Poly-Vi-flor 0.25mg 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 (intended for pediatric use); components vary (e.g., Fluoride is C, most vitamins are A/C)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a chewable tablet that provides essential vitamins for your child's growth and development, along with fluoride to help strengthen their teeth and prevent cavities. It's especially important for children who don't get enough fluoride from their drinking water.
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 have specific requirements regarding food intake. Consult your pharmacist to determine the best approach for this particular drug.
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 to clarify the proper administration method.
Storage and Disposal
Store this medication in its original container at room temperature, in a dry location, and away from bathrooms. Protect it from heat and light to maintain its effectiveness.
Missed 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 the same time or extra doses to make up for the missed one.
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 have specific requirements regarding food intake. Consult your pharmacist to determine the best approach for this particular drug.
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 to clarify the proper administration method.
Storage and Disposal
Store this medication in its original container at room temperature, in a dry location, and away from bathrooms. Protect it from heat and light to maintain its effectiveness.
Missed 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 the same time or extra doses to make up for the missed one.
Lifestyle & Tips
- Administer daily as directed by your healthcare provider, typically at bedtime after brushing teeth, or at least 2 hours before/after milk or antacids.
- Ensure proper dental hygiene, including regular brushing and flossing.
- Encourage a balanced diet rich in fruits, vegetables, and whole grains.
- Store out of reach of children in a child-resistant container to prevent accidental overdose.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable (pediatric product)
Pediatric Dosing
Neonatal:
Not established (chewable form not suitable for neonates)
Infant:
Typically for infants 6 months to 3 years of age, if fluoride concentration in drinking water is less than 0.3 ppm. Dose: 1 tablet (0.25 mg fluoride) once daily.
Child:
For children 3 to 6 years of age, if fluoride concentration in drinking water is 0.3 to 0.6 ppm. Dose: 1 tablet (0.25 mg fluoride) once daily. For children 6 years and older, higher fluoride doses (0.5mg or 1.0mg) may be indicated depending on water fluoridation.
Adolescent:
Not typically the primary formulation for adolescents; higher fluoride doses or adult multivitamin formulations may be more appropriate based on individual needs and water fluoridation.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; fluoride is primarily renally excreted. Monitor for signs of fluorosis.
Moderate:
Contraindicated or significant dose reduction required due to risk of fluoride accumulation and fluorosis.
Severe:
Contraindicated due to high risk of fluoride accumulation and toxicity.
Dialysis:
Contraindicated due to high risk of fluoride accumulation and toxicity.
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, but monitor for signs of hypervitaminosis if severe liver disease impacts vitamin metabolism/storage.
Pharmacology
Mechanism of Action
Multivitamins provide essential vitamins (e.g., A, C, D, E, B-complex) necessary for normal growth, development, and metabolic functions, acting as coenzymes or cofactors in various biochemical reactions. Fluoride incorporates into the crystalline structure of developing tooth enamel (pre-eruptive effect) and remineralizes demineralized enamel surfaces (post-eruptive effect), making teeth more resistant to acid dissolution and dental caries.
Pharmacokinetics
Absorption:
Bioavailability:
Variable for individual vitamins (e.g., Vitamin B12 requires intrinsic factor, fat-soluble vitamins require dietary fat); Fluoride: Approximately 80-90% absorbed from the GI tract.
Tmax:
Variable for individual vitamins; Fluoride: 30-60 minutes.
FoodEffect:
Fat-soluble vitamins (A, D, E) are better absorbed with food containing fat. Fluoride absorption can be reduced by co-ingestion with calcium, magnesium, or aluminum-containing products (e.g., milk, antacids).
Distribution:
Vd:
Not available for combination; Fluoride: Distributes rapidly to extracellular fluid, then concentrates in calcified tissues (bones, teeth).
ProteinBinding:
Variable for individual vitamins; Fluoride: Minimal protein binding.
CnssPenetration:
Limited for most vitamins; Fluoride: Limited penetration into CNS.
Elimination:
HalfLife:
Variable for individual vitamins (e.g., water-soluble vitamins generally shorter, fat-soluble longer); Fluoride: Plasma half-life is short (2-9 hours), but accumulation occurs in bone.
Clearance:
Not available for combination; Fluoride: Primarily renal clearance.
