Poly-Vi-flor 0.5-10mg Chewable Tabs
WARNING: Accidental overdose of drugs that have iron in them is a leading cause of deadly poisoning in children younger than 6 years of age. Keep away from children. If this drug is taken by accident, call a doctor or poison control center right away. @ COMMON USES: It is used to help growth and good health.Fluoride may be in the vitamin to prevent tooth decay.
Drug Class
Multivitamin with Fluoride and Iron Supplement
Pharmacologic Class
Vitamin/Mineral Supplement; Dental Caries Prophylactic; Hematinic
Pregnancy Category
Not applicable (pediatric formulation); individual components vary (e.g., Fluoride C, Iron B)
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, iron, and fluoride. The vitamins and iron help your child grow strong and healthy, while the fluoride helps make their teeth stronger and protects them from cavities.
How to Use This Medicine
Administering This Medication
To ensure your child takes this medication correctly, follow the doctor's instructions and read all provided 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 location, and away from bathrooms. Protect it from heat and light to maintain its effectiveness.
Missed Dose
If you miss a dose, give it to your child 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 be harmful.
To ensure your child takes this medication correctly, follow the doctor's instructions and read all provided 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 location, and away from bathrooms. Protect it from heat and light to maintain its effectiveness.
Missed Dose
If you miss a dose, give it to your child 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 be harmful.
Lifestyle & Tips
- Take exactly as prescribed by your doctor. Do not exceed the recommended dose.
- Chew the tablet thoroughly before swallowing. Do not swallow whole.
- Administer at bedtime or after the evening meal for best fluoride absorption and retention in the mouth.
- Store in a cool, dry place, tightly closed, and out of reach of children. Iron overdose can be fatal.
- Continue regular dental check-ups and good oral hygiene practices (brushing, flossing).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated for adult use
Pediatric Dosing
Neonatal:
Not established (typically not used in neonates unless specific deficiency)
Infant:
Not established for chewable form (drops typically used for infants 6 months to 3 years). For chewable 0.5mg F: Not typically recommended for infants due to choking hazard and fluoride dose.
Child:
Dosing is based on age and local water fluoridation levels. Typically one chewable tablet daily. For Poly-Vi-Flor 0.5 mg F Chewable: Children 3-6 years (if water fluoridation < 0.3 ppm). For Poly-Vi-Flor 1.0 mg F Chewable: Children 6-16 years (if water fluoridation < 0.3 ppm). Iron and vitamin content are standard for pediatric daily requirements.
Adolescent:
For Poly-Vi-Flor 1.0 mg F Chewable: Adolescents 6-16 years (if water fluoridation < 0.3 ppm). One chewable tablet daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for multivitamin/iron components. Fluoride excretion is primarily renal; caution with chronic use.
Moderate:
Use with caution. Fluoride accumulation risk. Monitor serum fluoride levels if prolonged use. Iron accumulation possible.
Severe:
Contraindicated due to risk of fluoride and iron accumulation. Consult nephrologist.
Dialysis:
Contraindicated due to risk of fluoride and iron accumulation.
Hepatic Impairment:
Mild:
No specific adjustment for multivitamin/fluoride components. Caution with iron if severe liver disease (e.g., hemochromatosis).
Moderate:
Caution with iron if severe liver disease (e.g., hemochromatosis).
Severe:
Contraindicated in conditions like hemochromatosis or hemosiderosis where iron accumulation is a concern.
Pharmacology
Mechanism of Action
Poly-Vi-Flor provides essential vitamins (e.g., A, C, D, E, B-complex) and minerals (iron) necessary for normal growth, development, and metabolic functions. Fluoride acts systemically by incorporating into developing tooth enamel (pre-eruptive effect) and topically by promoting remineralization, inhibiting demineralization, and suppressing bacterial acid production in the oral cavity (post-eruptive effect), thereby increasing resistance to dental caries. Iron is a crucial component of hemoglobin, myoglobin, and various enzymes involved in oxygen transport and cellular respiration.
Pharmacokinetics
Absorption:
Bioavailability:
Varies widely by vitamin/mineral (e.g., fat-soluble vitamins require fat for absorption, iron absorption is regulated and influenced by diet). Fluoride is rapidly and almost completely absorbed (80-90%) from the GI tract.
Tmax:
Not available (highly variable for combination products). Fluoride: 30-60 minutes.
FoodEffect:
Absorption of some vitamins (e.g., fat-soluble) is enhanced by food. Iron absorption can be reduced by certain foods (e.g., dairy, tea, coffee, high fiber) but enhanced by Vitamin C. Fluoride absorption is slightly reduced by calcium-rich foods.
