Poly-Vi-flor 0.25mg Drops
It is used to help growth and good health.Fluoride may be in the vitamin to prevent tooth decay.
Drug Class
Dental Caries Prophylaxis; Vitamin/Mineral Supplement
Pharmacologic Class
Fluoride; Multivitamin
Pregnancy Category
Not applicable (Pediatric product, but fluoride is Category C in high doses, vitamins vary)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Poly-Vi-flor 0.25mg Drops is a liquid vitamin supplement for babies and young children that also contains a small amount of fluoride. It helps ensure your child gets enough essential vitamins for healthy growth and helps strengthen their teeth to prevent cavities, especially if your tap water doesn't have enough fluoride.
How to Use This Medicine
Administering This Medication
To ensure your child takes this medication correctly, follow the instructions provided by their doctor and read all accompanying information carefully. Take this medication with or without food, but if it causes stomach upset, give it with food. However, some medications must be taken with food or on an empty stomach, so consult with your pharmacist to determine the best approach for this specific drug.
When measuring liquid doses, use the measuring device that comes with the medication to ensure accuracy. Before administering, shake the medication well. Some products can be mixed with formula, fruit juice, or other foods and liquids, while others should be placed directly in your child's mouth. It's essential to understand the correct administration method for this medication, so be sure to ask your pharmacist if you have any questions.
Storing and Disposing of This Medication
Store this medication in its original container at room temperature, in a dry location away from bathrooms. Protect the medication from heat and light to maintain its effectiveness.
Managing Missed Doses
If you miss a dose, administer it as soon as you remember. However, if it's close to the time for your child's next scheduled dose, skip the missed dose and resume the regular dosing schedule. Do not give your child two doses at the same time or extra doses, as this can increase the risk of adverse effects.
To ensure your child takes this medication correctly, follow the instructions provided by their doctor and read all accompanying information carefully. Take this medication with or without food, but if it causes stomach upset, give it with food. However, some medications must be taken with food or on an empty stomach, so consult with your pharmacist to determine the best approach for this specific drug.
When measuring liquid doses, use the measuring device that comes with the medication to ensure accuracy. Before administering, shake the medication well. Some products can be mixed with formula, fruit juice, or other foods and liquids, while others should be placed directly in your child's mouth. It's essential to understand the correct administration method for this medication, so be sure to ask your pharmacist if you have any questions.
Storing and Disposing of This Medication
Store this medication in its original container at room temperature, in a dry location away from bathrooms. Protect the medication from heat and light to maintain its effectiveness.
Managing Missed Doses
If you miss a dose, administer it as soon as you remember. However, if it's close to the time for your child's next scheduled dose, skip the missed dose and resume the regular dosing schedule. Do not give your child two doses at the same time or extra doses, as this can increase the risk of adverse effects.
Lifestyle & Tips
- Administer exactly as prescribed by your doctor, usually once daily.
- Measure the dose carefully using the provided dropper. Do not use household spoons.
- Do not exceed the recommended dose, as too much fluoride can cause dental fluorosis (white or brown spots on teeth).
- Store at room temperature, away from light and moisture, and out of reach of children.
- Continue regular dental check-ups for your child.
- Inform your dentist and doctor about all medications and supplements your child is taking.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated for adult use.
Pediatric Dosing
Neonatal:
Not established (Generally not recommended for infants under 6 months)
Infant:
0.25 mg fluoride daily (1 mL of Poly-Vi-flor 0.25mg Drops) for infants 6 months to 3 years of age, when the fluoride content of drinking water is less than 0.3 ppm.
Child:
For children 3 to 6 years of age, 0.25 mg fluoride daily (1 mL of Poly-Vi-flor 0.25mg Drops) when the fluoride content of drinking water is between 0.3 and 0.6 ppm. Higher fluoride doses (0.5 mg or 1.0 mg) are typically given via different formulations for children in areas with very low water fluoride.
Adolescent:
Not typically indicated for adolescents as a primary fluoride source; higher fluoride doses (1.0 mg) are usually given via tablets for this age group if needed.
Dose Adjustments
Renal Impairment:
Mild:
Caution advised. Fluoride is primarily renally excreted. Accumulation may occur.
