Vitamin D3 1.25mg Capsules
It is used to treat or prevent vitamin D deficiency.
Drug Class
Vitamin; Nutritional Supplement; Bone Health Agent
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 vitamin that helps your body absorb calcium and phosphorus, which are essential for strong bones and teeth. It also plays a role in muscle function and the immune system. This high-dose capsule is typically used to treat significant vitamin D deficiency.
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 every day. Make sure you understand your medication 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 your medication in a bathroom. Keep all medications in a safe 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 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 dose, skip the missed dose and return to your regular 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 every day. Make sure you understand your medication 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 your medication in a bathroom. Keep all medications in a safe 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 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 dose, skip the missed dose and return to your regular 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 the largest meal of the day, to improve absorption.
- Do not exceed the prescribed dose without consulting your doctor.
- Maintain a balanced diet rich in calcium and phosphorus.
- Regular, moderate sun exposure can help your body produce vitamin D, but do not rely solely on it, especially if you have a deficiency.
- Report any symptoms of high calcium (nausea, vomiting, constipation, excessive thirst/urination, muscle weakness) to your doctor immediately.
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 Vitamin D deficiency (serum 25(OH)D < 20 ng/mL): 50,000 IU (1.25 mg) orally once weekly for 8-12 weeks, or until 25(OH)D levels are normalized.
Dose Range:
50000 - 50000 mg
Condition-Specific Dosing:
Vitamin D Deficiency:
50,000 IU (1.25 mg) orally once weekly for 8-12 weeks.
Maintenance (after deficiency correction):
Typically 600-2000 IU daily, but higher doses (e.g., 50,000 IU monthly) may be used in some cases, especially with malabsorption or specific medical conditions, under medical supervision.
Pediatric Dosing
Neonatal:
Not established for 1.25mg (50,000 IU) capsules. Routine supplementation is typically 400 IU daily.
Infant:
Not established for 1.25mg (50,000 IU) capsules. Routine supplementation is typically 400 IU daily. High doses (e.g., 50,000 IU) are only for severe deficiency under strict medical supervision.
Child:
Not established for 1.25mg (50,000 IU) capsules. High doses (e.g., 50,000 IU) are only for severe deficiency (e.g., rickets) under strict medical supervision, typically 50,000 IU weekly for 6-8 weeks.
Adolescent:
For severe deficiency: 50,000 IU (1.25 mg) orally once weekly for 8-12 weeks, or until 25(OH)D levels are normalized, under medical supervision.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required for cholecalciferol.
Moderate:
No specific adjustment typically required for cholecalciferol, but monitor calcium and phosphate levels closely.
Severe:
Use with caution. Cholecalciferol may not be effectively converted to its active form (calcitriol) in severe renal impairment. Active vitamin D analogs (e.g., calcitriol) may be preferred. Monitor calcium, phosphate, and PTH.
Dialysis:
Use with caution. Cholecalciferol may not be effectively converted. Active vitamin D analogs are generally preferred. Monitor calcium, phosphate, and PTH.
Hepatic Impairment:
Mild:
No specific adjustment.
Moderate:
No specific adjustment, but monitor 25(OH)D levels as hepatic 25-hydroxylation may be impaired.
Severe:
Use with caution. Hepatic 25-hydroxylation may be significantly impaired, reducing conversion to calcifediol. Monitor 25(OH)D levels and consider alternative forms if levels do not rise adequately.
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 or 25(OH)D), and then further hydroxylated in the kidneys to 1,25-dihydroxyvitamin D (calcitriol or 1,25(OH)2D), the biologically active form of vitamin D. Calcitriol acts as a hormone, binding to the vitamin D receptor (VDR) in target tissues. This binding regulates gene expression, primarily promoting intestinal absorption of calcium and phosphate, maintaining serum calcium and phosphate concentrations, and supporting bone mineralization. It also plays roles in immune function, cell growth, and neuromuscular function.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable, generally good (approx. 50-80%) when taken with fatty meals.
Tmax:
Cholecalciferol: 4-6 hours; 25(OH)D (calcifediol): 24-48 hours.
