Vitamin D2 50,000iu (ergo) Cap Rx
It is used to treat poor parathyroid function.It is used to treat or prevent low phosphate levels.It is used to treat rickets.It may be given to you for other reasons. Talk with the doctor.
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?
Ergocalciferol, also known as Vitamin D2, is a form of vitamin D. It helps your body absorb calcium and phosphorus, which are essential for strong bones and teeth. This high-dose form is typically prescribed to treat severe vitamin D deficiency or certain medical conditions like hypoparathyroidism.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If you experience stomach upset, taking it with food may help. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom. Keep all medications in a safe place, out of 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. Instead, check with your pharmacist for guidance on proper disposal. You may also have access to local drug take-back programs.
Missing 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 a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If you experience stomach upset, taking it with food may help. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom. Keep all medications in a safe place, out of 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. Instead, check with your pharmacist for guidance on proper disposal. You may also have access to local drug take-back programs.
Missing 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 a missed one.
Lifestyle & Tips
- Take with food, preferably the largest meal of the day, to improve absorption as it is a fat-soluble vitamin.
- Do not take more than the prescribed dose. High doses can be harmful.
- Maintain a balanced diet rich in calcium and phosphorus.
- Discuss safe sun exposure with your doctor, as sunlight helps your body produce vitamin D naturally (though this medication provides a much higher dose than typical sun exposure).
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
50,000 IU orally once weekly for 8-12 weeks for Vitamin D deficiency (serum 25(OH)D < 20 ng/mL)
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, then maintenance.
Vitamin D Insufficiency (25(OH)D 20-30 ng/mL):
Often lower doses or less frequent 50,000 IU (e.g., every 2-4 weeks) or daily cholecalciferol.
Hypoparathyroidism:
50,000 to 200,000 IU orally daily, adjusted based on serum calcium and phosphorus levels.
Pediatric Dosing
Neonatal:
Not established for 50,000 IU; lower doses of Vitamin D are used for deficiency/rickets.
Infant:
Not established for 50,000 IU; lower doses of Vitamin D are used for deficiency/rickets.
Child:
Not established for routine use of 50,000 IU; highly individualized for severe deficiency or specific conditions (e.g., rickets, hypoparathyroidism) under specialist supervision. Doses typically range from 1,000-50,000 IU weekly/bi-weekly depending on age, weight, and severity.
Adolescent:
Similar to adult dosing for severe deficiency, but individualized based on weight and severity.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, but monitor calcium and phosphorus closely.
Severe:
Not recommended for severe renal impairment (CrCl < 30 mL/min) as conversion to active form (1,25(OH)2D) is impaired. Active vitamin D metabolites (e.g., calcitriol, paricalcitol) are preferred.
Dialysis:
Not recommended. Active vitamin D metabolites are preferred.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Use with caution; monitor vitamin D levels and calcium. Dose adjustment may be necessary if metabolism is significantly impaired.
Severe:
Use with caution; monitor vitamin D levels and calcium. Significant dose reduction or alternative therapy may be required due to impaired hydroxylation.
Pharmacology
Mechanism of Action
Ergocalciferol (Vitamin D2) is a fat-soluble vitamin that is metabolically inert and must be hydroxylated in the liver to 25-hydroxyvitamin D2 (calcidiol) and then in the kidneys to 1,25-dihydroxyvitamin D2 (calcitriol), the active form. Calcitriol acts as a hormone to regulate calcium and phosphate homeostasis. It promotes calcium and phosphate absorption from the small intestine, increases calcium and phosphate reabsorption in the renal tubules, and stimulates bone mineralization and remodeling. It also plays a role in immune function, cell growth, and neuromuscular function.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (approximately 50-80%), dependent on fat absorption.
Tmax:
Approximately 4-6 hours for parent compound; 2-3 days for 25(OH)D metabolite.
FoodEffect:
Enhanced absorption when taken with fatty meals.
Distribution:
Vd:
Large, distributed into adipose tissue.
ProteinBinding:
Highly protein-bound, primarily to vitamin D-binding protein (DBP).
CnssPenetration:
Limited
Elimination:
HalfLife:
Parent compound: 19-48 hours; 25(OH)D2: approximately 15-30 days; 1,25(OH)2D2: approximately 3-6 hours.
Clearance:
Not precisely quantified, but involves hepatic metabolism and biliary excretion.
ExcretionRoute:
Primarily fecal (biliary excretion), with some renal excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Effects on calcium and phosphorus levels may be seen within days to weeks.
PeakEffect:
Peak increase in 25(OH)D levels typically occurs within 1-2 weeks of initiation of weekly 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.
