Vitamin D3 5,000 IU (chole) Tab
It is used to treat or prevent vitamin D deficiency.
Drug Class
Vitamin; Nutritional Supplement; Bone Health Agent
Pharmacologic Class
Vitamin D Analog; Secosteroid
Pregnancy Category
Category C (for doses exceeding recommended daily allowance; Category A for doses within RDA)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vitamin D3 (cholecalciferol) 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 5,000 IU dose is often used to correct a vitamin D deficiency.
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 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 your pharmacist for guidance on the best way to take your medication. It's also important to note that some strengths of this medication may not be taken daily, so be sure 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 medication, 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 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 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 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 your pharmacist for guidance on the best way to take your medication. It's also important to note that some strengths of this medication may not be taken daily, so be sure 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 medication, 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 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 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 a meal, preferably the largest meal of the day or one containing fat, to improve absorption.
- Continue to get regular sun exposure (10-15 minutes, 2-3 times per week, without sunscreen) if safe and appropriate, but do not rely solely on sun for vitamin D.
- Include vitamin D-rich foods in your diet (e.g., fatty fish like salmon, mackerel; fortified milk, cereals, orange juice).
- Maintain a balanced diet rich in calcium.
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:
5,000 IU (125 mcg) orally once daily or as directed by a healthcare professional for vitamin D deficiency.
Dose Range:
1000 - 10000 mg
Condition-Specific Dosing:
deficiency_repletion:
5,000-10,000 IU daily for 8-12 weeks, then maintenance.
maintenance:
1,000-2,000 IU daily (or higher based on serum 25(OH)D levels).
Pediatric Dosing
Neonatal:
Not established for 5,000 IU dose; typically 400 IU daily for breastfed infants.
Infant:
Not established for 5,000 IU dose; typically 400 IU daily.
Child:
Not established for 5,000 IU dose; doses vary by age and deficiency severity (e.g., 600-1000 IU daily for maintenance, higher for deficiency).
Adolescent:
Not established for 5,000 IU dose; doses vary by age and deficiency severity (e.g., 600-1000 IU daily for maintenance, higher for deficiency).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for cholecalciferol, but monitor calcium/phosphate.
Moderate:
No specific adjustment needed for cholecalciferol, but monitor calcium/phosphate. Conversion to active form (calcitriol) may be impaired.
Severe:
Cholecalciferol may not be effective due to impaired 1-alpha-hydroxylation; active vitamin D forms (e.g., calcitriol) are often preferred. Monitor calcium, phosphate, PTH.
Dialysis:
Cholecalciferol may be used, but active vitamin D forms are often necessary. Monitor calcium, phosphate, PTH closely.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
May impair 25-hydroxylation of cholecalciferol to calcifediol. Monitor 25(OH)D levels and adjust dose as needed.
Severe:
Significant impairment of 25-hydroxylation may occur. Monitor 25(OH)D levels and consider calcifediol (25(OH)D) supplementation if cholecalciferol is ineffective.
Pharmacology
Mechanism of Action
Cholecalciferol (Vitamin D3) is a fat-soluble secosteroid 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 biologically active form. Calcitriol acts as a hormone, binding to the vitamin D receptor (VDR) in target cells. This binding modulates gene expression, primarily regulating calcium and phosphate homeostasis. It promotes intestinal absorption of calcium and phosphate, regulates bone mineralization, and influences 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 bile salts. Approximately 50-80% when taken with a fatty meal.
Tmax:
Approximately 10-24 hours for cholecalciferol; 2-4 days for 25(OH)D.
FoodEffect:
Absorption is significantly enhanced when taken with a fatty meal.
Distribution:
Vd:
Not precisely quantified for cholecalciferol; stored extensively in adipose tissue and muscle.
ProteinBinding:
Cholecalciferol and its metabolites are highly bound to vitamin D-binding protein (DBP) and albumin (>99%).
CnssPenetration:
Limited
Elimination:
HalfLife:
Cholecalciferol: Approximately 24 hours; 25(OH)D (calcifediol): Approximately 15-30 days; 1,25(OH)2D (calcitriol): Approximately 4-6 hours.
Clearance:
Not precisely quantified; primarily through metabolism.
ExcretionRoute:
Biliary and fecal excretion (major route); minor renal excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Weeks to months for significant changes in serum 25(OH)D levels and clinical effects.
PeakEffect:
Peak serum 25(OH)D levels typically achieved after 2-3 months of consistent daily dosing.
DurationOfAction:
Effects can persist for several weeks to months 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 may occur. Many people experience no side effects or only mild ones. If you have any side effects that bother you or persist, 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. 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 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 may occur. Many people experience no side effects or only mild ones. If you have any side effects that bother you or persist, 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. 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:
- Nausea
- Vomiting
- Loss of appetite
- Excessive thirst
- Frequent urination
- Weakness
- Fatigue
- Confusion
- Constipation
- Muscle pain
- 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 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 disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter 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 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 disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter 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 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. 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:
- Hypercalcemia (high blood calcium)
- Nausea
- Vomiting
- Anorexia
- Constipation
- Polyuria
- Polydipsia
- Weakness
- Fatigue
- Confusion
- Kidney stones
- Kidney damage
- Cardiac arrhythmias (in severe cases)
What to Do:
Discontinue vitamin D and calcium supplements. Hydration with intravenous fluids may be necessary. Loop diuretics may be used to increase calcium excretion. In severe cases, corticosteroids or bisphosphonates may be administered. Call 1-800-222-1222 (Poison Control) immediately if overdose is suspected.
