Trivit W/fluor 0.5mg Drops 50ml
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 (intended for pediatric use); Fluoride: C; Multivitamins: A/B (depending on specific vitamin levels)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medicine is a liquid vitamin supplement for babies and young children that also contains fluoride. The vitamins help your child grow and stay healthy, and the fluoride helps make their teeth strong and prevent cavities.
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 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 in your child's mouth. It's essential to understand the correct method for giving this medication to your child.
Storage and Disposal
Store the 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 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, 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. 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 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 in your child's mouth. It's essential to understand the correct method for giving this medication to your child.
Storage and Disposal
Store the 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 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, as this can increase the risk of adverse effects.
Lifestyle & Tips
- Administer the drops directly into the mouth or mix with formula, juice, or food. Do NOT mix with milk or dairy products as they can reduce fluoride absorption.
- Do not exceed the recommended dose. More is not better and can be harmful.
- Store at room temperature, away from light and moisture.
- Keep out of reach of children. Accidental overdose of fluoride can be dangerous.
- Continue regular dental check-ups for your child.
- Ensure proper oral hygiene, including brushing teeth twice daily with fluoride toothpaste (age-appropriate amount).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable (product intended for pediatric use)
Pediatric Dosing
Neonatal:
Not established (generally not recommended for infants under 6 months)
Infant:
For infants 6 months to 3 years: 0.25 mL (delivering 0.25 mg fluoride) once daily if local drinking water contains less than 0.3 ppm fluoride. Consult pediatrician for specific multivitamin needs.
Child:
For children 3 to 6 years: 0.5 mL (delivering 0.5 mg fluoride) once daily if local drinking water contains less than 0.3 ppm fluoride. For children 6 to 16 years: 0.5 mL (delivering 0.5 mg fluoride) once daily if local drinking water contains 0.3-0.6 ppm fluoride. Consult pediatrician for specific multivitamin needs.
Adolescent:
For adolescents 6 to 16 years: 0.5 mL (delivering 0.5 mg fluoride) once daily if local drinking water contains 0.3-0.6 ppm fluoride. Higher fluoride doses (1.0 mg) may be indicated if water fluoride is <0.3 ppm, typically via chewable tablets. Consult pediatrician for specific multivitamin needs.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; fluoride is primarily renally excreted. Monitor for signs of fluorosis.
Moderate:
Use with caution; consider dose reduction or avoidance due to increased risk of fluoride accumulation and toxicity.
Severe:
Contraindicated or use with extreme caution; significant risk of fluoride toxicity.
Dialysis:
Contraindicated due to high risk of fluoride accumulation and toxicity.
Hepatic Impairment:
Mild:
No specific adjustment typically needed for fluoride or common multivitamins.
Moderate:
No specific adjustment typically needed.
Severe:
No specific adjustment typically needed, but monitor overall nutritional status.
Pharmacology
Mechanism of Action
Multivitamins provide essential vitamins (e.g., A, C, D, E, B-complex) necessary for normal growth, development, and metabolic functions, acting as coenzymes or precursors for various biochemical processes. Fluoride incorporates into the enamel structure of developing teeth, making them more resistant to acid demineralization and enhancing remineralization. It also has antibacterial properties against oral bacteria.
Pharmacokinetics
Absorption:
Bioavailability:
Varies by vitamin (e.g., Vitamin D >90%, Vitamin B12 ~1-5% at high doses); Fluoride: Rapidly and extensively absorbed from the GI tract (80-90%).
Tmax:
Varies by vitamin (e.g., Vitamin C: 2-3 hours; Vitamin D: 10-24 hours); Fluoride: 30-60 minutes.
FoodEffect:
Absorption of fat-soluble vitamins (A, D, E) is enhanced by dietary fat. Fluoride absorption can be reduced by calcium, magnesium, and aluminum-containing foods/supplements.
Distribution:
Vd:
Varies by vitamin; Fluoride: Approximately 0.5-0.7 L/kg, distributes widely, with high affinity for calcified tissues (bones, teeth).
ProteinBinding:
Varies by vitamin (e.g., Vitamin D metabolites are highly protein-bound); Fluoride: Minimal protein binding.
CnssPenetration:
Limited for most vitamins; Fluoride: Yes, crosses blood-brain barrier to a limited extent.
Elimination:
HalfLife:
Varies by vitamin (e.g., Vitamin C: 2-3 hours; Vitamin D: 15-30 days); Fluoride: Plasma half-life is 2-9 hours, but retention in bone is long-term.
Clearance:
Varies by vitamin; Fluoride: Primarily renal clearance.
ExcretionRoute:
Varies by vitamin (renal, biliary); Fluoride: Primarily renal (50-60% within 24 hours), small amounts in feces and sweat.
Unchanged:
Varies by vitamin; Fluoride: 50-60% renally excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Nutritional benefits are long-term and cumulative; Fluoride's prophylactic effect on teeth develops over time with consistent use.
PeakEffect:
Not acutely measurable for nutritional or prophylactic effects.
DurationOfAction:
Long-term for nutritional support; Fluoride's protective effect is sustained with continued exposure.
Confidence:
High
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 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 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.
Reporting Side Effects
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 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 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.
Reporting Side Effects
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 (signs of fluorosis)
- Nausea, vomiting, stomach pain, diarrhea (signs of acute overdose)
- Unusual tiredness or weakness
- Increased urination or thirst
- Headache, dizziness
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 medication may interact with other medications 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
To ensure safe treatment, do not start, stop, or modify the dosage of any medication your child is taking without first consulting with your doctor. This will help prevent potential interactions and ensure the safe use of this medication.
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 medication may interact with other medications 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
To ensure safe treatment, do not start, stop, or modify the dosage of any medication your child is taking without first consulting with your doctor. This will help prevent potential interactions and ensure the safe use of this medication.