Confidence:
High
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
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 side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is 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
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 side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is 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, headache, bone pain, or kidney stones (severe back/side pain, blood in urine).
- Seek immediate medical attention if you experience severe symptoms.
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:
+ High calcium levels
+ High vitamin D levels
+ Malabsorption 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 provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) 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. This will help prevent potential interactions and ensure the safe use of this medication.
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:
+ High calcium levels
+ High vitamin D levels
+ Malabsorption 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 provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) 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. This will help prevent potential interactions and ensure the safe use of this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a known allergy to tartrazine (FD&C Yellow No. 5), consult your doctor, as some formulations of this drug may contain this ingredient.
Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. It is crucial to adhere to the prescribed dosage of this medication, as excessive levels of vitamin D in the body can lead to adverse effects. Be aware of the signs of vitamin D toxicity and discuss any concerns or questions with your doctor.
If you are taking additional sources of vitamin D, inform your doctor to avoid potential interactions. Follow the dietary plan recommended by your doctor to ensure safe and effective use of this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. A discussion about the benefits and risks of this medication to both you and your baby is necessary to make an informed decision.
Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. It is crucial to adhere to the prescribed dosage of this medication, as excessive levels of vitamin D in the body can lead to adverse effects. Be aware of the signs of vitamin D toxicity and discuss any concerns or questions with your doctor.
If you are taking additional sources of vitamin D, inform your doctor to avoid potential interactions. Follow the dietary plan recommended by your doctor to ensure safe and effective use of this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. A discussion about the benefits and risks of this medication to both you and your baby is necessary to make an informed decision.
Overdose Information
Overdose Symptoms:
- Severe hypercalcemia (calcium levels > 12 mg/dL)
- Nausea, vomiting, anorexia, constipation
- Polyuria, polydipsia, dehydration
- Muscle weakness, fatigue, lethargy, confusion, stupor, coma
- Cardiac arrhythmias
- Renal impairment (nephrocalcinosis, kidney stones, acute kidney injury)
- Soft tissue calcification (e.g., in kidneys, blood vessels, heart)
What to Do:
Immediately discontinue ergocalciferol and calcium supplements. Hydrate with intravenous saline. Consider loop diuretics (e.g., furosemide) to increase calcium excretion. In severe cases, calcitonin, bisphosphonates, or corticosteroids may be used. Hemodialysis may be necessary for life-threatening hypercalcemia. Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention.
Drug Interactions
Major Interactions
- Thiazide diuretics (e.g., hydrochlorothiazide): May increase risk of hypercalcemia due to decreased urinary calcium excretion.
- Digoxin: Hypercalcemia induced by vitamin D can potentiate the effects of digoxin, leading to cardiac arrhythmias.
- Mineral oil, Cholestyramine, Colestipol: May decrease absorption of vitamin D.
Moderate Interactions
- Anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine): May increase vitamin D metabolism, leading to decreased vitamin D levels and requiring higher doses.
- Corticosteroids: May decrease the effects of vitamin D by inhibiting calcium absorption and increasing calcium excretion.
- Orlistat: May decrease absorption of fat-soluble vitamins, including vitamin D.
Minor Interactions
- Aluminum-containing antacids: May increase serum aluminum levels, especially in patients with renal impairment, due to increased absorption.
Monitoring
Baseline Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Rationale: To establish baseline vitamin D status and guide dosing.
Timing: Prior to initiation of therapy.
Serum Calcium
Rationale: To assess baseline calcium levels and monitor for hypercalcemia.
Timing: Prior to initiation of therapy.
Serum Phosphorus
Rationale: To assess baseline phosphorus levels.
Timing: Prior to initiation of therapy.
Serum Parathyroid Hormone (PTH)
Rationale: To assess secondary hyperparathyroidism due to vitamin D deficiency.
Timing: Prior to initiation of therapy.
Renal Function (BUN, Creatinine, eGFR)
Rationale: To assess kidney function, as vitamin D metabolism and calcium excretion are influenced by renal health.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Frequency: After 8-12 weeks of therapy, then every 3-6 months or as clinically indicated.
Target: 30-60 ng/mL (optimal for most individuals).
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: Weekly or bi-weekly during initial high-dose therapy, then monthly or every 3-6 months.
Target: 8.5-10.2 mg/dL (normal range).
Action Threshold: If > 10.5 mg/dL (hypercalcemia), reduce dose or temporarily discontinue vitamin D and investigate cause. If severe (>12 mg/dL), seek urgent medical attention.
