Quflora Pediatric 1mg 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 (pediatric formulation); Fluoride is Category C, most vitamins are A/B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Quflora Pediatric 1mg Chew Tabs is a chewable tablet that provides essential vitamins and minerals for your child's healthy growth, plus 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
Taking This Medication
To ensure your child takes this medication correctly, follow the doctor's instructions 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.
Storing and Disposing of This Medication
Store the medication in its original container at room temperature, in a dry place, away from heat and light. Avoid storing it in a bathroom.
Missing a Dose
If you miss a dose, give it to your child as soon as you remember. However, if it's close to the time for the next scheduled dose, 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 ensure your child takes this medication correctly, follow the doctor's instructions 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.
Storing and Disposing of This Medication
Store the medication in its original container at room temperature, in a dry place, away from heat and light. Avoid storing it in a bathroom.
Missing a Dose
If you miss a dose, give it to your child as soon as you remember. However, if it's close to the time for the next scheduled dose, skip the missed dose and resume the regular dosing schedule. Do not give your child two doses at the same time or extra doses.
Lifestyle & Tips
- Take exactly as prescribed by your doctor or dentist.
- Do not exceed the recommended dose, as too much fluoride can be harmful to developing teeth (causing fluorosis).
- Chew the tablet thoroughly before swallowing, do not swallow whole.
- Take at bedtime after brushing teeth for best results, allowing fluoride to remain on teeth.
- Avoid taking with milk or dairy products, or calcium/magnesium/aluminum-containing antacids, as these can reduce fluoride absorption. Separate by at least 2 hours.
- Continue good oral hygiene practices, including brushing twice daily with fluoride toothpaste and regular dental check-ups.
- Ensure your child's total fluoride intake from all sources (water, diet, toothpaste) is considered.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable (pediatric formulation)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (fluoride supplementation typically starts after 6 months, often with lower doses or drops)
Child:
Children 6 years and older: 1 chewable tablet daily (containing 1 mg fluoride) in areas where the fluoride content of drinking water is less than 0.3 ppm. Dosing must be individualized based on age, weight, and total fluoride intake from other sources (e.g., drinking water, diet).
Adolescent:
Adolescents (up to 16 years): 1 chewable tablet daily (containing 1 mg fluoride) in areas where the fluoride content of drinking water is less than 0.3 ppm. Dosing must be individualized based on age, weight, and total fluoride intake from other sources.
Dose Adjustments
Renal Impairment:
Mild:
Caution advised; monitor fluoride levels if prolonged use. Fluoride is primarily renally excreted.
Moderate:
Contraindicated or significant dose reduction required due to risk of fluoride accumulation and toxicity (e.g., skeletal fluorosis).
Severe:
Contraindicated due to high risk of fluoride accumulation and toxicity.
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
No specific adjustment typically needed.
Moderate:
No specific adjustment typically needed.
Severe:
No specific adjustment typically 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 (as sodium fluoride) incorporates into the enamel structure of developing teeth, forming fluorapatite, which is more resistant to acid demineralization. It also promotes remineralization of early carious lesions and has antibacterial effects on plaque.
Pharmacokinetics
Absorption:
Bioavailability:
Varies by vitamin/mineral (e.g., fluoride ~90-95%, fat-soluble vitamins require bile salts for absorption).
Tmax:
Varies by vitamin/mineral (e.g., fluoride ~30-60 minutes).
FoodEffect:
Absorption of some vitamins (especially fat-soluble) is enhanced with food. Fluoride absorption can be reduced by calcium, magnesium, and aluminum-containing foods/supplements.
Distribution:
Vd:
Varies by vitamin/mineral. Fluoride distributes throughout the body, with high concentrations in mineralized tissues (bones, teeth).
ProteinBinding:
Varies by vitamin/mineral. 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/mineral (e.g., fluoride plasma half-life ~2-9 hours, but bone half-life is much longer).
Clearance:
Varies by vitamin/mineral. Fluoride is primarily cleared renally.
ExcretionRoute:
Renal (fluoride, water-soluble vitamins), Biliary/Fecal (some fat-soluble vitamins).
