Tri-Vi-flor 0.25mg/ml 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 (pediatric product); components generally Category A/B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tri-Vi-flor drops are a daily supplement for babies and young children. They provide essential vitamins needed for healthy growth and development, along with fluoride to help make 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 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 administration method for this medication, so be sure to ask your pharmacist if you have any questions.
Storage and Disposal
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.
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 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 administration method for this medication, so be sure to ask your pharmacist if you have any questions.
Storage and Disposal
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.
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 drops directly into the mouth or mix with formula, juice, or food (avoid dairy products when giving fluoride).
- Do not exceed the recommended dose.
- Store at room temperature, away from light and moisture.
- Keep out of reach of children.
- Continue good oral hygiene practices (brushing, flossing) even with fluoride supplementation.
- Ensure regular dental check-ups for your child.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated for adult use
Pediatric Dosing
Neonatal:
Not established; generally not recommended for infants under 6 months unless specific deficiency identified.
Infant:
For infants 6 months to 3 years: 0.25 mg fluoride daily (1 mL of Tri-Vi-flor 0.25mg/ml) if drinking water fluoride concentration is less than 0.3 ppm. Dosing of other vitamins as per pediatric multivitamin guidelines.
Child:
For children 3 to 6 years: 0.5 mg fluoride daily (2 mL of Tri-Vi-flor 0.25mg/ml) if drinking water fluoride concentration is less than 0.3 ppm. For children 6 to 16 years: 1.0 mg fluoride daily (4 mL of Tri-Vi-flor 0.25mg/ml) if drinking water fluoride concentration is less than 0.3 ppm. Dosing of other vitamins as per pediatric multivitamin guidelines.
Adolescent:
For adolescents 6 to 16 years: 1.0 mg fluoride daily (4 mL of Tri-Vi-flor 0.25mg/ml) if drinking water fluoride concentration is less than 0.3 ppm. Dosing of other vitamins as per pediatric multivitamin guidelines.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically needed for multivitamin components. Monitor fluoride levels in severe cases.
Moderate:
Use with caution due to fluoride excretion. Consult pediatrician.
Severe:
Contraindicated or use with extreme caution due to risk of fluoride accumulation and toxicity. Consult pediatrician/nephrologist.
Dialysis:
Not established; likely contraindicated due to fluoride accumulation.
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 (e.g., A, C, D, E, B-complex) necessary for normal growth, development, metabolic processes, and cellular function. Fluoride incorporates into the developing tooth enamel (hydroxyapatite crystals), forming fluorapatite, which is more resistant to acid demineralization, thereby preventing dental caries. It also inhibits bacterial acid production in dental plaque.
Pharmacokinetics
Absorption:
Bioavailability:
Varies by vitamin (e.g., Vitamin C high, Vitamin B12 variable). Fluoride is rapidly and almost completely absorbed from the gastrointestinal tract (80-90%).
Tmax:
Varies by vitamin. 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 antacids or dairy products.
Distribution:
Vd:
Not applicable for a combination product; varies by component. Fluoride: distributes widely, with high affinity for mineralized tissues (bones, teeth).
ProteinBinding:
Varies by vitamin. Fluoride: Low 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: 10-20 hours; Vitamin D: 24 hours for calcifediol, longer for calcitriol). 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), some fecal.
Unchanged:
Varies by vitamin. Fluoride: 50-60% excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Benefits are cumulative over time with consistent use.
PeakEffect:
Not applicable for chronic supplementation; benefits accrue over time.
DurationOfAction:
Benefits are sustained with continued daily administration.
Confidence:
Medium
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
While 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. Although many people may not experience any side effects or only minor ones, it's essential to monitor your child's response to the medication. If your child experiences any of the following side effects or any other unusual symptoms that bother them or persist, consult their doctor:
* Upset stomach or vomiting
Note: This list is not exhaustive, and your child may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your child's doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While 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. Although many people may not experience any side effects or only minor ones, it's essential to monitor your child's response to the medication. If your child experiences any of the following side effects or any other unusual symptoms that bother them or persist, consult their doctor:
* Upset stomach or vomiting
Note: This list is not exhaustive, and your child may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your child's doctor for guidance. 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:
- Severe stomach upset, nausea, vomiting, diarrhea (may indicate overdose or intolerance).
- White or brown spots on teeth (dental fluorosis, indicates excessive fluoride intake).
- Unusual fatigue, weakness, changes in skin or hair (may indicate vitamin imbalance).
- Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing).
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.
Additionally, it is crucial to discuss the following with your doctor and pharmacist:
All medications your child is currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems your child may have.
To ensure safe treatment, always verify with your doctor before:
Starting any new medication
* Stopping or changing the dose of any medication your child is taking
This will help prevent potential interactions and ensure the safe use of this medication with your child's other medications and health conditions.
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.
Additionally, it is crucial to discuss the following with your doctor and pharmacist:
All medications your child is currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems your child may have.
To ensure safe treatment, always verify with your doctor before:
Starting any new medication
* Stopping or changing the dose of any medication your child is taking
This will help prevent potential interactions and ensure the safe use of this medication with your child's other medications and health conditions.
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 discussing the specific brand and formulation of the drug, as different brands may be intended for use in different age groups. Before administering this medication to a child, consult with the doctor to ensure the correct dosage and formulation are used.
Administration and Dosage
Do not exceed the recommended dose or frequency of administration. If you are unsure about the correct dose for your child, consult with the doctor. The dosage may vary depending on your child's age, so it is crucial to confirm the correct dose with the doctor.
