Quflora Pediatric 0.5mg Chew 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 for intended use (pediatric product)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a chewable tablet that provides essential vitamins and minerals your child needs for healthy growth, along with fluoride to help strengthen their teeth and prevent cavities. It's especially important if your child's drinking 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 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 the medication 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 the same time 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.
Storage and Disposal
Store this medication in its original container at room temperature, in a dry location, and away from bathrooms. Protect the medication 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 the same time or 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, as too much fluoride can cause dental fluorosis (staining or mottling of teeth).
- Chew the tablet thoroughly before swallowing.
- Avoid taking with milk, dairy products, or antacids, as these can reduce fluoride absorption. Separate by at least 1-2 hours.
- Continue good oral hygiene practices, including brushing with fluoride toothpaste and regular dental check-ups.
- Ensure your child has a balanced diet in addition to the supplement.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable for intended use
Pediatric Dosing
Neonatal:
Not established (fluoride supplementation generally not recommended for infants under 6 months)
Infant:
Not established for 0.5mg dose. For infants 6 months to 3 years, 0.25 mg fluoride daily is typically recommended if drinking water fluoride concentration is less than 0.3 ppm.
Child:
For children 3 to 6 years of age: 0.5 mg fluoride daily if drinking water fluoride concentration is less than 0.3 ppm. For children 6 to 16 years of age: 0.5 mg fluoride daily if drinking water fluoride concentration is between 0.3 and 0.6 ppm. Dosing also includes age-appropriate multivitamin components.
Adolescent:
For adolescents 6 to 16 years of age: 0.5 mg fluoride daily if drinking water fluoride concentration is between 0.3 and 0.6 ppm. Dosing also includes age-appropriate multivitamin components.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for mild impairment.
Moderate:
Caution advised; monitor for signs of fluorosis. Consider dose reduction or discontinuation if fluoride accumulation is a concern.
Severe:
Adjustment needed. Contraindicated or significant dose reduction required due to risk of fluoride accumulation and skeletal fluorosis. Consult a nephrologist.
Dialysis:
Contraindicated due to significant risk of fluoride accumulation and toxicity.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Multivitamins provide essential vitamins and minerals necessary for normal growth, development, and metabolic functions, acting as coenzymes or cofactors in various biochemical reactions. Fluoride primarily acts by incorporating into the enamel structure of developing teeth, making them more resistant to acid demineralization. It also promotes remineralization of early carious lesions and inhibits bacterial acid production in dental plaque.
Pharmacokinetics
Absorption:
Bioavailability:
Varies by vitamin/mineral (e.g., fluoride ~80-90%, fat-soluble vitamins vary with fat intake).
Tmax:
Varies by vitamin/mineral (e.g., fluoride ~30-60 minutes).
FoodEffect:
Absorption of some vitamins (e.g., fat-soluble) is enhanced with food. Fluoride absorption may be reduced by calcium-rich foods or dairy products.
Distribution:
Vd:
Varies by vitamin/mineral (e.g., fluoride distributes widely, concentrating in calcified tissues like bones and teeth).
ProteinBinding:
Varies by vitamin/mineral (e.g., fluoride has low protein binding).
CnssPenetration:
Limited for most vitamins; fluoride can cross the blood-brain barrier to a limited extent.
Elimination:
HalfLife:
Varies by vitamin/mineral (e.g., fluoride plasma half-life is short, but accumulation in bone is long-term).
Clearance:
Varies by vitamin/mineral (e.g., fluoride primarily renal clearance).
ExcretionRoute:
Varies by vitamin/mineral (e.g., water-soluble vitamins primarily renal; fat-soluble vitamins primarily biliary/fecal; fluoride primarily renal).
Unchanged:
Varies by vitamin/mineral (e.g., significant portion of fluoride excreted unchanged).
Pharmacodynamics
OnsetOfAction:
Chronic effect for dental caries prevention; nutritional effects are gradual.
PeakEffect:
Not acutely defined for chronic supplementation.
