Quflora Ped 0.5mg/ml Liq Drops
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
Category C (due to fluoride component, though product is for pediatric use)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Quflora Ped drops are a liquid supplement for babies and children that contain essential vitamins and fluoride. The vitamins help your child grow and stay healthy, while the fluoride helps strengthen their teeth and protect them from cavities, especially if your tap water doesn't have enough fluoride.
How to Use This Medicine
Taking This Medication
To ensure your child takes this medication safely and effectively, follow the instructions provided by their doctor and the information included with the medication. You can give this medication to your child with or without food. If it causes stomach upset, administer it with food to help minimize this side effect. However, some medications must be taken with food or on an empty stomach, so it's essential to consult with your pharmacist to determine the best approach for this specific medication.
When measuring liquid doses, use the measuring device that comes with the medication to ensure accuracy. Before administering, shake the medication well. Some products can be mixed with formula, fruit juice, or other foods and liquids, while others should be placed directly into your child's mouth. Make sure you understand the correct method for giving this medication to your child.
Storing and Disposing of This Medication
Store the medication in its original container at room temperature, in a dry location away from bathrooms. Protect the medication from heat and light to preserve its effectiveness.
What to Do If a Dose Is Missed
If you miss giving your child a dose, administer it as soon as you remember. However, if it's close to the time for the next scheduled dose, skip the missed dose and continue with the regular dosing schedule. Do not give your child two doses at the same time or extra doses, as this can increase the risk of adverse effects.
To ensure your child takes this medication safely and effectively, follow the instructions provided by their doctor and the information included with the medication. You can give this medication to your child with or without food. If it causes stomach upset, administer it with food to help minimize this side effect. However, some medications must be taken with food or on an empty stomach, so it's essential to consult with your pharmacist to determine the best approach for this specific medication.
When measuring liquid doses, use the measuring device that comes with the medication to ensure accuracy. Before administering, shake the medication well. Some products can be mixed with formula, fruit juice, or other foods and liquids, while others should be placed directly into your child's mouth. Make sure you understand the correct method for giving this medication to your child.
Storing and Disposing of This Medication
Store the medication in its original container at room temperature, in a dry location away from bathrooms. Protect the medication from heat and light to preserve its effectiveness.
What to Do If a Dose Is Missed
If you miss giving your child a dose, administer it as soon as you remember. However, if it's close to the time for the next scheduled dose, skip the missed dose and continue with the regular dosing schedule. Do not give your child two doses at the same time or extra doses, as this can increase the risk of adverse effects.
Lifestyle & Tips
- Always measure the dose carefully using the dropper provided. Do not exceed the recommended dose.
- Administer directly into the mouth or mix with formula, milk, juice, or food. Do not mix with dairy products or calcium-rich foods immediately before or after administration, as this can reduce fluoride absorption.
- For best results in preventing cavities, administer the dose at bedtime after brushing teeth, or at least 30 minutes before or after eating.
- Encourage good oral hygiene practices, including regular brushing with fluoride toothpaste (age-appropriate amount) and routine dental check-ups.
- Store at room temperature, away from light and moisture, and out of reach of children.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable (Pediatric formulation)
Pediatric Dosing
Neonatal:
Not established (Generally not recommended for infants under 6 months unless specific deficiency and under medical supervision)
Infant:
For infants 6 months to 3 years: 0.25 mg fluoride daily if drinking water contains less than 0.3 ppm fluoride. This corresponds to 0.5 mL of Quflora Ped 0.5mg/ml Liq Drops.
Child:
For children 3 to 6 years: 0.5 mg fluoride daily if drinking water contains less than 0.3 ppm fluoride, OR 0.25 mg fluoride daily if drinking water contains 0.3 to 0.6 ppm fluoride. This corresponds to 1 mL or 0.5 mL of Quflora Ped 0.5mg/ml Liq Drops, respectively. For children 6 to 16 years: 1.0 mg fluoride daily if drinking water contains less than 0.3 ppm fluoride, OR 0.5 mg fluoride daily if drinking water contains 0.3 to 0.6 ppm fluoride. This corresponds to 2 mL or 1 mL of Quflora Ped 0.5mg/ml Liq Drops, respectively.
Adolescent:
For adolescents 6 to 16 years: 1.0 mg fluoride daily if drinking water contains less than 0.3 ppm fluoride, OR 0.5 mg fluoride daily if drinking water contains 0.3 to 0.6 ppm fluoride. This corresponds to 2 mL or 1 mL of Quflora Ped 0.5mg/ml Liq Drops, respectively. (Note: Older adolescents may transition to chewable tablets).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for vitamins. Fluoride excretion is primarily renal; monitor for signs of fluorosis with prolonged use.
Moderate:
Use with caution. Fluoride accumulation can occur. Consider lower doses or alternative supplementation if water fluoride levels are not low.
Severe:
Contraindicated due to risk of fluoride accumulation and toxicity (e.g., skeletal fluorosis).
