Vitamin D3 5,000iu Drops
It is used to treat or prevent vitamin D deficiency.
Drug Class
Vitamin, Fat-soluble
Pharmacologic Class
Vitamin D analog
Pregnancy Category
Category C (for doses exceeding recommended daily allowance)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cholecalciferol, also known as Vitamin D3, is a vitamin that helps your body absorb calcium and phosphorus. This is very important for strong bones and teeth. It also plays a role in your immune system and overall health. These drops provide a concentrated dose of Vitamin D3.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist to determine the best way to take your medication.
Measuring Liquid Medications
When taking a liquid medication, it's essential to measure the dose accurately. Use the measuring device that comes with your medication, or ask your pharmacist for a suitable device if one is not provided. Before taking your medication, shake the bottle well.
Administering Your Medication
You can take your medication directly into your mouth or mix it with a small amount of formula, fruit juice, cereal, or other food. Make sure to take the entire dose.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, away from direct light.
Keep it in a dry place, avoiding storage in a bathroom.
Do not freeze your medication.
* Be aware of the expiration date or the length of time you can store your medication before it needs to be discarded.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist to determine the best way to take your medication.
Measuring Liquid Medications
When taking a liquid medication, it's essential to measure the dose accurately. Use the measuring device that comes with your medication, or ask your pharmacist for a suitable device if one is not provided. Before taking your medication, shake the bottle well.
Administering Your Medication
You can take your medication directly into your mouth or mix it with a small amount of formula, fruit juice, cereal, or other food. Make sure to take the entire dose.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, away from direct light.
Keep it in a dry place, avoiding storage in a bathroom.
Do not freeze your medication.
* Be aware of the expiration date or the length of time you can store your medication before it needs to be discarded.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take with food, preferably a fatty meal, to improve absorption.
- Follow your doctor's instructions carefully regarding dosage and frequency.
- Do not exceed the recommended dose without medical advice, as too much vitamin D can be harmful.
- Regular sun exposure (10-15 minutes, 2-3 times per week) can help your body produce vitamin D, but be mindful of skin cancer risk.
- Include vitamin D-rich foods in your diet (e.g., fatty fish like salmon, mackerel; fortified milk, cereals, orange juice).
Available Forms & Alternatives
Available Strengths:
- Vitamin D3 50,000 IU (chole) Cap
- Vitamin D3 2,000unit Capsules
- Vitamin D3 5,000 IU (chole) Tab
- Vitamin D3 2,000iu Tablets
- Vitamin D3 1,000 Unit Tablets
- Vitamin D3 400unit Chw Tablets
- Vitamin D3 1,000unit Chew Tablets
- Vitamin D3 10,000unt Capsules
- Vitamin D3 5000 Unit Capsules
- Vitamin D3 50mcg Tablets
- Vitamin D3 400iu Tablets
- Vitamin D3 1.25mg Capsules
- Vitamin D3 5,000iu Drops
- Vitamin D3 5000 Unit Capsules
Dosing & Administration
Adult Dosing
Standard Dose:
For Vitamin D deficiency (serum 25(OH)D < 20 ng/mL): 5,000 IU (0.125 mg) daily or 50,000 IU weekly for 6-8 weeks, followed by maintenance. For maintenance/sufficiency: 1,000-2,000 IU daily. The 5,000 IU drops can be used for daily supplementation or as part of a loading dose regimen.
Dose Range:
1000 - 10000 mg
Condition-Specific Dosing:
deficiency_treatment:
5,000 IU daily or 50,000 IU weekly for 6-8 weeks, then re-evaluate.
maintenance_sufficiency:
1,000-2,000 IU daily, up to 4,000 IU daily for some individuals.
Pediatric Dosing
Neonatal:
Not established for 5,000 IU drops. Typically 400 IU daily for breastfed infants.
Infant:
Not established for 5,000 IU drops. Typically 400 IU daily for breastfed infants. For deficiency, higher doses may be prescribed by a physician.
Child:
Not established for 5,000 IU drops as a standard dose. For deficiency, doses up to 2,000-4,000 IU daily may be used under medical supervision. Maintenance: 600-1,000 IU daily.
Adolescent:
Not established for 5,000 IU drops as a standard dose. For deficiency, doses up to 2,000-4,000 IU daily may be used under medical supervision. Maintenance: 600-1,000 IU daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for cholecalciferol, but monitor serum calcium and phosphate.
Moderate:
No specific adjustment needed for cholecalciferol, but monitor serum calcium and phosphate. Active vitamin D forms (calcitriol) may be preferred in severe renal disease.
Severe:
Use with caution. Cholecalciferol may not be effectively converted to its active form (calcitriol). Monitor serum calcium, phosphate, and PTH. Active vitamin D forms (e.g., calcitriol, paricalcitol) are often preferred.