DurationOfAction:
Long-term (as long as supplementation continues and for fluoride, its incorporation into enamel provides lasting benefit).
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 emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Watch for 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
Also, contact your child's doctor right away if you notice any changes in the appearance of their teeth or gums.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If your child experiences any of the following side effects, or if they bother your child or do not go away, contact their doctor:
Upset stomach
* Vomiting
Not all possible side effects are listed here. If you have questions or concerns about side effects, contact your child's doctor for guidance. 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 emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Watch for 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
Also, contact your child's doctor right away if you notice any changes in the appearance of their teeth or gums.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If your child experiences any of the following side effects, or if they bother your child or do not go away, contact their doctor:
Upset stomach
* Vomiting
Not all possible side effects are listed here. If you have questions or concerns about side effects, contact your child's doctor for guidance. 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 on teeth (signs of fluorosis)
- Nausea, vomiting, stomach pain, or diarrhea (especially with acute overdose)
- Unusual fatigue or weakness
- Changes in vision or skin
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:
If your child is allergic to this medication, any of its components, or any other medications, foods, or substances. Please describe the allergy and the symptoms your child experienced.
If your child has a history of certain health conditions, including:
+ Bone problems
+ Joint problems
+ Kidney problems
+ 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 is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to:
Inform your doctor and pharmacist about all medications your child is taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your child's health problems with your doctor and pharmacist to ensure safe use of this medication.
Never start, stop, or change the dosage of any medication your child is taking without first consulting with your doctor.
It is essential to inform your doctor about the following:
If your child is allergic to this medication, any of its components, or any other medications, foods, or substances. Please describe the allergy and the symptoms your child experienced.
If your child has a history of certain health conditions, including:
+ Bone problems
+ Joint problems
+ Kidney problems
+ 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 is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to:
Inform your doctor and pharmacist about all medications your child is taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your child's health problems with your doctor and pharmacist to ensure safe use of this medication.
Never start, stop, or change the dosage of any medication your child is taking without first consulting with your doctor.
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 any brand of this medication, as different brands may be suitable for different age groups. Before administering this medication to a child, consult with the doctor to ensure the correct brand and dosage are used.
Administration and Dosage
Do not exceed the recommended dose or frequency of this medication. If you are unsure about the correct dosage for your child, consult with the doctor. The dosage may vary depending on your child's age, so it is crucial to follow the doctor's instructions.
Lab Tests and Interactions
This medication may affect the results of certain lab tests. Inform all of your child's healthcare providers and lab workers that your child is taking this medication.
Special Considerations for Children
Different brands of this medication may not be suitable for children under 4 years of age, as they may pose a choking hazard. If you are unsure about the suitability of this medication for your child, consult with the doctor.
Dental Care
If your child's teeth become stained or spotted, inform the dentist. Regular dental check-ups are essential to maintain your child's oral health.
Overdose and Poisoning
In case of an overdose, where a large amount of this medication is swallowed, seek immediate medical attention by calling a doctor or poison control center.
Interactions with Other Products
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. If your child drinks purified water, note that it may not contain fluoride.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with the doctor to discuss the 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 any brand of this medication, as different brands may be suitable for different age groups. Before administering this medication to a child, consult with the doctor to ensure the correct brand and dosage are used.
Administration and Dosage
Do not exceed the recommended dose or frequency of this medication. If you are unsure about the correct dosage for your child, consult with the doctor. The dosage may vary depending on your child's age, so it is crucial to follow the doctor's instructions.
Lab Tests and Interactions
This medication may affect the results of certain lab tests. Inform all of your child's healthcare providers and lab workers that your child is taking this medication.
Special Considerations for Children
Different brands of this medication may not be suitable for children under 4 years of age, as they may pose a choking hazard. If you are unsure about the suitability of this medication for your child, consult with the doctor.
Dental Care
If your child's teeth become stained or spotted, inform the dentist. Regular dental check-ups are essential to maintain your child's oral health.
Overdose and Poisoning
In case of an overdose, where a large amount of this medication is swallowed, seek immediate medical attention by calling a doctor or poison control center.
