Quflora Ped 0.25mg/ml Liq Drops

Manufacturer CARWIN ASSOCIATES Active Ingredient Pediatric Multivitamin Drops with Fluoride(MUL ti VYE ta min with FLOR ide) Pronunciation Koo-FLOR-uh Ped
It is used to help growth and good health.Fluoride may be in the vitamin to prevent tooth decay.
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Drug Class
Nutritional Supplement; Dental Caries Prophylaxis
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Pharmacologic Class
Multivitamin; Fluoride Supplement
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Pregnancy Category
Not applicable (Pediatric product); Ingredients generally Category A/B
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Quflora Ped is a liquid drop supplement for babies and young children. It contains essential vitamins needed for healthy growth and development, plus fluoride to help strengthen teeth and prevent cavities, especially if your child's drinking water does not contain enough fluoride.
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How to Use This Medicine

Administering 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. 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 with your pharmacist to determine the best approach for this specific drug.

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 in your child's mouth. It's essential to 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, and away from heat and light. Avoid storing it in a bathroom.

Managing Missed Doses

If you miss 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 resume the regular dosing schedule. Do not give your child two doses at the same time or extra doses.
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Lifestyle & Tips

  • Administer drops directly into the mouth or mix with formula, milk, fruit juice, or cereal. Do NOT mix with hot foods or liquids.
  • Do NOT exceed the recommended dose. More is not better and can be harmful, especially with fluoride and fat-soluble vitamins.
  • Store at room temperature, away from light and moisture, and out of reach of children.
  • Ensure proper dental hygiene, including brushing teeth regularly.
  • Consult your pediatrician or dentist to determine if your child needs fluoride supplementation based on your local water fluoridation levels.

Dosing & Administration

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Adult Dosing

Standard Dose: Not recommended for adult use; pediatric formulation
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Pediatric Dosing

Neonatal: Not established (consult pediatrician)
Infant: Typically 0.25 mL to 0.5 mL daily, depending on age and fluoride concentration in drinking water. Specific dosing must be determined by a pediatrician based on the child's age and local water fluoridation levels.
Child: Typically 0.5 mL to 1 mL daily, depending on age and fluoride concentration in drinking water. Specific dosing must be determined by a pediatrician based on the child's age and local water fluoridation levels.
Adolescent: Not typically indicated; higher fluoride doses may be needed or adult formulations of multivitamins.
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Dose Adjustments

Renal Impairment:

Mild: Not available (consult pediatrician/nephrologist due to fluoride excretion)
Moderate: Not available (consult pediatrician/nephrologist due to fluoride excretion)
Severe: Not available (contraindicated or significant dose reduction due to fluoride accumulation)

Hepatic Impairment:

Mild: Not available
Moderate: Not available
Severe: Not available

Pharmacology

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Mechanism of Action

Multivitamins provide essential vitamins (e.g., A, C, D, E, B-complex) necessary for normal growth, development, and metabolic functions. Fluoride incorporates into the enamel structure of developing teeth, making them more resistant to acid demineralization, and promotes remineralization of early carious lesions.
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Pharmacokinetics

Absorption:

Bioavailability: Varies widely by vitamin/mineral (e.g., water-soluble vitamins are readily absorbed, fat-soluble vitamins require bile salts for absorption; fluoride is rapidly absorbed from the GI tract).
Tmax: Not precisely defined for combination; varies by component.
FoodEffect: Absorption of fat-soluble vitamins is enhanced with food. Fluoride absorption may be reduced by calcium-rich foods/beverages.

Distribution:

Vd: Varies by vitamin/mineral; fluoride distributes to calcified tissues (bones, teeth).
ProteinBinding: Varies by vitamin/mineral; 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., water-soluble vitamins have short half-lives, fat-soluble vitamins can be stored). Fluoride half-life is approximately 2-9 hours in adults, shorter in children.
Clearance: Varies by vitamin/mineral; fluoride is primarily cleared renally.
ExcretionRoute: Renal (water-soluble vitamins, fluoride); Biliary/fecal (fat-soluble vitamins).
Unchanged: Varies
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Pharmacodynamics

OnsetOfAction: Chronic effect; not an acute onset for nutritional benefits or dental protection.
PeakEffect: Not applicable for chronic supplementation.
DurationOfAction: Continuous with regular daily administration.

Safety & Warnings

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Side Effects

Important Side Effects to Report to Your Doctor 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, 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 concern you or do not go away, contact your child's doctor:

* Upset stomach or vomiting

Note: This is not an exhaustive list of 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.
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Seek Immediate Medical Attention If You Experience:

  • Nausea
  • Vomiting
  • Diarrhea
  • Stomach pain
  • Rash
  • Unusual tiredness or weakness
  • Changes in urination (more or less)
  • White or brown spots on teeth (signs of fluorosis)
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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:

Any allergies your child may have to this medication, its components, or other substances, including foods and drugs. Please 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.
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 medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications your child is taking
Any natural products or vitamins your child is using
Your child's 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 ensure safety and avoid potential interactions.
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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. Adhering to the prescribed dosage is vital to ensure the safe and effective use of this medication. If you are unsure about the correct dose for your child, consult with their doctor to determine the appropriate amount based on their age.

