride crosses the placenta, topical application results in minimal systemic absorption. Use during pregnancy should be based on a clear need and after discussion with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Minimal risk from topical use.
Second Trimester:
Minimal risk from topical use.
Third Trimester:
Minimal risk from topical use.
Lactation
L3 (Moderately Safe). Fluoride is excreted in breast milk, but the amount from topical maternal use is expected to be very low and unlikely to cause adverse effects in the infant. Use with caution and monitor infant for signs of fluorosis if other fluoride sources are present.
Infant Risk:
Low risk of adverse effects from maternal topical use.
Pediatric Use
Not recommended for children under 6 years of age due to the risk of dental fluorosis from swallowing. For children 6-16 years, use a pea-sized amount under adult supervision to ensure proper spitting and minimize ingestion. Assess total fluoride intake from all sources (water, supplements, other dental products) to prevent excessive exposure.
Geriatric Use
Generally safe for use in geriatric patients. No specific dose adjustments are typically required. Monitor for potential dry mouth, which can be common in this population and affect product retention.
Clinical Information
Clinical Pearls
- Emphasize the 'spit, don't rinse' instruction to maximize fluoride's topical effect.
- Advise patients not to eat or drink for at least 30 minutes after brushing to allow fluoride to penetrate the enamel.
- Stress the importance of keeping the product out of reach of young children due to the risk of fluorosis if swallowed.
- This product is a prescription-strength fluoride and should be used under the guidance of a dental professional.
- Regular dental check-ups are crucial to monitor effectiveness and detect any signs of fluorosis.
Alternative Therapies
- Lower concentration fluoride toothpastes (OTC)
- Fluoride rinses (OTC or prescription)
- Fluoride gels (prescription)
- Xylitol-containing products
- Chlorhexidine rinses (for specific bacterial control)
- Dental sealants
- Dietary modifications (reducing sugar intake)
Cost & Coverage
Average Cost:
$20 - $50 per 112g tube
Generic Available:
Yes
Insurance Coverage:
Often covered by dental insurance plans; may require prescription. Some medical plans may cover if prescribed for specific conditions.
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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.