Quflora Pediatric 0.25mg Chew Tabs
It is used to help growth and good health.Fluoride may be in the vitamin to prevent tooth decay.
Drug Class
Nutritional Supplement; Dental Caries Prophylaxis
Pharmacologic Class
Vitamin/Mineral Supplement; Fluoride
Pregnancy Category
Not applicable (pediatric formulation)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Quflora Pediatric 0.25mg Chew Tabs are chewable tablets that provide essential vitamins and minerals for your child's growth and development, along with a small amount of fluoride. The fluoride helps strengthen your child's tooth enamel and protect against cavities, especially if your drinking water does not have enough fluoride.
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 the 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, and away from the bathroom. Protect it from heat and light to maintain its effectiveness.
Missing a 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 be harmful.
To ensure your child takes this medication correctly, follow the doctor's instructions and read all accompanying information carefully. Take the 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, and away from the bathroom. Protect it from heat and light to maintain its effectiveness.
Missing a 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 be harmful.
Lifestyle & Tips
- Administer daily as directed by your healthcare provider, typically at bedtime or after brushing teeth.
- Do not exceed the recommended dose, as too much fluoride can be harmful.
- Ensure your child brushes their teeth twice daily with a fluoride toothpaste (age-appropriate amount).
- Limit sugary snacks and drinks to further protect against cavities.
- Regular dental check-ups are essential for monitoring dental health and fluoride intake.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable (pediatric formulation)
Pediatric Dosing
Neonatal:
Not typically indicated for this specific fluoride strength.
Infant:
For infants 6 months to 1 year of age: 1 chewable tablet daily, if the fluoride concentration in the drinking water is less than 0.3 ppm.
Child:
For children 1 to 3 years of age: 1 chewable tablet daily, if the fluoride concentration in the drinking water is less than 0.3 ppm. For children 3 to 6 years of age, a higher fluoride strength (e.g., 0.5 mg) may be indicated depending on water fluoridation.
Adolescent:
Not typically indicated for this specific fluoride strength; higher fluoride doses (e.g., 1.0 mg) or different formulations are usually recommended for adolescents.
Dose Adjustments
Renal Impairment:
Mild:
Not specified; caution with severe renal impairment due to fluoride excretion.
Moderate:
Not specified; caution with severe renal impairment due to fluoride excretion.
Severe:
Use with caution; fluoride excretion is primarily renal, and accumulation can occur, increasing risk of fluorosis or toxicity.
Dialysis:
Not specified; generally avoided or used with extreme caution due to risk of fluoride accumulation.
Hepatic Impairment:
Mild:
Not specified
Moderate:
Not specified
Severe:
Not specified
Pharmacology
Mechanism of Action
Multivitamins provide essential vitamins and minerals necessary for normal growth, development, and metabolic functions. Fluoride incorporates into the crystalline structure of developing tooth enamel, forming fluorapatite, which is more resistant to acid dissolution than hydroxyapatite. It also inhibits bacterial acid production in dental plaque and promotes remineralization of early carious lesions.
Pharmacokinetics
Absorption:
Bioavailability:
Variable depending on specific vitamin/mineral and formulation; fluoride is well absorbed (80-90%) from the gastrointestinal tract.
Tmax:
Variable; for fluoride, typically 30-60 minutes.
FoodEffect:
Absorption of some vitamins (e.g., fat-soluble) is enhanced by food; absorption of some minerals (e.g., iron, fluoride) can be reduced by certain food components (e.g., calcium, dairy).
Distribution:
Vd:
Not available for combination; fluoride distributes throughout body water and concentrates in calcified tissues (bones, teeth).
ProteinBinding:
Not available for combination; fluoride has low protein binding.
CnssPenetration:
Limited for most vitamins; fluoride can cross the blood-brain barrier to a limited extent.
Elimination:
HalfLife:
Variable for vitamins; for fluoride, plasma half-life is typically 2-9 hours.
Clearance:
Not available for combination; fluoride is primarily cleared renally.
ExcretionRoute:
Water-soluble vitamins and fluoride primarily renal; fat-soluble vitamins primarily biliary/fecal.
Unchanged:
Not available for combination; significant portion of absorbed fluoride is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Nutritional effects are gradual and cumulative; dental caries prevention with fluoride is a continuous, long-term effect with consistent use.
PeakEffect:
Not applicable for nutritional supplementation; for fluoride, peak plasma levels occur within an hour, but the therapeutic effect on enamel is cumulative.
DurationOfAction:
Continuous with daily supplementation.
Safety & Warnings
Side Effects
Important Side Effects to Report Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If your child exhibits any of the following symptoms, contact their doctor or 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 or seek medical help:
* 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, contact 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, some people may experience severe and potentially life-threatening side effects while taking this medication. If your child exhibits any of the following symptoms, contact their doctor or 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 or seek medical help:
* 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, contact 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:
- White or brown spots/streaks on teeth (signs of dental fluorosis)
- Nausea, vomiting, stomach pain, or diarrhea (especially after taking a large amount)
- Muscle weakness or tremors
- Any unusual or severe symptoms
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. Be sure to 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're unsure, consult with your doctor to determine the appropriate course of action.
It's essential to note that this is not an exhaustive list of potential interactions. Therefore, it's crucial to inform your doctor and pharmacist about all the medications your child is taking, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Additionally, disclose any existing health problems your child may have. This information will help your doctor and pharmacist assess potential interactions and ensure safe treatment. Never start, stop, or adjust the dosage of any medication your child is taking without first consulting with your doctor.
