Denta 5000 Plus Cream 51gm
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?
Denta 5000 Plus Cream is a special toothpaste with a high amount of fluoride. It's used to make your teeth stronger and help prevent cavities, especially if you're at high risk for them. 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 properly, follow your doctor's instructions and read all the information provided. 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 to avoid swallowing this medication.
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 safe location that is out of the 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 by your doctor or pharmacist. Instead, ask your pharmacist about the best disposal method or check if there are any 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 a missed one.
To use this medication properly, follow your doctor's instructions and read all the information provided. 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 to avoid swallowing this medication.
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 safe location that is out of the 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 by your doctor or pharmacist. Instead, ask your pharmacist about the best disposal method or check if there are any 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 a missed one.
Lifestyle & Tips
- Maintain good oral hygiene practices, including regular brushing and flossing.
- Limit sugary foods and drinks.
- Visit your dentist regularly for check-ups and cleanings.
- Do not swallow the cream; spit it out after brushing.
- Keep out of reach of children, especially those under 6 years old, to prevent accidental ingestion.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin ribbon (pea-sized amount) to a toothbrush and brush thoroughly once daily, preferably at bedtime, in place of regular toothpaste. Spit out after brushing and do not rinse.
Condition-Specific Dosing:
highCariesRisk:
Once daily application.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Children 6 years and older: Apply a thin ribbon (pea-sized amount) to a toothbrush and brush thoroughly once daily, preferably at bedtime, in place of regular toothpaste. Supervise brushing to minimize swallowing. Spit out after brushing and do not rinse.
Adolescent:
Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for topical use.
Moderate:
No adjustment needed for topical use.
Severe:
No adjustment needed for topical use. Caution advised if significant ingestion is anticipated due to potential for systemic fluoride accumulation.
Dialysis:
No specific adjustment for topical use. Avoid ingestion.
Hepatic Impairment:
Mild:
No adjustment needed for topical use.
Moderate:
No adjustment needed for topical use.
Severe:
No adjustment needed for topical use.
Pharmacology
Mechanism of Action
Fluoride acts topically to prevent dental caries by several mechanisms: 1) Enhances remineralization of demineralized enamel and inhibits demineralization. 2) Incorporates into the enamel structure, forming fluorapatite, which is more resistant to acid dissolution. 3) Inhibits bacterial enzymes, reducing acid production by oral bacteria.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from topical application to intact oral mucosa. Significant absorption can occur if ingested.
Tmax:
Not applicable for topical therapeutic effect. If ingested, peak plasma levels typically within 30-60 minutes.
FoodEffect:
Not applicable for topical use.
Distribution:
Vd:
Not applicable for topical use. If absorbed, distributes throughout the body, primarily accumulating in calcified tissues (bones, teeth).
ProteinBinding:
Not applicable for topical use. If absorbed, minimal protein binding.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not applicable for topical use. If absorbed, plasma half-life is typically 2-9 hours, but terminal half-life from bone can be much longer.
Clearance:
Not applicable for topical use. If absorbed, primarily renal clearance.
ExcretionRoute:
Primarily renal (urine) if absorbed systemically. Unabsorbed fluoride is eliminated via feces.
Unchanged:
Nearly 100% of absorbed fluoride is excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Immediate topical effect on enamel surface.
PeakEffect:
Continuous effect with regular daily use.
DurationOfAction:
Sustained effect on enamel with daily application; benefits persist as long as regular use continues.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening 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, or 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:
Please note that this list is not exhaustive, and you should consult your doctor if you have questions about side effects.
Reporting Side Effects
If you have concerns about side effects, you can:
- Call your doctor for medical advice
- Report side effects to the FDA at 1-800-332-1088
- Submit a report online at https://www.fda.gov/medwatch
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening 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, or 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:
Please note that this list is not exhaustive, and you should consult your doctor if you have questions about side effects.
Reporting Side Effects
If you have concerns about side effects, you can:
- Call your doctor for medical advice
- Report side effects to 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, or stomach upset (if swallowed in large amounts).
- White or brown spots on teeth (signs of fluorosis, especially in young children).
- Any unusual swelling or irritation in the mouth.
