Vitamin D3 10,000unt Capsules
It is used to treat or prevent vitamin D deficiency.
Drug Class
Vitamin, Bone Health Agent
Pharmacologic Class
Vitamin D Analog
Pregnancy Category
Category C (for doses exceeding RDA; Category B for doses within RDA)
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's like a key that unlocks calcium for your body. This 10,000 IU dose is a higher strength, often used to correct significant vitamin D deficiency under a doctor's guidance.
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 the dosage 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 it in a bathroom. Keep all medications in a safe 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 scheduled dose, skip the missed dose and resume your regular dosage 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 the dosage 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 it in a bathroom. Keep all medications in a safe 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 scheduled dose, skip the missed dose and resume your regular dosage 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 a meal containing fat to improve absorption.
- Follow your doctor's instructions regarding dose and duration.
- Do not exceed the recommended dose without medical advice, as too much vitamin D can be harmful.
- Maintain a balanced diet rich in calcium and phosphorus.
- Moderate sun exposure can help your body produce vitamin D, but it's often not enough, especially in certain climates or for those with deficiency.
- Regular weight-bearing exercise also supports bone health.
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 severe deficiency: 10,000 IU daily for 8-12 weeks, then maintenance. For maintenance: 600-2000 IU daily (higher for deficiency prevention).
Dose Range:
600 - 50000 mg
Condition-Specific Dosing:
severe_deficiency:
10,000 IU daily for 8-12 weeks, or 50,000 IU weekly for 8-12 weeks, followed by maintenance.
maintenance:
600-2000 IU daily (up to 4000 IU daily for some individuals or conditions).
osteoporosis_prevention:
800-2000 IU daily in conjunction with calcium.
Pediatric Dosing
Neonatal:
Not established (typically 400 IU daily for breastfed infants). 10,000 IU is not a standard neonatal dose.
Infant:
Not established (typically 400 IU daily). 10,000 IU is not a standard infant dose.
Child:
Not established (doses vary by age and deficiency severity, e.g., 600-1000 IU daily for maintenance; higher for deficiency under medical supervision, but 10,000 IU is generally reserved for severe deficiency and short-term use).
Adolescent:
Not established (doses vary by age and deficiency severity, e.g., 600-1000 IU daily for maintenance; higher for deficiency under medical supervision, but 10,000 IU is generally reserved for severe deficiency and short-term use).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for cholecalciferol, but monitor calcium and phosphate levels closely.
Moderate:
No specific adjustment for cholecalciferol, but monitor calcium and phosphate levels closely. Active vitamin D forms (calcitriol) may be preferred in advanced CKD.
Severe:
Use with caution. Cholecalciferol may not be effectively converted to active form. Monitor calcium, phosphate, and PTH. Active vitamin D forms (calcitriol, paricalcitol, doxercalciferol) are generally preferred.
Dialysis:
Use with caution. Cholecalciferol may not be effectively converted. Active vitamin D forms are generally preferred for managing secondary hyperparathyroidism.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, as 25-hydroxylation occurs in the liver, but severe liver disease may impair this process. Monitor 25(OH)D levels.
Severe:
Use with caution. May impair 25-hydroxylation. Monitor 25(OH)D levels and clinical response.
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 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 promotes intestinal absorption of calcium and phosphate, regulates bone mineralization, and influences parathyroid hormone (PTH) secretion, thereby maintaining calcium and phosphate homeostasis. It also plays roles in immune function, cell growth, and differentiation.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable, depends on fat intake and individual factors. Approximately 50-80% when taken with a fatty meal.
Tmax:
Approximately 10-12 hours for 25(OH)D after a single dose of cholecalciferol.
FoodEffect:
Absorption is significantly enhanced when taken with a fatty meal.
Distribution:
Vd:
Approximately 0.1-0.2 L/kg (for 25(OH)D). Stored primarily in adipose tissue and muscle.
ProteinBinding:
Approximately 88% bound to vitamin D binding protein (DBP) and 12% to albumin.