Moderate:
Avoid or use with extreme caution. Significant risk of fluoride accumulation and toxicity (e.g., skeletal fluorosis).
Severe:
Contraindicated. High risk of fluoride toxicity.
Dialysis:
Contraindicated. Fluoride is not effectively removed by dialysis and can accumulate.
Hepatic Impairment:
Mild:
No specific adjustment typically needed for fluoride or most vitamins.
Moderate:
No specific adjustment typically needed.
Severe:
No specific adjustment typically needed.
Pharmacology
Mechanism of Action
Fluoride: Incorporated into the enamel of developing teeth, forming fluorapatite, which is more resistant to acid demineralization. Also exerts topical antibacterial effects on plaque. Multivitamins: Provide essential vitamins (e.g., A, C, D, E, B-complex) necessary for normal growth, development, and metabolic functions, acting as coenzymes or antioxidants.
Pharmacokinetics
Absorption:
Bioavailability:
Fluoride: High (80-90%); Vitamins: Variable depending on the specific vitamin (e.g., fat-soluble vs. water-soluble) and formulation.
Tmax:
Fluoride: ~30-60 minutes; Vitamins: Variable.
FoodEffect:
Fluoride absorption can be reduced by calcium, magnesium, and aluminum-containing foods/supplements. Vitamin absorption can be enhanced (fat-soluble with fat) or reduced (some water-soluble with certain foods).
Distribution:
Vd:
Fluoride: Distributes widely, with high affinity for calcified tissues (bones, teeth); Vitamins: Variable, distributed to various tissues.
ProteinBinding:
Fluoride: Low; Vitamins: Variable.
CnssPenetration:
Fluoride: Limited, but can cross the blood-brain barrier; Vitamins: Variable.
Elimination:
HalfLife:
Fluoride: ~2-9 hours (plasma), but much longer in bone; Vitamins: Variable (e.g., water-soluble excreted rapidly, fat-soluble stored).
Clearance:
Fluoride: Primarily renal; Vitamins: Variable.
ExcretionRoute:
Fluoride: Urine (primary), feces (minor); Vitamins: Urine (water-soluble), feces (some fat-soluble).
Unchanged:
Fluoride: >90% renally excreted unchanged; Vitamins: Variable.
Pharmacodynamics
OnsetOfAction:
Fluoride: Long-term (incorporation into developing teeth); Vitamins: Long-term (correction of deficiencies).
PeakEffect:
Fluoride: Continuous effect with consistent use; Vitamins: Continuous effect with consistent use.
DurationOfAction:
Fluoride: Persistent effect due to incorporation into enamel; Vitamins: Dependent on storage and continuous intake.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
It's essential to be aware of rare but potentially severe side effects that can occur when taking this medication. If your child experiences any of the following symptoms, contact their doctor immediately or seek 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
Changes in the appearance of teeth or gums
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 crucial to monitor your child's response to the medication. If your child experiences any of the following side effects or any other unusual symptoms that bother them or persist, contact their doctor:
* Upset stomach or vomiting
Reporting Side Effects
This list is not exhaustive, and your child may experience other side effects. If you have questions or concerns about side effects, consult your child's doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
It's essential to be aware of rare but potentially severe side effects that can occur when taking this medication. If your child experiences any of the following symptoms, contact their doctor immediately or seek 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
Changes in the appearance of teeth or gums
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 crucial to monitor your child's response to the medication. If your child experiences any of the following side effects or any other unusual symptoms that bother them or persist, contact their doctor:
* Upset stomach or vomiting
Reporting Side Effects
This list is not exhaustive, and your child may experience other side effects. If you have questions or concerns about side effects, consult your child's doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of dental fluorosis (white flecks, streaks, or brown stains on teeth)
- Severe stomach upset, nausea, vomiting, or diarrhea (may indicate overdose)
- Allergic reactions (rash, itching, swelling, difficulty breathing) - rare
Before Using This Medicine
Before Giving Your Child This Medication, Inform Your Doctor About the Following:
Any allergies your child may have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
If your child has a history of certain health conditions, such as bone problems, joint problems, kidney problems, or ulcers.
* Whether your child's drinking water contains sufficient fluoride. If you are unsure, consult with your doctor to determine the appropriate course of action.
It is essential to note that this is not an exhaustive list of all potential interactions between this medication and other substances or health conditions.
