Decara 50000 IU D3 (chole) Capsules
It is used to treat or prevent vitamin D deficiency.
Drug Class
Vitamin, Nutritional Supplement
Pharmacologic Class
Fat-soluble vitamin; Vitamin D analog
Pregnancy Category
Category C (for doses exceeding the recommended daily allowance)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cholecalciferol, also known as Vitamin D3, is a vital nutrient that helps your body absorb calcium and phosphorus, which are essential for strong bones and teeth. It also plays a role in muscle function, nerve signaling, and immune health. This high-dose capsule is typically prescribed to correct a significant 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 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.
It's also important to note that some strengths of this medication may not be taken daily. Make sure you understand your 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 moisture. Keep it in a dry place, away from bathrooms, and out of reach of children and pets. When you're finished with your medication or it's expired, dispose of it properly. 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 guidance on 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 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.
It's also important to note that some strengths of this medication may not be taken daily. Make sure you understand your 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 moisture. Keep it in a dry place, away from bathrooms, and out of reach of children and pets. When you're finished with your medication or it's expired, dispose of it properly. 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 guidance on 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 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 your largest meal of the day or a meal containing fat to improve absorption.
- Do not take more than prescribed, as excessive vitamin D can be harmful.
- Maintain a balanced diet rich in calcium and phosphorus.
- Moderate sun exposure (10-15 minutes, 2-3 times per week) can help your body produce vitamin D, but this capsule is for deficiency correction and should not be replaced by sun exposure alone.
- Inform your doctor about all other medications and supplements you are taking.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For severe deficiency: 50,000 IU orally once weekly for 8-12 weeks, then maintenance.
Dose Range:
50000 - 50000 mg
Condition-Specific Dosing:
Vitamin D Deficiency (25(OH)D < 20 ng/mL):
50,000 IU orally once weekly for 8-12 weeks, or 50,000 IU orally every other week for 8-12 weeks, followed by maintenance dosing (e.g., 1,000-2,000 IU daily).
Maintenance (after repletion):
Not typically 50,000 IU; usually 1,000-2,000 IU daily or 50,000 IU monthly/bi-monthly.
Pediatric Dosing
Neonatal:
Not established for 50,000 IU. Standard prophylaxis is 400 IU daily.
Infant:
Not established for 50,000 IU. Standard prophylaxis is 400 IU daily. For deficiency, lower doses (e.g., 1,000-2,000 IU daily) are used under medical supervision.
Child:
Not established for 50,000 IU. For deficiency, doses like 2,000-4,000 IU daily or 50,000 IU every 2-4 weeks may be used under medical supervision.
Adolescent:
For severe deficiency, similar to adult dosing (50,000 IU weekly for 6-8 weeks) may be considered under medical supervision.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, but monitor serum calcium and phosphate.
Moderate:
No specific adjustment needed, but monitor serum calcium and phosphate closely. Cholecalciferol requires renal 1-alpha-hydroxylation for full activation, which may be impaired in advanced renal disease.
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) are often preferred. Monitor serum calcium, phosphate, and PTH.
Dialysis:
Use with caution. Active vitamin D analogs are generally preferred. Monitor serum calcium, phosphate, and PTH closely.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, but monitor serum calcium and phosphate. Impaired bile flow may reduce absorption.
Severe:
No specific adjustment needed, but monitor serum calcium and phosphate. Impaired bile flow may significantly reduce absorption.
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 1,25-dihydroxyvitamin D [1,25(OH)2D, calcitriol], the active form. Calcitriol acts as a hormone, binding to vitamin D receptors (VDRs) in target tissues. Its primary role is to maintain calcium and phosphate homeostasis by promoting intestinal absorption of calcium and phosphate, regulating bone remodeling, and influencing renal reabsorption of calcium and phosphate. It also plays roles in immune function, cell growth, and differentiation.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable, depends on diet, fat intake, and gastrointestinal health. Approximately 50-80% from dietary sources.
Tmax:
Approximately 10-24 hours for 25(OH)D after a single oral dose of cholecalciferol.
FoodEffect:
Absorption is significantly enhanced when taken with a fatty meal due to its fat-soluble nature and requirement for bile salts.
