Poly-Vi-flor 1mg Chewable Tabs
It is used to help growth and good health.Fluoride may be in the vitamin to prevent tooth decay.
Drug Class
Vitamin/Mineral Supplement, Dental Caries Prophylaxis
Pharmacologic Class
Multivitamin, Fluoride Supplement
Pregnancy Category
Not applicable (Product intended for pediatric use); Fluoride is Category C, most vitamins are A or C.
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Poly-Vi-flor is a chewable tablet for children that provides essential vitamins and fluoride. The fluoride helps strengthen teeth and prevent cavities, especially in areas where the drinking water does not have enough fluoride. The vitamins help your child grow and stay healthy.
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 your pharmacist for specific guidance on administering this drug to your child.
It's essential to have your child chew the medication thoroughly before swallowing. Note that some brands can be swallowed whole or dissolved in the mouth; if you're unsure, discuss this with your pharmacist.
Storage and Disposal
Store this medication in its original container at room temperature, in a dry place, and away from the bathroom. Protect it from heat and light to maintain its effectiveness.
Missed Dose
If you miss giving your child a dose, administer it as soon as you remember. However, if the next scheduled dose is near, skip the missed dose and resume the regular dosing schedule. Do not give two doses at the same time or provide extra doses, as this can lead to 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 your pharmacist for specific guidance on administering this drug to your child.
It's essential to have your child chew the medication thoroughly before swallowing. Note that some brands can be swallowed whole or dissolved in the mouth; if you're unsure, discuss this with your pharmacist.
Storage and Disposal
Store this medication in its original container at room temperature, in a dry place, and away from the bathroom. Protect it from heat and light to maintain its effectiveness.
Missed Dose
If you miss giving your child a dose, administer it as soon as you remember. However, if the next scheduled dose is near, skip the missed dose and resume the regular dosing schedule. Do not give two doses at the same time or provide extra doses, as this can lead to adverse effects.
Lifestyle & Tips
- Take exactly as prescribed by your doctor or dentist.
- Do not exceed the recommended dose to avoid serious side effects like fluorosis.
- Chew the tablet thoroughly before swallowing; do not swallow whole.
- Administer at bedtime or after brushing teeth for maximum topical fluoride effect, and avoid eating or drinking for at least 30 minutes afterward.
- Keep out of reach of children, as fluoride overdose can be serious.
- Ensure your child brushes their teeth twice daily with fluoride toothpaste (pea-sized amount for children 3-6 years, smear for <3 years).
- Maintain regular dental check-ups.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated for adult use
Pediatric Dosing
Neonatal:
Not established (Chewable formulation not suitable for neonates)
Infant:
Not established (Chewable formulation not suitable for infants; fluoride supplementation typically 0.25 mg/day as drops for 6 months to <3 years if water fluoride <0.3 ppm)
Child:
1 tablet (1 mg fluoride) once daily. Typically for children 6 years and older if community water fluoride concentration is less than 0.3 ppm. Dosing must be individualized based on age and local water fluoride levels. For children 3 to <6 years, 0.5 mg/day is typically recommended if water fluoride <0.3 ppm, meaning a 1mg tablet would need to be split or a lower dose product used.
Adolescent:
1 tablet (1 mg fluoride) once daily if community water fluoride concentration is less than 0.3 ppm.
Dose Adjustments
Renal Impairment:
Mild:
Caution advised; monitor for signs of fluorosis.
Moderate:
Caution advised; monitor for signs of fluorosis. Dose reduction may be necessary.
Severe:
Contraindicated due to risk of fluoride accumulation and fluorosis.
Dialysis:
Contraindicated due to risk of fluoride accumulation and fluorosis.
Hepatic Impairment:
Mild:
No specific adjustment typically needed.
Moderate:
No specific adjustment typically needed.
Severe:
No specific adjustment typically needed.
Pharmacology
Mechanism of Action
Poly-Vi-flor provides essential vitamins (e.g., A, C, D, E, B-complex) necessary for normal growth, development, and metabolic functions. Fluoride acts primarily by incorporating into the enamel structure of developing teeth, forming fluoroapatite, which is more resistant to acid demineralization. It also promotes remineralization of early carious lesions and has antibacterial effects against cariogenic bacteria.
