Vitamin D3 2,000unit Capsules
It is used to treat or prevent vitamin D deficiency.
Drug Class
Vitamin
Pharmacologic Class
Vitamin D analog
Pregnancy Category
Category C (for doses above RDA), Category A (for 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, nerve function, and your immune system. This 2,000 IU capsule is a common dose for maintaining healthy 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. Additionally, some strengths of this medication may not be taken daily, so it's essential to understand your specific dosing schedule. If you have any questions or concerns, discuss them 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. Keep all medications in a 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 according to the recommended disposal methods. 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 dosing 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. Additionally, some strengths of this medication may not be taken daily, so it's essential to understand your specific dosing schedule. If you have any questions or concerns, discuss them 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. Keep all medications in a 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 according to the recommended disposal methods. 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 dosing 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.
- Sun exposure (10-30 minutes, several times a week) can help your body produce vitamin D, but use sunscreen to prevent skin damage.
- Include vitamin D-rich foods in your diet (fatty fish like salmon, tuna, mackerel; fortified milk, cereal, and 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:
2,000 IU (50 mcg) orally once daily for maintenance; higher doses for deficiency.
Dose Range:
600 - 10000 mg
Condition-Specific Dosing:
Vitamin D Deficiency (mild-moderate):
50,000 IU orally once weekly for 8-12 weeks, or 6,000 IU daily for 8-12 weeks, then maintenance.
Osteoporosis Prevention/Treatment:
800-2,000 IU daily (often with calcium).
Maintenance:
600-2,000 IU daily.
Pediatric Dosing
Neonatal:
400 IU daily (breastfed infants).
Infant:
400 IU daily (breastfed infants); 400-600 IU daily (formula-fed, if not getting enough from formula).
Child:
600-1,000 IU daily for maintenance; higher doses (e.g., 2,000 IU daily) for deficiency.
Adolescent:
600-1,000 IU daily for maintenance; higher doses (e.g., 2,000 IU daily) for deficiency.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, but monitor 25(OH)D and calcium/phosphate levels.
Severe:
Cholecalciferol may be less effective; active vitamin D analogs (e.g., calcitriol) often preferred. Monitor closely.
Dialysis:
Cholecalciferol may be less effective; active vitamin D analogs (e.g., calcitriol) often preferred. Monitor closely.
Hepatic Impairment:
Mild:
No specific adjustment.
Moderate:
No specific adjustment, but monitor 25(OH)D levels.
Severe:
No specific adjustment, but monitor 25(OH)D levels as metabolism may be impaired.
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 (calcifediol) and then in the kidneys to 1,25-dihydroxyvitamin D (calcitriol), the active form. Calcitriol acts as a hormone, binding to the vitamin D receptor (VDR) in target cells. This binding regulates gene expression, primarily promoting calcium and phosphate absorption from the intestine, regulating bone remodeling, and influencing parathyroid hormone (PTH) secretion. 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% with adequate fat.
Tmax:
Approximately 10-12 hours for 25(OH)D after a single dose.
FoodEffect:
Enhanced absorption when taken with a fatty meal.
Distribution:
Vd:
Large, distributed into adipose tissue and muscle.
ProteinBinding:
Primarily bound 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 precisely quantified for cholecalciferol, but metabolites are cleared via bile and urine.
ExcretionRoute:
Primarily biliary/fecal, with some renal excretion of metabolites.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Weeks to months for significant changes in 25(OH)D levels and clinical effects.
PeakEffect:
Peak 25(OH)D levels typically reached after 2-3 months of consistent dosing.
DurationOfAction:
Effects on 25(OH)D levels can persist for several weeks after discontinuation due to storage in adipose tissue.
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 or seek immediate 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Fatigue
+ Headache
+ Nausea 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 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. If you notice any of the following symptoms, contact your doctor or seek immediate 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Fatigue
+ Headache
+ Nausea 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 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:
- Signs of too much vitamin D (hypercalcemia): nausea, vomiting, constipation, frequent urination, increased thirst, muscle weakness, confusion, fatigue.
- Seek medical attention if these symptoms occur.
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 your safety, please 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 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 your safety, please 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 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, to determine the best course of action.