ExcretionRoute:
Vitamins: Primarily renal (water-soluble), biliary/fecal (fat-soluble); Fluoride: Primarily renal (urine), with minor fecal excretion.
Unchanged:
Fluoride: Approximately 50% of absorbed dose excreted unchanged in urine within 24 hours.
Pharmacodynamics
OnsetOfAction:
Chronic supplementation for vitamins; Fluoride: Continuous exposure provides ongoing benefit, with effects on enamel occurring during tooth development and throughout life.
PeakEffect:
Not applicable for chronic supplementation; Fluoride: Sustained effect with daily use.
DurationOfAction:
Sustained with daily administration.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If your child experiences any of the following symptoms, contact their doctor immediately or seek medical attention, as they may be signs of a severe and potentially life-threatening side effect:
- 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 essential to monitor your child's response to the medication. Contact your child's doctor or seek medical help if your child experiences any of the following side effects or if they persist or bother your child:
- Upset stomach
- Vomiting
Reporting Side Effects
This list does not include all possible 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.
If your child experiences any of the following symptoms, contact their doctor immediately or seek medical attention, as they may be signs of a severe and potentially life-threatening side effect:
- 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 essential to monitor your child's response to the medication. Contact your child's doctor or seek medical help if your child experiences any of the following side effects or if they persist or bother your child:
- Upset stomach
- Vomiting
Reporting Side Effects
This list does not include all possible 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/streaks on teeth (signs of fluorosis)
- Nausea, vomiting, stomach pain (especially with acute overdose)
- Unusual fatigue, weakness, or changes in appetite (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 drugs or health conditions. Therefore, 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
Before making any changes to your child's medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to ensure safety and avoid potential interactions.
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 drugs or health conditions. Therefore, 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
Before making any changes to your child's medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your 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 administering this medication. Similarly, do not give products containing aluminum or magnesium, such as certain antacids, within 2 hours of this medication.
Special Considerations for Children
If your child is under 4 years of age, consult with their doctor before giving this medication, as some brands may not be suitable for this age group due to an increased risk of choking. Regular dental check-ups are recommended to monitor your child's teeth for staining or spotting. If you notice any changes in your child's teeth, inform their dentist.
Accidental Ingestion and Poisoning
In case of accidental ingestion of a large amount of this medication, contact a doctor or poison control center immediately.
Dental Care and Fluoride
Regular dental care is essential to maintain your child's oral health. Schedule frequent dental check-ups and ensure your child receives adequate fluoride, as purified water may not contain sufficient amounts.
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 this medication 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 administering this medication. Similarly, do not give products containing aluminum or magnesium, such as certain antacids, within 2 hours of this medication.
Special Considerations for Children
If your child is under 4 years of age, consult with their doctor before giving this medication, as some brands may not be suitable for this age group due to an increased risk of choking. Regular dental check-ups are recommended to monitor your child's teeth for staining or spotting. If you notice any changes in your child's teeth, inform their dentist.
Accidental Ingestion and Poisoning
In case of accidental ingestion of a large amount of this medication, contact a doctor or poison control center immediately.
Dental Care and Fluoride
Regular dental care is essential to maintain your child's oral health. Schedule frequent dental check-ups and ensure your child receives adequate fluoride, as purified water may not contain sufficient amounts.
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 this medication to both your child and the baby.
Overdose Information
Overdose Symptoms:
- Acute Fluoride Toxicity: Nausea, vomiting, abdominal pain, diarrhea, excessive salivation, thirst, muscle weakness, tremors, convulsions, cardiac arrhythmias, coma. Severe cases can be fatal.
- Chronic Fluoride Toxicity (Fluorosis): Dental fluorosis (enamel mottling), skeletal fluorosis (bone pain, stiffness, joint immobility).
- Hypervitaminosis: Symptoms vary by vitamin (e.g., Hypervitaminosis A: headache, nausea, vomiting, blurred vision, dry skin; Hypervitaminosis D: hypercalcemia, nausea, vomiting, weakness, kidney stones).
What to Do:
Immediately contact a Poison Control Center (Call 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, as directed by poison control. Hospitalization for monitoring and supportive care may be necessary.
Drug Interactions
Major Interactions
- Antacids (calcium, magnesium, aluminum-containing): Can bind fluoride and reduce its absorption.