Pharmacokinetics
Absorption:
Bioavailability:
Varies by vitamin (e.g., fat-soluble vitamins require dietary fat for optimal absorption). Fluoride is rapidly and almost completely absorbed (80-90%) from the gastrointestinal tract.
Tmax:
Varies by vitamin. For fluoride, typically 30-60 minutes.
FoodEffect:
Absorption of fat-soluble vitamins is enhanced with food. Fluoride absorption can be reduced by co-ingestion with calcium, magnesium, or aluminum-containing products.
Distribution:
Vd:
Varies by vitamin. Fluoride distributes throughout the body, with approximately 50% of absorbed fluoride in children being rapidly deposited in calcified tissues (bones, teeth).
ProteinBinding:
Varies by vitamin. Fluoride is minimally protein bound.
CnssPenetration:
Limited for most vitamins. Fluoride can cross the blood-brain barrier to a limited extent.
Elimination:
HalfLife:
Varies by vitamin (e.g., water-soluble vitamins have shorter half-lives, fat-soluble longer). For fluoride, plasma half-life is typically 2-9 hours.
Clearance:
Varies by vitamin. For fluoride, primarily renal clearance.
ExcretionRoute:
Varies by vitamin (renal, biliary). Fluoride is primarily excreted renally (50-60% within 24 hours in adults, higher in children).
Unchanged:
Not applicable for vitamins (metabolized). For fluoride, 50-60% excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Not applicable for acute effect; benefits are cumulative over time for vitamin supplementation and dental caries prevention.
PeakEffect:
Not applicable for acute effect; benefits are cumulative.
DurationOfAction:
Not applicable for acute effect; benefits are cumulative.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
It's essential to be aware of potential severe side effects, although they are rare. 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. 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 potential severe side effects, although they are rare. 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. 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:
- White or brown spots/streaks on teeth (signs of dental fluorosis)
- Nausea, vomiting, stomach pain, diarrhea (signs of acute overdose)
- Muscle weakness or tremors (signs of severe acute overdose)
- Unusual fatigue, changes in vision, or headache (possible signs of hypervitaminosis)
Before Using This Medicine
Before Your Child Takes This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies your child may have to this medication, its components, or other substances, including foods and drugs. Please 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.
If your child's drinking water contains sufficient fluoride. If you are unsure, consult with your doctor to determine the appropriate course of action.
This medication may interact with other substances, so it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications your child is taking
Any natural products or vitamins your child is using
Your child's existing health problems
To ensure safe treatment, do not start, stop, or change the dosage of any medication your child is taking without first consulting with your doctor. It is vital to verify that this medication can be safely administered in conjunction with your child's other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies your child may have to this medication, its components, or other substances, including foods and drugs. Please 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.
If your child's drinking water contains sufficient fluoride. If you are unsure, consult with your doctor to determine the appropriate course of action.
This medication may interact with other substances, so it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications your child is taking
Any natural products or vitamins your child is using
Your child's existing health problems
To ensure safe treatment, do not start, stop, or change the dosage of any medication your child is taking without first consulting with your doctor. It is vital to verify that this medication can be safely administered in conjunction with your child's other medications and health conditions.
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 includes discussing the specific brand and formulation of the drug, as different brands may be approved for use in different age groups.
Administration and Dosage
Do not exceed the recommended dose or frequency of administration. If you are unsure about the correct dosage for your child, consult with their doctor. The prescribed dose may vary depending on your child's age, so it is crucial to follow the doctor's instructions.
Interactions with Lab Tests and Other Substances
This medication may interfere with certain laboratory tests. Be sure to inform all healthcare providers and lab personnel that your child is taking this drug. Additionally, avoid giving your child products containing calcium, such as dairy products, within 2 hours of taking this medication. Similarly, do not give products containing aluminum or magnesium, such as certain antacids, within 2 hours of taking this medication.