To ensure safe use, inform your doctor and pharmacist about all medications your child is taking, including prescription and over-the-counter drugs, natural products, and vitamins. Additionally, disclose any health problems your child may have. Before starting, stopping, or modifying the dosage of any medication your child is taking, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
Any allergies your child may have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
If your child has a history of certain health conditions, such as bone problems, joint problems, kidney problems, or ulcers.
* Whether your child's drinking water contains sufficient fluoride. If you are unsure, consult with your doctor to determine the appropriate course of action.
It is essential to note that this is not an exhaustive list of all potential interactions between this medication and other substances or health conditions.
To ensure safe use, inform your doctor and pharmacist about all medications your child is taking, including prescription and over-the-counter drugs, natural products, and vitamins. Additionally, disclose any health problems your child may have. Before starting, stopping, or modifying the dosage of any medication your child is taking, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
Important Information for Patients Taking This Medication
It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication. This is crucial because different brands of this medication may be suitable for different age groups, and your child's doctor needs to be consulted before administering this medication to a child.
Administration and Dosage
Do not exceed the recommended dose or frequency of administration, as this may lead to adverse effects. The dosage may vary depending on your child's age, so it is crucial to consult with the doctor if you are unsure about the correct dose.
Lab Tests and Interactions
This medication may interfere with certain laboratory tests, so it is vital to inform all healthcare providers and lab personnel that your child is taking this medication.
Dental Care
Regular dental check-ups are essential to maintain your child's oral health. If your child's teeth become stained or spotted, inform the dentist. Additionally, encourage good oral hygiene practices to prevent dental problems.
Safety Precautions
In case of accidental ingestion of a large amount of this medication, seek medical attention immediately by calling a doctor or poison control center. To minimize the risk of interactions, avoid giving your child products containing calcium (such as dairy products) or aluminum/magnesium (such as certain antacids) within 2 hours of administering this medication. Also, note that purified water may not contain fluoride.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with the doctor to discuss the potential benefits and risks to both your child and the baby. This will help you make an informed decision about continuing or modifying treatment.
It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication. This is crucial because different brands of this medication may be suitable for different age groups, and your child's doctor needs to be consulted before administering this medication to a child.
Administration and Dosage
Do not exceed the recommended dose or frequency of administration, as this may lead to adverse effects. The dosage may vary depending on your child's age, so it is crucial to consult with the doctor if you are unsure about the correct dose.
Lab Tests and Interactions
This medication may interfere with certain laboratory tests, so it is vital to inform all healthcare providers and lab personnel that your child is taking this medication.
Dental Care
Regular dental check-ups are essential to maintain your child's oral health. If your child's teeth become stained or spotted, inform the dentist. Additionally, encourage good oral hygiene practices to prevent dental problems.
Safety Precautions
In case of accidental ingestion of a large amount of this medication, seek medical attention immediately by calling a doctor or poison control center. To minimize the risk of interactions, avoid giving your child products containing calcium (such as dairy products) or aluminum/magnesium (such as certain antacids) within 2 hours of administering this medication. Also, note that purified water may not contain fluoride.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with the doctor to discuss the potential benefits and risks to both your child and the baby. This will help you make an informed decision about continuing or modifying treatment.
Overdose Information
Overdose Symptoms:
- Acute overdose: Nausea, vomiting, diarrhea, abdominal pain, salivation, headache, weakness, muscle spasms, convulsions, cardiac arrhythmias.
- Chronic overdose (fluorosis): Dental fluorosis (white flecks to brown staining and pitting of enamel), skeletal fluorosis (bone pain, stiffness, joint calcification).
What to Do:
Immediately contact a poison control center (Call 1-800-222-1222) or seek emergency medical attention. For acute overdose, milk or calcium-containing liquids may be given to bind fluoride. Induce vomiting if conscious and advised by poison control. Hospitalization for supportive care may be necessary.
Drug Interactions
Moderate Interactions
- Antacids (aluminum, calcium, magnesium-containing): Can bind fluoride and reduce its absorption.
- Dairy products/Calcium supplements: Can bind fluoride and reduce its absorption.
- Tetracyclines: Some vitamins (e.g., calcium, iron) can chelate tetracyclines, reducing their absorption. Avoid co-administration.
