Vitamin D3 50mcg Tablets
It is used to treat or prevent vitamin D deficiency.
Drug Class
Vitamin, Nutritional Supplement
Pharmacologic Class
Fat-soluble vitamin, Secosteroid
Pregnancy Category
Category A (at recommended daily allowance); Category C/D (at doses exceeding RDA, depending on dose and duration)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vitamin D3 is a fat-soluble vitamin that helps your body absorb calcium and phosphorus, which are essential for strong bones. It also plays a role in muscle function and immune health. This medication helps prevent or treat low vitamin D levels.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. 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.
It's also important to note that some strengths of this medication may not be taken daily. Make sure you understand your dosage schedule and talk to your doctor if you have any questions.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, throw it away in a responsible manner. You can also check with your pharmacist to see if there are any drug take-back programs in your area.
What to Do If You Miss 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. 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.
It's also important to note that some strengths of this medication may not be taken daily. Make sure you understand your dosage schedule and talk to your doctor if you have any questions.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, throw it away in a responsible manner. You can also check with your pharmacist to see if there are any drug take-back programs in your area.
What to Do If You Miss 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take with food, preferably the largest meal of the day, to improve absorption.
- Maintain a balanced diet rich in calcium and phosphorus.
- Moderate sun exposure (10-15 minutes, 2-3 times per week) can help the body produce its own vitamin D, but use sunscreen to prevent skin damage.
- Do not exceed the recommended dose without consulting your doctor, as too much vitamin D can be harmful.
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:
50 mcg (2000 IU) orally once daily for maintenance or mild deficiency
Dose Range:
50 - 100 mg
Condition-Specific Dosing:
Vitamin D Deficiency (mild to moderate):
50 mcg (2000 IU) to 100 mcg (4000 IU) orally once daily
Maintenance:
50 mcg (2000 IU) orally once daily
Pediatric Dosing
Neonatal:
Not established (consult pediatrician for specific dosing)
Infant:
10 mcg (400 IU) orally once daily (AAP recommendation for breastfed infants)
Child:
15-25 mcg (600-1000 IU) orally once daily (for maintenance/prevention); higher doses for deficiency as directed by physician
Adolescent:
15-50 mcg (600-2000 IU) orally once daily (for maintenance/prevention); higher doses for deficiency as directed by physician
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, monitor calcium and phosphate
Moderate:
No specific adjustment needed, monitor calcium and phosphate; consider active vitamin D forms if 1-alpha-hydroxylase activity is impaired
Severe:
Use with caution, monitor calcium and phosphate closely; cholecalciferol may not be effectively converted to active form; consider calcitriol or other active vitamin D analogs
Dialysis:
Cholecalciferol is generally not removed by dialysis. Monitor calcium, phosphate, and PTH. Active vitamin D forms often preferred.
Hepatic Impairment:
Mild:
No specific adjustment needed
Moderate:
No specific adjustment needed, monitor vitamin D levels and calcium
Severe:
Use with caution, monitor vitamin D levels and calcium; impaired bile flow may reduce absorption
Pharmacology
Mechanism of Action
Cholecalciferol (Vitamin D3) is a prohormone that is metabolically inert. It is hydroxylated in the liver to 25-hydroxyvitamin D [25(OH)D, calcifediol] and then in the kidneys to the active form, 1,25-dihydroxyvitamin D [1,25(OH)2D, calcitriol]. Calcitriol acts as a hormone, binding to the vitamin D receptor (VDR) in target tissues. This binding regulates gene expression, primarily promoting calcium and phosphate absorption from the intestine, reabsorption in the kidneys, and bone mineralization. It also plays roles in immune function, cell growth, and neuromuscular function.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (approximately 50-80% from dietary sources, can be higher from supplements)
Tmax:
Approximately 10-12 hours for 25(OH)D (after single dose of cholecalciferol)
FoodEffect:
Enhanced absorption when taken with fatty meals due to its fat-soluble nature
Distribution:
Vd:
Approximately 0.1-0.2 L/kg (for cholecalciferol); 0.6-0.8 L/kg (for 25(OH)D)
ProteinBinding:
Approximately 88% to vitamin D binding protein (DBP) and albumin
CnssPenetration:
Limited
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 metabolism and storage
ExcretionRoute:
Biliary/fecal (primary), minor renal
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Days to weeks (as 25(OH)D levels gradually increase)
PeakEffect:
Weeks to months (to achieve steady-state 25(OH)D levels)
DurationOfAction:
Weeks to months (due to storage in adipose tissue and long half-life of 25(OH)D)
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:
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
As with all medications, side effects can occur. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. 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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:
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
As with all medications, side effects can occur. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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
- Unusual tiredness or weakness
- Frequent urination
- Increased thirst
- Metallic taste in mouth
- Muscle weakness or pain
- Confusion
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 medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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 medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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 vitamin D intake, do not take any additional supplements or medications containing vitamin D without consulting 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 (high blood calcium)
- Nausea, vomiting, anorexia, constipation
- Polyuria, polydipsia
- Weakness, fatigue, confusion
- Kidney stones, kidney damage
- Cardiac arrhythmias (in severe cases)
What to Do:
Discontinue vitamin D, restrict calcium intake, ensure hydration. In severe cases, IV fluids, loop diuretics, calcitonin, or corticosteroids may be used. Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Hypercalcemia
- Vitamin D toxicity
Major Interactions
- Thiazide diuretics (increased risk of hypercalcemia)
- Digoxin (increased risk of arrhythmias with hypercalcemia)
Moderate Interactions
- Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital - may increase vitamin D metabolism, reducing efficacy)
- Corticosteroids (may reduce vitamin D absorption and impair its metabolism)
- Bile acid sequestrants (e.g., cholestyramine, colestipol - may impair vitamin D absorption)
- Mineral oil (may impair vitamin D absorption)
- Orlistat (may impair vitamin D absorption)
- Magnesium-containing antacids (increased risk of hypermagnesemia in renal impairment)
Minor Interactions
- None commonly cited as minor clinical significance
Monitoring
Baseline Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Rationale: To assess baseline vitamin D status and guide dosing.
