Vitamin D3 1,000 Unit Tablets
It is used to treat or prevent vitamin D deficiency.
Drug Class
Vitamin; Nutritional Supplement
Pharmacologic Class
Vitamin D Analog
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vitamin D3 (cholecalciferol) is a type of vitamin D that helps your body absorb calcium and phosphorus, which are essential for strong bones and teeth. It also supports muscle function and a healthy immune system. This supplement helps ensure you have enough vitamin D, especially if you don't get enough from sunlight or diet.
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 your pharmacist for guidance on 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 dosage 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 method. You can also check with your pharmacist about potential 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, 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 your pharmacist for guidance on 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 dosage 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 method. You can also check with your pharmacist about potential 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 (e.g., breakfast, dinner) to improve absorption.
- Maintain a balanced diet rich in calcium and phosphorus.
- Discuss safe sun exposure with your doctor, as it's a natural source of vitamin D.
- Do not exceed the recommended dose without consulting a healthcare professional.
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:
1,000 IU (25 mcg) daily for maintenance
Dose Range:
600 - 2000 mg
Condition-Specific Dosing:
maintenance:
600-2,000 IU daily
deficiency_treatment:
50,000 IU once weekly for 8-12 weeks, or 6,000 IU daily for 8-12 weeks, followed by maintenance dosing (e.g., 1,000-2,000 IU daily)
osteoporosis_prevention:
800-1,000 IU daily (often with calcium)
Pediatric Dosing
Neonatal:
Not established for 1,000 IU; typically 400 IU daily for breastfed infants
Infant:
400 IU daily (0-12 months)
Child:
600-1,000 IU daily (1-18 years); higher doses for deficiency
Adolescent:
600-1,000 IU daily; higher doses for deficiency
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for cholecalciferol, but conversion to active form may be impaired.
Moderate:
No specific adjustment for cholecalciferol, but conversion to active form may be impaired. Monitoring of 25(OH)D and calcium is important.
Severe:
Cholecalciferol conversion to active form (calcitriol) is significantly impaired. Active vitamin D analogs (e.g., calcitriol) are often preferred. Doses of cholecalciferol may need to be higher if used.
Dialysis:
Cholecalciferol conversion to active form is impaired. Active vitamin D analogs are typically used. Consult nephrologist.
Hepatic Impairment:
Mild:
No specific adjustment; monitor vitamin D levels.
Moderate:
Impaired 25-hydroxylation may occur. Doses may need adjustment based on 25(OH)D levels. Calcifediol (25-hydroxyvitamin D) may be considered.
Severe:
Significant impairment of 25-hydroxylation. Doses may need significant adjustment or alternative forms of vitamin D may be necessary. Consult hepatologist.
Pharmacology
Mechanism of Action
Cholecalciferol (Vitamin D3) is a prohormone that is metabolically activated in the body. It is first hydroxylated in the liver by 25-hydroxylase (CYP2R1, CYP27A1) to 25-hydroxyvitamin D (calcifediol). Calcifediol is then further hydroxylated in the kidneys by 1-alpha-hydroxylase (CYP27B1) to its active form, 1,25-dihydroxyvitamin D (calcitriol). Calcitriol acts on vitamin D receptors (VDRs) in target tissues, primarily regulating calcium and phosphate homeostasis. It promotes intestinal absorption of calcium and phosphate, regulates bone mineralization and remodeling, and influences parathyroid hormone (PTH) secretion. It also has roles in immune function, cell growth, and differentiation.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (fat-soluble, requires bile salts); generally good with adequate fat intake.
Tmax:
For 25(OH)D: 4-5 hours after oral administration of cholecalciferol.
FoodEffect:
Enhanced absorption when taken with a fatty meal.
Distribution:
Vd:
Large (stored in adipose tissue)
ProteinBinding:
Highly bound (>99%) to vitamin D binding protein (DBP) and albumin.
CnssPenetration:
Limited
Elimination:
HalfLife:
Cholecalciferol (parent): short (hours); 25-hydroxyvitamin D: ~15-30 days; 1,25-dihydroxyvitamin D: ~4-6 hours.
Clearance:
Not precisely quantified for parent compound; metabolites are cleared via various pathways.
ExcretionRoute:
Primarily biliary/fecal; minor renal excretion.
Unchanged:
Negligible
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 3-5 months of consistent daily dosing or 8-12 weeks after high-dose loading.
DurationOfAction:
Effects on 25(OH)D levels can persist for several weeks after discontinuation 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
While rare, some individuals may experience severe and potentially life-threatening side effects when taking this medication. If you exhibit 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
As with all medications, side effects can occur. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for guidance.
Please note that 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.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor can also provide medical advice and guidance on managing side effects.
While rare, some individuals may experience severe and potentially life-threatening side effects when taking this medication. If you exhibit 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
As with all medications, side effects can occur. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for guidance.