Unchanged:
Significant portion of fluoride is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Chronic (nutritional effects); Dental benefits of fluoride are cumulative over time.
PeakEffect:
Not applicable for chronic supplementation.
DurationOfAction:
Continuous with daily administration for nutritional and dental benefits.
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If your child exhibits any of the following symptoms, seek medical attention 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. 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 any other symptoms that bother them or do not go away, contact their doctor:
* Upset stomach or vomiting
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your child's doctor. For medical advice about side effects, you can also contact your child's doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If your child exhibits any of the following symptoms, seek medical attention 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. 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 any other symptoms that bother them or do not go away, contact their doctor:
* Upset stomach or vomiting
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your child's doctor. For medical advice about side effects, you can also contact your child's doctor. Additionally, you can 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 (dental fluorosis)
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Excessive salivation
- Headache
- Weakness
- Tremors
Before Using This Medicine
Before Giving Your Child This Medication, Inform Your Doctor About the Following:
Any allergies your child may have to this medication, its components, or other substances, including foods and drugs. 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.
* Whether your child's drinking water contains sufficient fluoride. If you are unsure, consult with your doctor to determine the appropriate course of action.
It is essential to note that this is not an exhaustive list of all potential interactions between this medication and other substances or health conditions.
To ensure safe treatment, inform your doctor and pharmacist about all medications your child is taking, including prescription and over-the-counter drugs, natural products, and vitamins. Additionally, disclose any existing health problems. Before making any changes to your child's medication regimen, including starting, stopping, or adjusting the dose of any medication, consult with your doctor to confirm that it is safe to do so.
Any allergies your child may have to this medication, its components, or other substances, including foods and drugs. 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.
* Whether your child's drinking water contains sufficient fluoride. If you are unsure, consult with your doctor to determine the appropriate course of action.
It is essential to note that this is not an exhaustive list of all potential interactions between this medication and other substances or health conditions.
To ensure safe treatment, inform your doctor and pharmacist about all medications your child is taking, including prescription and over-the-counter drugs, natural products, and vitamins. Additionally, disclose any existing health problems. Before making any changes to your child's medication regimen, including starting, stopping, or adjusting the dose of any medication, consult with your doctor to confirm that it is safe to do so.
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 dosage and brand are used.
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 the doctor. The dose may vary depending on your child's age, so it is crucial to discuss this with the doctor if you are unsure.
Interactions with Lab Tests and Other Substances
This medication may affect the results of certain lab tests. Inform all healthcare providers and lab personnel that your child is taking this medication. Additionally, be aware that different brands of this medication may not be suitable for children under 4 years of age, as this may increase the risk of choking. Consult with the doctor if you are unsure about the suitability of this medication for your child.
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.
Safety Precautions
In case of accidental ingestion of a large amount of this medication, seek medical attention or contact a poison control center immediately. To minimize interactions, do not administer products containing calcium (such as dairy products) or aluminum/magnesium (such as certain antacids) within 2 hours of taking this medication. Also, note that purified water may not contain fluoride.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with the 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 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 dosage and brand are used.
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 the doctor. The dose may vary depending on your child's age, so it is crucial to discuss this with the doctor if you are unsure.
Interactions with Lab Tests and Other Substances
This medication may affect the results of certain lab tests. Inform all healthcare providers and lab personnel that your child is taking this medication. Additionally, be aware that different brands of this medication may not be suitable for children under 4 years of age, as this may increase the risk of choking. Consult with the doctor if you are unsure about the suitability of this medication for your child.
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.
Safety Precautions
In case of accidental ingestion of a large amount of this medication, seek medical attention or contact a poison control center immediately. To minimize interactions, do not administer products containing calcium (such as dairy products) or aluminum/magnesium (such as certain antacids) within 2 hours of taking this medication. Also, note that purified water may not contain fluoride.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with the doctor to discuss the potential benefits and risks to both your child and the baby.
Overdose Information
Overdose Symptoms:
- Acute overdose: Nausea, vomiting, diarrhea, abdominal pain, excessive salivation, headache, weakness, tremors, convulsions, cardiac arrhythmias, respiratory depression.