Interactions with Lab Tests and Other Substances

This medication may interfere with certain laboratory tests. Therefore, it is crucial to inform all healthcare providers and lab personnel that your child is taking this medication. Additionally, be aware of potential interactions with other substances:

Avoid giving your child products containing calcium, such as dairy products, within 2 hours of taking this medication.
Do not administer products containing aluminum or magnesium, such as certain antacids, within 2 hours of taking this medication.
* If your child's water supply is purified, it may not contain fluoride, which is an essential consideration for their dental health.

Dental Care

Regular dental check-ups are vital for maintaining your child's oral health. Inform your child's dentist if their teeth become stained or spotted. Furthermore, encourage good oral hygiene practices to prevent dental problems.

Accidental Ingestion and Overdose

In the event of a large amount of this medication being swallowed, seek medical attention immediately by calling a doctor or poison control center.

Special Considerations for Pregnant or Breast-feeding Women

If your child is pregnant, becomes pregnant, or is breast-feeding, consult with their doctor to discuss the potential benefits and risks of this medication to both your child and the baby.
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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, ranging from white flecks to brown stains and pitting), skeletal fluorosis (bone pain, stiffness, joint deformities).
  • Vitamin overdose (hypervitaminosis): Symptoms vary by vitamin (e.g., Vitamin A: dry skin, hair loss, headache, liver damage; Vitamin D: hypercalcemia, kidney stones, nausea, vomiting).

What to Do:

Immediately contact a poison control center (Call 1-800-222-1222) or seek emergency medical attention. For acute fluoride overdose, milk or calcium-containing liquids may be given to bind fluoride. Induce vomiting if advised by poison control. Supportive care for symptoms.

Drug Interactions

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Major Interactions

  • Warfarin (with high doses of Vitamin K)
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Moderate Interactions

  • Tetracyclines/Quinolones (with calcium/magnesium/iron/fluoride - chelation, reduced absorption)
  • Antacids containing aluminum/magnesium (with fluoride - reduced absorption)
  • Phenytoin (with Vitamin D - reduced Vitamin D levels)
  • Cholestyramine/Orlistat (with fat-soluble vitamins - reduced absorption)
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Minor Interactions

  • Certain diuretics (with calcium/magnesium - altered excretion)
  • Alcohol (with B vitamins - increased excretion)

Monitoring

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Baseline Monitoring

Assessment of dietary intake and water fluoridation status

Rationale: To determine the need for supplementation and appropriate fluoride dose.

Timing: Before initiation

Dental examination

Rationale: To assess baseline dental health and risk for caries.

Timing: Before initiation

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Routine Monitoring

Growth and development milestones

Frequency: Regular pediatric check-ups

Target: Age-appropriate growth charts

Action Threshold: Deviation from normal growth patterns

Dental health (e.g., signs of fluorosis, caries)

Frequency: Regular dental check-ups (every 6-12 months)

Target: Absence of fluorosis or caries

Action Threshold: Presence of dental fluorosis (white flecks/streaks) or new caries

Review of total fluoride intake (from all sources)

Frequency: Annually or as needed

Target: Within recommended daily intake for age

Action Threshold: Excessive intake, especially if water is fluoridated

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Rash
  • Signs of dental fluorosis (white or brown spots on teeth)
  • Signs of hypervitaminosis (e.g., Vitamin A toxicity: dry skin, hair loss, headache; Vitamin D toxicity: hypercalcemia, polyuria)

Special Patient Groups

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Pregnancy

Not applicable for this pediatric product. For pregnant individuals, prenatal vitamins with appropriate fluoride levels (if indicated) are recommended.

Trimester-Specific Risks:

First Trimester: Not applicable
Second Trimester: Not applicable
Third Trimester: Not applicable
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Lactation

Not applicable for this pediatric product. For lactating individuals, appropriate vitamin and mineral intake is important, and fluoride supplementation may be considered if indicated.

Infant Risk: Not applicable
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Pediatric Use

This product is specifically formulated for pediatric use. Dosing must be carefully determined by a healthcare professional based on the child's age, weight, and local water fluoridation levels to prevent under-dosing or over-dosing (especially fluoride toxicity).

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Geriatric Use

Not indicated for geriatric use.

Clinical Information

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Clinical Pearls

  • Always verify the fluoride concentration in the local drinking water before recommending or prescribing fluoride supplements.
  • Educate parents on the importance of accurate dosing using the provided dropper to prevent both under-dosing (ineffective) and over-dosing (potential for fluorosis).
  • Stress the importance of keeping all medications and supplements, especially those containing fluoride, out of reach of children.
  • Advise parents to report any signs of dental fluorosis to their dentist or pediatrician.
  • This product is a supplement and does not replace a balanced diet.
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Alternative Therapies

  • Dietary counseling to ensure adequate vitamin intake
  • Fluoridated drinking water (if available and sufficient)
  • Topical fluoride applications (e.g., toothpaste, varnish, gel) for dental caries prevention
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Cost & Coverage

Average Cost: Typically $10-$30 per 50 mL bottle
Generic Available: Yes
Insurance Coverage: Often OTC; may be covered by some insurance plans with a prescription, but typically out-of-pocket.
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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 detailed 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. Additionally, you can check with your pharmacist to see if there is a separate patient information leaflet available for this medication. In the event of a suspected overdose, immediately call the poison control center or seek medical attention. Be prepared to provide critical information, including the name of the medication taken, the quantity, and the time it was taken, to facilitate prompt and effective treatment.