Vitamin D3 5000 Unit 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 (at doses above RDA); Category A (at RDA doses)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vitamin D3 is a 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 to prevent or treat low vitamin D levels.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. 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 the correct dosage schedule, and don't hesitate to discuss any questions or concerns with your doctor.
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, and keep it out of reach of children and pets. When you're finished with your medication or it has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, or look into local drug take-back programs.
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 get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. 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 the correct dosage schedule, and don't hesitate to discuss any questions or concerns with your doctor.
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, and keep it out of reach of children and pets. When you're finished with your medication or it has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, or look into local drug take-back programs.
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 food, preferably a fatty meal, to improve absorption.
- Maintain a balanced diet rich in calcium and phosphorus.
- Regular weight-bearing exercise is beneficial for bone health.
- Sun exposure (10-30 minutes, 2-3 times per week) can help the body produce vitamin D, but use sunscreen to prevent skin damage.
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:
5000 IU (125 mcg) orally once daily or every other day for maintenance or mild deficiency.
Dose Range:
600 - 10000 mg
Condition-Specific Dosing:
RDA:
600-800 IU/day
Deficiency_Treatment:
50,000 IU orally once weekly for 8-12 weeks, or 6000 IU orally once daily for 8-12 weeks, followed by maintenance.
Pediatric Dosing
Neonatal:
Not established (specific dosing for deficiency varies, often 400 IU/day for prophylaxis)
Infant:
Not established (specific dosing for deficiency varies, often 400 IU/day for prophylaxis)
Child:
Not established (dosing varies by age, weight, and deficiency severity; e.g., 1000-2000 IU/day for deficiency)
Adolescent:
Not established (dosing varies by age, weight, and deficiency severity; e.g., 1000-2000 IU/day for deficiency)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed.
Moderate:
No adjustment typically needed.
Severe:
Cholecalciferol may not be effective due to impaired 1-alpha-hydroxylation; active forms (e.g., calcitriol) may be required. Monitor serum calcium and phosphate.
Dialysis:
Cholecalciferol may not be effective; active forms (e.g., calcitriol) are generally preferred. Monitor serum calcium and phosphate.
Hepatic Impairment:
Mild:
No adjustment typically needed.
Moderate:
No adjustment typically needed; monitor 25-hydroxyvitamin D levels.
Severe:
Impaired conversion to 25-hydroxyvitamin D may occur; monitor levels and consider alternative forms if needed.
Pharmacology
Mechanism of Action
Cholecalciferol (Vitamin D3) is a fat-soluble vitamin that is metabolically inert. It is hydroxylated in the liver by 25-hydroxylase (CYP2R1, CYP27A1) to form 25-hydroxyvitamin D (calcifediol). Calcifediol is then further hydroxylated in the kidneys by 1-alpha-hydroxylase (CYP27B1) to form 1,25-dihydroxyvitamin D (calcitriol), the biologically active form of vitamin D. Calcitriol acts as a hormone to regulate calcium and phosphate homeostasis, promoting intestinal absorption of calcium and phosphate, renal reabsorption of calcium, and bone mineralization.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable, depends on diet and fat intake.
Tmax:
Approximately 4-5 hours for cholecalciferol; 24-48 hours for 25-hydroxyvitamin D.
FoodEffect:
Enhanced absorption when taken with fatty meals.
Distribution:
Vd:
Not readily quantifiable due to extensive tissue storage (fat, muscle).
ProteinBinding:
Approximately 88% bound to vitamin D binding protein (DBP) and 12% to albumin.
CnssPenetration:
Limited
Elimination:
HalfLife:
Cholecalciferol: Approximately 24 hours; 25-hydroxyvitamin D: 2-3 weeks; 1,25-dihydroxyvitamin D: 4-6 hours.
Clearance:
Not readily quantifiable.
ExcretionRoute:
Primarily biliary/fecal, with some renal excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Gradual, clinical effects (e.g., increase in serum 25-OH D levels) typically observed over weeks to months.
PeakEffect:
Peak serum 25-OH D levels achieved after several weeks of consistent dosing.
DurationOfAction:
Effects on serum 25-OH D levels can persist for weeks after discontinuation due to storage in fat tissue.
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 side effect:
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
Not all possible side effects are listed here. 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. Your doctor can provide medical advice about side effects.
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 side effect:
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
Not all possible side effects are listed here. 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. Your doctor can provide medical advice about side effects.
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.
- Seek medical attention if you experience severe abdominal pain, persistent vomiting, or signs of kidney stones (e.g., 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 symptoms you experienced.
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, tell your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your complete medical history
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 symptoms you experienced.