FoodEffect:
Absorption is significantly enhanced when taken with a fatty meal.
Distribution:
Vd:
Not readily quantifiable due to extensive storage in adipose tissue and muscle.
ProteinBinding:
Cholecalciferol: Highly bound to vitamin D-binding protein (DBP) and albumin. 25(OH)D: >99% bound to DBP.
CnssPenetration:
Limited
Elimination:
HalfLife:
Cholecalciferol: Approximately 24 hours. Calcifediol (25(OH)D): 2-3 weeks (reflects body stores). Calcitriol (1,25(OH)2D): 4-6 hours.
Clearance:
Not readily quantifiable due to complex metabolism and storage.
ExcretionRoute:
Primarily biliary/fecal, with a small amount of metabolites excreted renally.
Unchanged:
Negligible amount excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Slow (weeks to months for significant increase in 25(OH)D levels and clinical effects due to storage and metabolic activation).
PeakEffect:
Peak serum 25(OH)D levels typically achieved after 2-3 months of consistent dosing.
DurationOfAction:
Prolonged (months) due to storage in adipose tissue and slow elimination of 25(OH)D.
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 advice.
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 advice.
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:
- Nausea
- Vomiting
- Constipation
- Abdominal pain
- Loss of appetite
- Excessive thirst (polydipsia)
- Frequent urination (polyuria)
- Muscle weakness
- Fatigue
- Confusion
- Headache
- Metallic taste
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
Please note that this list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, inform your doctor and pharmacist about all the medications you are taking, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
It is vital to verify that it is safe to take this medication with all your existing drugs and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
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
Please note that this list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, inform your doctor and pharmacist about all the medications you are taking, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
It is vital to verify that it is safe to take this medication with all your existing drugs and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
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 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 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 (as listed above)
- Kidney damage (nephrocalcinosis, kidney stones)
- Cardiac arrhythmias
- Soft tissue calcification
What to Do:
Discontinue vitamin D, restrict calcium intake, ensure adequate hydration. In severe cases, medical intervention (e.g., IV fluids, loop diuretics, corticosteroids, bisphosphonates) may be required. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Contraindicated Interactions
- Hypercalcemia (pre-existing)
Major Interactions
- Thiazide diuretics (increased risk of hypercalcemia)
- Digoxin (increased risk of cardiac arrhythmias with hypercalcemia)
Moderate Interactions
- Anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine - may increase vitamin D metabolism, reducing efficacy)
- Corticosteroids (may reduce vitamin D effects and calcium absorption)
- Bile acid sequestrants (e.g., cholestyramine, colestipol - may impair vitamin D absorption)
- Mineral oil (may impair vitamin D absorption)
- Orlistat (may impair vitamin D absorption)
Minor Interactions
- Aluminum-containing antacids (increased risk of hyperaluminemia in renal failure)
Monitoring
Baseline Monitoring
Serum 25-hydroxyvitamin D (25(OH)D)
Rationale: To assess baseline vitamin D status and confirm deficiency.
Timing: Before initiating therapy.
Serum Calcium
Rationale: To assess baseline calcium levels and identify pre-existing hypercalcemia.
Timing: Before initiating therapy.
Serum Phosphate
Rationale: To assess baseline phosphate levels.
Timing: Before initiating therapy.
Parathyroid Hormone (PTH)
Rationale: To assess secondary hyperparathyroidism associated with vitamin D deficiency.
Timing: Before initiating therapy (optional, but recommended in deficiency).
Renal Function (SCr, eGFR)
Rationale: To assess kidney function, which is crucial for vitamin D metabolism and calcium excretion.
Timing: Before initiating therapy.
Routine Monitoring
Serum 25-hydroxyvitamin D (25(OH)D)
Frequency: After 8-12 weeks of treatment, then every 3-6 months or as clinically indicated.
Target: 30-100 ng/mL (75-250 nmol/L) for sufficiency.
Action Threshold: If levels remain below target, consider dose adjustment or investigate malabsorption. If levels exceed 100 ng/mL, reduce or hold dose.
