Decara 25000 IU D3 (chole) Capsules
It is used to treat or prevent vitamin D deficiency.
Drug Class
Vitamin; Nutritional Supplement
Pharmacologic Class
Vitamin D Analog; Fat-soluble Vitamin
Pregnancy Category
Category A (for recommended daily allowance); Category C (for doses exceeding recommended daily allowance)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cholecalciferol is Vitamin D3, 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. Decara 25000 IU D3 is a high-dose form used to correct low vitamin D levels.
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 daily. Make sure you understand the correct dosage 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, as the humidity and temperature can affect its potency. Keep all medications in a safe and 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 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 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, 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 daily. Make sure you understand the correct dosage 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, as the humidity and temperature can affect its potency. Keep all medications in a safe and 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 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 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 the largest meal of the day, to improve absorption.
- Ensure adequate dietary calcium intake (e.g., dairy products, fortified foods, leafy greens).
- Moderate sun exposure (10-15 minutes, 2-3 times per week, without sunscreen) can help the body produce its own vitamin D, but this should not replace supplementation if deficient.
- Avoid excessive sun exposure to prevent skin damage.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For severe deficiency (serum 25(OH)D < 10 ng/mL): 50,000 IU once weekly for 8-12 weeks, or 25,000 IU twice weekly for 8-12 weeks. For moderate deficiency (10-20 ng/mL): 50,000 IU once every 2-4 weeks. Maintenance: 600-2000 IU daily (or equivalent weekly/monthly dose). Decara 25000 IU D3 is typically used for deficiency correction.
Dose Range:
600 - 50000 mg
Condition-Specific Dosing:
deficiency_correction:
25,000 IU to 50,000 IU weekly for 8-12 weeks
maintenance:
600 IU to 2000 IU daily (or equivalent weekly/monthly)
Pediatric Dosing
Neonatal:
400 IU daily (preterm infants may require higher doses, consult guidelines)
Infant:
400 IU daily
Child:
600 IU daily (for deficiency, higher doses may be used under medical supervision, e.g., 2000 IU daily for 6 weeks)
Adolescent:
600 IU daily (for deficiency, higher doses may be used under medical supervision, e.g., 2000 IU daily for 6 weeks)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed. Monitor calcium and phosphate.
Severe:
Cholecalciferol may not be effectively converted to its active form (calcitriol) in severe renal impairment (eGFR < 30 mL/min/1.73m²). Active vitamin D analogs (e.g., calcitriol) are often preferred. Monitor calcium, phosphate, and PTH closely.
Dialysis:
Cholecalciferol is generally not removed by dialysis. Active vitamin D analogs are typically used for bone mineral disease in dialysis patients. Monitor calcium, phosphate, and PTH.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed. Monitor vitamin D levels and calcium.
Severe:
No specific adjustment needed, as 25-hydroxylation occurs in the liver, but significant liver disease may impair this process. Monitor vitamin D levels and calcium.
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 [25(OH)D, calcifediol] and then in the kidneys to the active form, 1,25-dihydroxyvitamin D [1,25(OH)2D, calcitriol]. Calcitriol acts as a hormone, primarily regulating calcium and phosphate homeostasis. It promotes calcium and phosphate absorption from the intestine, reabsorption in the kidneys, and mobilization from bone. It also plays a role in immune function, cell growth, and differentiation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-80% (highly variable, dependent on fat intake and bile salts)
Tmax:
Approximately 10-12 hours for cholecalciferol; 2-3 days for 25(OH)D
FoodEffect:
Enhanced absorption with fatty meals.
Distribution:
Vd:
Large (stored in adipose tissue and muscle)
ProteinBinding:
Approximately 50-80% (bound to vitamin D binding protein and albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Cholecalciferol: Approximately 24 hours; 25(OH)D: Approximately 15-30 days; 1,25(OH)2D: Approximately 4-6 hours
Clearance:
Not precisely quantified, but involves metabolic conversion and excretion.
ExcretionRoute:
Primarily biliary/fecal, with some renal excretion of metabolites.
Unchanged:
< 5%
Pharmacodynamics
OnsetOfAction:
Weeks to months for full effect on bone mineral density and serum 25(OH)D levels.
PeakEffect:
Serum 25(OH)D levels typically peak after 2-3 months of consistent dosing.
DurationOfAction:
Effects on serum 25(OH)D can persist for several weeks to months 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 immediately or seek emergency 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 concern 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 immediately or seek emergency 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 concern 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
- Loss of appetite
- Unusual tiredness or weakness
- Frequent urination
- Increased thirst
- Muscle pain
- Bone pain
- Confusion
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, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or allergies
Before starting, stopping, or changing the dose of any medication, including this one, 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, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or allergies
Before starting, stopping, or changing the dose of any medication, including this one, 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 immediately. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Hypercalcemia (high blood calcium levels)
- Nausea
- Vomiting
- Anorexia
- Constipation
- Polyuria
- Polydipsia
- Dehydration
- Weakness
- Fatigue
- Headache
- Metallic taste
- Nephrocalcinosis (calcium deposits in kidneys)
- Kidney stones
- Renal failure
- Cardiac arrhythmias
- Coma
What to Do:
Immediately discontinue cholecalciferol. Seek emergency medical attention. Management involves hydration, loop diuretics, and sometimes corticosteroids or bisphosphonates to lower calcium levels. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Thiazide diuretics (increased risk of hypercalcemia)
- Corticosteroids (may reduce vitamin D effects by impairing calcium absorption)
- Anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine - may increase vitamin D metabolism, leading to deficiency)
- 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)
- Digoxin (hypercalcemia due to vitamin D can potentiate digoxin toxicity)
Monitoring
Baseline Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Rationale: To assess baseline vitamin D status and guide dosing.