- Dairy products (milk, yogurt): Can bind fluoride and reduce its absorption.
Moderate Interactions
- Tetracyclines: Concurrent use with calcium (in some multivitamins) can reduce tetracycline absorption.
- Levothyroxine: Calcium (in some multivitamins) can impair levothyroxine absorption.
- Bisphosphonates: Calcium (in some multivitamins) can impair bisphosphonate absorption.
- Warfarin: High doses of Vitamin K (if present in multivitamin) can antagonize warfarin effects. (Note: Pediatric multivitamins typically have low or no Vitamin K).
Minor Interactions
- Certain diuretics (e.g., thiazides): Can decrease urinary excretion of calcium, potentially leading to hypercalcemia with high calcium intake.
- Cholestyramine/Colestipol: Can impair absorption of fat-soluble vitamins (A, D, E).
Monitoring
Baseline Monitoring
Drinking water fluoride concentration
Rationale: To determine appropriate fluoride supplementation dose and prevent fluorosis.
Timing: Prior to initiation of fluoride supplementation.
Dietary intake assessment
Rationale: To assess overall nutritional status and need for vitamin supplementation.
Timing: Prior to initiation.
Routine Monitoring
Dental examinations
Frequency: Every 6-12 months
Target: Healthy teeth, no signs of dental caries or fluorosis
Action Threshold: Presence of dental caries or signs of fluorosis (e.g., white flecks, brown stains on teeth) warrant re-evaluation of fluoride intake.
Growth and development
Frequency: Regular pediatric check-ups
Target: Normal growth curves for age
Action Threshold: Growth faltering or developmental delays may indicate underlying nutritional deficiencies or other issues.
Symptom Monitoring
- Signs of dental fluorosis (e.g., white flecks, streaks, or brown stains on tooth enamel)
- Gastrointestinal upset (nausea, vomiting, diarrhea) - especially with acute overdose
- Signs of hypervitaminosis (e.g., hypercalcemia with excess Vitamin D, headache/nausea with excess Vitamin A, peripheral neuropathy with excess Vitamin B6)
Special Patient Groups
Pregnancy
Not applicable for intended pediatric use. For pregnant individuals, vitamin and fluoride needs should be assessed by a healthcare provider. Excessive fluoride intake during pregnancy is generally not recommended.
Trimester-Specific Risks:
First Trimester:
Not applicable for intended pediatric use.
Second Trimester:
Not applicable for intended pediatric use.
Third Trimester:
Not applicable for intended pediatric use.
Lactation
Not applicable for intended pediatric use. For lactating individuals, vitamin and fluoride needs should be assessed by a healthcare provider. Fluoride is excreted in breast milk in small amounts.
Infant Risk:
Not applicable for intended pediatric use.
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 their primary drinking water source to prevent dental fluorosis while providing adequate caries protection. Chewable tablets are generally not suitable for infants or very young children due to choking risk; liquid formulations are preferred for this age group.
Geriatric Use
Not applicable (product intended for pediatric use).
Clinical Information
Clinical Pearls
- Always verify the fluoride concentration in the child's drinking water before prescribing or recommending fluoride supplements to prevent dental fluorosis.
- Chewable tablets are generally recommended for children who can reliably chew and swallow, typically around 2-3 years of age and older, to avoid choking hazards.
- Advise parents to administer fluoride supplements at bedtime after brushing teeth, or at least 2 hours apart from milk, dairy products, or antacids to maximize absorption.
- Emphasize that fluoride supplementation is an adjunct to, not a replacement for, good oral hygiene practices and regular dental check-ups.
- Store all fluoride-containing products safely out of reach of children due to the risk of accidental overdose.
Alternative Therapies
- Separate multivitamin supplements and fluoride supplements (e.g., sodium fluoride drops/tablets)
- Fluoridated toothpaste (for children old enough to spit, typically 2+ years)
- Fluoride varnish or gel applied by a dental professional
- Community water fluoridation
Cost & Coverage
Average Cost:
Varies, typically $15-$30 per 100 tablets
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans, especially for pediatric use, but 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 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. Be prepared to provide critical information, including the name of the medication taken, the amount, and the time it occurred, to facilitate prompt and effective treatment.