Vitamin D3 50,000 IU (chole) Cap
It is used to treat or prevent vitamin D deficiency.
Drug Class
Vitamin, Bone density regulator, Nutritional supplement
Pharmacologic Class
Vitamin D analog, Secosteroid
Pregnancy Category
Category C (for doses exceeding recommended daily allowance, Category A for physiological doses)
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, nerve signaling, and immune health. This high-dose form is typically used to treat severe vitamin D deficiency.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication 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 medication schedule and talk to your doctor if you have any questions or concerns.
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 your medication in a bathroom, as the humidity and temperature can affect its potency. Keep all medications in a safe and secure location, out of the reach of children and pets.
When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, throw them 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 scheduled dose, skip the missed dose and continue with your regular medication 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, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication 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 medication schedule and talk to your doctor if you have any questions or concerns.
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 your medication in a bathroom, as the humidity and temperature can affect its potency. Keep all medications in a safe and secure location, out of the reach of children and pets.
When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, throw them 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 scheduled dose, skip the missed dose and continue with your regular medication 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 your largest meal of the day or a meal containing fat to improve absorption.
- Do not take more than prescribed, as excessive vitamin D can be harmful.
- Maintain adequate calcium intake through diet or supplements as advised by your doctor.
- Regular, moderate sun exposure (10-30 minutes, 2-3 times per week) can help your body produce vitamin D, but this should not replace prescribed medication for deficiency.
- Discuss any other medications or supplements you are taking with your doctor or pharmacist.
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:
50,000 IU once weekly for 8-12 weeks for vitamin D deficiency (serum 25(OH)D < 20 ng/mL), followed by maintenance.
Dose Range:
50000 - 50000 mg
Condition-Specific Dosing:
deficiency:
50,000 IU once weekly or bi-weekly for 8-12 weeks, then maintenance (e.g., 600-2000 IU daily or 50,000 IU monthly).
malabsorption:
Higher doses may be required, e.g., 50,000 IU 1-3 times weekly, adjusted based on serum 25(OH)D levels.
Pediatric Dosing
Neonatal:
Not typically 50,000 IU. Prophylaxis: 400 IU daily. Deficiency: 1000-2000 IU daily.
Infant:
Not typically 50,000 IU. Prophylaxis: 400 IU daily. Deficiency: 1000-2000 IU daily.
Child:
Not typically 50,000 IU. Prophylaxis: 600 IU daily. Deficiency: 2000-4000 IU daily for 6-8 weeks.
Adolescent:
Not typically 50,000 IU. Prophylaxis: 600 IU daily. Deficiency: 2000-4000 IU daily for 6-8 weeks.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, monitor calcium and phosphate.
Moderate:
No specific adjustment, monitor calcium and phosphate. Use with caution if hypercalcemia develops.
Severe:
Use with caution. Cholecalciferol may not be effectively converted to active form (calcitriol) in severe renal failure. Active vitamin D analogs (e.g., calcitriol) may be preferred. Monitor calcium, phosphate, and PTH closely. Avoid if hypercalcemia is present.
Dialysis:
Cholecalciferol is generally not recommended for primary treatment of secondary hyperparathyroidism in dialysis patients; active vitamin D analogs are preferred. If used, monitor calcium and phosphate closely.
Hepatic Impairment:
Mild:
No specific adjustment.
Moderate:
No specific adjustment, but monitor vitamin D levels as conversion to 25(OH)D may be impaired in severe liver disease.
Severe:
Use with caution. Conversion to 25(OH)D may be impaired. Monitor serum 25(OH)D levels and adjust dose as needed.
Pharmacology
Mechanism of Action
Cholecalciferol (Vitamin D3) is a prohormone that is metabolically inert. It is hydroxylated in the liver by 25-hydroxylase (CYP2R1, CYP27A1) to 25-hydroxyvitamin D (calcifediol or calcidiol), the major circulating form of vitamin D. Calcifediol is then further hydroxylated in the kidneys by 1-alpha-hydroxylase (CYP27B1) to 1,25-dihydroxyvitamin D (calcitriol), the biologically active form of vitamin D. Calcitriol acts as a secosteroid hormone, binding to the vitamin D receptor (VDR) in target tissues. This binding regulates gene expression involved in calcium and phosphate homeostasis, promoting intestinal absorption of calcium and phosphate, renal reabsorption of calcium, and bone mineralization. It also plays roles in immune function, cell growth, and differentiation.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable, generally good (around 50-80%) when taken with food, as it is fat-soluble.