Dialysis:
Contraindicated due to 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 (e.g., A, C, D, E, B vitamins) that act as coenzymes or participate in various metabolic processes crucial for growth, development, and overall health. Fluoride primarily acts topically and systemically to prevent dental caries. It incorporates 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:
Variable for individual vitamins (e.g., Vitamin B12 requires intrinsic factor, fat-soluble vitamins require dietary fat). Fluoride is rapidly and almost completely absorbed from the gastrointestinal tract (up to 90-95%).
Tmax:
Varies by vitamin (e.g., 2-4 hours for water-soluble vitamins). Fluoride Tmax is typically 30-60 minutes.
FoodEffect:
Absorption of fat-soluble vitamins (A, D, E) is enhanced by dietary fat. Fluoride absorption may be reduced by co-ingestion with calcium, magnesium, or aluminum-containing foods/supplements.
Distribution:
Vd:
Varies widely for individual vitamins. Fluoride distributes throughout the body, with approximately 50% of absorbed fluoride in children being rapidly deposited in calcified tissues (bones and teeth).
ProteinBinding:
Varies for individual vitamins. Fluoride is minimally protein-bound.
CnssPenetration:
Limited for most vitamins. Fluoride can cross the blood-brain barrier to a limited extent.
Elimination:
HalfLife:
Varies widely for individual vitamins (e.g., minutes to days). Fluoride plasma half-life is typically 2-9 hours, but its retention in calcified tissues is prolonged.
Clearance:
Varies for individual vitamins. Fluoride is primarily cleared renally.
ExcretionRoute:
Mainly renal for fluoride and water-soluble vitamins. Fat-soluble vitamins are excreted via bile/feces or renally after metabolism.
Unchanged:
Significant portion of fluoride is excreted unchanged in urine (50-60% in adults, higher in children).
Pharmacodynamics
OnsetOfAction:
Chronic supplementation; effects on growth and development are gradual. Dental caries prevention effects are long-term.
PeakEffect:
Not applicable for chronic supplementation.
DurationOfAction:
Effects are sustained with continuous daily administration.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent 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 immediately or seek emergency medical attention:
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 if they bother your child or do not go away, contact their doctor:
* Upset stomach or vomiting
Important Note
This is not a comprehensive 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, this medication can cause severe and potentially life-threatening side effects. If your child experiences any of the following symptoms, contact their doctor immediately or seek emergency medical attention:
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 if they bother your child or do not go away, contact their doctor:
* Upset stomach or vomiting
Important Note
This is not a comprehensive 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, indicating too much fluoride)
- Nausea, vomiting, stomach pain, diarrhea (especially with acute overdose)
- Rash or allergic reaction
- Unusual fatigue or weakness
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 to ensure safe treatment.
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 to ensure safe treatment.
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 is crucial because different brands of this medication may be suitable for different age groups, and your child's doctor needs to be consulted before administering this medication to a child.
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, as the dose may vary depending on your child's age.
Interactions with Lab Tests and Other Substances
This medication may interfere with certain laboratory tests. Therefore, it is vital to notify all healthcare providers and lab personnel that your child is taking this medication.
Dental Care
Regular dental check-ups are crucial to maintain your child's oral health. If your child's teeth become stained or spotted, inform their dentist. Additionally, encourage good oral hygiene practices to prevent dental problems.
Safety Precautions
In case of accidental ingestion of a large amount of this medication, seek immediate medical attention or contact a poison control center. To minimize the risk of interactions, avoid giving your child products containing calcium (such as dairy products) or aluminum/magnesium (found in some antacids) within 2 hours of taking this medication. Also, note that purified water may not contain fluoride.
Special Considerations for Pregnant or Breastfeeding Mothers
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 is crucial because different brands of this medication may be suitable for different age groups, and your child's doctor needs to be consulted before administering this medication to a child.
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, as the dose may vary depending on your child's age.
Interactions with Lab Tests and Other Substances
This medication may interfere with certain laboratory tests. Therefore, it is vital to notify all healthcare providers and lab personnel that your child is taking this medication.
Dental Care
Regular dental check-ups are crucial to maintain your child's oral health. If your child's teeth become stained or spotted, inform their dentist. Additionally, encourage good oral hygiene practices to prevent dental problems.
Safety Precautions
In case of accidental ingestion of a large amount of this medication, seek immediate medical attention or contact a poison control center. To minimize the risk of interactions, avoid giving your child products containing calcium (such as dairy products) or aluminum/magnesium (found in some antacids) within 2 hours of taking this medication. Also, note that purified water may not contain fluoride.
Special Considerations for Pregnant or Breastfeeding Mothers
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 overdose: Nausea, vomiting, abdominal pain, diarrhea, excessive salivation, headache, weakness, muscle spasms, convulsions, cardiac arrhythmias, coma.
- Chronic fluoride overdose (fluorosis): Dental fluorosis (mottling of tooth enamel), skeletal fluorosis (bone pain, stiffness, increased bone density).
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. Monitor vital signs and manage symptoms.
Drug Interactions
Major Interactions
- Antacids (calcium, magnesium, aluminum-containing): Can bind fluoride and reduce its absorption. Administer fluoride at least 2 hours before or after antacids.