CnssPenetration:
Limited
Elimination:
HalfLife:
Cholecalciferol: Approximately 24 hours. 25(OH)D: Approximately 15-30 days. 1,25(OH)2D: Approximately 4-6 hours.
Clearance:
Not readily quantifiable for cholecalciferol due to storage and slow release.
ExcretionRoute:
Primarily biliary/fecal, with some renal excretion of metabolites.
Unchanged:
Minimal unchanged excretion; primarily metabolized.
Pharmacodynamics
OnsetOfAction:
Weeks to months for significant changes in serum 25(OH)D levels and clinical effects, due to storage and metabolic activation.
PeakEffect:
Peak serum 25(OH)D levels typically reached after 2-3 months of consistent daily dosing.
DurationOfAction:
Long, due to storage in adipose tissue and the long half-life of 25(OH)D. Effects can persist for several weeks to months after discontinuation of high doses.
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. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
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, talk to 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. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
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, talk to 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:
- Symptoms of too much vitamin D (hypercalcemia): nausea, vomiting, constipation, loss of appetite, increased thirst, increased urination, muscle weakness, fatigue, confusion, bone pain, and kidney stones. Contact your doctor immediately if you experience these symptoms.
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 and its symptoms.
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 for you 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 and its symptoms.
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 for you 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 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 to both you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Severe hypercalcemia (calcium levels >12 mg/dL)
- Nausea, vomiting, constipation, anorexia
- Polyuria, polydipsia, dehydration
- Muscle weakness, fatigue, lethargy
- Confusion, stupor, coma
- Cardiac arrhythmias
- Kidney damage (nephrocalcinosis, kidney stones, renal failure)
What to Do:
Discontinue vitamin D and calcium supplements. Hydrate with intravenous saline. Loop diuretics (e.g., furosemide) may be used to increase calcium excretion. Calcitonin, bisphosphonates, or corticosteroids may be used in severe cases. Dialysis may be necessary in life-threatening hypercalcemia with renal failure. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
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)
- Mineral oil (decreased absorption)
Moderate Interactions
- Corticosteroids (may reduce vitamin D effects and calcium absorption)
- Anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine; may increase vitamin D metabolism and reduce efficacy)
- Isoniazid (may increase vitamin D metabolism)
- Ketoconazole (may inhibit 25-hydroxylation)
- Verapamil (may reduce calcium absorption)
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 with high doses.
Serum Calcium
Rationale: To establish baseline and monitor for hypercalcemia.
Timing: Before initiating therapy.
Serum Phosphate
Rationale: To establish baseline and monitor for imbalances.
Timing: Before initiating therapy.
Parathyroid Hormone (PTH)
Rationale: To assess secondary hyperparathyroidism in deficiency.
Timing: Before initiating therapy for deficiency.
Renal Function (e.g., Creatinine, eGFR)
Rationale: To assess kidney health, as kidneys are crucial for vitamin D activation and calcium excretion.
Timing: Before initiating therapy.
Routine Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Frequency: Every 3-6 months during high-dose therapy, then annually for maintenance.
Target: 30-100 ng/mL (75-250 nmol/L) for optimal health, though some sources suggest 20-50 ng/mL.
Action Threshold: If levels remain low despite therapy, consider adherence, malabsorption, or higher dose. If levels exceed 100 ng/mL, reduce dose.
Serum Calcium
Frequency: Monthly for first 3 months of high-dose therapy, then every 3-6 months. More frequently if hypercalcemia risk factors are present.
Target: 8.5-10.2 mg/dL (2.1-2.55 mmol/L)
Action Threshold: If >10.5 mg/dL, reduce or temporarily stop vitamin D. If >11 mg/dL, consider urgent intervention.
Serum Phosphate
Frequency: Every 3-6 months.
Target: 2.5-4.5 mg/dL (0.81-1.45 mmol/L)
Action Threshold: Monitor for significant deviations, especially hyperphosphatemia in renal impairment.