Special Considerations for Children
If your child is under 4 years of age, consult with their doctor to determine if this medication is suitable, as some brands may not be approved for use in this age group. There is a risk of choking associated with this medication in young children. Furthermore, if your child's teeth become stained or spotted, inform their dentist.
Dental Care
Regular dental check-ups are essential to maintain your child's oral health. Encourage good oral hygiene practices to prevent tooth staining or other dental problems.
Overdose and Poisoning
If a large amount of this medication is swallowed, seek medical attention immediately by calling a doctor or poison control center.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with their doctor to discuss the potential benefits and risks of 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 includes discussing the specific brand and formulation of the drug, as different brands may be approved for use in different age groups.
Administration and Dosage
Do not exceed the recommended dose or frequency of administration. If you are unsure about the correct dosage for your child, consult with their doctor. The prescribed dose may vary depending on your child's age, so it is crucial to follow the doctor's instructions.
Interactions with Lab Tests and Other Substances
This medication may interfere with certain laboratory tests. Be sure to inform all healthcare providers and lab personnel that your child is taking this drug. Additionally, avoid giving your child products containing calcium, such as dairy products, within 2 hours of taking this medication. Similarly, do not give products containing aluminum or magnesium, such as certain antacids, within 2 hours of taking this medication.
Special Considerations for Children
If your child is under 4 years of age, consult with their doctor to determine if this medication is suitable, as some brands may not be approved for use in this age group. There is a risk of choking associated with this medication in young children. Furthermore, if your child's teeth become stained or spotted, inform their dentist.
Dental Care
Regular dental check-ups are essential to maintain your child's oral health. Encourage good oral hygiene practices to prevent tooth staining or other dental problems.
Overdose and Poisoning
If a large amount of this medication is swallowed, seek medical attention immediately by calling a doctor or poison control center.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with their doctor to discuss the potential benefits and risks of taking this medication.
Overdose Information
Overdose Symptoms:
- Acute fluoride overdose: Nausea, vomiting, abdominal pain, diarrhea, excessive salivation, thirst, muscle weakness, tremors, convulsions, cardiac arrhythmias, coma.
- Chronic fluoride overdose (fluorosis): Dental fluorosis (enamel mottling), skeletal fluorosis (bone pain, stiffness, joint immobility).
- Hypervitaminosis (rare with typical doses): Symptoms vary by vitamin (e.g., Vitamin A: headache, blurred vision, dry skin; Vitamin D: hypercalcemia, nausea, vomiting, kidney stones).
What to Do:
Immediately contact a poison control center (1-800-222-1222) or seek emergency medical attention. For acute fluoride overdose, milk or calcium-containing liquids may be given to bind fluoride. Induce vomiting if conscious and within minutes of ingestion. Hospitalization for severe cases may involve gastric lavage, IV calcium, and supportive care.
Drug Interactions
Major Interactions
- Aluminum, Calcium, Magnesium-containing products (e.g., antacids, dairy products, supplements): Can chelate fluoride, significantly reducing its absorption. Administer fluoride at least 2 hours before or after these products.
- Tetracyclines: Fluoride can chelate tetracyclines, reducing absorption of both. Separate administration by several hours.
Moderate Interactions
- Orlistat, Cholestyramine: May reduce absorption of fat-soluble vitamins (A, D, E, K).
- Mineral oil: May reduce absorption of fat-soluble vitamins.
- Warfarin (Coumadin): High doses of Vitamin K (not typically in pediatric multivitamins) can reduce anticoagulant effect. Vitamin E may increase anticoagulant effect at very high doses.
- Phenytoin: May increase metabolism of Vitamin D and folic acid.
- Isoniazid: May increase excretion of pyridoxine (Vitamin B6).
Minor Interactions
- Iron supplements: Vitamin C enhances iron absorption.
- Levodopa: Pyridoxine (Vitamin B6) can reduce the effectiveness of levodopa (but not carbidopa/levodopa combinations).
Monitoring
Baseline Monitoring
Dental examination
Rationale: To assess oral health, existing caries, and risk of fluorosis, and to determine the need for fluoride supplementation.