Distribution:
Vd:
Large, as it is stored in adipose tissue and muscle.
ProteinBinding:
Approximately 88% bound to vitamin D-binding protein (DBP) and 12% to albumin.
CnssPenetration:
Limited, but vitamin D receptors are present in the brain.
Elimination:
HalfLife:
Terminal half-life of 25(OH)D is approximately 15-30 days. Half-life of 1,25(OH)2D is 4-6 hours.
Clearance:
Not precisely quantified for cholecalciferol itself, but its metabolites are cleared via hepatic and renal pathways.
ExcretionRoute:
Primarily fecal (biliary excretion), with a small amount excreted renally.
Unchanged:
Negligible amount of unchanged cholecalciferol is excreted.
Pharmacodynamics
OnsetOfAction:
Effects on serum 25(OH)D levels are seen within days to weeks.
PeakEffect:
Peak serum 25(OH)D levels typically reached within 1-3 months of consistent dosing.
DurationOfAction:
Due to storage in adipose tissue and the long half-life of 25(OH)D, effects can persist for several weeks to months after discontinuation of high-dose therapy.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to contact your doctor or seek medical help if you have any side effects that bother you or do not go away. Not all possible side effects are listed here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice about side effects.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to contact your doctor or seek medical help if you have any side effects that bother you or do not go away. Not all possible side effects are listed here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice about 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, kidney stones.
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
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, 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 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
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, 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:
- Severe hypercalcemia (calcium levels > 12 mg/dL)
- Nausea, vomiting, abdominal pain
- Constipation or diarrhea
- Polyuria (frequent urination), polydipsia (excessive thirst)
- Muscle weakness, fatigue, lethargy
- Confusion, disorientation, stupor, coma
- Cardiac arrhythmias
- Kidney damage (nephrocalcinosis, kidney stones)
- Bone demineralization (paradoxical effect with chronic toxicity)
What to Do:
Immediately discontinue vitamin D and calcium supplements. Seek emergency medical attention. Treatment involves hydration (intravenous saline), loop diuretics (e.g., furosemide) to promote calcium excretion, calcitonin, bisphosphonates, or corticosteroids in severe cases. Monitor serum calcium, phosphate, and renal function. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Contraindicated Interactions
- Hypercalcemia
- Vitamin D toxicity
Major Interactions
- Thiazide diuretics (e.g., hydrochlorothiazide): May increase risk of hypercalcemia due to reduced urinary calcium excretion.
- Digoxin: Hypercalcemia induced by vitamin D can potentiate the effects of digoxin, leading to cardiac arrhythmias.
- Orlistat: May reduce absorption of fat-soluble vitamins, including vitamin D.
- Cholestyramine, Colestipol: May reduce absorption of fat-soluble vitamins, including vitamin D.
Moderate Interactions
- Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital): May increase vitamin D metabolism, leading to lower 25(OH)D levels and potentially requiring higher vitamin D doses.
- Corticosteroids: May reduce calcium absorption and impair vitamin D metabolism, potentially increasing vitamin D requirements.
- Mineral oil: May reduce absorption of fat-soluble vitamins, including vitamin D.
Minor Interactions
- Not many clinically significant minor interactions beyond those affecting absorption or metabolism.
Monitoring
Baseline Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Rationale: To assess baseline vitamin D status and confirm deficiency.
Timing: Before initiating high-dose therapy.
Serum Calcium
Rationale: To assess for pre-existing hypercalcemia and establish a baseline for monitoring toxicity.
Timing: Before initiating therapy.
Serum Phosphate
Rationale: To assess baseline phosphate levels, as vitamin D affects phosphate homeostasis.
Timing: Before initiating therapy.
Parathyroid Hormone (PTH)
Rationale: To assess for secondary hyperparathyroidism, which is often associated with vitamin D deficiency.
Timing: Before initiating therapy (optional, but recommended for deficiency).
Routine Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Frequency: After 8-12 weeks of repletion therapy, then annually or as clinically indicated for maintenance.