Timing: Prior to initiation of therapy
Serum Calcium
Rationale: To assess for pre-existing hypercalcemia and establish baseline for monitoring.
Timing: Prior to initiation of therapy
Serum Phosphate
Rationale: To assess baseline phosphate levels, as vitamin D affects phosphate homeostasis.
Timing: Prior to initiation of therapy
Parathyroid Hormone (PTH)
Rationale: To assess for secondary hyperparathyroidism, which can be corrected with vitamin D supplementation.
Timing: Prior to initiation of therapy (especially in deficiency)
Routine Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Frequency: 3-6 months after initiation or dose change, then annually for maintenance
Target: 30-100 ng/mL (75-250 nmol/L)
Action Threshold: Below 30 ng/mL (consider dose increase); Above 100 ng/mL (consider dose reduction/hold)
Serum Calcium
Frequency: Monthly for first 3 months, then every 3-6 months for maintenance
Target: 8.5-10.2 mg/dL
Action Threshold: Above 10.5 mg/dL (investigate hypercalcemia, reduce/hold vitamin D)
Serum Phosphate
Frequency: Every 3-6 months
Target: 2.5-4.5 mg/dL
Action Threshold: Outside normal range (investigate underlying cause)
Symptom Monitoring
- Nausea
- Vomiting
- Constipation
- Anorexia
- Fatigue
- Muscle weakness
- Polyuria
- Polydipsia
- Confusion
- Headache
- Metallic taste
Special Patient Groups
Pregnancy
Vitamin D is essential during pregnancy for fetal bone development and maternal health. Recommended daily intake is 600 IU (15 mcg). Higher doses (e.g., 2000 IU/50 mcg) may be used to treat deficiency under medical supervision. Excessive doses can be harmful.
Trimester-Specific Risks:
First Trimester:
Adequate vitamin D is crucial for early fetal development. No known risks at recommended doses.
Second Trimester:
Continued importance for fetal skeletal development. No known risks at recommended doses.
Third Trimester:
Important for calcium homeostasis and bone mineralization. No known risks at recommended doses.
Lactation
Vitamin D is excreted in breast milk. Maternal supplementation at recommended doses (e.g., 600-2000 IU/day) is generally considered safe and can increase vitamin D levels in breast milk, benefiting the infant. However, breastfed infants often require direct supplementation (400 IU/day) as maternal intake alone may not provide sufficient vitamin D.
Infant Risk:
L1 - Compatible. No known adverse effects on breastfed infants at typical maternal doses. High maternal doses could theoretically lead to infant hypercalcemia, but this is rare.
Pediatric Use
Dosing varies significantly by age and indication (prevention vs. treatment of deficiency). Infants, especially breastfed, require direct supplementation. Close monitoring of 25(OH)D and calcium levels is important, particularly with higher doses.
Geriatric Use
Elderly individuals are at higher risk for vitamin D deficiency due to decreased skin synthesis, reduced dietary intake, and potential malabsorption. Standard adult dosing (50 mcg/2000 IU) is often appropriate for maintenance or mild deficiency. Monitoring for hypercalcemia is important, especially in those with impaired renal function.
Clinical Information
Clinical Pearls
- Cholecalciferol (D3) is generally preferred over ergocalciferol (D2) as it is more potent and effective at raising and maintaining 25(OH)D levels.
- Always advise patients to take vitamin D with a meal containing fat to maximize absorption.
- The 50 mcg (2000 IU) dose is a common daily maintenance dose for many adults, but higher doses may be needed to correct significant deficiency.
- Regular monitoring of serum 25(OH)D, calcium, and phosphate is crucial, especially when initiating therapy or adjusting doses for deficiency.
- Educate patients on symptoms of hypercalcemia to prevent toxicity.
Alternative Therapies
- Ergocalciferol (Vitamin D2)
- Calcitriol (active form of vitamin D, used in specific conditions like chronic kidney disease)
- Calcifediol (25-hydroxyvitamin D, used in specific conditions like liver disease or severe renal impairment)
Cost & Coverage
Average Cost:
$5 - $20 per 30 tablets (50mcg/2000IU)
Generic Available:
Yes
Insurance Coverage:
Often covered as a Tier 1 or Tier 2 generic, or as an OTC supplement (may not require prescription coverage)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, 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. If you have any questions or concerns about this 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.