Timing: Prior to initiation of therapy.
Assessment of community water fluoride concentration
Rationale: To determine appropriate fluoride dosing and prevent excessive intake.
Timing: Prior to initiation of therapy and periodically if residence changes.
Dietary intake assessment
Rationale: To identify any existing vitamin deficiencies or excessive intake from other sources.
Timing: Prior to initiation of therapy.
Routine Monitoring
Dental examination for signs of fluorosis
Frequency: Annually or as recommended by dentist.
Target: Absence of dental fluorosis.
Action Threshold: Presence of white flecks or brown staining on teeth (signs of fluorosis) warrants immediate re-evaluation of fluoride intake.
Growth and development monitoring
Frequency: Regular pediatric check-ups.
Target: Normal growth parameters for age.
Action Threshold: Significant deviations may indicate underlying issues or nutritional imbalances.
Review of all fluoride sources (water, toothpaste, other supplements)
Frequency: Annually or at each well-child visit.
Target: Total fluoride intake within recommended limits for age.
Action Threshold: Excessive total fluoride intake warrants dose adjustment or discontinuation.
Symptom Monitoring
- Signs of dental fluorosis (white flecks, streaks, or brown discoloration on tooth enamel)
- Gastrointestinal upset (nausea, vomiting, abdominal pain) - especially with acute overdose
- Skeletal pain or stiffness (rare, with chronic excessive fluoride intake)
- Signs of hypervitaminosis (e.g., headache, blurred vision, fatigue for Vitamin A; hypercalcemia for Vitamin D; bleeding for Vitamin E at very high doses)
Special Patient Groups
Pregnancy
Not indicated for use in pregnant individuals. Fluoride crosses the placenta. While essential in appropriate amounts, excessive intake during pregnancy is not recommended. Most vitamins are safe and often recommended during pregnancy at appropriate doses.
Trimester-Specific Risks:
First Trimester:
Not indicated.
Second Trimester:
Not indicated.
Third Trimester:
Not indicated.
Lactation
Not indicated for use in lactating individuals. Fluoride is excreted in breast milk in small amounts. Most vitamins are excreted in breast milk and are generally safe and beneficial for the infant at appropriate maternal doses.
Infant Risk:
Not indicated.
Pediatric Use
This product is specifically formulated for pediatric use. Dosing must be carefully determined based on the child's age and the fluoride concentration in the local drinking water to prevent dental fluorosis. Chewable tablets are generally suitable for children who can chew reliably (typically 2-3 years and older).
Geriatric Use
Not indicated for geriatric use. Fluoride supplementation in adults is typically not for systemic caries prevention but for specific dental conditions (e.g., dry mouth, radiation therapy).
Clinical Information
Clinical Pearls
- Always assess the fluoride concentration of the child's primary drinking water source before prescribing or recommending fluoride supplements.
- Educate parents/caregivers on the importance of proper dosing and the risks of excessive fluoride intake (dental fluorosis).
- Emphasize that chewable tablets must be chewed thoroughly and not swallowed whole, especially in younger children, to prevent choking and maximize topical fluoride effect.
- Advise administration at bedtime or after brushing teeth for optimal topical fluoride exposure to tooth surfaces.
- Keep all fluoride-containing products (supplements, toothpaste, mouthwash) out of reach of children to prevent accidental overdose.
Alternative Therapies
- Separate multivitamin and fluoride supplements (e.g., sodium fluoride drops/tablets)
- Fluoridated toothpaste and community water fluoridation (primary methods of fluoride delivery)
- Dietary counseling for vitamin deficiencies
Cost & Coverage
Average Cost:
Variable, typically $15-$40 per 100 tablets
Generic Available:
Yes
Insurance Coverage:
Often considered an over-the-counter (OTC) supplement; may not be covered by insurance unless prescribed and deemed medically necessary.
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 and effective treatment, never share your child's medication with others, and do not administer someone else's medication to your child. For detailed 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 medical attention. When reporting the incident, be prepared to provide crucial details, including the substance taken, the amount, and the time it occurred.