Drisdol 50,000 IU (d2, Ergo) Caps
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 D analog
Pharmacologic Class
Vitamin D analog; Fat-soluble vitamin
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ergocalciferol is a form of vitamin D (D2) that helps your body absorb calcium and phosphorus, which are essential for strong bones and overall health. It's used to treat and prevent vitamin D deficiency and certain bone conditions.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, but if it causes stomach upset, take it with food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store the medication at room temperature, away from light and moisture. Keep it in a dry place, avoiding storage in a bathroom. Ensure that all medications are kept in a safe 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. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to check if there are any drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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 use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, but if it causes stomach upset, take it with food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store the medication at room temperature, away from light and moisture. Keep it in a dry place, avoiding storage in a bathroom. Ensure that all medications are kept in a safe 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. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to check if there are any drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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 food, preferably the largest meal of the day, to improve absorption.
- 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 it also contributes to vitamin D production.
- Avoid taking mineral oil or certain cholesterol-lowering medications (like cholestyramine) at the same time as ergocalciferol, as they can reduce its absorption. Separate doses by several hours if necessary.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly based on indication and baseline vitamin D levels.
Condition-Specific Dosing:
Vitamin D Deficiency (severe):
50,000 IU orally once weekly for 8-12 weeks, then maintenance.
Hypoparathyroidism:
50,000 to 200,000 IU orally daily, adjusted based on serum calcium and phosphate levels.
Vitamin D-Resistant Rickets:
12,000 to 500,000 IU orally daily, adjusted based on clinical response and biochemical parameters.
Pediatric Dosing
Neonatal:
Not established for routine use; specific conditions like rickets may require individualized dosing.
Infant:
Nutritional Rickets: 1,600 to 5,000 IU orally daily for 2-3 months, then maintenance. Hypoparathyroidism: Individualized.
Child:
Nutritional Rickets: 1,600 to 5,000 IU orally daily for 2-3 months, then maintenance. Hypoparathyroidism: Individualized.
Adolescent:
Similar to adult dosing for deficiency or specific conditions, individualized.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment, but monitor calcium and phosphate levels closely.
Moderate:
No specific dose adjustment, but monitor calcium and phosphate levels closely. Use with caution.
Severe:
Ergocalciferol may be less effective in severe renal impairment due to impaired 1-alpha-hydroxylation. Active vitamin D analogs (e.g., calcitriol) are often preferred. Monitor closely.
Dialysis:
Ergocalciferol is generally not recommended for patients on dialysis with chronic kidney disease-mineral and bone disorder (CKD-MBD) due to impaired activation. Active vitamin D analogs are preferred. Monitor calcium and phosphate levels.
Hepatic Impairment:
Mild:
No specific dose adjustment.
Moderate:
No specific dose adjustment, but monitor vitamin D levels and calcium/phosphate, as hepatic 25-hydroxylation may be impaired.
Severe:
No specific dose adjustment, but monitor vitamin D levels and calcium/phosphate, as hepatic 25-hydroxylation may be significantly impaired.
Pharmacology
Mechanism of Action
Ergocalciferol (Vitamin D2) is a fat-soluble vitamin that is metabolized in the liver to 25-hydroxyvitamin D2 (calcifediol) 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 intestinal absorption of calcium and phosphate, stimulates bone resorption to release calcium and phosphate into the blood, and inhibits parathyroid hormone (PTH) secretion. It also plays a role in renal reabsorption of calcium and phosphate.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, depends on fat absorption; generally well absorbed from the small intestine in the presence of bile salts.
Tmax:
Approximately 4-5 hours for parent compound; peak serum 25(OH)D2 levels occur within 2-3 days.
FoodEffect:
Absorption is enhanced when taken with fatty meals.
Distribution:
Vd:
Large, as it is fat-soluble and stored in adipose tissue and muscle.
ProteinBinding:
Highly protein-bound, primarily to vitamin D-binding protein (DBP).
CnssPenetration:
Limited
Elimination:
HalfLife:
Parent compound: relatively short (hours). 25-hydroxyvitamin D2: approximately 15-30 days. 1,25-dihydroxyvitamin D2: approximately 4-6 hours.