- Chronic overdose (fluorosis): Dental fluorosis (white flecks, brown stains, pitting of enamel), 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 conscious and within 30 minutes of ingestion. Administer milk or calcium-containing liquids to bind fluoride. Hospital management may include gastric lavage, IV calcium, and supportive care.
Drug Interactions
Moderate Interactions
- Antacids (calcium, magnesium, aluminum-containing): Can chelate fluoride, reducing its absorption. Administer fluoride at least 2 hours before or after antacids.
- Dairy products/Calcium supplements: Can bind fluoride, reducing absorption. Avoid taking with milk or calcium-rich foods/supplements.
- Iron supplements: Some vitamins (e.g., Vitamin E) can interfere with iron absorption, and iron can interfere with some vitamin absorption. Separate administration if possible.
Minor Interactions
- Tetracyclines: Some mineral components (e.g., calcium, iron) can chelate tetracyclines, reducing their absorption. Separate administration.
- Quinolone antibiotics: Similar to tetracyclines, some mineral components can chelate quinolones. Separate administration.
Monitoring
Baseline Monitoring
Drinking water fluoride concentration
Rationale: To determine appropriate fluoride supplementation dose and prevent over-fluoridation.
Timing: Before initiating therapy and periodically if water source changes.
Dietary fluoride intake
Rationale: To ensure total fluoride intake from all sources is within recommended limits.
Timing: Before initiating therapy.
Routine Monitoring
Dental examination for fluorosis
Frequency: Annually or as recommended by dentist
Target: Absence of dental fluorosis
Action Threshold: Presence of mild to severe dental fluorosis may indicate excessive fluoride intake, requiring dose adjustment or discontinuation.
Growth and development
Frequency: Regular pediatric check-ups
Target: Normal growth parameters
Action Threshold: Significant deviations may warrant further nutritional assessment.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Skin rash
- Headache
- Unusual fatigue
- Changes in tooth appearance (white flecks, brown stains - signs of fluorosis)
Special Patient Groups
Pregnancy
Not applicable for this pediatric formulation. For general information, fluoride crosses the placenta. While essential for fetal development, excessive intake should be avoided. Most prenatal vitamins contain adequate vitamins.
Trimester-Specific Risks:
First Trimester:
Not applicable.
Second Trimester:
Not applicable.
Third Trimester:
Not applicable.
Lactation
Not applicable for this pediatric formulation. For general information, fluoride is excreted in breast milk in small amounts. Most vitamins are also excreted in breast milk. Generally considered safe when taken at recommended doses.
Infant Risk:
Not applicable.
Pediatric Use
This product is specifically formulated for pediatric use. Dosing must be carefully individualized based on the child's age, weight, and the fluoride concentration in their primary drinking water source to prevent dental fluorosis. Not recommended for infants under 6 months. Children under 3 years may require a different formulation (e.g., drops) if unable to chew safely.
Geriatric Use
Not applicable (product is for pediatric use).
Clinical Information
Clinical Pearls
- Always assess the fluoride content of the patient's drinking water before prescribing or recommending fluoride supplements to prevent over-fluoridation.
- Educate parents/caregivers on the importance of proper dosing and storage (out of reach of children) to prevent accidental overdose.
- Advise taking the chewable tablet at bedtime after brushing teeth to maximize topical fluoride exposure to enamel.
- Remind patients to avoid taking the tablet with milk, dairy products, or calcium/magnesium/aluminum-containing antacids due to reduced fluoride absorption.
- Dental fluorosis is a sign of chronic excessive fluoride intake during tooth development; monitor for this during dental check-ups.
Alternative Therapies
- Fluoride varnish/gel (topical application by dental professional)
- Fluoridated toothpaste
- Fluoridated drinking water
- Separate multivitamin and fluoride supplements (e.g., Luride Lozi-Tabs for fluoride only)
Cost & Coverage
Average Cost:
Varies, typically $15-$40 per 100 tablets
Generic Available:
Yes
Insurance Coverage:
Often Tier 1 or 2, may require prescription for fluoride component
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 comprehensive 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 details about the overdose, including the substance taken, the amount, and the time it occurred, to facilitate prompt and appropriate treatment.