- Dairy products/Calcium supplements: Can bind fluoride and reduce its absorption. Administer fluoride at least 2 hours before or after dairy products/calcium.
Moderate Interactions
- Tetracyclines: Some multivitamin components (e.g., calcium, iron) can chelate tetracyclines, reducing their absorption. Separate administration by at least 2 hours.
- Levothyroxine: Iron and calcium 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.
Monitoring
Baseline Monitoring
Local drinking water fluoride concentration
Rationale: Essential to determine appropriate fluoride supplementation dose to prevent fluorosis and ensure adequate caries prevention.
Timing: Prior to initiating therapy and periodically if water source changes.
Dietary fluoride intake
Rationale: To assess total fluoride exposure from all sources (water, food, toothpaste) and adjust supplementation accordingly.
Timing: Prior to initiating therapy.
Overall nutritional status
Rationale: To identify specific vitamin deficiencies and ensure the multivitamin component is appropriate.
Timing: Prior to initiating therapy.
Routine Monitoring
Dental examinations
Frequency: Every 6-12 months (as per pediatric dental guidelines)
Target: Healthy teeth, no signs of dental caries or fluorosis.
Action Threshold: Presence of dental caries or signs of dental fluorosis (e.g., white flecks, brown stains) warrants re-evaluation of fluoride intake.
Growth and development milestones
Frequency: Regular pediatric check-ups
Target: Age-appropriate growth and development.
Action Threshold: Failure to thrive or developmental delays may indicate underlying nutritional issues requiring further investigation.
Symptom Monitoring
- Signs of dental fluorosis (e.g., white flecks, streaks, or brown stains on tooth enamel)
- Gastrointestinal upset (nausea, vomiting, abdominal pain) - especially with acute overdose
- Signs of vitamin deficiency (e.g., fatigue, skin changes, vision problems, bleeding gums) - rare with supplementation
- Signs of vitamin toxicity (e.g., hypervitaminosis A or D symptoms) - rare with recommended doses
Special Patient Groups
Pregnancy
This product is for pediatric use. For pregnant individuals, fluoride supplementation is generally not recommended unless the water supply is deficient and under medical guidance. Excessive fluoride intake during pregnancy is not associated with dental fluorosis in offspring.
Trimester-Specific Risks:
First Trimester:
Not applicable for patient use. No known specific risks if handled by pregnant individual.
Second Trimester:
Not applicable for patient use. No known specific risks if handled by pregnant individual.
Third Trimester:
Not applicable for patient use. No known specific risks if handled by pregnant individual.
Lactation
This product is for pediatric use. For lactating individuals, fluoride passes into breast milk in small amounts. The amount is generally insufficient to provide adequate fluoride for the infant if the mother's water supply is deficient. Consult a healthcare provider regarding infant fluoride supplementation.
Infant Risk:
Low risk for the infant from maternal exposure, but direct infant supplementation should be based on water fluoride levels.
Pediatric Use
This is the primary target population. Dosing must be carefully determined based on the child's age and the fluoride concentration in the local drinking water supply to prevent both dental caries and dental fluorosis. Regular dental check-ups are crucial.
Geriatric Use
Not applicable for this specific pediatric liquid drop formulation. Geriatric patients typically receive fluoride via fluoridated water, toothpaste, or specific adult formulations if needed.
Clinical Information
Clinical Pearls
- Always verify the fluoride concentration in the child's primary drinking water source (e.g., municipal water report, well water testing) before prescribing or recommending fluoride supplementation.
- Educate parents on the importance of accurate dosing using the provided dropper to avoid under-dosing (ineffective) or over-dosing (risk of fluorosis).
- Advise parents to store the drops safely out of reach of children, as acute fluoride overdose can be serious.
- Remind parents that fluoride supplementation is an adjunct to, not a replacement for, good oral hygiene practices and regular dental visits.
- Consider the child's total fluoride exposure, including fluoridated toothpaste, other supplements, and processed foods/beverages, when determining the appropriate dose.
Alternative Therapies
- Separate multivitamin drops and fluoride drops/tablets
- Fluoridated drinking water (if available and sufficient)
- Fluoride varnish or gel applied by a dental professional
- Dietary counseling for vitamin intake
Cost & Coverage
Generic Available:
Yes
Insurance Coverage:
Often OTC; if prescribed, may be covered as Tier 3 or 4 by some insurance plans. Coverage varies.
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 provided with the drug. If you have any questions or concerns, discuss them with your child's doctor, nurse, pharmacist, or other healthcare provider. Your pharmacist may also have additional patient information leaflets available for your reference.
In the event of a suspected 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. This information is crucial for receiving appropriate care and treatment.
For comprehensive information about this medication, consult the patient information leaflet provided with the drug. If you have any questions or concerns, discuss them with your child's doctor, nurse, pharmacist, or other healthcare provider. Your pharmacist may also have additional patient information leaflets available for your reference.
In the event of a suspected 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. This information is crucial for receiving appropriate care and treatment.