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.
Dosage and Administration
Do not exceed the recommended dose or frequency of administration. Adhering to the prescribed dosage and schedule 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.
Lab Tests and Interactions
This medication may interfere with certain laboratory tests. Therefore, it is crucial to inform all of your child's healthcare providers and laboratory personnel that your child is taking this medication.
Dental Care
Regular dental check-ups are essential to maintain your child's oral health. Inform your child's dentist if their teeth become stained or spotted. 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 medical attention immediately by calling a doctor or poison control center. To minimize the risk of interactions, avoid giving your child 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 their doctor to discuss the potential benefits and risks to both your child and the baby. This will help you make an informed decision about the use of this medication during pregnancy or breastfeeding.
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.
Dosage and Administration
Do not exceed the recommended dose or frequency of administration. Adhering to the prescribed dosage and schedule 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.
Lab Tests and Interactions
This medication may interfere with certain laboratory tests. Therefore, it is crucial to inform all of your child's healthcare providers and laboratory personnel that your child is taking this medication.
Dental Care
Regular dental check-ups are essential to maintain your child's oral health. Inform your child's dentist if their teeth become stained or spotted. 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 medical attention immediately by calling a doctor or poison control center. To minimize the risk of interactions, avoid giving your child 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 their doctor to discuss the potential benefits and risks to both your child and the baby. This will help you make an informed decision about the use of this medication during pregnancy or breastfeeding.
Overdose Information
Overdose Symptoms:
- Acute fluoride overdose: Nausea, vomiting, abdominal pain, diarrhea, excessive salivation, muscle weakness, tremors, convulsions, cardiac arrhythmias, coma.
- Chronic fluoride overdose (fluorosis): Dental fluorosis (mild: white flecks/streaks; severe: brown stains, pitting, enamel hypoplasia). Skeletal fluorosis (rare, joint pain, stiffness, bone changes).
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. Hospitalization may be required for supportive care.
Drug Interactions
Major Interactions
- Aluminum, Calcium, Magnesium-containing antacids/supplements (can bind fluoride and reduce absorption)
- Dairy products (can bind fluoride and reduce absorption)
Moderate Interactions
- Tetracyclines (multivitamins containing calcium/iron can chelate tetracyclines, reducing absorption)
- Phenytoin (some vitamins, e.g., folic acid, can affect phenytoin levels)
- Warfarin (high doses of Vitamin K, not typically in pediatric drops, can reduce warfarin effect; high doses of Vitamin E can increase bleeding risk)
Minor Interactions
- Certain antibiotics (some B vitamins may be affected by gut flora changes)
- Cholestyramine/Orlistat (can reduce absorption of fat-soluble vitamins)
Monitoring
Baseline Monitoring
Local drinking water fluoride concentration
Rationale: To determine appropriate fluoride supplementation dose and prevent fluorosis.
Timing: Before initiating therapy and periodically if water source changes.
Dietary intake assessment
Rationale: To assess baseline nutritional status and identify specific deficiencies.
Timing: Before initiating therapy.
Routine Monitoring
Dental examination
Frequency: Every 6-12 months
Target: Absence of dental caries, absence of 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 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.
Symptom Monitoring
- Signs of dental fluorosis (white flecks, streaks, or brown stains on teeth)
- Nausea, vomiting, abdominal pain (acute fluoride overdose)
- Diarrhea
- Muscle weakness or spasms (severe fluoride toxicity)
- Signs of hypervitaminosis (e.g., Vitamin A: dry skin, hair loss, headache; Vitamin D: hypercalcemia symptoms like fatigue, polyuria, constipation)
Special Patient Groups
Pregnancy
Not intended for use during pregnancy. If a pregnant individual requires vitamin/mineral supplementation, a prenatal vitamin without fluoride is typically recommended unless specific fluoride deficiency is diagnosed and water fluoride levels are low. High fluoride intake during pregnancy is not recommended.
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 intended for use by lactating individuals. Fluoride is excreted in breast milk in small amounts. If a lactating individual requires vitamin/mineral supplementation, a postnatal vitamin without fluoride is typically recommended. Consult a healthcare provider.
Infant Risk:
Low risk to breastfed infant from maternal fluoride intake at typical dietary levels; however, this product is for direct pediatric administration, not maternal 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 the local drinking water supply to prevent dental fluorosis while ensuring adequate caries prophylaxis. Regular dental check-ups are crucial.
Geriatric Use
Not applicable (product intended for pediatric use).
Clinical Information
Clinical Pearls
- Always verify the local drinking water fluoride concentration before prescribing or recommending fluoride supplementation to avoid over-supplementation and fluorosis.
- Educate parents on the importance of accurate dosing and the risks of exceeding the recommended dose.
- Advise against mixing the drops with milk or dairy products due to reduced fluoride absorption.
- Emphasize that this product is a supplement and does not replace a balanced diet or good oral hygiene practices.
- Monitor for early signs of dental fluorosis, especially in children under 8 years old, as enamel is still developing.
Alternative Therapies
- Separate multivitamin drops/supplements and fluoride supplements (e.g., sodium fluoride drops/tablets)
- Fluoridated toothpaste (age-appropriate use)
- Fluoridated community water supply (primary source of fluoride)
- Topical fluoride applications (e.g., varnishes, gels) by a dental professional
Cost & Coverage
Average Cost:
Price varies, typically $10-$30 per 50ml bottle
Generic Available:
Yes
Insurance Coverage:
Often OTC; may be covered by some insurance plans with a prescription (Tier 2 or 3)
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 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. When reporting the incident, be prepared to provide critical information, including the name of the medication taken, the quantity, and the time it occurred.