Distribution:
Vd:
Not available (highly variable for combination products). Fluoride: Distributes throughout the body, with high affinity for mineralized tissues (bones, teeth).
ProteinBinding:
Not available (highly variable). Fluoride: Minimal protein binding.
CnssPenetration:
Limited for most components. Fluoride: Limited, but can cross the blood-brain barrier to some extent.
Elimination:
HalfLife:
Not available (highly variable for combination products). Fluoride: Approximately 2-9 hours (plasma).
Clearance:
Not available (highly variable). Fluoride: Primarily renal.
ExcretionRoute:
Varies by component. Water-soluble vitamins primarily renal. Fat-soluble vitamins primarily biliary/fecal. Iron primarily via GI tract (sloughing cells). Fluoride primarily renal (50-60% within 24 hours).
Unchanged:
Not available (highly variable). Fluoride: Significant portion excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Not applicable (supplemental product, effects are gradual and cumulative).
PeakEffect:
Not applicable.
DurationOfAction:
Not applicable (daily supplementation required for sustained effect).
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
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 attention immediately:
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
Change in the appearance of teeth or gums
Black, tarry, or bloody stools
Fever
Vomiting blood or coffee ground-like material
Stomach cramps
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 condition. If your child experiences any of the following side effects or if they persist or worsen, contact their doctor:
Upset stomach or vomiting
Diarrhea or constipation
Green-colored stool
Stomach pain
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.
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 attention immediately:
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
Change in the appearance of teeth or gums
Black, tarry, or bloody stools
Fever
Vomiting blood or coffee ground-like material
Stomach cramps
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 condition. If your child experiences any of the following side effects or if they persist or worsen, contact their doctor:
Upset stomach or vomiting
Diarrhea or constipation
Green-colored stool
Stomach pain
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:
- Signs of dental fluorosis (white, chalky, or brown spots on teeth)
- Severe stomach pain, nausea, vomiting, or diarrhea (especially after taking the medication)
- Black, tarry stools (can be normal due to iron, but report if accompanied by other symptoms)
- Allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 drugs, foods, or substances. Describe the allergy and the symptoms your child experienced.
- Your child has a history of certain health conditions, including bone problems, joint problems, kidney problems, or ulcers.
- Your child's drinking water contains sufficient fluoride. If you're unsure, consult with the doctor.
- Your child has elevated levels of iron in the body.
Important: This list is not exhaustive. It's crucial to inform the doctor and pharmacist about all your child's medications (including prescription, over-the-counter, natural products, and vitamins) and health issues to ensure safe use. Always verify with the doctor before starting, stopping, or adjusting the dose of any medication your child is taking to avoid potential interactions.
- Your child is allergic to this medication, any of its components, or any other drugs, foods, or substances. Describe the allergy and the symptoms your child experienced.
- Your child has a history of certain health conditions, including bone problems, joint problems, kidney problems, or ulcers.
- Your child's drinking water contains sufficient fluoride. If you're unsure, consult with the doctor.
- Your child has elevated levels of iron in the body.
Important: This list is not exhaustive. It's crucial to inform the doctor and pharmacist about all your child's medications (including prescription, over-the-counter, natural products, and vitamins) and health issues to ensure safe use. Always verify with the doctor before starting, stopping, or adjusting the dose of any medication your child is taking to 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 old, consult with their doctor to determine if this medication is suitable, as some brands may not be approved for use in this age group due to an increased risk of choking. Regular dental check-ups are essential to monitor your child's teeth for staining or spotting. If you notice any changes, inform your child's dentist.
Accidental Ingestion and Poisoning
In the event of accidental ingestion of a large amount of this medication, contact a doctor or poison control center immediately.
Dental Care and Fluoride Supplementation
Regular dental care is vital to maintain your child's oral health. Schedule frequent dental check-ups and ensure your child receives adequate fluoride supplementation, as purified water may not contain sufficient 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 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 old, consult with their doctor to determine if this medication is suitable, as some brands may not be approved for use in this age group due to an increased risk of choking. Regular dental check-ups are essential to monitor your child's teeth for staining or spotting. If you notice any changes, inform your child's dentist.
Accidental Ingestion and Poisoning
In the event of accidental ingestion of a large amount of this medication, contact a doctor or poison control center immediately.
Dental Care and Fluoride Supplementation
Regular dental care is vital to maintain your child's oral health. Schedule frequent dental check-ups and ensure your child receives adequate fluoride supplementation, as purified water may not contain sufficient 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 of this medication to both your child and the baby.
Overdose Information
Overdose Symptoms:
- Acute iron overdose: Nausea, vomiting, diarrhea (may be bloody), abdominal pain, lethargy, pallor, cyanosis, shock, metabolic acidosis, liver damage.