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, 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
Any natural products or vitamins you are using
Your existing health problems
It is crucial to verify that this medication is safe to take 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 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, 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
Any natural products or vitamins you are using
Your existing health problems
It is crucial to verify that this medication is safe to take 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. Regular dental care is crucial, so schedule frequent dental check-ups to maintain good oral health.
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 right away, as it can cause harm. 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, as they 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 right away, as it can cause harm. 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, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Acute fluoride toxicity (if large amounts are ingested): nausea, vomiting, abdominal pain, diarrhea, salivation, lacrimation, sweating, headache, weakness, tremors, convulsions, cardiac arrhythmias, and potentially death.
- Chronic fluoride toxicity (fluorosis): dental fluorosis (enamel discoloration, pitting), skeletal fluorosis (bone pain, stiffness, increased bone density).
What to Do:
For acute ingestion, immediately seek emergency medical attention or call Poison Control (1-800-222-1222). Induce vomiting if advised by Poison Control. Administer milk or calcium-containing antacids to bind fluoride. For chronic fluorosis, discontinue fluoride exposure.
Drug Interactions
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 flossing
Action Threshold: Poor oral hygiene may indicate need for patient education or re-evaluation of treatment plan.
Caries status
Frequency: At each dental visit (e.g., every 6-12 months)
Target: Reduction or arrest of carious lesions
Action Threshold: Continued caries progression may require re-evaluation of fluoride therapy or other interventions.
Signs of fluorosis (especially in children)
Frequency: At each dental visit
Target: Absence of fluorosis or very mild, non-esthetic fluorosis
Action Threshold: Presence of moderate to severe fluorosis may indicate excessive fluoride intake and require discontinuation or reduction of fluoride therapy.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Headache
- Weakness
- Skin rash (rare, allergic reaction)
- Signs of dental fluorosis (white flecks, streaks, or brown stains on teeth, especially in children under 8 years old)
Special Patient Groups
Pregnancy
Use during pregnancy is generally considered safe when applied topically as directed, due to minimal systemic absorption. However, systemic fluoride crosses the placenta. Category C indicates that animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Trimester-Specific Risks:
First Trimester:
Minimal risk with proper topical use; avoid ingestion.
Second Trimester:
Minimal risk with proper topical use; avoid ingestion.
Third Trimester:
Minimal risk with proper topical use; avoid ingestion.
Lactation
Fluoride is excreted in breast milk in very small amounts following systemic absorption. Given the minimal systemic absorption from topical application, the risk to a breastfed infant is considered low. L3 (Moderately Safe) rating.
Infant Risk:
Low risk with proper topical use by the mother. Monitor infant for signs of fluorosis if other sources of fluoride are present.
Pediatric Use
Not recommended for children under 6 years of age due to the risk of dental fluorosis from accidental ingestion. For children 6 years and older, supervise brushing to ensure minimal swallowing and proper spitting. Dosage should be carefully controlled.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. Topical fluoride is beneficial for preventing root caries and managing dry mouth-related caries, which are common in this population.
Clinical Information
Clinical Pearls
- This is a prescription-strength fluoride product; it should not be used as a regular toothpaste unless directed by a dental professional.
- Emphasize the 'spit, don't rinse' instruction to maximize fluoride retention on tooth surfaces.
- Advise patients to avoid eating or drinking for at least 30 minutes after application to allow fluoride to work effectively.
- For children, ensure strict supervision to prevent swallowing, which can lead to dental fluorosis.
- Patients with xerostomia (dry mouth) may particularly benefit from high-concentration fluoride due to increased caries risk.
Alternative Therapies
- Lower concentration fluoride toothpastes (e.g., 0.24% sodium fluoride, 1000-1500 ppm)
- Fluoride rinses (e.g., 0.05% sodium fluoride daily, 0.2% sodium fluoride weekly)
- Fluoride varnishes (professional application)
- Fluoride gels (prescription or over-the-counter)
- Silver Diamine Fluoride (SDF) for arresting caries
- Xylitol-containing products
Cost & Coverage
Average Cost:
$15 - $40 per 51gm tube
Generic Available:
Yes
Insurance Coverage:
Often covered by dental insurance plans, sometimes by medical plans with a prescription. May be Tier 2 or 3.
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 medication taken, the amount, and the time it occurred.