- Warfarin: High doses of Vitamin K can antagonize warfarin. (Unlikely with pediatric multivitamin doses).
Minor Interactions
- Cholestyramine/Colestipol: May impair absorption of fat-soluble vitamins.
- Mineral oil: May impair absorption of fat-soluble vitamins.
Monitoring
Baseline Monitoring
Local drinking water fluoride concentration
Rationale: Essential to determine appropriate fluoride supplementation dose and prevent fluorosis.
Timing: Before initiating therapy and periodically if water source changes.
Dietary fluoride intake (e.g., fluoridated toothpaste use, other supplements)
Rationale: To ensure total fluoride intake is within recommended limits.
Timing: Before initiating therapy.
Routine Monitoring
Dental examination for signs of fluorosis
Frequency: Annually or as recommended by dentist
Target: No signs of dental fluorosis (white flecks, brown stains)
Action Threshold: Presence of even mild fluorosis may indicate excessive fluoride intake and necessitate dose adjustment or discontinuation.
Growth and development (general pediatric check-ups)
Frequency: Regularly as per pediatric guidelines
Target: Normal growth parameters
Action Threshold: Not directly related to this product unless severe deficiency/toxicity, but part of overall pediatric care.
Symptom Monitoring
- Signs of dental fluorosis (white flecks, streaks, or brown stains on teeth)
- Gastrointestinal upset (nausea, vomiting, diarrhea) - rare with therapeutic doses
- Allergic reactions (rash, itching, swelling) - rare
Special Patient Groups
Pregnancy
Not indicated for use in pregnant individuals. Fluoride crosses the placenta. While essential in appropriate amounts, excessive fluoride intake during pregnancy is not recommended.
Trimester-Specific Risks:
First Trimester:
Risk of dental fluorosis in offspring is primarily during tooth development, which begins in the second trimester.
Second Trimester:
Risk of dental fluorosis in offspring if maternal fluoride intake is excessive.
Third Trimester:
Risk of dental fluorosis in offspring if maternal fluoride intake is excessive.
Lactation
Not indicated for use in lactating individuals. Fluoride is excreted in breast milk in small amounts. The primary source of fluoride for breastfed infants should be from the mother's water intake or direct supplementation if indicated.
Infant Risk:
Low risk at therapeutic maternal doses, but direct infant supplementation is preferred if needed.
Pediatric Use
This product is specifically formulated for pediatric use. Dosing is critical and must be based on the child's age and the fluoride concentration in the local drinking water to prevent dental fluorosis.
Geriatric Use
Not indicated for geriatric use. Fluoride supplementation in adults is typically for osteoporosis or specific dental conditions, not routine caries prophylaxis in this form.
Clinical Information
Clinical Pearls
- Always confirm the fluoride concentration of the patient's primary drinking water source before prescribing or recommending fluoride supplementation.
- Educate parents thoroughly on the importance of accurate dosing and the risks of dental fluorosis with excessive intake.
- This product is typically prescribed when the local water fluoride concentration is less than 0.3 ppm for infants 6 months to 3 years, or between 0.3 and 0.6 ppm for children 3-6 years.
- Advise parents to store the product safely out of reach of children due to the fluoride content.
- Consider the child's total fluoride exposure, including fluoridated toothpaste, other supplements, and processed foods/beverages made with fluoridated water.
Alternative Therapies
- Separate multivitamin drops and fluoride drops/tablets (e.g., Sodium Fluoride drops/tablets)
- Fluoridated drinking water (primary and most effective method)
- Fluoridated toothpaste
- Topical fluoride applications (e.g., varnishes, gels) by a dental professional
Cost & Coverage
Average Cost:
Varies, typically $20-$40 per 50 mL bottle
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans, may require prior authorization or be Tier 2/3.
General Drug Facts
If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safe use, never share your child's medication with others, and do not administer someone else's medication to your child. For comprehensive information about this medication, consult the patient information leaflet that may accompany it. If you have any questions or concerns, discuss them with your child's doctor, nurse, pharmacist, or other healthcare provider. Additionally, you can check with your pharmacist to see if there is a separate patient information leaflet available for this drug. In the event of a suspected overdose, immediately call the 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 occurred, to facilitate timely and effective treatment.