Serum Phosphorus
Frequency: Monthly or every 3-6 months.
Target: 2.5-4.5 mg/dL (normal range).
Action Threshold: Monitor for significant deviations, especially in hypoparathyroidism.
Renal Function (BUN, Creatinine, eGFR)
Frequency: Every 6-12 months, or more frequently if risk factors for renal impairment or hypercalcemia are present.
Target: Normal for age.
Action Threshold: Monitor for worsening renal function, which can be exacerbated by hypercalcemia.
Symptom Monitoring
- Symptoms of hypercalcemia: Nausea, vomiting, constipation, anorexia, polyuria, polydipsia, muscle weakness, fatigue, confusion, headache, bone pain, kidney stones.
- Symptoms of vitamin D toxicity: Persistent hypercalcemia, hypercalciuria, renal impairment, soft tissue calcification.
Special Patient Groups
Pregnancy
Pregnancy Category C. While vitamin D is essential during pregnancy, high doses of ergocalciferol (50,000 IU) should be used only if the potential benefit justifies the potential risk to the fetus. Excessive maternal vitamin D intake leading to hypercalcemia can cause fetal abnormalities, including supravalvular aortic stenosis, mental retardation, and growth retardation. Close monitoring of maternal calcium levels is crucial.
Trimester-Specific Risks:
First Trimester:
Risk of hypercalcemia-induced fetal abnormalities, though less data specifically for first trimester.
Second Trimester:
Risk of hypercalcemia-induced fetal abnormalities (e.g., supravalvular aortic stenosis) if maternal hypercalcemia occurs.
Third Trimester:
Risk of hypercalcemia-induced fetal abnormalities; potential for neonatal hypocalcemia if maternal hypercalcemia is prolonged.
Lactation
L3 (Moderately Safe). Ergocalciferol and its metabolites are excreted into breast milk. While generally considered safe at recommended doses for the mother, high doses (50,000 IU) should be used with caution. Monitor the infant for signs of hypercalcemia (e.g., poor feeding, vomiting, constipation, lethargy). The amount transferred to milk is usually not enough to cause toxicity in the infant, but excessive maternal dosing could theoretically lead to high infant levels.
Infant Risk:
Low risk of adverse effects at typical therapeutic doses. Potential for hypercalcemia in infant if maternal dose is excessive or if infant is also receiving high vitamin D supplementation.
Pediatric Use
High-dose ergocalciferol (50,000 IU) is generally not recommended for routine pediatric use due to the risk of toxicity. Dosing must be highly individualized by a specialist for severe deficiency or specific conditions (e.g., rickets, hypoparathyroidism) and requires careful monitoring of serum 25(OH)D, calcium, and phosphorus levels. Lower doses of vitamin D (e.g., cholecalciferol) are typically preferred for supplementation.
Geriatric Use
No specific dose adjustment is generally required based on age alone. However, geriatric patients may have impaired renal function, which can affect vitamin D metabolism and calcium excretion. They may also be more susceptible to hypercalcemia. Close monitoring of serum calcium, phosphorus, and renal function is recommended.
Clinical Information
Clinical Pearls
- Ergocalciferol (Vitamin D2) requires activation in the liver and kidneys. Cholecalciferol (Vitamin D3) is often preferred as it is considered more potent and effective at raising and maintaining 25(OH)D levels.
- 50,000 IU is a high dose typically used for initial repletion of severe vitamin D deficiency, not for daily maintenance.
- Always take with food, especially fatty meals, to maximize absorption.
- Regular monitoring of serum 25(OH)D, calcium, and phosphorus is crucial to prevent toxicity, especially with high doses.
- Patients with severe renal impairment should generally receive active vitamin D metabolites (e.g., calcitriol) rather than ergocalciferol, as their kidneys cannot adequately convert ergocalciferol to its active form.
- Educate patients on symptoms of hypercalcemia and the importance of not exceeding the prescribed dose.
Alternative Therapies
- Cholecalciferol (Vitamin D3): Often preferred for vitamin D repletion and maintenance due to potentially higher potency and longer duration of action.
- Calcitriol (1,25-dihydroxyvitamin D3): Active form of vitamin D, used primarily in patients with renal failure or hypoparathyroidism who cannot activate ergocalciferol.
- Paricalcitol, Doxercalciferol: Synthetic vitamin D analogs used in chronic kidney disease.
- Alfacalcidol: A vitamin D analog that only requires hepatic hydroxylation, useful in renal impairment.
Cost & Coverage
Average Cost:
$10 - $50 per 12 capsules (50,000 IU)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.