Dialysis:
Cholecalciferol may be used, but active vitamin D forms are typically preferred due to impaired renal hydroxylation. Monitor serum calcium, phosphate, and PTH closely.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, but monitor vitamin D levels as conversion to 25(OH)D may be impaired in severe liver disease.
Severe:
Use with caution. Impaired hepatic hydroxylation may reduce efficacy. Monitor 25(OH)D levels.
Pharmacology
Mechanism of Action
Cholecalciferol (Vitamin D3) is a fat-soluble vitamin that is metabolically inert. It is hydroxylated in the liver to 25-hydroxyvitamin D [25(OH)D, calcifediol] and then in the kidneys to 1,25-dihydroxyvitamin D [1,25(OH)2D, calcitriol], the biologically active form. Calcitriol acts as a hormone, primarily regulating calcium and phosphate homeostasis. It promotes calcium and phosphate absorption from the intestine, reabsorption in the kidneys, and mobilization from bone, thereby maintaining serum calcium and phosphate levels necessary for bone mineralization, neuromuscular function, and other cellular processes. It also plays a role in immune function, cell growth, and differentiation.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable, depends on dietary fat, liver/pancreatic function. Enhanced by presence of fat.
Tmax:
Approximately 10-24 hours for 25(OH)D after a single dose of cholecalciferol.
FoodEffect:
Absorption is significantly increased when taken with a fatty meal.
Distribution:
Vd:
Large, distributed to adipose tissue and muscle.
ProteinBinding:
Primarily bound to vitamin D-binding protein (DBP) and albumin.
CnssPenetration:
Limited, but vitamin D receptors are present in the brain.
Elimination:
HalfLife:
Cholecalciferol: Approximately 24 hours. 25(OH)D: Approximately 2-3 weeks. 1,25(OH)2D: Approximately 4-6 hours.
Clearance:
Not readily quantifiable for cholecalciferol due to extensive storage and slow release.
ExcretionRoute:
Mainly fecal (biliary excretion), minor renal excretion.
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Weeks to months for significant changes in serum 25(OH)D levels and clinical effects.
PeakEffect:
Peak serum 25(OH)D levels typically reached after 1-3 months of consistent daily dosing.
DurationOfAction:
Effects on serum 25(OH)D can persist for several weeks to months after discontinuation due to storage in adipose tissue.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
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 you have any side effects that bother you or do not go away, contact your doctor or seek medical help.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your 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 you experience any of the following symptoms, contact your doctor or seek medical help 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
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
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 you have any side effects that bother you or do not go away, contact your doctor or seek medical help.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your 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:
- Nausea
- Vomiting
- Constipation
- Loss of appetite
- Increased thirst
- Increased urination
- Muscle weakness
- Fatigue
- Confusion
- Kidney stones (severe back pain, blood in urine)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Malabsorption syndrome
+ Overactive parathyroid gland
+ Sarcoidosis
+ Elevated levels of vitamin D or calcium in your body
+ Williams syndrome
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Malabsorption syndrome
+ Overactive parathyroid gland
+ Sarcoidosis
+ Elevated levels of vitamin D or calcium in your body
+ Williams syndrome
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To avoid excessive intake, do not take any additional vitamin D supplements unless advised by your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. Your doctor will discuss the potential benefits and risks of this medication with you, considering both your health and the health of your baby, to determine the best course of action.
Overdose Information
Overdose Symptoms:
- Severe hypercalcemia (calcium levels > 10.5 mg/dL)
- Nausea, vomiting, anorexia, constipation
- Polyuria, polydipsia
- Muscle weakness, fatigue, lethargy
- Confusion, stupor, coma
- Cardiac arrhythmias
- Kidney damage (nephrocalcinosis, kidney stones, renal failure)
- Soft tissue calcification
What to Do:
Immediately discontinue vitamin D and calcium supplements. Seek urgent medical attention. Treatment involves hydration (intravenous saline), loop diuretics (e.g., furosemide), corticosteroids, and in severe cases, calcitonin or bisphosphonates. Monitor serum calcium, phosphate, and renal function closely. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Thiazide diuretics (increased risk of hypercalcemia)
- Digoxin (increased risk of arrhythmias due to hypercalcemia)
- Orlistat (decreased absorption of fat-soluble vitamins)
- Bile acid sequestrants (e.g., cholestyramine, colestipol) (decreased absorption of fat-soluble vitamins)
- Mineral oil (decreased absorption of fat-soluble vitamins)
Moderate Interactions
- Corticosteroids (may reduce vitamin D effects by increasing its metabolism and decreasing calcium absorption)
- Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital) (may increase vitamin D metabolism, leading to deficiency)
- Isoniazid (may increase vitamin D metabolism)
- Rifampin (may increase vitamin D metabolism)
Monitoring
Baseline Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Rationale: To assess baseline vitamin D status and guide dosing.
Timing: Before initiating therapy, especially for deficiency.
Serum Calcium
Rationale: To assess for pre-existing hypercalcemia and monitor for hypercalcemia during treatment.