Any allergies your child may have to this medication, its components, or other substances, including foods and drugs. Be sure to 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're unsure, consult with your doctor to determine the appropriate course of action.
It's essential to note that this is not an exhaustive list of potential interactions. Therefore, it's crucial to inform your doctor and pharmacist about all the medications your child is taking, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Additionally, disclose any existing health problems your child may have. This information will help your doctor and pharmacist assess potential interactions and ensure safe treatment. Never start, stop, or adjust 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 dosage and brand are used.
Administration and Dosage
Do not exceed the recommended dosage or frequency of administration. 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 discuss this with the doctor.
Interactions with Lab Tests and Other Substances
This medication may interfere with 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.
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, contact a doctor or poison control center immediately, as this may cause harm. To minimize interactions, avoid giving your child products containing calcium (such as dairy products) or aluminum/magnesium (such as certain antacids) within 2 hours of administering this medication. If your child's drinking water is purified, 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 dosage and brand are used.
Administration and Dosage
Do not exceed the recommended dosage or frequency of administration. 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 discuss this with the doctor.
Interactions with Lab Tests and Other Substances
This medication may interfere with 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.
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, contact a doctor or poison control center immediately, as this may cause harm. To minimize interactions, avoid giving your child products containing calcium (such as dairy products) or aluminum/magnesium (such as certain antacids) within 2 hours of administering this medication. If your child's drinking water is purified, 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 fluoride overdose: Nausea, vomiting, abdominal pain, salivation, diarrhea, muscle weakness, tremors, convulsions, cardiac arrhythmias, and potentially death.
- Chronic fluoride overdose (fluorosis): Dental fluorosis (mild: white flecks/streaks; severe: brown stains, pitting, enamel defects), skeletal fluorosis (bone pain, stiffness, joint deformities).
What to Do:
In case of suspected overdose, immediately contact 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 supportive care.
Drug Interactions
Moderate Interactions
- Antacids (containing calcium, magnesium, aluminum): Can chelate fluoride, reducing its absorption.
- Dairy products/Calcium-rich foods: Can bind fluoride, reducing absorption; administer fluoride at least 1 hour before or 2 hours after dairy/calcium supplements.
- Tetracyclines: Some multivitamin components (e.g., calcium, iron) can chelate tetracyclines, reducing antibiotic absorption. Separate administration by several hours.
- Levothyroxine: Calcium and iron can impair levothyroxine absorption. Separate administration by at least 4 hours.
Minor Interactions
- Certain foods (e.g., high fiber, phytates): May slightly reduce absorption of some minerals.
- Other mineral supplements: Concurrent use of multiple mineral supplements may lead to competitive absorption.
Monitoring
Baseline Monitoring
Dental examination
Rationale: To assess baseline dental health and identify any existing caries or signs of fluorosis.
Timing: Prior to initiation of fluoride supplementation.
Assessment of local water fluoridation level
Rationale: To ensure appropriate fluoride dosing and prevent over-supplementation.
Timing: Prior to initiation and periodically if water source changes.
Dietary assessment
Rationale: To evaluate overall nutritional intake and identify potential deficiencies or excesses.
Timing: Prior to initiation.
Routine Monitoring
Dental check-ups
Frequency: Every 6-12 months
Target: Healthy teeth, no new caries, no signs of fluorosis
Action Threshold: Presence of new caries, signs of fluorosis, or other dental concerns warrant re-evaluation of fluoride intake and oral hygiene practices.
Growth and development monitoring
Frequency: Regular pediatric visits
Target: Normal growth curves
Action Threshold: Growth faltering or developmental delays may indicate underlying nutritional issues.
Symptom Monitoring
- Signs of dental fluorosis (e.g., white flecks, streaks, or brown stains on tooth enamel)
- Gastrointestinal upset (nausea, vomiting, abdominal pain, diarrhea) - especially with acute overdose
- Muscle weakness or tremors (in severe toxicity)
- Signs of specific vitamin/mineral deficiencies (e.g., fatigue, skin changes, vision problems, bone pain)
Special Patient Groups
Pregnancy
Not applicable for this pediatric formulation. General multivitamin and fluoride supplementation in pregnancy should be discussed with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Not applicable for this pediatric formulation. General multivitamin and fluoride supplementation during lactation should be discussed with a healthcare provider.
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 their primary drinking water source to prevent both deficiency and excessive intake (fluorosis). Regular dental check-ups are crucial.
Geriatric Use
Not applicable for this pediatric formulation.
Clinical Information
Clinical Pearls
- Always assess the child's primary drinking water fluoride concentration before prescribing or recommending fluoride supplements to prevent over-supplementation and fluorosis.
- Educate parents on proper storage to prevent accidental ingestion by children, as acute fluoride overdose can be serious.
- Emphasize that fluoride supplements are an adjunct to, not a replacement for, good oral hygiene practices (brushing with fluoride toothpaste, limiting sugary foods).
- Advise parents to administer the chewable tablet at bedtime or after brushing teeth to maximize topical fluoride exposure to the enamel.
Alternative Therapies
- Fluoridated drinking water (primary source of systemic fluoride)
- Fluoride toothpaste (topical fluoride)
- Topical fluoride varnishes or gels applied by a dental professional
- Dietary counseling for general nutritional needs
Cost & Coverage
Average Cost:
Varies widely, typically $15-$40 per 100 chewable tablets
Generic Available:
Yes
Insurance Coverage:
Often not covered by insurance as it's an over-the-counter or prescription supplement; coverage varies by plan.
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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the quantity, and the time it occurred.