Sod Fluoride 5000 Ppm Ena Pro Pst

Manufacturer SHEFFIELD 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.
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Drug Class
Dental desensitizing agent; Anti-caries agent
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Pharmacologic Class
Fluoride (topical); Potassium salt (nerve desensitizer)
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Pregnancy Category
Not available
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This dental paste contains two main ingredients: Sodium Fluoride helps strengthen your tooth enamel and protect against cavities, while Potassium Nitrate helps reduce tooth sensitivity by calming the nerves inside your teeth. It's used daily to improve overall dental health and reduce discomfort from sensitive teeth.
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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. 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, 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, consult with your pharmacist for guidance on the proper disposal method. You may also want to inquire about drug take-back programs available in your area.

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 take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Brush thoroughly for at least one minute, preferably at bedtime.
  • Spit out the paste after brushing; do not swallow.
  • Do not rinse your mouth immediately after brushing to allow the ingredients to work.
  • Maintain good oral hygiene practices, including regular flossing and dental check-ups.
  • Avoid highly acidic foods and drinks that can erode enamel and worsen sensitivity.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin ribbon of paste to a toothbrush and brush thoroughly once daily for at least one minute, preferably at bedtime, or as directed by a dental professional.

Condition-Specific Dosing:

dental hypersensitivity: Apply to affected areas with a toothbrush or finger for 1 minute, once daily.
caries prevention: Brush thoroughly once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not recommended for children under 6 years of age due to risk of fluorosis from ingestion. For children 6-12 years, use a pea-sized amount and supervise brushing to minimize swallowing.
Adolescent: Same as adult dosing, apply once daily.
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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

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Mechanism of Action

Sodium Fluoride: Enhances remineralization of demineralized enamel, inhibits demineralization, and interferes with bacterial acid production. It incorporates into the enamel structure, forming fluorapatite, which is more resistant to acid dissolution. Potassium Nitrate: Desensitizes nerve endings in the dentinal tubules by depolarizing the nerve, thereby reducing the transmission of pain signals.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption from topical dental application. Fluoride can be absorbed through the oral mucosa and gastrointestinal tract if swallowed.
Tmax: Not applicable for topical dental use (systemic absorption is minimal).
FoodEffect: Not applicable for topical dental use.

Distribution:

Vd: Not applicable for topical dental use (minimal systemic distribution). Fluoride that is absorbed distributes to mineralized tissues (bones, teeth).
ProteinBinding: Not applicable for topical dental use (minimal systemic protein binding).
CnssPenetration: No (minimal systemic absorption).

Elimination:

HalfLife: Not applicable for topical dental use (systemic half-life of fluoride is variable, typically hours, but not relevant for topical action).
Clearance: Not applicable for topical dental use.
ExcretionRoute: Primarily renal if systemically absorbed.
Unchanged: Not applicable for topical dental use.
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Pharmacodynamics

OnsetOfAction: Desensitization: Typically within 2-4 weeks of consistent use. Caries prevention: Immediate protective effect on enamel, long-term benefits with continued use.
PeakEffect: Desensitization: After 2-4 weeks of consistent use.
DurationOfAction: Desensitization: Maintained with continued daily use. Caries prevention: Ongoing with daily application.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

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. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice.

Reporting Side Effects

This list does not include all possible side effects. If you have questions or concerns about side effects, talk 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.
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Seek Immediate Medical Attention If You Experience:

  • Persistent or worsening tooth sensitivity
  • Oral irritation, redness, or swelling
  • Rash or itching (signs of allergic reaction)
  • Nausea, vomiting, or stomach upset (if accidentally swallowed in large amounts)
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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 as a result of the allergy.
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 use, it is crucial to discuss all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins

with your doctor and pharmacist. This will help identify any potential interactions between this medication and your other health conditions or medications. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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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 report this to 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 right away, as it can cause harm.

When administering this medication to children, note that different brands may have varying dosage recommendations. Before giving this medication to a child, consult with their doctor to determine the appropriate dosage.

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.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Salivation
  • Headache
  • Weakness
  • In severe cases (especially in children), hypocalcemia, convulsions, cardiac arrhythmias, and respiratory depression.

What to Do:

If a large amount is accidentally swallowed, especially by a child, seek immediate medical attention or call a Poison Control Center at 1-800-222-1222. Administer milk or calcium-containing liquids to bind fluoride.

Drug Interactions

Monitoring

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Baseline Monitoring

Dental examination

Rationale: To assess oral health, identify cause of sensitivity, and determine suitability for product use.

Timing: Prior to initiation of therapy

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Routine Monitoring

Tooth sensitivity symptoms

Frequency: Daily, self-assessment

Target: Reduction or elimination of sensitivity

Action Threshold: If sensitivity persists or worsens after 2-4 weeks, consult dental professional.

Oral irritation/adverse reactions

Frequency: Daily, self-assessment

Target: Absence of irritation

Action Threshold: Discontinue use and consult dental professional if irritation, rash, or swelling occurs.

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Symptom Monitoring

  • Reduction in tooth sensitivity to hot, cold, sweet, or touch
  • Absence of oral irritation (e.g., burning, redness, swelling)
  • Absence of allergic reactions (e.g., rash, itching)

Special Patient Groups

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Pregnancy

Considered safe for use during pregnancy due to minimal systemic absorption from topical application. Consult with a dental professional or physician if concerns exist.

Trimester-Specific Risks:

First Trimester: Low risk due to minimal systemic absorption.
Second Trimester: Low risk due to minimal systemic absorption.
Third Trimester: Low risk due to minimal systemic absorption.
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Lactation

Considered safe for use during lactation due to minimal systemic absorption, making transfer to breast milk unlikely to be clinically significant. Consult with a dental professional or physician if concerns exist.

Infant Risk: Low risk.
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Pediatric Use

Not recommended for children under 6 years of age due to the risk of dental fluorosis from accidental ingestion. For children 6-12 years, use a pea-sized amount and supervise brushing to minimize swallowing. Consult a dental professional for appropriate fluoride recommendations for young children.

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Geriatric Use

Generally safe for use in geriatric patients. No specific dose adjustments are typically required. Monitor for any signs of oral irritation or discomfort.

Clinical Information

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Clinical Pearls

  • Emphasize the 'spit, don't rinse' instruction to maximize the contact time of fluoride and potassium nitrate with the tooth surface.
  • Advise patients that consistent daily use is crucial for achieving and maintaining desensitization and caries protection.
  • For optimal results, apply at bedtime after the last meal/drink to allow the paste to work overnight.
  • Educate patients that while this product helps with sensitivity, it's important to address the underlying cause of sensitivity with a dental professional (e.g., gum recession, clenching, cavities).
  • This product is a prescription-strength fluoride toothpaste and should not be used as a regular over-the-counter toothpaste unless directed by a dentist.
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Alternative Therapies

  • Fluoride varnishes (applied by dental professional)
  • Fluoride gels/foams (applied by dental professional)
  • Dental bonding/fillings for exposed dentin
  • Gum grafting for recession
  • Laser therapy for sensitivity
  • Other desensitizing toothpastes (e.g., strontium chloride, arginine-based)
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Cost & Coverage

Average Cost: $15 - $30 per 50g tube
Generic Available: Yes
Insurance Coverage: Often covered by dental insurance plans or available as an out-of-pocket purchase. Some formulations are OTC.
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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'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 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 details about the overdose, including the medication taken, the amount, and the time it occurred.