Tmax:
Cholecalciferol: 10-24 hours (for initial absorption). 25(OH)D: 2-7 days (for peak circulating levels after a single large dose).
FoodEffect:
Absorption is significantly enhanced when taken with a fatty meal.
Distribution:
Vd:
Large (approximately 0.1-0.7 L/kg for cholecalciferol; 0.1-0.2 L/kg for 25(OH)D). Stored in adipose tissue.
ProteinBinding:
Cholecalciferol: Highly bound to vitamin D-binding protein (DBP) and albumin (>99%). 25(OH)D: Highly bound to DBP (>99%).
CnssPenetration:
Limited
Elimination:
HalfLife:
Cholecalciferol: Approximately 24 hours (initial), but can be stored for weeks to months. 25(OH)D: 2-3 weeks. 1,25(OH)2D: 4-6 hours.
Clearance:
Not readily quantifiable as a single rate due to storage and enterohepatic recirculation.
ExcretionRoute:
Primarily biliary/fecal, with some renal excretion of metabolites.
Unchanged:
<1% (of active form)
Pharmacodynamics
OnsetOfAction:
Days to weeks (for significant increase in serum 25(OH)D and clinical effects).
PeakEffect:
Weeks to months (for stabilization of serum 25(OH)D levels and full therapeutic effect).
DurationOfAction:
Weeks to months (due to storage in adipose tissue and long half-life of 25(OH)D).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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 for advice.
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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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 for advice.
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:
- Signs of too much vitamin D (hypercalcemia): nausea, vomiting, constipation, loss of appetite, increased thirst, increased urination, muscle weakness, fatigue, confusion, headache, bone pain.
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 your safety, please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, you must 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 your safety, please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, you must 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 supplements or products 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.
Overdose Information
Overdose Symptoms:
- Severe hypercalcemia (serum calcium >12 mg/dL)
- Kidney stones (nephrolithiasis)
- Kidney damage (nephrocalcinosis, acute kidney injury)
- Cardiac arrhythmias
- Coma
- Death (rare)
What to Do:
Immediately discontinue vitamin D and calcium supplements. Seek emergency medical attention. Call 1-800-222-1222 (Poison Control). Treatment may involve hydration, loop diuretics, corticosteroids, calcitonin, or bisphosphonates to lower serum calcium.
Drug Interactions
Contraindicated Interactions
- Hypercalcemia
- Vitamin D toxicity
- Hyperphosphatemia
Major Interactions
- Thiazide diuretics (increased risk of hypercalcemia)
- Digoxin (increased risk of arrhythmias due to hypercalcemia)
- Mineral oil, Cholestyramine, Colestipol (decreased absorption of vitamin D)
- Orlistat (decreased absorption of vitamin D)
Moderate Interactions
- Corticosteroids (may reduce vitamin D effects by impairing 1-alpha-hydroxylation and increasing vitamin D metabolism)
- Phenytoin, Barbiturates, Carbamazepine (may increase vitamin D metabolism, leading to lower 25(OH)D levels)
- Ketoconazole (may inhibit 1-alpha-hydroxylase, reducing calcitriol synthesis)
- Aluminum-containing antacids (increased risk of hyperaluminemia in renal failure)
Minor Interactions
- Not many clinically significant minor interactions reported for cholecalciferol at therapeutic doses.
Monitoring
Baseline Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Rationale: To assess baseline vitamin D status and guide dosing.
Timing: Before initiating therapy.
Serum Calcium
Rationale: To assess for pre-existing hypercalcemia and establish baseline for monitoring hypercalcemia risk.
Timing: Before initiating therapy.
Serum Phosphate
Rationale: To assess baseline phosphate levels, as vitamin D affects phosphate absorption.
Timing: Before initiating therapy.
Parathyroid Hormone (PTH)
Rationale: To assess the severity of secondary hyperparathyroidism due to vitamin D deficiency.
Timing: Before initiating therapy (optional, but recommended for deficiency).
