Denta 5000 Plus Sensitive Paste

Manufacturer RISING PHARMACEUTICALS Active Ingredient Sodium Fluoride and Potassium Nitrate(SOW dee um FLOR ide & po TAS ee um NYE trate) Pronunciation SOW-dee-um FLOR-ide & po-TAS-ee-um NYE-trate
This supplement is used to prevent cavities.It is used to help sensitive teeth.
đŸˇī¸
Drug Class
Dental desensitizing agent; Anticaries agent
đŸ§Ŧ
Pharmacologic Class
Fluoride (for anticaries); Potassium salt (for desensitizing)
🤰
Pregnancy Category
Not assigned (topical dental product)
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Denta 5000 Plus Sensitive Paste is a toothpaste designed to relieve tooth sensitivity and help prevent cavities. Sodium Fluoride strengthens tooth enamel to protect against decay, while Potassium Nitrate calms the nerves inside your teeth to reduce pain from sensitivity.
📋

How to Use This Medicine

Taking Your Medication

To use this medication correctly, 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. Do not swallow it. Rinse your mouth thoroughly and spit out the rinse water.

Storing and Disposing of Your Medication

Store this medication at room temperature, in a safe location that is out of the 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 dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
💡

Lifestyle & Tips

  • Brush teeth thoroughly at least twice a day, or after meals.
  • Use a soft-bristled toothbrush.
  • Avoid rinsing immediately after brushing to allow fluoride to work.
  • Limit sugary foods and drinks.
  • Visit your dentist regularly for check-ups and professional cleanings.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Apply a pea-sized amount to a soft-bristled toothbrush. Brush thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and night), or as directed by a dentist or physician.

Condition-Specific Dosing:

sensitive teeth: Use twice daily for at least 2-4 weeks for noticeable relief of sensitivity.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Children 6-12 years: Use a pea-sized amount and supervise brushing to minimize swallowing. Children under 6 years: Consult a dentist or physician. Generally not recommended for children under 2 years.
Adolescent: Same as adult dosing.
âš•ī¸

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

đŸ”Ŧ

Mechanism of Action

Sodium Fluoride: Works by incorporating into the tooth enamel to form fluorapatite, which is more resistant to acid demineralization. It also inhibits bacterial acid production and promotes remineralization of early carious lesions. Potassium Nitrate: Desensitizes the nerves within the tooth pulp. It works by depolarizing the nerve fibers, reducing their ability to transmit pain signals in response to stimuli like cold, heat, or touch.
📊

Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (primarily topical action)
Tmax: Not applicable (topical)
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not applicable (minimal systemic absorption)
ProteinBinding: Not applicable (minimal systemic absorption)
CnssPenetration: No (minimal systemic absorption)

Elimination:

HalfLife: Not applicable (minimal systemic absorption)
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Not applicable (minimal systemic absorption)
Unchanged: Not applicable (minimal systemic absorption)
âąī¸

Pharmacodynamics

OnsetOfAction: Sodium Fluoride: Immediate topical effect on enamel. Potassium Nitrate: Relief typically begins within 2-4 weeks of consistent use.
PeakEffect: Sodium Fluoride: Ongoing with consistent use. Potassium Nitrate: Maximum relief usually achieved after 4 weeks of continuous use.
DurationOfAction: Sodium Fluoride: Provides ongoing protection with regular use. Potassium Nitrate: Relief persists as long as the product is used regularly.
Confidence: Medium

Safety & Warnings

âš ī¸

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 minor ones, it's essential to discuss any concerns with your doctor. If you have side effects that bother you or persist, contact your doctor for guidance.

Reporting Side Effects
This list is not exhaustive, and you may have questions about other potential side effects. If you do, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice on managing side effects.
🚨

Seek Immediate Medical Attention If You Experience:

  • Sensitivity persists or worsens after 4 weeks of use.
  • Oral irritation, rash, or swelling develops.
  • Symptoms of fluoride overdose (if ingested): nausea, vomiting, diarrhea, abdominal pain, salivation, thirst.
📋

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.

Additionally, to ensure safe treatment, it is crucial to disclose all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

This will enable your doctor and pharmacist to assess potential interactions and determine the safety of taking this medication with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
âš ī¸

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 mention this to your dentist. Regular dental check-ups are crucial 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. Be aware that different brands of this medication may have varying dosage recommendations for children, 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, it is vital to discuss the potential benefits and risks of this medication with your doctor, as this will help you make an informed decision about its use and its potential impact on you and your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Salivation
  • Thirst
  • Weakness
  • Tremors
  • Convulsions (severe cases)
  • Cardiac arrhythmias (severe cases)

What to Do:

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. For large ingestions, milk or calcium-containing liquids may be given to bind fluoride.

Drug Interactions

Monitoring

📊

Routine Monitoring

Dental sensitivity

Frequency: Ongoing with use

Target: Reduction or elimination of sensitivity

Action Threshold: If sensitivity persists or worsens after 4 weeks of use, consult a dentist.

Oral irritation/allergic reaction

Frequency: Daily

Target: Absence of redness, swelling, rash, or discomfort

Action Threshold: Discontinue use and consult a healthcare professional if irritation or allergic symptoms occur.

đŸ‘ī¸

Symptom Monitoring

  • Persistent or worsening tooth sensitivity
  • Gum irritation
  • Oral rash or swelling
  • Unusual taste
  • Nausea or stomach upset (if ingested)

Special Patient Groups

🤰

Pregnancy

Generally considered safe for topical use during pregnancy. Minimal systemic absorption is expected.

Trimester-Specific Risks:

First Trimester: Low risk
Second Trimester: Low risk
Third Trimester: Low risk
🤱

Lactation

Generally considered safe for use by breastfeeding mothers. Minimal systemic absorption is expected, making transfer to breast milk unlikely to be clinically significant.

Infant Risk: Low risk
đŸ‘ļ

Pediatric Use

Use in children should be supervised to minimize swallowing. Children under 6 years should use a pea-sized amount. Consult a dentist for children under 2 years. Risk of fluorosis (discoloration of teeth) if excessive fluoride is ingested during tooth development.

👴

Geriatric Use

No specific dosage adjustments or precautions are generally needed for geriatric patients beyond those for the general adult population. May be beneficial for age-related gum recession and increased sensitivity.

Clinical Information

💎

Clinical Pearls

  • Advise patients that consistent, twice-daily use is crucial for effective relief of sensitivity and cavity prevention.
  • Emphasize that this toothpaste addresses symptoms of sensitivity but does not treat underlying dental problems (e.g., cavities, gum disease). Patients should still see a dentist for diagnosis of persistent sensitivity.
  • Instruct patients not to rinse immediately after brushing to maximize fluoride's topical effect.
  • For best results, avoid eating or drinking for at least 30 minutes after brushing.
🔄

Alternative Therapies

  • Fluoride rinses (for anticaries)
  • In-office fluoride varnish applications (for anticaries and sensitivity)
  • Dental bonding or sealants (for exposed dentin causing sensitivity)
  • Gum grafting (for severe gum recession leading to sensitivity)
  • Root canal therapy (if sensitivity is due to pulpitis)
💰

Cost & Coverage

Average Cost: $5 - $15 per tube (e.g., 4.3 oz)
Generic Available: Yes
Insurance Coverage: Not typically covered by medical insurance; may be eligible for FSA/HSA reimbursement or covered by some dental plans.
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 taken, the amount, and the time it happened.