Interactions with Other Products
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. If your child drinks purified water, note that it may not contain fluoride.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with the doctor to discuss the benefits and risks of this medication to both your child and the baby.
Overdose Information
Overdose Symptoms:
- Acute overdose: Nausea, vomiting, abdominal pain, diarrhea, excessive salivation, headache, weakness, muscle spasms, convulsions, cardiac arrhythmias.
- Chronic overdose (fluorosis): Dental fluorosis (enamel mottling, pitting), skeletal fluorosis (joint pain, stiffness, bone changes).
What to Do:
Immediately contact a poison control center (1-800-222-1222) or seek emergency medical attention. Induce vomiting if advised by medical professional. Administer calcium (e.g., milk, calcium gluconate) to bind fluoride.
Drug Interactions
Moderate Interactions
- Antacids (calcium, magnesium, aluminum-containing): Can chelate fluoride, reducing its absorption.
- Dairy products/Calcium-rich foods: Can reduce fluoride absorption if consumed concurrently.
- Iron supplements: May interfere with absorption of some vitamins or vice versa if taken together.
Monitoring
Baseline Monitoring
Drinking water fluoride concentration
Rationale: To determine appropriate fluoride supplementation dose and prevent fluorosis.
Timing: Prior to initiating fluoride supplementation.
Dietary intake assessment
Rationale: To assess overall nutritional status and need for vitamin supplementation.
Timing: Prior to initiating vitamin supplementation.
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) warrants re-evaluation of fluoride intake.
Growth and development
Frequency: Regular pediatric check-ups
Target: Normal growth curves for age.
Action Threshold: Failure to thrive 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 teeth)
- Gastrointestinal upset (nausea, vomiting, diarrhea, abdominal pain) - especially with acute overdose
- Signs of vitamin deficiency (e.g., fatigue, skin changes, vision problems, poor growth)
- Signs of vitamin toxicity (rare with typical doses, but possible with excessive intake of fat-soluble vitamins)
Special Patient Groups
Pregnancy
Not applicable for intended use (pediatric product).
Trimester-Specific Risks:
First Trimester:
Not applicable for intended use
Second Trimester:
Not applicable for intended use
Third Trimester:
Not applicable for intended use
Lactation
Not applicable for intended use (pediatric product).
Infant Risk:
Not applicable for intended 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 ensuring adequate caries prevention. Regular dental check-ups are crucial.
Geriatric Use
Not applicable for intended use (pediatric product).
Clinical Information
Clinical Pearls
- Always determine the fluoride concentration of the child's primary drinking water source (e.g., municipal water report, well water testing) before prescribing or recommending fluoride supplements.
- Dental fluorosis is a dose-dependent effect of excessive fluoride intake during tooth development. Educate parents on the signs and the importance of not exceeding the prescribed dose.
- Chewable tablets should be chewed thoroughly and not swallowed whole to ensure proper absorption and local fluoride effect.
- Advise parents to administer the supplement at a different time than dairy products or antacids to maximize fluoride absorption.
- This product is a supplement, not a substitute for good oral hygiene practices (brushing, flossing) and regular dental visits.
Alternative Therapies
- Fluoride varnish applications by a dental professional
- Fluoride toothpaste (age-appropriate)
- Fluoridated community water supply
- Dietary counseling for vitamin/mineral deficiencies
- Separate vitamin supplements and fluoride supplements
Cost & Coverage
Average Cost:
Varies widely, typically $15-$50 per 30 chewable tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often covered by prescription drug plans, especially for pediatric patients)
General Drug Facts
If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safety and efficacy, 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 accompanying patient information leaflet, if available. Alternatively, you can discuss any questions or concerns with your child's doctor, nurse, pharmacist, or other healthcare provider. Additionally, you may inquire with your pharmacist about the availability of a patient information leaflet for this specific drug. In the event of a suspected overdose, immediately contact your local poison control center or seek urgent medical attention. When reporting the incident, be prepared to provide detailed information, including the substance taken, the quantity, and the time of occurrence.