Lab Tests and Interactions
This medication may interfere with certain laboratory tests. Inform all healthcare providers and lab personnel that your child is taking this medication to ensure accurate test results.
Dental Care
Regular dental check-ups are crucial while taking this medication. If your child's teeth become stained or spotted, notify the dentist. Additionally, maintain 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. 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 potential benefits and risks to both your child and the baby. This will help determine the best course of action for their specific situation.
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 discussing the specific brand and formulation of the drug, as different brands may be intended for use in different age groups. Before administering this medication to a child, consult with the doctor to ensure the correct dosage and formulation are used.
Administration and Dosage
Do not exceed the recommended dose or frequency of administration. If you are unsure about the correct dose for your child, consult with the doctor. The dosage may vary depending on your child's age, so it is crucial to confirm the correct dose with the doctor.
Lab Tests and Interactions
This medication may interfere with certain laboratory tests. Inform all healthcare providers and lab personnel that your child is taking this medication to ensure accurate test results.
Dental Care
Regular dental check-ups are crucial while taking this medication. If your child's teeth become stained or spotted, notify the dentist. Additionally, maintain 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. 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 potential benefits and risks to both your child and the baby. This will help determine the best course of action for their specific situation.
Overdose Information
Overdose Symptoms:
- Acute fluoride toxicity: Nausea, vomiting, abdominal pain, diarrhea, salivation, headache, weakness, tremors, convulsions (rare at typical doses).
- Chronic fluoride toxicity: Dental fluorosis (mottling of tooth enamel).
- Hypervitaminosis (e.g., Vitamin A: dry skin, hair loss, irritability, increased intracranial pressure; Vitamin D: hypercalcemia, nausea, vomiting, constipation, kidney stones).
What to Do:
Immediately contact a poison control center (e.g., 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.
Drug Interactions
Major Interactions
- High-dose Vitamin A with retinoids (e.g., isotretinoin, acitretin) - risk of hypervitaminosis A.
- Vitamin K (if present in significant amounts) with warfarin - may reduce anticoagulant effect.
Moderate Interactions
- Calcium/Magnesium-containing products (e.g., antacids, dairy) with fluoride - may decrease fluoride absorption.
- Iron supplements with Vitamin E - may reduce iron absorption.
- Certain anticonvulsants (e.g., phenytoin, phenobarbital) with Vitamin D - may increase Vitamin D metabolism.
- Tetracyclines/Quinolones with multivitamin/minerals - chelation may reduce antibiotic absorption (separate administration by several hours).
Minor Interactions
- Alcohol with B vitamins - may increase B vitamin requirements.
- Certain foods (e.g., raw fish with thiamine) - may affect vitamin absorption.
Monitoring
Baseline Monitoring
Drinking water fluoride concentration
Rationale: To determine appropriate fluoride supplementation dosage and prevent fluorosis.
Timing: Prior to initiation of fluoride supplementation.
Dietary intake assessment
Rationale: To assess overall nutritional status and need for supplementation.
Timing: At initial consultation.
Routine Monitoring
Dental examination
Frequency: Annually or as recommended by dentist
Target: Healthy teeth, no signs 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
Frequency: Regular pediatric check-ups
Target: Normal growth curves for age
Action Threshold: Growth faltering or developmental delays may indicate underlying nutritional issues.
Symptom Monitoring
- Signs of vitamin deficiency (e.g., fatigue, skin changes, vision problems)
- Signs of vitamin excess (e.g., hypervitaminosis A: dry skin, hair loss; hypervitaminosis D: hypercalcemia, nausea, vomiting)
- Signs of fluoride toxicity (acute: nausea, vomiting, abdominal pain, salivation; chronic: dental fluorosis - white flecks, brown stains on teeth)
- Gastrointestinal upset (nausea, vomiting, diarrhea, constipation)
Special Patient Groups
Pregnancy
Not indicated for use in pregnant individuals as it is a pediatric formulation. Pregnant individuals should consult their healthcare provider for appropriate prenatal vitamin supplementation.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Not indicated for use in lactating individuals as it is a pediatric formulation. Lactating individuals should consult their healthcare provider for appropriate vitamin supplementation.
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 dental fluorosis and ensure adequate vitamin intake. Regular dental check-ups are crucial.
Geriatric Use
Not indicated for geriatric use. Geriatric individuals have different nutritional needs and should consult their healthcare provider for appropriate vitamin/mineral supplementation.
Clinical Information
Clinical Pearls
- Always verify the fluoride concentration in the child's drinking water before initiating or adjusting the dose of fluoride-containing supplements to prevent dental fluorosis.
- Administer fluoride supplements at bedtime after brushing teeth for optimal topical effect on enamel.
- Educate parents that this supplement is not a substitute for a balanced diet and good oral hygiene practices.
- Store fluoride-containing products safely out of reach of children to prevent accidental overdose.
- Be aware that some infant formulas are already fortified with vitamins and minerals, and excessive supplementation can lead to toxicity.
Alternative Therapies
- Fluoridated community water supply (primary source of fluoride)
- Topical fluoride applications (e.g., fluoride toothpaste, varnishes, gels)
- Dietary counseling to ensure adequate vitamin intake from food sources.
Cost & Coverage
Average Cost:
$10 - $30 per 50ml bottle
Generic Available:
Yes
Insurance Coverage:
Generally Over-The-Counter (OTC); may be covered by some insurance plans with a prescription for specific medical necessity.
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 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 critical information, including the name of the medication taken, the amount, and the time it occurred.