Prevident 1.1% Gel Berry 56.6gm
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 1.1% Gel is a prescription-strength fluoride gel used to help prevent cavities (dental caries) and strengthen tooth enamel. It works by making your teeth more resistant to acid attacks from bacteria and food.
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. Unless your doctor advises otherwise, use this gel in place of your regular toothpaste.
To apply:
Use a pea-sized amount of the gel
Brush your teeth thoroughly
Allow the medication to stay on your teeth for 1 minute before spitting it out
Do not swallow the medication
After using the medication:
Avoid eating, drinking, or rinsing your mouth for at least 30 minutes
Storing and Disposing of Your Medication
Store the medication at room temperature, keeping it in a safe location that is out of reach of children and pets. When disposing of unused or expired medication:
Do not flush it down the toilet or pour it down the drain unless instructed to do so
Check with your pharmacist for guidance on proper disposal
Consider participating in a drug take-back program in your area, if available
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. Do not take two doses at the same time or use extra doses to make up for a missed dose.
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Unless your doctor advises otherwise, use this gel in place of your regular toothpaste.
To apply:
Use a pea-sized amount of the gel
Brush your teeth thoroughly
Allow the medication to stay on your teeth for 1 minute before spitting it out
Do not swallow the medication
After using the medication:
Avoid eating, drinking, or rinsing your mouth for at least 30 minutes
Storing and Disposing of Your Medication
Store the medication at room temperature, keeping it in a safe location that is out of reach of children and pets. When disposing of unused or expired medication:
Do not flush it down the toilet or pour it down the drain unless instructed to do so
Check with your pharmacist for guidance on proper disposal
Consider participating in a drug take-back program in your area, if available
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. Do not take two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Use as directed by your dentist or doctor, usually once daily at bedtime.
- Brush thoroughly for at least one minute.
- After brushing, spit out the gel completely. Do NOT swallow the gel.
- Do NOT rinse your mouth immediately after use to allow the fluoride to work effectively. Wait at least 30 minutes before eating or drinking.
- Maintain good oral hygiene practices, including regular brushing and flossing.
- 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 thin ribbon of gel to a toothbrush and brush thoroughly once daily for at least one minute, preferably at bedtime. After use, adults should expectorate (spit out) the gel and rinse thoroughly.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Children 6-16 years of age: Apply a thin ribbon of gel to a toothbrush and brush thoroughly once daily for at least one minute, preferably at bedtime. After use, children should expectorate (spit out) the gel and rinse thoroughly. Supervise children to minimize swallowing.
Adolescent:
Adolescents 16 years and older: 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 (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
Mechanism of Action
Fluoride acts topically to prevent dental caries by several mechanisms: 1) It enhances remineralization of demineralized enamel and inhibits demineralization. 2) It incorporates into the tooth structure (as fluorapatite), making the enamel more resistant to acid attacks. 3) It inhibits bacterial enzymes, thereby reducing acid production by oral bacteria.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from topical application to teeth and oral mucosa. Primarily acts locally.
Tmax:
Not applicable for topical action; systemic Tmax not clinically relevant.
FoodEffect:
Not applicable for topical dental gel.
Distribution:
Vd:
Not clinically relevant for topical application.
ProteinBinding:
Not clinically relevant for topical application.
CnssPenetration:
No
Elimination:
HalfLife:
Not clinically relevant for topical application; systemically absorbed fluoride is renally excreted with a half-life of several hours.
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
Unabsorbed fluoride is expectorated. Systemically absorbed fluoride is primarily excreted renally.
Unchanged:
Not applicable for topical action.
Pharmacodynamics
OnsetOfAction:
Immediate local effect upon application.
PeakEffect:
Continuous local effect with regular use.
DurationOfAction:
Local effect persists on tooth surface until removed by brushing/eating; systemic effects are not the goal.
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:
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. While many people may not experience any side effects or only minor 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 contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and answering any questions you may have.
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:
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. While many people may not experience any side effects or only minor 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 contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and answering any questions you may have.
Seek Immediate Medical Attention If You Experience:
- Nausea, vomiting, or stomach pain (if swallowed)
- Oral irritation, burning, or soreness
- White or brown spots on teeth (signs of fluorosis, especially in children)
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
* If the fluoride level in your drinking water is 0.6 parts per million or higher.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues 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 adjust the dosage 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 symptoms you experienced.
Certain health conditions, including:
+ Bone problems
+ Joint problems
+ Kidney problems
+ Ulcers
* If the fluoride level in your drinking water is 0.6 parts per million or higher.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues 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 adjust the dosage 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. 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. 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 overdose (from swallowing large amounts): Nausea, vomiting, abdominal pain, diarrhea, salivation, weakness, tremors, convulsions, cardiac arrhythmias, and potentially death.
- Chronic overdose (from excessive long-term ingestion): Dental fluorosis (enamel discoloration, pitting, or mottling).
What to Do:
For acute ingestion, immediately seek emergency medical attention or call a poison control center (1-800-222-1222). Induce vomiting if advised by medical professional. Administer calcium (e.g., milk, calcium gluconate) to bind fluoride. Hospitalization may be required for supportive care.
Drug Interactions
Monitoring
Baseline Monitoring
Dental examination
Rationale: To assess baseline oral health and identify areas of concern for caries prevention.
Timing: Prior to initiation of therapy
Routine Monitoring
Regular dental check-ups
Frequency: Every 6-12 months, or as recommended by dentist
Target: Healthy teeth, no new caries
Action Threshold: Presence of new caries, signs of fluorosis, or oral irritation
Symptom Monitoring
- Oral irritation (e.g., burning, soreness)
- Stomach upset (if swallowed)
- Signs of dental fluorosis (white or brown spots on teeth, especially in children)
Special Patient Groups
Pregnancy
Topical fluoride gels are generally considered safe for 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
Lactation
Topical fluoride gels are considered safe for use during lactation due to minimal systemic absorption and negligible transfer into breast milk.
Infant Risk:
Low risk (L1)
Pediatric Use
Use in children under 6 years of age is generally not recommended for gels due to the risk of swallowing and subsequent dental fluorosis. For children 6-16 years, supervise use to ensure proper spitting and minimize swallowing. Risk of dental fluorosis is highest during tooth development.
Geriatric Use
No specific dose adjustments are necessary. Use as directed for adults. May be particularly beneficial for older adults with increased risk of root caries or xerostomia.
Clinical Information
Clinical Pearls
- This is a prescription-strength fluoride product; it is stronger than over-the-counter fluoride toothpastes.
- Emphasize the importance of spitting out the gel and not rinsing immediately after use to maximize fluoride's topical effect.
- Educate patients, especially parents, about the risk of dental fluorosis if children swallow the gel excessively during tooth development.
- Often prescribed for patients with high caries risk, orthodontic appliances, xerostomia (dry mouth), or exposed root surfaces.
Alternative Therapies
- Other prescription-strength fluoride toothpastes (e.g., 5000 ppm fluoride)
- Fluoride varnishes (applied by dental professional)
- Fluoride rinses (e.g., 0.05% sodium fluoride daily rinse)
- Over-the-counter fluoride toothpastes (e.g., 1000-1500 ppm fluoride)
- Water fluoridation
Cost & Coverage
Average Cost:
$15 - $30 per 56.6gm tube
Generic Available:
Yes
Insurance Coverage:
Often covered by dental insurance plans or medical plans for specific conditions (e.g., xerostomia, radiation therapy).
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 overdose, including the medication taken, the amount, and the time it occurred.