Clearance:
Not readily quantifiable for the parent compound due to extensive metabolism and storage.
ExcretionRoute:
Primarily biliary/fecal, with some renal excretion of metabolites.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Days to weeks for significant changes in serum 25(OH)D levels.
PeakEffect:
Weeks to months for full therapeutic effect on calcium homeostasis.
DurationOfAction:
Weeks to months, due to storage in adipose tissue and long half-life of 25(OH)D metabolite.
Safety & Warnings
Side Effects
Important Safety Information: Potential Side Effects
While taking this medication, it's essential to be aware of possible side effects. Although rare, some individuals may experience severe and potentially life-threatening reactions. If you notice any of the following symptoms, 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Additional 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 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. For medical advice about side effects, you can also contact your doctor.
Reporting Side Effects
You can report any side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While taking this medication, it's essential to be aware of possible side effects. Although rare, some individuals may experience severe and potentially life-threatening reactions. If you notice any of the following symptoms, 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Additional 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 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. For medical advice about side effects, you can also contact your doctor.
Reporting Side Effects
You can report any 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:
- Signs of too much vitamin D (hypercalcemia): nausea, vomiting, constipation, loss of appetite, unusual thirst, increased urination, muscle weakness, fatigue, confusion, bone pain, or kidney stones (back pain, blood in urine).
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, any of 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 disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of 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 disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
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 with 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, such as supplements or fortified foods, inform your doctor to avoid excessive intake. 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 breastfeeding, consult with your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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, such as supplements or fortified foods, inform your doctor to avoid excessive intake. 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 breastfeeding, consult with your doctor 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, anorexia, constipation
- Polyuria, polydipsia, dehydration
- Muscle weakness, fatigue, lethargy
- Confusion, stupor, coma
- Cardiac arrhythmias
- Kidney damage (nephrocalcinosis, renal failure)
What to Do:
Discontinue ergocalciferol immediately. Hydration with intravenous saline. Loop diuretics (e.g., furosemide) may be used to increase calcium excretion. Calcitonin or bisphosphonates may be used in severe cases. Monitor serum calcium, phosphate, and renal function closely. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Cardiac glycosides (e.g., digoxin): Increased risk of arrhythmias due to hypercalcemia.
- Thiazide diuretics (e.g., hydrochlorothiazide): Increased risk of hypercalcemia due to decreased calcium excretion.
Moderate Interactions
- Bile acid sequestrants (e.g., cholestyramine, colestipol): May impair absorption of ergocalciferol.
- Mineral oil: May impair absorption of ergocalciferol.
- Orlistat: May impair absorption of ergocalciferol.
- Anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine): May increase metabolism of vitamin D, leading to reduced efficacy.
- Corticosteroids: May antagonize the effects of vitamin D by inhibiting calcium absorption.
Monitoring
Baseline Monitoring
Serum 25-hydroxyvitamin D [25(OH)D]
Rationale: To assess baseline vitamin D status and guide dosing.
Timing: Prior to initiation of therapy.
Serum Calcium
Rationale: To establish baseline and monitor for hypercalcemia.
Timing: Prior to initiation of therapy.
Serum Phosphate
Rationale: To establish baseline and monitor for imbalances.
Timing: Prior to initiation of therapy.
Serum Parathyroid Hormone (PTH)
Rationale: To assess parathyroid function, especially in hypoparathyroidism or severe deficiency.
Timing: Prior to initiation of therapy, if indicated.
Renal Function (BUN, Creatinine)
Rationale: To assess kidney function, which is crucial for vitamin D activation and calcium excretion.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum Calcium
Frequency: Weekly or bi-weekly initially, then monthly or every 3-6 months once stable.
Target: 8.5-10.2 mg/dL (adjust based on clinical context)
Action Threshold: >10.5 mg/dL (consider dose reduction/interruption), >11 mg/dL (urgent intervention)
Serum Phosphate
Frequency: Weekly or bi-weekly initially, then monthly or every 3-6 months once stable.