- Acute fluoride overdose: Nausea, vomiting, abdominal pain, diarrhea, salivation, lacrimation, sweating, weakness, tremors, convulsions, cardiac arrhythmias, hypocalcemia.
- Chronic fluoride overdose (fluorosis): Dental fluorosis (mottling of enamel), skeletal fluorosis (joint pain, stiffness, bone changes).
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Induce vomiting only if instructed by Poison Control. For iron overdose, deferoxamine may be used. For fluoride overdose, calcium-containing liquids (milk) may be given to bind fluoride. Hospitalization for supportive care and monitoring is often required.
Drug Interactions
Contraindicated Interactions
- None known for typical use, but caution with specific conditions (e.g., hemochromatosis for iron, severe renal impairment for fluoride).
Major Interactions
- Antacids (calcium, aluminum, magnesium): Can decrease iron and fluoride absorption.
- Tetracyclines/Quinolones: Iron can chelate these antibiotics, reducing their absorption. Separate administration by at least 2-4 hours.
- Levothyroxine: Iron can impair absorption. Separate administration by at least 4 hours.
Moderate Interactions
- Bisphosphonates: Fluoride and iron can interfere with absorption. Separate administration.
- Penicillamine: Iron can reduce absorption.
- Zinc supplements: High doses of zinc can interfere with copper and iron absorption.
- Vitamin E: High doses may increase bleeding risk in patients on anticoagulants (though unlikely with typical multivitamin doses).
Minor Interactions
- Dairy products/Calcium supplements: Can reduce iron and fluoride absorption if taken concurrently.
- Tea/Coffee: Tannins can reduce iron absorption.
Monitoring
Baseline Monitoring
Water Fluoridation Level
Rationale: To determine appropriate fluoride supplementation dose and prevent fluorosis.
Timing: Before initiating fluoride supplementation.
Dietary Intake Assessment
Rationale: To assess overall nutritional status and need for supplementation.
Timing: Before initiating multivitamin/iron supplementation.
Routine Monitoring
Dental Examination
Frequency: Every 6-12 months
Target: Absence of dental fluorosis or caries
Action Threshold: Presence of fluorosis (white flecks/streaks) or new caries may indicate inappropriate dosing or need for dental intervention.
Growth and Development
Frequency: Regular pediatric check-ups
Target: Normal growth curves
Action Threshold: Failure to thrive or developmental delays may indicate underlying issues or inadequate nutrition.
Hemoglobin/Hematocrit (if iron deficiency suspected)
Frequency: As clinically indicated
Target: Age-appropriate normal ranges
Action Threshold: Low levels may indicate persistent iron deficiency requiring higher dose iron or further investigation.
Symptom Monitoring
- Signs of dental fluorosis (white flecks, streaks, or brown stains on teeth)
- Gastrointestinal upset (nausea, constipation, dark stools from iron)
- Allergic reactions (rash, itching, swelling)
- Symptoms of vitamin deficiency (unlikely with supplementation, but monitor if underlying conditions)
Special Patient Groups
Pregnancy
Not indicated for use in pregnant individuals as it is a pediatric formulation. Consult a healthcare provider for appropriate prenatal vitamin and mineral supplementation.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Not indicated for use in lactating individuals as it is a pediatric formulation. Consult a healthcare provider for appropriate postnatal vitamin and mineral supplementation.
Infant Risk:
Not applicable
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 not recommended for children under 3 years due to choking hazard and difficulty with proper chewing.
Geriatric Use
Not indicated for geriatric use.
Clinical Information
Clinical Pearls
- Always verify the local water fluoridation level before prescribing fluoride supplements to prevent over-supplementation and fluorosis.
- Emphasize the importance of keeping iron-containing products out of reach of children due to the high risk of fatal poisoning.
- Advise parents to administer the chewable tablet at bedtime or after the evening meal to maximize the topical effect of fluoride on teeth.
- Educate on proper chewing of the tablet to avoid choking hazards in young children.
- Remind patients that this is a supplement and does not replace a balanced diet or good oral hygiene practices.
Alternative Therapies
- Separate vitamin, iron, and fluoride supplements (e.g., individual fluoride tablets/drops, iron drops, multivitamin drops/chewables)
- Dietary modifications to address vitamin/mineral deficiencies
- Topical fluoride applications (varnishes, gels, rinses) for dental caries prevention
Cost & Coverage
Average Cost:
$20 - $50 per 30-100 tablets
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans, but may require prior authorization or be Tier 2/3. Some may be OTC.
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 additional information about this medication, consult the patient information leaflet that may be provided with the drug. If you have any questions or concerns, discuss them with your child's doctor, nurse, pharmacist, or other healthcare provider. In case of an overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.