Poly-Vi-flor 0.5mg Chewable Tabs
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 Supplement; Multivitamin
Pregnancy Category
Not applicable (pediatric product); components vary (e.g., Fluoride is Category C in high doses, most vitamins are A/B/C).
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Poly-Vi-flor 0.5mg Chewable Tabs are a daily chewable vitamin supplement for children that also contain fluoride. The vitamins help support your child's healthy growth and development, while the fluoride helps strengthen their tooth enamel to prevent cavities.
How to Use This Medicine
Taking 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 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.
Storing and Disposing of This Medication
Store this medication in its original container at room temperature, in a dry place, away from bathrooms. Protect it from heat and light to maintain its effectiveness.
Missing a Dose
If you miss 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 your child two doses at once or 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 with 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.
Storing and Disposing of This Medication
Store this medication in its original container at room temperature, in a dry place, away from bathrooms. Protect it from heat and light to maintain its effectiveness.
Missing a Dose
If you miss 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 your child two doses at once or extra doses, as this can lead to adverse effects.
Lifestyle & Tips
- Ensure your child brushes their teeth twice daily with fluoride toothpaste (age-appropriate amount).
- Encourage regular flossing once daily.
- Schedule regular dental check-ups for your child (typically every 6 months).
- Maintain a balanced diet and limit sugary snacks and drinks.
- Do not exceed the prescribed dose, as too much fluoride can be harmful.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated
Pediatric Dosing
Neonatal:
Not established (generally not recommended for infants under 6 months)
Infant:
Not indicated for 0.5mg strength (typically 0.25mg fluoride if needed for infants 6 months to <3 years with water fluoride <0.3 ppm)
Child:
1 chewable tablet daily (0.5 mg fluoride) for children 3 to <6 years of age if community water fluoride concentration is less than 0.3 ppm. For children 6 to 16 years of age if community water fluoride concentration is between 0.3 and 0.6 ppm.
Adolescent:
1 chewable tablet daily (0.5 mg fluoride) for adolescents 6 to 16 years of age if community water fluoride concentration is between 0.3 and 0.6 ppm.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically needed for standard use.
Moderate:
Caution advised; monitor for signs of fluorosis. Consult dentist/nephrologist.
Severe:
Contraindicated or used with extreme caution due to risk of fluoride accumulation and toxicity.
Dialysis:
Contraindicated due to risk of fluoride accumulation.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Fluoride: Incorporated into the developing enamel of teeth, forming fluorapatite, which is more resistant to acid demineralization and bacterial acid production. It also inhibits bacterial enzymes in plaque. Vitamins: Act as essential cofactors for various metabolic processes, enzyme functions, and cellular growth and development.
Pharmacokinetics
Absorption:
Bioavailability:
Fluoride: Approximately 80-90%; Vitamins: Varies widely by vitamin (e.g., water-soluble vs. fat-soluble, presence of food).
Tmax:
Fluoride: 30-60 minutes; Vitamins: Varies (hours).
FoodEffect:
Fluoride absorption can be reduced by calcium, magnesium, and aluminum-containing foods/supplements. Vitamin absorption can be enhanced or reduced by food depending on the specific vitamin.
Distribution:
Vd:
Not available for combination; Fluoride: Distributes primarily to mineralizing tissues (bones, teeth); Vitamins: Distribute widely to various tissues.
ProteinBinding:
Not available for combination; Fluoride: Minimal; Vitamins: Varies.
CnssPenetration:
Fluoride: Limited; Vitamins: Varies.
Elimination:
HalfLife:
Fluoride: Approximately 2-9 hours (plasma); Vitamins: Varies widely.
Clearance:
Not available for combination; Fluoride: Primarily renal.
ExcretionRoute:
Fluoride: Urine (primarily); Vitamins: Urine (water-soluble), feces (fat-soluble, unabsorbed).