Please note that 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.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor can also provide medical advice and guidance on managing 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, 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 consume other sources of vitamin D while taking this drug. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypercalcemia (calcium levels >12 mg/dL)
- Kidney stones
- Kidney damage (nephrocalcinosis)
- Arrhythmias
- Coma (in severe cases)
What to Do:
Discontinue vitamin D and calcium supplements. Seek immediate medical attention. Hydration with intravenous fluids, loop diuretics, and calcitonin may be used to lower calcium levels. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Thiazide diuretics (increased risk of hypercalcemia)
- Digoxin (hypercalcemia can potentiate digoxin toxicity)
- Orlistat (decreased absorption of fat-soluble vitamins)
- Bile acid sequestrants (e.g., cholestyramine, colestipol; decreased absorption)
- Mineral oil (decreased absorption)
Moderate Interactions
- Corticosteroids (may decrease vitamin D effects by inhibiting 1-alpha-hydroxylase and increasing vitamin D catabolism)
- Anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine; may increase vitamin D metabolism, leading to lower 25(OH)D levels)
- Ketoconazole (may inhibit 1-alpha-hydroxylase)
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, as vitamin D affects phosphate absorption.
Timing: Prior to initiation of therapy.
Parathyroid Hormone (PTH)
Rationale: To assess for secondary hyperparathyroidism due to vitamin D deficiency.
Timing: Consider if vitamin D deficiency is suspected or confirmed.
Routine Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Frequency: 3-6 months after initiating or changing high-dose therapy, then annually for maintenance.
Target: 30-100 ng/mL (75-250 nmol/L) for optimal health (Endocrine Society guidelines).
Action Threshold: Below target range: consider dose increase; Above 100 ng/mL: consider dose reduction.
Serum Calcium
Frequency: Periodically (e.g., every 3-6 months) during therapy, especially with higher doses.
Target: 8.5-10.2 mg/dL (2.1-2.55 mmol/L)
Action Threshold: Above upper limit of normal: investigate for hypercalcemia, reduce or discontinue vitamin D.
Serum Phosphate
Frequency: Periodically (e.g., every 3-6 months) during therapy.
Target: 2.5-4.5 mg/dL (0.81-1.45 mmol/L)
Action Threshold: Above upper limit of normal: investigate, consider dose adjustment.
Symptom Monitoring
- Symptoms of hypercalcemia: nausea, vomiting, constipation, abdominal pain, polyuria (frequent urination), polydipsia (increased thirst), muscle weakness, fatigue, confusion, headache, anorexia.
Special Patient Groups
Pregnancy
Vitamin D is essential during pregnancy for maternal and fetal bone health. Physiological doses (e.g., 600-2000 IU daily) are generally considered safe and recommended to prevent deficiency. Higher doses (up to 4000 IU daily) may be used to treat deficiency under medical supervision. Excessive doses can lead to hypercalcemia, which may be harmful to the fetus.
Trimester-Specific Risks:
First Trimester:
Essential for early fetal development; deficiency can impact fetal growth.
Second Trimester:
Continued importance for fetal skeletal development.
Third Trimester:
Crucial for fetal bone mineralization and calcium homeostasis.
Lactation
Cholecalciferol is excreted in breast milk in small amounts. It is generally considered compatible with breastfeeding at recommended maternal doses (e.g., 600-2000 IU daily). Maternal supplementation can increase vitamin D levels in breast milk, which may contribute to the infant's vitamin D intake, though infant supplementation (400 IU daily) is still typically recommended.
Infant Risk:
Low risk at recommended maternal doses. High maternal doses leading to hypercalcemia could theoretically pose a risk to the infant, but this is rare.
Pediatric Use
Essential for bone growth and prevention of rickets. Dosing varies by age (see detailed dosing). Infants (especially breastfed) require supplementation. Monitoring for hypercalcemia is important with higher doses.
Geriatric Use
Older adults are at increased risk of vitamin D deficiency due to reduced skin synthesis, decreased dietary intake, and potential malabsorption. Supplementation is often recommended to maintain bone health and reduce fracture risk. Doses of 800-2000 IU daily are commonly used.
Clinical Information
Clinical Pearls
- Cholecalciferol (Vitamin D3) is generally preferred over ergocalciferol (Vitamin D2) for supplementation due to its higher potency and longer duration of action in raising 25(OH)D levels.
- Vitamin D is fat-soluble; taking it with a meal containing fat significantly improves absorption.
- Regular monitoring of serum 25(OH)D levels is crucial, especially when treating deficiency, to ensure efficacy and avoid toxicity.
- Many factors influence vitamin D status, including sun exposure, diet, obesity, malabsorption syndromes (e.g., celiac disease, Crohn's disease, bariatric surgery), and chronic kidney or liver disease.
- Symptoms of hypercalcemia should be recognized and reported immediately. Patients should be educated on these symptoms.
- While 1,000 IU is a common maintenance dose, higher doses may be required to correct deficiency, especially in individuals with malabsorption or obesity.
Alternative Therapies
- Calcitriol (1,25-dihydroxyvitamin D, active form, used in severe renal disease or hypoparathyroidism)
- Calcifediol (25-hydroxyvitamin D, used in some liver diseases or for faster repletion)
- Parathyroid hormone analogs (e.g., teriparatide, abaloparatide for severe osteoporosis)
Cost & Coverage
Average Cost:
$5 - $20 per 30 tablets (1,000 IU)
Generic Available:
Yes
Insurance Coverage:
Often considered an over-the-counter (OTC) supplement and may not be covered by standard prescription drug plans. May be eligible for FSA/HSA reimbursement.
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 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.