Denta 5000 Plus Cream 2x51gm
This supplement is used to prevent cavities.
Drug Class
Dental Caries Prophylactic; Remineralizing Agent
Pharmacologic Class
Fluoride Salt; Ionic Fluoride
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This cream contains a high concentration of fluoride, a natural mineral that helps make your teeth stronger and more resistant to cavities. It works by rebuilding weakened enamel and protecting your teeth from acid attacks caused by bacteria in your mouth. It's like a super-charged shield for your teeth.
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 inaccessible to 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 by your doctor or pharmacist. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs 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 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 inaccessible to 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 by your doctor or pharmacist. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs 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
- Maintain good oral hygiene practices, including regular brushing and flossing.
- Limit sugary foods and drinks, as they contribute to tooth decay.
- Visit your dentist regularly for check-ups and professional cleanings.
- Do not swallow the cream; spit it out after brushing.
- Do not rinse your mouth immediately after use to allow the fluoride to work effectively.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin ribbon (approximately 1 inch or 1 gram) to a soft-bristled toothbrush once daily, preferably at bedtime, in place of regular toothpaste. Brush thoroughly for at least one minute. After use, spit out the paste and do not rinse. Do not eat or drink for 30 minutes after use.
Condition-Specific Dosing:
highCariesRisk:
Once daily application.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6 years and older: Apply a pea-sized amount (approximately 0.5 gram) once daily, preferably at bedtime, in place of regular toothpaste. Brush thoroughly. Supervise children to ensure they spit out the paste and do not swallow. Do not eat or drink for 30 minutes after use.
Adolescent:
Same as adult dosing, or as directed by a dental professional.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment required for topical use due to minimal systemic absorption.
Severe:
Use with caution in patients with severe renal impairment due to potential for fluoride accumulation if significant amounts are swallowed. Consult a dental professional.
Dialysis:
Considerations: Minimal systemic absorption from topical use makes dialysis considerations generally not applicable. However, avoid ingestion.
Hepatic Impairment:
Mild:
No specific adjustment required for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment required for topical use due to minimal systemic absorption.
Severe:
No specific adjustment required for topical use due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Fluoride acts primarily by enhancing the remineralization of demineralized enamel and inhibiting the demineralization process. It incorporates into the tooth structure, forming fluorapatite, which is more resistant to acid dissolution than hydroxyapatite. Fluoride also inhibits bacterial enzymes, thereby reducing acid production by oral bacteria, and can have direct antibacterial effects.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from topical application to teeth and oral mucosa. Significant absorption occurs only if swallowed.
Tmax:
Not applicable for topical action; if swallowed, peak plasma levels typically occur within 30-60 minutes.
FoodEffect:
Not applicable for topical use. Ingested fluoride absorption can be reduced by calcium-rich foods.
Distribution:
Vd:
Not applicable for topical action. If absorbed systemically, fluoride distributes throughout the body, with high affinity for calcified tissues (bones, teeth).
ProteinBinding:
Not significant.
CnssPenetration:
Limited
Elimination:
HalfLife:
Systemic half-life is variable, typically 2-9 hours for plasma, but much longer for fluoride incorporated into bone.
Clearance:
Primarily renal clearance for systemic fluoride.
ExcretionRoute:
Renal (urine) for systemically absorbed fluoride; unabsorbed fluoride is eliminated via feces.
Unchanged:
100% (if absorbed systemically)
Pharmacodynamics
OnsetOfAction:
Immediate upon contact with tooth surface.
PeakEffect:
Continuous effect with regular use as fluoride incorporates into enamel.
DurationOfAction:
Prolonged due to incorporation into enamel and residual fluoride in saliva and plaque.
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 is also available to 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 is also available to 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 in large amounts)
- Oral irritation or soreness
- White or brown spots/streaks 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
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. Always verify that it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust 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 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. Always verify that it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust 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 (from ingestion): Nausea, vomiting, abdominal pain, diarrhea, excessive salivation, headache, weakness, tremors, convulsions, cardiac arrhythmias, hypocalcemia.