Renal Function (BUN, Creatinine, eGFR)
Rationale: To assess kidney function, which is crucial for vitamin D metabolism and calcium excretion.
Timing: Before initiating therapy.
Routine Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Frequency: After 8-12 weeks of high-dose therapy, then every 3-6 months during maintenance.
Target: 30-60 ng/mL (75-150 nmol/L)
Action Threshold: If below target, consider dose increase; if significantly above, consider dose reduction or temporary cessation.
Serum Calcium
Frequency: After 8-12 weeks of high-dose therapy, then every 3-6 months during maintenance.
Target: 8.5-10.2 mg/dL (2.1-2.55 mmol/L)
Action Threshold: If >10.5 mg/dL, reduce dose or temporarily stop vitamin D; investigate cause of hypercalcemia.
Serum Phosphate
Frequency: After 8-12 weeks of high-dose therapy, then every 3-6 months during maintenance.
Target: 2.5-4.5 mg/dL (0.81-1.45 mmol/L)
Action Threshold: If significantly elevated, consider dose reduction.
Symptom Monitoring
- Symptoms of hypercalcemia: nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, fatigue, confusion, headache, anorexia, metallic taste.
- Symptoms of vitamin D toxicity: severe hypercalcemia, kidney stones, kidney damage, bone pain.
Special Patient Groups
Pregnancy
Vitamin D is essential during pregnancy. However, high doses (like 50,000 IU) should only be used to treat confirmed deficiency and under strict medical supervision. Excessive doses can lead to hypercalcemia in the mother and potentially adverse effects on the fetus (e.g., supravalvular aortic stenosis, mental retardation). Category C for doses exceeding RDA.
Trimester-Specific Risks:
First Trimester:
Risk of teratogenicity with excessive doses is theoretical but possible. Monitor closely.
Second Trimester:
Continued risk of maternal hypercalcemia and potential fetal effects if doses are excessive.
Third Trimester:
Continued risk of maternal hypercalcemia and potential fetal effects if doses are excessive.
Lactation
Cholecalciferol and its metabolites are excreted in breast milk. While vitamin D is essential for the infant, high maternal doses can lead to elevated levels in breast milk, potentially causing hypercalcemia in the infant. Use with caution and monitor infant's serum calcium if mother is on high doses.
Infant Risk:
Low to moderate risk. Monitor infant for signs of hypercalcemia (e.g., poor feeding, vomiting, constipation, lethargy).
Pediatric Use
50,000 IU is generally not used in pediatric patients for routine deficiency treatment due to the risk of toxicity and availability of lower, more appropriate doses. Only in very specific, severe cases of deficiency or malabsorption, and under strict specialist supervision, might such high doses be considered, but typically lower daily or weekly doses are preferred.
Geriatric Use
Elderly patients are at higher risk for vitamin D deficiency due to decreased skin synthesis, reduced dietary intake, and potential malabsorption. They may require higher doses of vitamin D. However, monitor for hypercalcemia and renal function, as these patients may be more susceptible to adverse effects.
Clinical Information
Clinical Pearls
- Always confirm vitamin D deficiency with a serum 25(OH)D level before initiating high-dose cholecalciferol.
- Advise patients to take cholecalciferol with the largest meal of the day or a meal containing fat to maximize absorption.
- Monitor serum calcium, phosphate, and 25(OH)D levels periodically during and after high-dose therapy to prevent toxicity and ensure efficacy.
- Educate patients on the symptoms of hypercalcemia and when to seek medical attention.
- Consider co-administration with calcium supplements if dietary intake is insufficient, but monitor calcium levels closely.
- Cholecalciferol is preferred over ergocalciferol (Vitamin D2) for repletion due to its higher potency and longer duration of action in raising 25(OH)D levels.
Alternative Therapies
- Lower dose cholecalciferol supplements (e.g., 1000 IU, 2000 IU, 5000 IU daily)
- Calcitriol (active vitamin D, used in severe renal disease or hypoparathyroidism)
- Alfacalcidol (another active vitamin D analog)
- Dietary sources of vitamin D (fatty fish, fortified foods)
- Sun exposure
Cost & Coverage
Average Cost:
$10 - $50 per 30 capsules (50,000 IU)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often covered by most insurance plans, especially for deficiency)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.