Serum Calcium
Frequency: After 8-12 weeks of treatment, then every 3-6 months or as clinically indicated.
Target: 8.5-10.2 mg/dL (2.1-2.55 mmol/L).
Action Threshold: If elevated (>10.5 mg/dL), reduce or hold dose, investigate cause of hypercalcemia.
Serum Phosphate
Frequency: After 8-12 weeks of treatment, then every 3-6 months or as clinically indicated.
Target: 2.5-4.5 mg/dL (0.81-1.45 mmol/L).
Action Threshold: If significantly elevated, investigate cause.
Symptom Monitoring
- Symptoms of hypercalcemia: nausea, vomiting, constipation, abdominal pain, polyuria, polydipsia, muscle weakness, fatigue, confusion, headache, anorexia, metallic taste.
- Symptoms of kidney stones: flank pain, hematuria.
Special Patient Groups
Pregnancy
Vitamin D is essential during pregnancy for maternal and fetal bone health. However, excessive doses can be harmful. While 50,000 IU weekly may be used to treat severe deficiency under medical supervision, routine supplementation should follow recommended daily allowances. Historically, classified as Category C; high doses may be considered Category D.
Trimester-Specific Risks:
First Trimester:
Essential for early fetal development. High doses should be used only if clearly indicated for severe deficiency, with careful monitoring.
Second Trimester:
Continued need for bone development. Monitor levels and calcium.
Third Trimester:
Important for fetal bone mineralization and maternal stores. Monitor levels and calcium.
Lactation
Cholecalciferol is excreted in breast milk in small amounts. It is generally considered compatible with breastfeeding at recommended doses. High doses (50,000 IU) used for maternal deficiency treatment are generally safe for the infant, as transfer to milk is limited and unlikely to cause toxicity in the infant. Monitor infant's vitamin D status if concerns arise.
Infant Risk:
Low risk at therapeutic maternal doses. Infant may receive some vitamin D through breast milk, but direct infant supplementation (e.g., 400 IU daily) is often still recommended.
Pediatric Use
High doses (1.25mg or 50,000 IU) are generally not for routine pediatric use. They are reserved for the treatment of severe vitamin D deficiency (e.g., rickets) under strict medical supervision, with specific dosing regimens based on age and severity. Routine pediatric supplementation is typically 400-600 IU daily.
Geriatric Use
Elderly patients are at higher risk for vitamin D deficiency due to decreased skin synthesis, reduced dietary intake, and potential malabsorption. Cholecalciferol is generally well-tolerated in this population. No specific dose adjustment is typically required beyond adult dosing, but monitoring for hypercalcemia is important, especially in those with impaired renal function.
Clinical Information
Clinical Pearls
- 1.25 mg of cholecalciferol is equivalent to 50,000 International Units (IU). This is a high dose typically used for treating significant vitamin D deficiency, not for daily maintenance.
- Always take cholecalciferol with a meal containing fat to maximize absorption.
- Regular monitoring of serum 25(OH)D, calcium, and phosphate levels is crucial during high-dose therapy to ensure efficacy and prevent toxicity.
- Cholecalciferol (D3) is generally preferred over ergocalciferol (D2) for raising and maintaining vitamin D levels, as it is more potent and has a longer duration of action.
- Educate patients on symptoms of hypercalcemia to ensure prompt reporting.
- Consider underlying causes of vitamin D deficiency (e.g., malabsorption, chronic kidney disease, certain medications) and address them if possible.
Alternative Therapies
- Ergocalciferol (Vitamin D2) - less potent and shorter duration than D3.
- Calcitriol (1,25-dihydroxyvitamin D) - active form, used in severe renal disease or hypoparathyroidism.
- Calcifediol (25-hydroxyvitamin D) - used in liver disease or severe renal impairment.
Cost & Coverage
Average Cost:
$10 - $50 per 30 capsules (50,000 IU)
Generic Available:
Yes
Insurance Coverage:
Often covered by insurance, especially for documented deficiency, typically 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 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 details about the overdose, including the medication taken, the amount, and the time it occurred.