Overdose Information
Overdose Symptoms:
- Severe hypercalcemia (calcium levels >12 mg/dL)
- Kidney stones
- Kidney damage
- Bone pain
- Arrhythmias
- Coma
What to Do:
Discontinue vitamin D, restrict calcium intake, hydrate with IV fluids, consider loop diuretics or corticosteroids. Call 1-800-222-1222 (Poison Control) or seek emergency medical attention.
Drug Interactions
Major Interactions
- Orlistat (decreased absorption of fat-soluble vitamins)
- Cholestyramine, Colestipol (decreased absorption of fat-soluble vitamins)
- Mineral oil (decreased absorption of fat-soluble vitamins)
- Phenytoin, Carbamazepine, Barbiturates (increased metabolism of vitamin D)
Moderate Interactions
- Thiazide diuretics (increased risk of hypercalcemia)
- Corticosteroids (may reduce 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 initial dosing.
Timing: Before initiating therapy, especially for deficiency.
Serum Calcium
Rationale: To assess for pre-existing hypercalcemia and establish baseline.
Timing: Before initiating therapy.
Serum Phosphate
Rationale: To assess for pre-existing abnormalities and establish baseline.
Timing: Before initiating therapy.
Parathyroid Hormone (PTH)
Rationale: To assess for secondary hyperparathyroidism in deficiency.
Timing: Before initiating therapy for deficiency.
Routine Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Frequency: 3-6 months after initiating high-dose therapy, then annually for maintenance.
Target: 30-100 ng/mL (75-250 nmol/L)
Action Threshold: <20 ng/mL (deficiency, increase dose); >100 ng/mL (potential toxicity, reduce/hold dose).
Serum Calcium
Frequency: Periodically, especially with high doses or in patients with renal impairment.
Target: 8.5-10.2 mg/dL
Action Threshold: >10.5 mg/dL (hypercalcemia, reduce/hold dose).
Serum Phosphate
Frequency: Periodically, especially with high doses or in patients with renal impairment.
Target: 2.5-4.5 mg/dL
Action Threshold: Abnormal levels (investigate cause, adjust dose if related to vitamin D).
Symptom Monitoring
- Symptoms of hypercalcemia (nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, confusion)
- Symptoms of vitamin D deficiency (fatigue, muscle weakness, bone pain, mood changes)
Special Patient Groups
Pregnancy
Vitamin D supplementation is generally recommended during pregnancy to support maternal and fetal bone health. The recommended daily allowance (RDA) is 600 IU, but higher doses (up to 4,000 IU/day) may be used for deficiency under medical supervision. Doses above RDA are Category C; RDA doses are Category A.
Trimester-Specific Risks:
First Trimester:
Generally safe and important for early fetal development.
Second Trimester:
Continued importance for fetal skeletal development.
Third Trimester:
Continued importance for fetal skeletal development and maternal bone health.
Lactation
Vitamin D is excreted in breast milk in small amounts. Supplementation of the mother can increase breast milk vitamin D levels, but infant supplementation (400 IU/day) is typically still recommended for breastfed infants. Considered L1 (safest).
Infant Risk:
Low risk; beneficial for infant bone health.
Pediatric Use
Essential for bone growth and development. Dosing varies by age and vitamin D status. Infants require 400 IU daily. Higher doses are used to treat deficiency, always under medical guidance.
Geriatric Use
Older adults are at higher risk for vitamin D deficiency due to decreased skin synthesis and reduced dietary intake. Supplementation is often recommended (e.g., 800-2,000 IU daily) to maintain bone health and reduce fall risk. Monitor for hypercalcemia, especially if on other medications affecting calcium.
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 take vitamin D supplements with a meal containing fat to maximize absorption.
- Routine monitoring of 25(OH)D levels is crucial when treating deficiency, but less frequent for maintenance doses in healthy individuals.
- Hypercalcemia is the primary concern with excessive vitamin D intake, not typically seen with doses up to 10,000 IU/day in healthy individuals, but individual sensitivity varies.
- Patients with malabsorption syndromes (e.g., celiac disease, Crohn's disease, bariatric surgery) may require higher doses and more frequent monitoring.
Alternative Therapies
- Ergocalciferol (Vitamin D2)
- Calcitriol (active vitamin D, used in severe renal disease)
- Paricalcitol (active vitamin D, used in renal disease)
- Doxercalciferol (active vitamin D, used in renal disease)
Cost & Coverage
Average Cost:
$5 - $20 per 100 capsules (2,000 IU)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (often OTC, may not be covered by prescription plans unless prescribed 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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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.