Timing: Before initiating therapy.
Serum Phosphate
Rationale: To assess baseline levels and monitor for changes.
Timing: Before initiating therapy.
Parathyroid Hormone (PTH)
Rationale: To assess for primary hyperparathyroidism or secondary hyperparathyroidism due to vitamin D deficiency.
Timing: Before initiating therapy, especially in deficiency.
Routine Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Frequency: Every 3-6 months during deficiency treatment, then annually for maintenance.
Target: 30-100 ng/mL (75-250 nmol/L)
Action Threshold: If < 30 ng/mL, consider dose increase; if > 100 ng/mL, consider dose reduction or temporary cessation.
Serum Calcium
Frequency: Monthly during initial high-dose therapy, then every 3-6 months for maintenance.
Target: 8.5-10.2 mg/dL (2.1-2.55 mmol/L)
Action Threshold: If > 10.5 mg/dL, investigate for hypercalcemia, reduce dose or discontinue.
Serum Phosphate
Frequency: Every 3-6 months, or as clinically indicated.
Target: 2.5-4.5 mg/dL (0.81-1.45 mmol/L)
Action Threshold: If significantly elevated, investigate for hyperphosphatemia.
Symptom Monitoring
- Nausea
- Vomiting
- Constipation
- Anorexia
- Excessive thirst (polydipsia)
- Frequent urination (polyuria)
- Muscle weakness
- Fatigue
- Confusion
- Kidney stones (flank pain, hematuria)
Special Patient Groups
Pregnancy
Vitamin D is essential during pregnancy for maternal and fetal bone health. Recommended daily intake is 600 IU. Higher doses (e.g., 5,000 IU) should only be used under medical supervision for documented deficiency, as excessive doses can lead to hypercalcemia in the mother and potential adverse effects on the fetus (e.g., supravalvular aortic stenosis). Monitor serum 25(OH)D and calcium levels.
Trimester-Specific Risks:
First Trimester:
Essential for early fetal development. High doses should be avoided unless medically indicated and monitored.
Second Trimester:
Continued need for bone development. Monitor for hypercalcemia with high doses.
Third Trimester:
Important for fetal bone mineralization and maternal stores. Monitor for hypercalcemia with high doses.
Lactation
Cholecalciferol is compatible with breastfeeding at recommended doses (600 IU daily). Higher doses (e.g., 5,000 IU) can be used for maternal deficiency, as only a small amount passes into breast milk. Monitor infant's vitamin D status if mother is on very high doses, though risk of infant hypercalcemia is low. Supplementation of the breastfed infant (400 IU daily) is generally recommended regardless of maternal intake.
Infant Risk:
L1 (compatible with breastfeeding at recommended doses; low risk of adverse effects to infant even with higher maternal doses, but monitor infant if mother is on very high doses).
Pediatric Use
Vitamin D is crucial for bone development and preventing rickets. Standard recommendation for breastfed infants is 400 IU daily. For deficiency, higher doses may be prescribed by a physician based on age, weight, and severity of deficiency. The 5,000 IU drops are a high dose and should only be used in children under strict medical supervision and monitoring of vitamin D and calcium levels.
Geriatric Use
Elderly individuals are at higher risk for vitamin D deficiency due to decreased skin synthesis, reduced dietary intake, and impaired absorption. Supplementation is often necessary. Standard maintenance doses are typically 800-2,000 IU daily, but higher doses may be needed for deficiency. Monitor for hypercalcemia, especially if also taking calcium supplements or thiazide diuretics.
Clinical Information
Clinical Pearls
- Cholecalciferol (Vitamin D3) is generally preferred over ergocalciferol (Vitamin D2) due to its higher potency and longer duration of action in raising serum 25(OH)D levels.
- Always advise patients to take vitamin D supplements with a meal containing fat to maximize absorption.
- The 5,000 IU dose is often used for treating moderate to severe vitamin D deficiency or as a higher maintenance dose for individuals with ongoing risk factors (e.g., malabsorption, obesity, limited sun exposure).
- Regular monitoring of serum 25(OH)D, calcium, and sometimes PTH is crucial, especially with higher doses, to prevent toxicity.
- Educate patients on symptoms of hypercalcemia to ensure early detection of potential toxicity.
- Consider drug interactions, especially with anticonvulsants, corticosteroids, and thiazide diuretics, which can affect vitamin D metabolism or calcium levels.
Alternative Therapies
- Ergocalciferol (Vitamin D2)
- Calcitriol (active form of vitamin D, used in severe renal disease or hypoparathyroidism)
- Alfacalcidol (another active vitamin D analog)
- Sun exposure (natural production of vitamin D)
Cost & Coverage
Average Cost:
$10 - $30 per 30mL bottle (approx. 600-1200 drops)
Generic Available:
Yes
Insurance Coverage:
Often not covered by insurance as it's an OTC supplement, but may be covered with a prescription for deficiency.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.