- Chronic toxicity (fluorosis, from excessive long-term ingestion during tooth development): Enamel discoloration (white flecks to brown stains), pitting of enamel, skeletal fluorosis (rare).
What to Do:
For acute ingestion, immediately seek emergency medical attention or call a Poison Control Center (1-800-222-1222). Induce vomiting only if advised by medical personnel. Administer calcium (e.g., milk, calcium gluconate) to bind fluoride. For chronic fluorosis, consult a dental professional for cosmetic or restorative options.
Drug Interactions
Monitoring
Baseline Monitoring
Comprehensive Dental Examination
Rationale: To assess current oral health, caries risk, and identify any pre-existing conditions.
Timing: Prior to initiation of therapy.
Caries Risk Assessment
Rationale: To determine the appropriate need and frequency of high-concentration fluoride therapy.
Timing: Prior to initiation and periodically.
Routine Monitoring
Oral Hygiene Compliance
Frequency: At each dental recall visit (e.g., every 6-12 months).
Target: Optimal brushing and flossing habits.
Action Threshold: Poor compliance may require re-education or alternative strategies.
Signs of Dental Fluorosis
Frequency: At each dental recall visit, especially in children.
Target: Absence of white flecks, streaks, or brown discoloration on enamel.
Action Threshold: Presence of fluorosis may indicate excessive fluoride intake and require dose adjustment or discontinuation.
Caries Activity
Frequency: At each dental recall visit.
Target: Reduction or arrest of new carious lesions.
Action Threshold: Continued caries activity may require re-evaluation of treatment plan or adjunctive therapies.
Symptom Monitoring
- Oral irritation (e.g., burning, soreness)
- Nausea or stomach upset (if swallowed)
- Signs of dental fluorosis (white or brown spots/streaks on teeth, especially in developing teeth)
Special Patient Groups
Pregnancy
Fluoride is generally considered safe for topical use during pregnancy (Category B). Systemic absorption from topical application is minimal. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk with topical use.
Second Trimester:
Low risk with topical use.
Third Trimester:
Low risk with topical use.
Lactation
Fluoride is considered safe for use during lactation (L1). Minimal systemic absorption from topical application means negligible amounts are excreted in breast milk.
Infant Risk:
Low risk to infant.
Pediatric Use
Use in children requires careful supervision to minimize ingestion and prevent dental fluorosis. Dosing should be age-appropriate (e.g., pea-sized amount for children 6 years and older). Not recommended for children under 6 years of age due to the risk of fluorosis from swallowing.
Geriatric Use
No specific dose adjustments are necessary. Beneficial for maintaining oral health and preventing root caries in older adults.
Clinical Information
Clinical Pearls
- High-concentration fluoride creams/pastes are prescription-strength and intended for individuals with moderate to high risk of dental caries.
- Emphasize the 'spit, don't rinse' instruction to maximize fluoride retention on tooth surfaces.
- Advise patients not to eat or drink for at least 30 minutes after bedtime application to allow fluoride to work overnight.
- For children, strict supervision is crucial to prevent swallowing, which can lead to dental fluorosis.
- This product is a supplement to, not a replacement for, regular fluoride toothpaste (if used at other times of the day) and professional dental care.
Alternative Therapies
- Lower concentration fluoride toothpastes (OTC)
- Fluoride rinses (OTC or prescription)
- Fluoride varnishes (professionally applied)
- Fluoride gels (professionally applied or home use trays)
- Non-fluoride remineralizing agents (e.g., amorphous calcium phosphate (ACP), casein phosphopeptide-amorphous calcium phosphate (CPP-ACP))
- Silver diamine fluoride (SDF) for caries arrest
Cost & Coverage
Average Cost:
$20 - $50 per 51gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (prescription drug plans); may be covered under some dental plans.
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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.