Unchanged:
Fluoride: High percentage (renal); Vitamins: Varies.
Pharmacodynamics
OnsetOfAction:
Long-term (for dental caries prevention and nutritional support)
PeakEffect:
Long-term (cumulative effect)
DurationOfAction:
Long-term (continuous supplementation required for sustained effect)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
It's essential to be aware that, although rare, this medication can cause severe and potentially life-threatening side effects. If your child experiences any of the following symptoms, contact their doctor or seek medical help right away:
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 do not go away, contact their doctor or seek medical help:
* 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 that, although rare, this medication can cause severe and potentially life-threatening side effects. If your child experiences any of the following symptoms, contact their doctor or seek medical help right away:
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 do not go away, contact their doctor or seek medical help:
* 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:
- White or brown spots or streaks on your child's teeth (signs of dental fluorosis, indicating too much fluoride)
- Nausea, vomiting, stomach pain, or diarrhea (especially after taking a large amount)
- Any unusual or severe side effects.
Before Using This Medicine
Before Giving This Medication to Your Child: Inform Your Doctor If:
- Your child is allergic to this medication, any of its components, or any other medications, foods, or substances. Be sure to describe the allergy and the symptoms your child experienced.
- Your child has a history of certain health issues, including bone problems, joint problems, kidney problems, or ulcers.
- Your child's drinking water contains sufficient fluoride. If you are unsure, consult with the doctor to determine the appropriate course of action.
Important: This list does not encompass all potential drug interactions or health problems associated with this medication.
It is crucial to inform the doctor and pharmacist about all medications your child is taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. Before starting, stopping, or adjusting the dosage of any medication your child is taking, consult with the doctor to ensure safety and avoid potential interactions.
- Your child is allergic to this medication, any of its components, or any other medications, foods, or substances. Be sure to describe the allergy and the symptoms your child experienced.
- Your child has a history of certain health issues, including bone problems, joint problems, kidney problems, or ulcers.
- Your child's drinking water contains sufficient fluoride. If you are unsure, consult with the doctor to determine the appropriate course of action.
Important: This list does not encompass all potential drug interactions or health problems associated with this medication.
It is crucial to inform the doctor and pharmacist about all medications your child is taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. Before starting, stopping, or adjusting the dosage of any medication your child is taking, consult with the doctor to ensure safety and avoid potential interactions.
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 old, consult with their doctor before administering this medication, as some brands may not be suitable for this age group due to an increased risk of choking. Regular dental care is essential, and you should schedule frequent dental check-ups. If your child's teeth become stained or spotted, inform their dentist.
Safety Precautions
In case of accidental ingestion of a large amount of this medication, contact a doctor or poison control center immediately. When using purified water, be aware that it may not contain fluoride.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with their doctor to discuss the potential benefits and risks to both your child and the baby.
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 old, consult with their doctor before administering this medication, as some brands may not be suitable for this age group due to an increased risk of choking. Regular dental care is essential, and you should schedule frequent dental check-ups. If your child's teeth become stained or spotted, inform their dentist.
Safety Precautions
In case of accidental ingestion of a large amount of this medication, contact a doctor or poison control center immediately. When using purified water, be aware that it may not contain fluoride.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with their doctor to discuss the potential benefits and risks to both your child and the baby.
Overdose Information
Overdose Symptoms:
- Acute: Nausea, vomiting, abdominal pain, diarrhea, excessive salivation, headache, weakness, muscle spasms, convulsions, cardiac arrhythmias, coma.
- Chronic (Fluorosis): Dental fluorosis (mild to severe enamel discoloration and pitting), skeletal fluorosis (joint pain, stiffness, bone changes - rare).
What to Do:
Immediately call a poison control center (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 only if advised by poison control. Hospitalization may be required for severe cases.
Drug Interactions
Moderate Interactions
- Calcium, magnesium, or aluminum-containing antacids/supplements (e.g., milk, dairy products, antacids): Can chelate fluoride, reducing its absorption. Administer fluoride at least 2 hours before or after these products.