Timing: Before initiating high-dose cholecalciferol.
Serum Calcium
Rationale: To assess baseline calcium levels and monitor for hypercalcemia.
Timing: Before initiating treatment.
Serum Phosphate
Rationale: To assess baseline phosphate levels, as vitamin D affects phosphate homeostasis.
Timing: Before initiating treatment.
Parathyroid Hormone (PTH)
Rationale: To assess secondary hyperparathyroidism, which is often associated with vitamin D deficiency.
Timing: Before initiating treatment, especially in cases of severe deficiency or bone disease.
Routine Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Frequency: Every 3-6 months during active treatment for deficiency, then annually for maintenance.
Target: 30-100 ng/mL (75-250 nmol/L)
Action Threshold: If levels remain below target, consider dose adjustment. If levels exceed 100 ng/mL, consider dose reduction or temporary cessation.
Serum Calcium
Frequency: Monthly for the first 3 months during high-dose therapy, 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 calcium levels rise above the upper limit of normal, reduce dose or discontinue cholecalciferol and investigate for hypercalcemia.
Serum Phosphate
Frequency: Every 3-6 months or as clinically indicated.
Target: 2.5-4.5 mg/dL (0.81-1.45 mmol/L)
Action Threshold: Significant deviations may require further investigation.
Symptom Monitoring
- Nausea
- Vomiting
- Constipation
- Anorexia
- Fatigue
- Muscle weakness
- Polyuria
- Polydipsia
- Confusion
- Headache
- Metallic taste
Special Patient Groups
Pregnancy
Vitamin D is essential during pregnancy for maternal and fetal bone health. The recommended daily allowance (RDA) is 600 IU. Higher doses (e.g., 2000-4000 IU daily) may be used to treat deficiency under medical supervision. Excessive doses should be avoided due to potential risks of hypercalcemia in the mother and fetus.
Trimester-Specific Risks:
First Trimester:
Essential for early fetal development; deficiency can impact later bone health.
Second Trimester:
Continued importance for fetal skeletal development.
Third Trimester:
Crucial for fetal bone mineralization and maternal vitamin D stores for lactation.
Lactation
Cholecalciferol is compatible with breastfeeding. The RDA for lactating women is 600 IU. Higher doses (e.g., 2000-4000 IU daily) can be used to treat maternal deficiency and increase vitamin D levels in breast milk, which is important for the infant. Monitor infant for signs of hypercalcemia if very high maternal doses are used, though this is rare.
Infant Risk:
Low risk at recommended doses. High maternal doses (e.g., >10,000 IU/day) may rarely lead to elevated infant vitamin D levels, but hypercalcemia is uncommon.
Pediatric Use
Essential for bone growth and development. Dosing varies by age and indication (prevention vs. treatment of deficiency). Infants exclusively breastfed should receive 400 IU daily. High doses like 25,000 IU are typically reserved for severe deficiency and administered under strict medical supervision, often as a single or weekly dose.
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. Supplementation is often necessary. Dosing may be similar to adults, but careful monitoring of calcium and 25(OH)D levels is important due to potential for polypharmacy and comorbidities.
Clinical Information
Clinical Pearls
- Cholecalciferol (D3) is generally preferred over ergocalciferol (D2) as it is more potent and effective at raising and maintaining serum 25(OH)D levels.
- Always take cholecalciferol with a meal containing fat to maximize absorption.
- High doses like 25,000 IU are typically prescribed for weekly or bi-weekly administration to correct significant deficiency, not for daily maintenance.
- Regular monitoring of serum 25(OH)D, calcium, and phosphate is crucial, especially during high-dose therapy, to prevent hypercalcemia.
- Patients with malabsorption syndromes (e.g., cystic fibrosis, Crohn's disease, bariatric surgery) may require higher doses and more frequent monitoring.
- Consider the total daily intake of vitamin D from all sources (diet, fortified foods, other supplements) to avoid excessive intake.
Alternative Therapies
- Ergocalciferol (Vitamin D2)
- Calcitriol (active vitamin D analog, used in renal failure or hypoparathyroidism)
- Paricalcitol (active vitamin D analog)
- Doxercalciferol (active vitamin D analog)
Cost & Coverage
Average Cost:
Varies widely per capsule/tablet
Generic Available:
Yes
Insurance Coverage:
Often covered by insurance if prescribed for a diagnosed deficiency, but may be considered OTC/supplement and not covered. Coverage varies by plan.
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 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 medication taken, the amount, and the time it happened.