Urinary Calcium (24-hour)
Frequency: Periodically, especially if hypercalcemia or nephrolithiasis risk.
Target: <250 mg/24 hours (women), <300 mg/24 hours (men)
Action Threshold: If elevated, reduce vitamin D dose.
Symptom Monitoring
- Symptoms of hypercalcemia: nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, fatigue, confusion, anorexia, bone pain, kidney stones.
Special Patient Groups
Pregnancy
Vitamin D is essential during pregnancy for maternal and fetal bone health. However, high doses (like 10,000 IU) should only be used under strict medical supervision to treat confirmed severe deficiency, as excessive intake can lead to hypercalcemia in the mother and potential adverse effects on the fetus (e.g., supravalvular aortic stenosis, mental retardation). The recommended daily allowance (RDA) for pregnant women is 600 IU, with a tolerable upper intake level (UL) of 4000 IU.
Trimester-Specific Risks:
First Trimester:
Essential for early fetal development; high doses should be avoided unless severe deficiency is confirmed and monitored.
Second Trimester:
Continued importance for fetal skeletal development; monitor calcium levels if high doses are used.
Third Trimester:
Crucial for fetal bone mineralization; risk of hypercalcemia in mother and fetus with excessive intake.
Lactation
Cholecalciferol is excreted into breast milk. While vitamin D is important for the infant, the amount transferred is generally low. High maternal doses can increase breast milk levels, but typically not to toxic levels for the infant. Monitor infant's vitamin D status if concerns exist. The American Academy of Pediatrics recommends 400 IU daily for breastfed infants.
Infant Risk:
Low risk at typical doses. High maternal doses (e.g., 10,000 IU) may increase infant exposure but are generally considered safe if maternal levels are monitored and remain within therapeutic range. Risk of infant hypercalcemia is very low but theoretical with extreme maternal overdose.
Pediatric Use
Dosing must be carefully individualized based on age, weight, and severity of deficiency. 10,000 IU is a very high dose for children and is typically reserved for short-term treatment of severe deficiency under strict medical supervision due to the risk of toxicity (hypercalcemia). Routine maintenance doses are much lower (e.g., 400-1000 IU daily).
Geriatric Use
Elderly individuals are at higher risk for vitamin D deficiency due to decreased skin synthesis, reduced dietary intake, and impaired absorption. They may require higher doses than younger adults. However, monitoring for hypercalcemia and renal function is crucial, as they may be more susceptible to adverse effects.
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.
- 10,000 IU is a high dose typically used for initial correction of severe vitamin D deficiency, not for routine daily supplementation or long-term maintenance unless specifically indicated and monitored by a healthcare professional.
- Always advise patients to take vitamin D with a meal containing fat to maximize absorption.
- Educate patients on the symptoms of hypercalcemia and the importance of not exceeding prescribed doses.
- Regular monitoring of serum 25(OH)D, calcium, and phosphate is crucial, especially with high-dose therapy.
- Consider underlying conditions (e.g., malabsorption syndromes, obesity, certain medications) that may affect vitamin D absorption or metabolism when determining dosing.
Alternative Therapies
- Ergocalciferol (Vitamin D2) - less potent and shorter-acting than D3.
- Calcitriol (1,25-dihydroxyvitamin D3) - active form, used in renal failure or hypoparathyroidism.
- Doxercalciferol (1-alpha-hydroxyvitamin D2) - synthetic analog, used in renal failure.
- Paricalcitol (19-nor-1,25-dihydroxyvitamin D2) - synthetic analog, used in renal failure.
- Alfacalcidol (1-alpha-hydroxycholecalciferol) - prodrug of calcitriol, used in renal failure.
- Sun exposure (natural production of D3)
- Dietary sources (fatty fish, fortified foods)
Cost & Coverage
Average Cost:
Highly variable, typically $10-$50 per 30-100 capsules (10,000 IU)
Generic Available:
Yes
Insurance Coverage:
Often OTC and not covered by insurance, or covered as a Tier 3/4 supplement if prescribed 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.