- Tetracycline antibiotics: Some vitamins (e.g., calcium, iron) can chelate tetracyclines, reducing antibiotic absorption. Separate administration by several hours.
- Warfarin: High doses of Vitamin K (not typically found in pediatric multivitamins) can reduce warfarin efficacy. Monitor INR if significant dietary changes or high-dose vitamin K supplementation occurs.
Minor Interactions
- Certain medications may affect absorption or metabolism of specific vitamins (e.g., anticonvulsants affecting folate, vitamin D).
Monitoring
Baseline Monitoring
Local Water Fluoridation Level
Rationale: To determine the appropriate fluoride dose and prevent over-supplementation and fluorosis.
Timing: Prior to initiation of therapy.
Dietary Intake Assessment
Rationale: To assess overall nutritional status and identify potential deficiencies or excesses.
Timing: Prior to initiation of therapy.
Dental History and Oral Exam
Rationale: To assess baseline dental health and identify existing caries or signs of fluorosis.
Timing: Prior to initiation of therapy.
Routine Monitoring
Dental Examination
Frequency: Every 6-12 months
Target: Healthy teeth, no new caries, no signs of fluorosis
Action Threshold: Presence of new caries, signs of dental fluorosis (white flecks, streaks, or brown discoloration), or other oral health concerns.
Growth and Development Monitoring
Frequency: Regular pediatric check-ups
Target: Normal growth curves for age
Action Threshold: Failure to thrive, significant deviations from growth curves, or signs of vitamin deficiency.
Symptom Monitoring
- Signs of dental fluorosis (e.g., white flecks, streaks, or brown discoloration on tooth enamel)
- Gastrointestinal upset (nausea, vomiting, abdominal pain) - especially with acute overdose
- Signs of vitamin deficiency (e.g., fatigue, skin changes, vision problems, bleeding gums - rare with supplementation)
- Signs of hypervitaminosis (e.g., headache, blurred vision, dry skin, joint pain - rare with standard multivitamin doses)
Special Patient Groups
Pregnancy
Not indicated for use in pregnant individuals. Fluoride supplementation during pregnancy is generally not recommended for caries prevention in offspring, and prenatal vitamins typically contain necessary vitamins.
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. Consult a healthcare provider regarding appropriate vitamin and mineral supplementation for nursing mothers.
Infant Risk:
Low risk from breast milk, but direct supplementation of the infant should be based on their age and water fluoridation.
Pediatric Use
This product is specifically designed 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 while ensuring adequate caries protection. Not recommended for infants under 6 months of age.
Geriatric Use
Not indicated for geriatric population. Specific vitamin and mineral needs for older adults differ, and fluoride supplementation for caries prevention is typically not necessary.
Clinical Information
Clinical Pearls
- Always verify the local community water fluoridation level before prescribing or recommending fluoride supplements to prevent over-supplementation and dental fluorosis.
- Instruct parents to administer the chewable tablet at bedtime or after brushing teeth for maximum topical fluoride effect on tooth enamel.
- Emphasize that chewable tablets must be chewed thoroughly before swallowing, not swallowed whole.
- Stress the importance of keeping all fluoride-containing products out of reach of children due to the risk of acute fluoride toxicity.
- This product is a supplement, not a substitute for good oral hygiene practices (brushing, flossing) and regular dental check-ups.
Alternative Therapies
- Fluoride-only supplements (drops or tablets) if vitamin supplementation is not needed.
- Topical fluoride applications (e.g., fluoride toothpaste, rinses, professional fluoride varnishes/gels).
- Dietary counseling for vitamin deficiencies.
Cost & Coverage
Average Cost:
Varies widely, typically $15-$40 per 100 tablets
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans, but may require prior authorization or be considered OTC by some plans. Varies by insurance provider.
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.