Target: 30-100 ng/mL (75-250 nmol/L)
Action Threshold: If levels remain below target, consider dose adjustment or investigate malabsorption. If levels exceed 100 ng/mL, consider dose reduction or temporary cessation.
Serum Calcium
Frequency: After 8-12 weeks of repletion therapy, then every 3-6 months during maintenance, or as clinically indicated.
Target: 8.5-10.2 mg/dL (2.1-2.55 mmol/L)
Action Threshold: If levels exceed upper limit of normal, reduce or stop vitamin D and investigate for hypercalcemia.
Serum Phosphate
Frequency: After 8-12 weeks of repletion therapy, then annually or as clinically indicated.
Target: 2.5-4.5 mg/dL (0.81-1.45 mmol/L)
Action Threshold: Monitor for significant changes, especially hyperphosphatemia in renal impairment.
Symptom Monitoring
- Symptoms of hypercalcemia: nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, fatigue, confusion, bone pain, kidney stones.
Special Patient Groups
Pregnancy
Vitamin D is essential during pregnancy for maternal and fetal bone health. However, high doses (like 50,000 IU) should only be used to treat documented deficiency under medical supervision. Excessive vitamin D intake during pregnancy can lead to hypercalcemia in the mother, which may be associated with fetal risks (e.g., supravalvular aortic stenosis, mental retardation).
Trimester-Specific Risks:
First Trimester:
Essential for early fetal development. High doses only for deficiency.
Second Trimester:
Continued importance for fetal skeletal development. Monitor calcium levels with high doses.
Third Trimester:
Crucial for fetal bone mineralization. Risk of maternal hypercalcemia and potential fetal effects with excessive dosing.
Lactation
Cholecalciferol is excreted into breast milk. It is generally considered compatible with breastfeeding at recommended daily allowances. High doses (50,000 IU) should be used with caution and under medical supervision, as excessive amounts in breast milk could potentially lead to hypercalcemia in the infant. Monitor infant's calcium levels if mother is on high-dose therapy.
Infant Risk:
Low risk at typical doses. Potential for hypercalcemia in infant with very high maternal doses, though rare.
Pediatric Use
High doses like 50,000 IU are generally not recommended for routine pediatric use and should only be administered for severe, documented deficiency under strict medical supervision due to the risk of toxicity. Dosing must be carefully individualized based on age, weight, and severity of deficiency. Standard pediatric supplementation is much lower (e.g., 400-600 IU daily).
Geriatric Use
Elderly individuals are at increased risk of vitamin D deficiency due to reduced skin synthesis, decreased dietary intake, and potential malabsorption. They often require supplementation. High doses like 50,000 IU are commonly used to correct deficiency. Monitor for hypercalcemia, especially if co-morbidities or interacting medications are present.
Clinical Information
Clinical Pearls
- Cholecalciferol (Vitamin D3) is generally preferred over ergocalciferol (Vitamin D2) for repletion due to its higher potency and longer duration of action in raising 25(OH)D levels.
- Always take high-dose vitamin D with a meal containing fat to maximize absorption.
- Regular monitoring of serum 25(OH)D and calcium levels is crucial during high-dose therapy to prevent toxicity.
- Patients with malabsorption syndromes (e.g., celiac disease, Crohn's disease, bariatric surgery) may require higher doses or alternative formulations (e.g., intramuscular injections) for effective repletion.
- Consider underlying causes of vitamin D deficiency (e.g., inadequate sun exposure, dietary intake, malabsorption, renal/hepatic dysfunction) and address them if possible.
Alternative Therapies
- Ergocalciferol (Vitamin D2) capsules/tablets
- Calcitriol (active vitamin D analog, used in renal disease or hypoparathyroidism)
- Alfacalcidol (active vitamin D analog)
- Sun exposure (natural production)
- Dietary sources (fatty fish, fortified foods)
Cost & Coverage
Average Cost:
$10 - $50 per 30 capsules (50,000 IU)
Generic Available:
Yes
Insurance Coverage:
Often covered by most prescription drug plans, especially for documented deficiency, but may require prior authorization for high doses or be considered an over-the-counter supplement.
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 your medication, don't hesitate to reach out to 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 occurred.