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, tell your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your complete medical history
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 intake, do not consume other sources of vitamin D while taking this drug. 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:
- Hypercalcemia (nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, fatigue, confusion, kidney stones, cardiac arrhythmias in severe cases)
- Hyperphosphatemia
What to Do:
Discontinue vitamin D and calcium supplements. Hydration with intravenous fluids. Loop diuretics (e.g., furosemide) may be used to increase calcium excretion. Calcitonin or bisphosphonates may be used in severe cases. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Orlistat (decreased absorption of vitamin D)
- Bile acid sequestrants (e.g., Cholestyramine, Colestipol - decreased absorption of vitamin D)
- Mineral oil (decreased absorption of vitamin D)
Moderate Interactions
- Thiazide diuretics (increased risk of hypercalcemia)
- Phenytoin (increased metabolism of vitamin D)
- Barbiturates (e.g., Phenobarbital - increased metabolism of vitamin D)
- Corticosteroids (may decrease vitamin D effects)
- Digoxin (increased risk of arrhythmias with hypercalcemia)
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, especially for deficiency treatment.
Serum Calcium
Rationale: To assess baseline calcium levels and monitor for hypercalcemia.
Timing: Prior to initiation of therapy.
Serum Phosphate
Rationale: To assess baseline phosphate levels.
Timing: Prior to initiation of therapy.
Parathyroid Hormone (PTH)
Rationale: To assess secondary hyperparathyroidism in deficiency.
Timing: Prior to initiation of therapy, especially in deficiency.
Routine Monitoring
Serum 25-hydroxyvitamin D (25-OH D)
Frequency: Every 3-6 months during treatment for deficiency, or annually for maintenance.
Target: 30-100 ng/mL (75-250 nmol/L)
Action Threshold: If levels remain below target despite adequate dosing, or if levels exceed 100 ng/mL (consider dose reduction).
Serum Calcium
Frequency: Every 3-6 months during treatment, or annually for maintenance.
Target: 8.5-10.2 mg/dL
Action Threshold: If levels exceed upper limit of normal (e.g., >10.5 mg/dL), consider dose reduction or temporary discontinuation.
Serum Phosphate
Frequency: Every 3-6 months during treatment, or annually for maintenance.
Target: 2.5-4.5 mg/dL
Action Threshold: If levels are consistently elevated, especially with hypercalcemia.
Symptom Monitoring
- Symptoms of hypercalcemia (nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, fatigue, confusion)
- Symptoms of vitamin D deficiency (bone pain, muscle weakness, fatigue, mood changes)
Special Patient Groups
Pregnancy
Vitamin D is essential during pregnancy for fetal bone development. Recommended daily intake is 600 IU. Doses up to 4000 IU/day are generally considered safe. High doses (>4000 IU/day) should be used with caution and only if clearly indicated, as excessive intake can lead to hypercalcemia in the mother and potential adverse effects on the fetus.
Trimester-Specific Risks:
First Trimester:
Essential for early fetal development; maintain adequate levels.
Second Trimester:
Continued importance for bone mineralization.
Third Trimester:
Crucial for fetal skeletal growth and calcium homeostasis.
Lactation
Cholecalciferol is excreted in breast milk. Maternal supplementation at recommended doses (e.g., 600-4000 IU/day) is generally considered safe and can increase vitamin D levels in breast milk, potentially benefiting the infant. Infant supplementation (400 IU/day) is often recommended regardless of maternal intake.
Infant Risk:
L1 (Safest - compatible with breastfeeding)
Pediatric Use
Dosing must be carefully individualized based on age, weight, and serum 25-OH D levels. Excessive dosing can lead to toxicity. Prophylactic dosing for infants is typically 400 IU/day. Treatment doses for deficiency are higher and should be guided by a healthcare professional.
Geriatric Use
Elderly individuals are at higher risk for vitamin D deficiency due to decreased skin synthesis, reduced dietary intake, and impaired renal 1-alpha-hydroxylation. Standard adult dosing is generally appropriate, but monitoring of 25-OH D levels is important.
Clinical Information
Clinical Pearls
- Cholecalciferol is Vitamin D3, the form naturally produced in the skin upon sun exposure and found in some animal products.
- It is a prohormone that requires activation in the liver and kidneys to become biologically active.
- Always advise patients to take vitamin D with a meal containing fat to maximize absorption.
- Regular monitoring of serum 25-hydroxyvitamin D, calcium, and phosphate levels is crucial, especially when treating deficiency or using higher doses.
- Symptoms of vitamin D toxicity (hypercalcemia) can be subtle and non-specific; educate patients on these symptoms.
- Consider co-administration with calcium supplements if dietary calcium intake is insufficient.
Alternative Therapies
- Ergocalciferol (Vitamin D2)
- Calcitriol (1,25-dihydroxyvitamin D, active form, used in severe renal impairment)
- Doxercalciferol (synthetic vitamin D analog)
- Paricalcitol (synthetic vitamin D analog)
Cost & Coverage
Average Cost:
$5 - $30 per 30 capsules (5000 IU)
Generic Available:
Yes
Insurance Coverage:
Often covered by insurance plans, especially if prescribed for deficiency. May be Tier 1 or 2.
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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.