Target: 2.5-4.5 mg/dL
Action Threshold: Outside normal range, especially if trending high with calcium.
Serum 25-hydroxyvitamin D [25(OH)D]
Frequency: After 3 months of therapy, then every 6-12 months or as clinically indicated.
Target: >30 ng/mL (for sufficiency), 20-30 ng/mL (insufficiency)
Action Threshold: <20 ng/mL (consider dose increase), >100 ng/mL (consider dose reduction/interruption due to potential toxicity)
Serum Parathyroid Hormone (PTH)
Frequency: Every 3-6 months or as clinically indicated, especially in hypoparathyroidism.
Target: Varies by indication (e.g., low-normal in hypoparathyroidism, suppressed in hypercalcemia)
Action Threshold: Persistently elevated despite adequate 25(OH)D, or suppressed with hypercalcemia.
Symptom Monitoring
- Symptoms of hypercalcemia: nausea, vomiting, constipation, anorexia, polyuria, polydipsia, weakness, fatigue, confusion, muscle pain, bone pain, kidney stones.
- Symptoms of vitamin D deficiency: bone pain, muscle weakness, fatigue.
Special Patient Groups
Pregnancy
Vitamin D is essential during pregnancy for fetal bone development. However, excessive doses can be harmful to the fetus, potentially leading to hypercalcemia in the mother and fetus, which can cause supravalvular aortic stenosis, mental retardation, and characteristic facial features in the infant. Use only if clearly needed and the potential benefit outweighs the potential risk. Monitor maternal calcium levels.
Trimester-Specific Risks:
First Trimester:
Risk of teratogenicity with excessive doses.
Second Trimester:
Risk of fetal hypercalcemia with excessive maternal doses.
Third Trimester:
Risk of fetal hypercalcemia and potential adverse effects on fetal development with excessive maternal doses.
Lactation
Ergocalciferol and its metabolites are excreted in breast milk. While generally considered safe at recommended doses, caution is advised. Monitor infant's serum calcium if maternal doses are high.
Infant Risk:
Low risk at therapeutic maternal doses. High maternal doses could theoretically lead to hypercalcemia in the infant, though rare.
Pediatric Use
Used to treat nutritional rickets and hypoparathyroidism. Dosing must be carefully individualized based on age, weight, and clinical response, with close monitoring of serum calcium, phosphate, and 25(OH)D levels to avoid toxicity.
Geriatric Use
No specific dose adjustments are typically needed, but elderly patients may have impaired renal function or be on medications that interact with vitamin D. Monitor serum calcium and 25(OH)D levels closely to prevent hypercalcemia and ensure efficacy.
Clinical Information
Clinical Pearls
- Ergocalciferol (Vitamin D2) requires activation in the liver (to 25-hydroxyvitamin D2) and kidneys (to 1,25-dihydroxyvitamin D2) to become active. Patients with severe liver or kidney disease may not adequately activate ergocalciferol and may require active vitamin D analogs (e.g., calcitriol).
- The 50,000 IU dose is typically used for initial repletion of severe vitamin D deficiency, often given weekly for 8-12 weeks, followed by a lower maintenance dose (e.g., 1,000-2,000 IU daily of D3 or D2).
- Always monitor serum calcium, phosphate, and 25(OH)D levels during therapy to ensure efficacy and prevent toxicity (hypercalcemia).
- Advise patients to take ergocalciferol with a fatty meal to enhance absorption.
- Educate patients on the symptoms of hypercalcemia and to report them immediately.
Alternative Therapies
- Cholecalciferol (Vitamin D3): Often preferred for vitamin D repletion due to potentially higher potency and longer duration of action in raising 25(OH)D levels.
- Calcitriol (1,25-dihydroxyvitamin D3): Active form of vitamin D, used in patients with severe renal impairment or hypoparathyroidism where activation of D2/D3 is impaired.
- Paricalcitol, Doxercalciferol: Other active vitamin D analogs used in chronic kidney disease.
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 12 capsules (50,000 IU)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 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 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, including the amount taken and the time it happened, to ensure you receive the best possible care.