Drug Interactions
Major Interactions
- Thiazide diuretics (increased risk of hypercalcemia)
- Cardiac glycosides (e.g., digoxin) (increased risk of arrhythmias due to hypercalcemia)
Moderate Interactions
- Bile acid sequestrants (e.g., cholestyramine, colestipol) (decreased vitamin D absorption)
- Mineral oil (decreased vitamin D absorption)
- Orlistat (decreased vitamin D absorption)
- Corticosteroids (decreased vitamin D effects, increased vitamin D requirements)
- Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital) (increased vitamin D metabolism, leading to deficiency)
- Calcitonin (antagonistic effect on calcium levels)
Monitoring
Baseline Monitoring
Serum 25-hydroxyvitamin D [25(OH)D] levels
Rationale: To assess baseline vitamin D status and guide dosing.
Timing: Before initiating therapy.
Serum Calcium
Rationale: To assess baseline calcium status and monitor for hypercalcemia.
Timing: Before initiating therapy.
Serum Phosphate
Rationale: To assess baseline phosphate status.
Timing: Before initiating therapy.
Parathyroid Hormone (PTH)
Rationale: To assess secondary hyperparathyroidism due to vitamin D deficiency.
Timing: Before initiating therapy (optional, but recommended for deficiency).
Routine Monitoring
Serum 25-hydroxyvitamin D [25(OH)D] levels
Frequency: Every 3-6 months during repletion, then annually for maintenance.
Target: 30-100 ng/mL (75-250 nmol/L)
Action Threshold: If levels remain below target after adequate repletion, consider dose adjustment or malabsorption. If levels exceed 100 ng/mL, consider dose reduction.
Serum Calcium
Frequency: Monthly during repletion, then every 3-6 months for maintenance.
Target: 8.5-10.2 mg/dL (2.1-2.55 mmol/L)
Action Threshold: If levels exceed upper limit of normal, reduce or discontinue vitamin D and investigate hypercalcemia.
Serum Phosphate
Frequency: Monthly during repletion, then every 3-6 months for maintenance.
Target: 2.5-4.5 mg/dL (0.81-1.45 mmol/L)
Action Threshold: Monitor for significant changes.
Symptom Monitoring
- Nausea
- Vomiting
- Constipation
- Anorexia
- Fatigue
- Weakness
- Polyuria
- Polydipsia
- Confusion
- Muscle weakness
- Bone pain
- Kidney stones
Special Patient Groups
Pregnancy
Vitamin D is essential during pregnancy for maternal and fetal bone health. The recommended daily intake is 600 IU, but higher doses (up to 4,000 IU/day) are considered safe and often used to treat deficiency. Doses of 5,000 IU should be used under medical supervision, especially if serum levels are not monitored, due to the Category C classification for higher doses.
Trimester-Specific Risks:
First Trimester:
Essential for early fetal development; high doses should be used cautiously and with monitoring.
Second Trimester:
Important for fetal skeletal development; monitor serum levels if using higher doses.
Third Trimester:
Continues to be important for fetal bone mineralization; monitor for hypercalcemia with higher doses.
Lactation
Vitamin D is excreted into breast milk. Maternal supplementation with cholecalciferol can increase vitamin D levels in breast milk, potentially providing adequate vitamin D to the infant. Doses up to 6,400 IU/day have been shown to be safe and effective for mothers and infants. Higher doses (5,000 IU) are generally considered compatible with breastfeeding, but monitoring of maternal and infant vitamin D levels is prudent.
Infant Risk:
Low risk at recommended doses. High maternal doses could theoretically lead to infant hypercalcemia, but this is rare and typically requires extremely high maternal intake. Monitor infant for signs of hypercalcemia (e.g., poor feeding, vomiting, constipation).
Pediatric Use
Dosing for children varies significantly by age, weight, and the severity of deficiency. 5,000 IU is generally not a standard maintenance dose for children and should only be used for specific deficiency repletion under strict medical supervision and monitoring of serum 25(OH)D and calcium levels. Risk of toxicity is higher in children with excessive dosing.
Geriatric Use
Elderly individuals are at increased risk for vitamin D deficiency due to decreased skin synthesis, reduced dietary intake, and impaired renal 1-alpha-hydroxylation. Cholecalciferol is generally well-tolerated in this population. Higher doses like 5,000 IU are often appropriate for deficiency repletion. Monitoring of serum 25(OH)D, calcium, and renal function is important.
Clinical Information
Clinical Pearls
- Always take cholecalciferol with a meal containing fat to maximize absorption.
- Serum 25(OH)D is the best indicator of vitamin D status, not 1,25(OH)2D.
- Target 25(OH)D levels are generally 30-60 ng/mL (75-150 nmol/L) for optimal bone health and overall health.
- Patients with malabsorption syndromes (e.g., celiac disease, Crohn's disease, cystic fibrosis, bariatric surgery) may require higher doses of vitamin D.
- Consider co-administration with magnesium, as magnesium is a cofactor for vitamin D activation.
- Educate patients on symptoms of hypercalcemia to prevent toxicity.
Alternative Therapies
- Increased dietary intake of vitamin D-rich foods (fatty fish, fortified dairy/cereals).
- Controlled sun exposure.
- Calcium supplementation (often co-administered with vitamin D for bone health).
Cost & Coverage
Average Cost:
$5 - $25 per 30 tablets (5,000 IU)
Generic Available:
Yes
Insurance Coverage:
Often not covered by insurance as it's typically an over-the-counter supplement. May be covered if prescribed for a diagnosed deficiency and considered a medical necessity.
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'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 reporting the incident, be prepared to provide detailed information about the medication taken, the amount, and the time it occurred.